AstraZeneca COVID-19 Vaccine (Vaxzevria) Description
The AstraZeneca COVID-19 (AZD1222) (C19VAZ) coronavirus vaccine, formerly known as ChAdOx1 nCoV-19, is made from a virus (ChAdOx1), a weakened version of a common cold virus (adenovirus). Genetic material has been added to the ChAdOx1 construct, which is used to make proteins from the SARS-CoV-2 coronavirus called Spike glycoprotein (S).
This protein is usually found on the surface of SARS-CoV-2 and plays an essential role in the infection pathway of the SARS-CoV-2 virus. The SARS-CoV-2 coronavirus uses its spike protein to bind to ACE2 receptors on human cells to enter the cells and cause an infection. After vaccination, the surface spike protein is produced, priming the immune system to attack the coronavirus if it later infects the body and causes COVID-19 disease.
By vaccinating people with C19VAZ, researchers hope to make the body recognize and develop an immune response to the Spike protein to help stop the SARS-CoV-2 virus from entering human cells and preventing infection.
The WHO published on February 10, 2021, background evidence related to the Interim recommendations for using the AZD1222 (ChAdOx1-S [recombinant]) vaccine against COVID-19 developed by Oxford University and AstraZeneca.
On March 25, 2021, Mene Pangalos, AstraZeneca's EVP, BioPharmaceuticals R&D, stated in a press release, “The primary analysis (released today) is consistent with our previously released interim analysis and confirms that our COVID-19 vaccine is highly effective in adults, including those aged 65 years and over. We look forward to filing our regulatory submission for Emergency Use Authorization in the US and preparing for the rollout of millions of doses across America.”
On March 26, 2021, the EMA posted 'Vaxzevria' as the new name for COVID-19 Vaccine AstraZeneca in Europe.
AstraZeneca's AZD1222 (C19VAZ) vaccine's Accession Number: DB15656. The UNII Preferred Substance Name: B5S3K2V0G8.
AstraZeneca COVID-19 Vaccine (Vaxzevria) History
A preliminary report of the COV001/2 phase 1/2 study published on July 20, 2020, showed a single dose of AZD1222 resulted in a 4-fold increase in antibodies to the SARS-CoV-2 virus spike protein in 95% of participants one month after injection. The AZD1222 vaccine candidate has progressed into late-stage Phase II/III clinical trials in various countries.
On August 31, 2020, the company said in a media statement: 'clinical development of AZD1222 is progressing globally with late-stage clinical trials ongoing in the UK, Brazil, South Africa, and trials are planned to start in Japan and Russia. Together with the US Phase III clinical trial, these trials will enroll up to 60,000 globally. If the vaccine is proven safe and effective, the first doses to be produced under this agreement are anticipated to be available in early 2021.
Vaccines will be released on a rolling basis as production is completed, and the full quota of 300 million doses is expected to be available by July 2021.
On November 18, 2020, The Lancet published a study review that describes this vaccine's safety and immunogenicity in a wider range of participants, including adults aged 70 years and older. The vaccine candidate, ChAdOx1 nCoV-19, appears to be better tolerated in older adults than in younger adults and has similar immunogenicity across all age groups after a booster dose.
Pascal Soriot, Chief Executive Officer, said in a press statement on November 23, 2020, announcing one vaccine dosing regimen showed vaccine efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose at least one month apart. Another dosing regimen showed 62% efficacy when given as (2) full doses at least one month apart. The combined analysis from both dosing regimens (n=11,636) resulted in an average efficacy of 70%.
“Today marks an important milestone in our fight against the pandemic. This vaccine’s efficacy and safety confirm that it will be highly effective against COVID-19 and immediately impact this public health emergency. Furthermore, the vaccine’s simple supply chain and our no-profit pledge and commitment to broad, equitable, and timely access means it will be affordable and globally available, supplying hundreds of millions of doses on approval," added Soriot.
On November 27, 2020, in a letter sent by the Department of Health and Social Care to the Medicines and Healthcare products Regulatory Agency (MHRA), the UK government had asked the regulator to assess the vaccine for authorization under Regulation 174 of the Human Medicines Regulations, which enables the temporary supply of medicines to be authorized in response to a public health need. The MHRA has already started a rolling review to determine whether the Oxford/AstraZeneca vaccine meets its strict safety, efficacy, and quality standards.
The Lancet issued a press release on December 8, 2020, announcing 'the first full results from interim analysis confirm that the Oxford COVID-19 vaccine (AZD1222) has an acceptable safety profile and is efficacious against symptomatic COVID-19 disease, with no hospitalizations or severe disease reported in the COVID-19 vaccine group so far.'
'When breaking this down based on vaccine dose, those who received two standard doses of the vaccine saw a vaccine efficacy of 62% (based on 27/4,440 (0.6%) cases in the vaccine group, and 71/4,455 (1.6%) cases in the control group), and the low-dose/standard-dose group vaccine efficacy was 90% (based on 3/1,367 (0.2%) cases in the vaccine group, and 30/1,374 (2.2%) cases in the control group).'
Study author Dr. Merryn Voysey, University of Oxford, UK, added: "The results presented in this report provide the key findings from our first interim analysis. In future analyses, with more data included as it becomes available, we will investigate differences in key subgroups such as older adults, various ethnicities, doses, timing of booster vaccines, and we will determine which immune responses equate to protection from infection or disease."
On December 17, 2020, Professor Katie Ewer, a lead author of a recent paper, said: ‘This highly detailed analysis of the immune responses to ChAdOx1 nCoV-19 further underpins the potential of this vaccine to induce protection against COVID-19 disease and provides additional reassurance of the safety of this approach. Using these advanced immunological techniques, we can better understand the different cellular and antibody-mediated mechanisms that contribute to the protection afforded by this vaccine, as demonstrated in the recent data from the subsequent Phase 3 trials’.
The Oxford Vaccine Centre’s COVID-19 vaccine trial is being run by the Jenner Institute and Oxford Vaccine Group. The team, who started developing a coronavirus vaccine candidate to prevent COVID-19 disease, began on January 20, 2020. The AZD1222 vaccine was developed by Oxford University’s Jenner Institute, working with the Oxford Vaccine Group. AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech.
Vaccitech owns the rights to the viral vector technology ChAdOx, which is used in the Oxford vaccine and was co-founded by Professor Sarah Gilbert, who has led the project.
On December 30, 2020, the UK's Medicines and Healthcare products Regulatory Agency provided authorization for an emergency supply of COVID-19 Vaccine AstraZeneca for the active immunization of individuals 18 years or older. On January 6, 2021, the Serum Institute of India obtained emergency use authorization in India for AstraZeneca’s COVID-19 vaccine. AstraZeneca’s COVID-19 vaccine has been granted emergency authorization in Argentina, Dominican Republic, El Salvador, Mexico, and Morocco. And on January 12, 2021, the EMA received an application for conditional marketing authorization of COVID-19 Vaccine AstraZeneca.
On January 29, 2021, the EMA stated it has recommended granting conditional marketing authorization for COVID-19 Vaccine AstraZeneca to prevent coronavirus disease 2019 (COVID-19) in people from 18 years of age. "With this third positive opinion, we have further expanded the arsenal of vaccines available to EU and EEA member states to combat the pandemic and protect their citizens,” said Emer Cooke, Executive Director of EMA. “As in previous cases, the CHMP has rigorously evaluated this vaccine, and the scientific basis of our work underpins our firm commitment to safeguarding the health of EU citizens.”
The primary analysis of Phase III clinical trials from the UK, Brazil, and South Africa, published as a preprint in The Lancet on February 1, 2021, confirmed COVID-19 Vaccine AstraZeneca is safe and effective at preventing COVID-19, with no severe cases and no hospitalizations, more than 22 days after the first dose. Results demonstrated vaccine efficacy of 76% (CI: 59% to 86%) after a first dose, with protection maintained to the second dose. With an inter-dose interval of 12 weeks or more, vaccine efficacy increased to 82% (CI: 63%, 92%). The analysis also showed the vaccine's potential to reduce the virus's asymptomatic transmission, based on weekly swabs obtained from volunteers in the UK trial. The data showed that PCR positive readings were reduced by 67% (CI: 49%, 78%) after a single dose and 50% (CI: 38% to 59%) after the two-dose regimen, supporting a substantial impact on the transmission of the virus.
On February 3, 2021, Sir Mene Pangalos, EVP BioPharmaceuticals R&D with AstraZeneca, said: “This primary analysis reconfirms that our vaccine prevents severe disease and keeps people out of the hospital. Also, extending the dosing interval boosts the vaccine’s efficacy and enables more people to be vaccinated upfront. Together with the new findings on reduced transmission, we believe this vaccine will have a real impact on the pandemic.”
On March 22, 2021, Ann Falsey, Professor of Medicine, University of Rochester School of Medicine, US, and co-lead Principal Investigator for the US Phase III trial, called D8110C00001, stated in a press release, “These findings reconfirm previous results observed in AZD1222 trials across all adult populations but it’s exciting to see similar efficacy results in people over 65 for the first time. This analysis validates the AstraZeneca COVID-19 vaccine as a much-needed additional vaccination option, offering confidence that adults of all ages can benefit from protection against the virus.”
AstraZeneca is a global, science-led biopharmaceutical company that focuses on discovering, developing, and commercializing prescription medicines, primarily for treating diseases in three therapy areas - Onc Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries.
AstraZeneca COVID-19 Vaccine (Vaxzevria) Side Effects
On January 29, 2021, the EMA stated, 'Combined results from 4 clinical trials in the United Kingdom, Brazil, and South Africa showed that COVID-19 Vaccine AstraZeneca was safe and effective preventing COVID-19 in people from 18 years of age. These studies involved around 24,000 people altogether. Half received the vaccine, and half were given a control injection, either a dummy injection or another non-COVID vaccine. People did not know if they had been given the test vaccine or the control injection. The safety of the vaccine has been demonstrated across the four studies. However, the Agency based its calculation of how well the vaccine worked on the results from study COV002 (conducted in the UK) and study COV003 (conducted in Brazil). The other two studies had fewer than 6 COVID-19 cases in each, which was not enough to measure the vaccine's preventive effect.
Vaccines made from the ChAdOx1 virus have been found safe and well-tolerated, although they can cause temporary side effects, such as a change in temperature, headache, or a sore arm.
Local media in India, Anadolu Agency, reported on January 17, 2021, “Of the 447 Adverse Event Following Immunization, three had to be hospitalized, while two of them have now been discharged after 24 hours, one continues to be under observation,” said Manohar Agnani, joint secretary at the Health Ministry.
On March 12, 2021, the EMA stated, 'Following the assessment of a safety signal regarding cases of anaphylaxis (severe allergic reactions) with COVID-19 Vaccine AstraZeneca, it recommends an update to the product information to include anaphylaxis and hypersensitivity (allergic reactions) as side effects with an unknown frequency and to update the existing warning to reflect that cases of anaphylaxis have been reported. The update is based on a review of 41 reports of possible anaphylaxis seen among around 5 million vaccinations in the United Kingdom.
On March 18, 2021, the EMA’s safety committee, PRAC, concluded its preliminary review of a signal of blood clots in people vaccinated with COVID-19 Vaccine AstraZeneca at its extraordinary meeting. The Committee confirmed that: the benefits of the vaccine in combating the still widespread threat of COVID-19 (which itself results in clotting problems and could be fatal) continue to outweigh the risk of side effects; the vaccine is not associated with an increase in the overall risk of blood clots (thromboembolic events) in those who receive it; there is no evidence of a problem related to specific batches of the vaccine or particular manufacturing sites; however, the vaccine may be associated with very rare cases of blood clots associated with thrombocytopenia, i.e., low levels of blood platelets (elements in the blood that help it to clot) with or without bleeding, including rare cases of clots in the vessels draining blood from the brain.
An independent data safety monitoring board identified no safety concerns on March 22, 2021, related to the vaccine candidate in the phase 3 clinical study.
On March 24, 2021, AstraZeneca AB, in agreement with the European Medicines Agency, confirmed the 'COVID-19 Vaccine AstraZeneca: benefits outweigh the risks despite possible link to very rare blood clots with low blood platelets. In some cases, a combination of thrombosis and thrombocytopenia, accompanied by bleeding, has been observed very rarely following vaccination with COVID-19 Vaccine AstraZeneca. And healthcare professionals should be alert to the signs and symptoms of thromboembolism and or thrombocytopenia, stated the EMA.
The EMA announced on April 7, 2021, the EMA’s safety committee had concluded today that unusual blood clots with low blood platelets should be listed as very rare side effects of Vaxzevria (formerly COVID-19 Vaccine AstraZeneca). Based on the currently available evidence, specific risk factors have not been confirmed. In reaching its conclusion, the EMA committee took into consideration all currently available evidence, including the advice from an ad hoc expert group.
And the UK and EU regulators requested their vaccine labels be updated to warn of these “extremely rare potential side effect(s).” The data suggest there is a slightly higher incidence reported in the younger adult age groups, and the MHRA advises that this evolving evidence should be taken into account when considering the use of the vaccine.
The UK regulatory agency issued a precaution saying 'administration of COVID-19 Vaccine AstraZeneca in people of any age who are at higher risk of blood clots because of their medical condition should be considered only if benefits from the protection from COVID-19 infection outweighs potential risks.'
AstraZeneca COVID-19 Vaccine (Vaxzevria) Ingredients
AstraZeneca COVID-19 Vaccine (AZD1222) (C19VAZ) ingredients can be found at this University of Oxford website.
AstraZeneca Indonesia spokesman Rizman Abudaeri said in a statement on March 21, 2021, "At all stages of the production process, this virus vector vaccine does not use nor come in contact with pork-derived products or other animal products." Indonesian authorities approved the use of AstraZeneca's vaccine after reviewing reports that it had caused blood clots among some recipients in Europe.
AstraZeneca COVID-19 Vaccine (Vaxzevria) Distribution
AstraZeneca continues to engage with governments, multilateral organizations, and collaborators worldwide to ensure broad and equitable access to the vaccine at no profit for the pandemic duration. The Company is making rapid progress in manufacturing with a capacity of up to 3 billion doses of the vaccine in 2021 on a rolling basis, pending regulatory approval.
AstraZeneca reached an agreement with Europe’s Inclusive Vaccines Alliance, spearheaded by Germany, France, Italy, and the Netherlands, to supply up to 400 million doses of the University of Oxford’s potential COVID-19 vaccine that is currently in clinical development.
Similar agreements with the UK, US, the Coalition for Epidemic Preparedness Innovations, and Gavi, the Vaccine Alliance for 700 million doses agreed on a license with India's Serum Institute for the supply of an additional one billion doses, principally for low-and-middle-income countries.
On December 8, 2020, HALIX B.V. announced it would provide commercial manufacturing of drug substances at its state-of-the-art cGMP facility at the Leiden Bio Science Park in the Netherlands. HALIX expands with 2 additional viral vector production lines to meet the increased demand.
On January 29, 2021, the European Commission granted conditional marketing authorization for AstraZeneca's COVID‑19 vaccine. This authorization follows a positive scientific recommendation based on a thorough assessment of the vaccine's safety, effectiveness, and quality by the European Medicines Agency and is endorsed by the Member States.
AstraZeneca and IDT Biologika announced on February 10, 2021; they explored options to accelerate the output of finished COVID-19 Vaccine AstraZeneca in the second quarter of 2021, supporting Europe’s immediate vaccination needs during the pandemic. AstraZeneca and IDT Biologika stated in a press release they intend to strengthen Europe’s vaccine manufacturing capability with a joint investment to build large additional drug substance capacity for the future. Both companies plan to invest in capacity expansion at IDT Biologika’s production site in Dessau, Germany, to build up to five 2,000-litre bioreactors capable of making tens of millions of doses per month of AstraZeneca’s COVID-19 vaccine. The new assets are estimated to be operational by the end of 2022.
On March 2, 2021, AstraZeneca announced it would supply 142 countries as part of the unprecedented effort with COVAX to bring broad and equitable access to the vaccine. The PAHO Revolving Fund, responsible for the procurement of vaccines against COVID-19 for the countries in the Americas, via the COVAX Mechanism, sent to Brazil on March 21, 2021, the 1,022,400 doses of the AstraZeneca/Oxford vaccine manufactured by SK Bioscience from South Korea.
India granted emergency approval for the coronavirus vaccine co-developed by AstraZeneca Plc and the University of Oxford on January 1, 2021. Covishield is the Serum Institute of India (SII) version of the AstraZeneca COVID-19 vaccine. SII is reported to have stockpiled 75 million doses of the CoviShield vaccine. SII's fact sheet for CoviShield.
On January 19, 2021, India announced it grant assistance to Bhutan, Maldives, Bangladesh, Nepal, Myanmar, and Seychelles by distributing CoviShield vaccines beginning January 20, 2021. In Sri Lanka, Afghanistan, and Mauritius, India is awaiting regulatory clearances.
To enable and support the country’s response in fighting the COVID-19 pandemic, South Africa's SAHPRA had, on January 22, 2021, granted a Section 21 authorization to the Department of Health for COVISHIELD (a covid-19 vaccine manufactured by Serum Institute of India) for the prevention of COVID-19.
On February 1, 2021, Pakistan's Dr. Faisal Sultan said to local media: “Though AstraZeneca's CoviShield is being prepared in India, it will come through Covax, an international alliance that has announced free vaccines for 20% of Pakistan’s population. The Drug Regulatory Authority of Pakistan has already registered AstraZeneca."
On March 13, 2021, AFP reported, 'We are looking at all the adverse events, severe adverse events like deaths and hospitalization. We will come back if we find anything of concern," N.K. Arora, a member of India's national task force on COVID-19.' Serum Institute of India joined with AstraZeneca to produce 1 billion doses of its COVID-19 vaccine.
The India Ministry of Health and Family Welfare announced on March 22, 2021, 'In view of the emerging scientific evidence, the interval between two doses of COVISHIELD, has been revisited by National Technical Advisory Group on Immunization and subsequently by National Expert Group on Vaccine Administration for COVID-19 in its 20th meeting. During this meeting, the recommendation has been revised to provide a 2nd dose of COVISHIELD at 4-8 weeks’ interval after the 1st dose, instead of an earlier practiced interval of 4-6 weeks.
On April 1, 2021, the Serum Institute of India is reported set to increase its output of CoviShield vaccines by 67% to 100 million doses a month beginning May 2021, up from 60 million doses a month currently.
Sputnik V Vaccine Co-Development
The Russian Direct Investment Fund announced on February 9, 2021, that the Ministry of Health of the Republic of Azerbaijan had issued a permit to conduct local clinical trials of a combined COVID-19 vaccine candidate, which includes the Sputnik V vaccine and one co-developed by AstraZeneca and Oxford University. These clinical trials will begin in late February 2021 and plan to evaluate the combined vaccine's immunogenicity and safety over the course of six months in several countries.
AstraZeneca COVID-19 (Vaxzevria) Indication
The AstraZeneca (AZD1222) (ChAdOx1 nCoV-19) vaccine candidate is being tested to prevent infection of SARS-CoV-2, which causes COVID-19 disease. The global trials evaluate participants aged 18 years or over from diverse racial and geographic groups who are healthy or have stable underlying medical conditions. On February 11, 2021, the WHO Strategic Advisory Group of Experts on Immunization issued interim recommendations for using the Oxford - AstraZeneca COVID-19 vaccine (AZD1222). This article provides a summary of the interim guidance.
Following reports of cases of thromboembolic events in unusual locations, France's Haute Autorite de Sante (HAS) recommended on April 9, 2021, that the AstraZeneca COVID-19 vaccine be reserved for people over 55 years of age. Given the existence of a scientific rationale and encouraging data, the HAS now 'recommends using a dose of one of the mRNA vaccines currently available.
AstraZeneca COVID-19 (Vaxzevria) Dosing
AstraZeneca announced on November 23, 2020, the 1-dosing regimen (n=2,741) showed vaccine efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose at least one month apart, and another dosing regimen (n=8,895) showed 62% efficacy when given as two full doses at least one month apart. The combined analysis from both dosing regimens (n=11,636) resulted in an average efficacy of 70%. All results were statistically significant (p<=0.0001).
Participants in Phase 3 COVID-19 vaccine study group received 2-doses, each containing 5x1010 viral particles (a standard dose). However, a subset (1,367 people) in the UK received a half dose as their first dose, followed by a full second dose. This was because of differences in quantification methods between batches of the vaccine. The low-dose/standard-dose group did not include adults over the age of 55; the low-dose was given in an early stage of the trial before the recruitment of older adults had commenced.
A study published on December 17, 2020, reported the booster doses of the vaccine are both shown to induce more robust antibody responses than a single dose, with the standard dose / standard dose inducing the best response – supporting the decision taking previously to move to a 2-dose vaccine regimen in the Phase III clinical trials.
AstraZeneca COVID-19 Vaccine (Vaxzevria) Storage Requirements
The vaccine can be stored, transported, and handled at normal refrigerated conditions (2-8 degrees Celsius/ 36-46 degrees Fahrenheit) for at least 6-months and administered within existing healthcare settings.
AstraZeneca COVID-19 Vaccine (Vaxzevria) CPT Code
The American Medical Association offers the appropriate CPT code combination for the type and dose of the COVID-19 vaccine.
AstraZeneca COVID-19 Vaccine (Vaxzevria) News
April 9, 2021 - France's Haute Autorite de Sante recommended on April 9, 2021, that the AstraZeneca COVID-19 vaccine be reserved for people over 55 years of age.
April 9, 2021 - The European Medicines Agency's safety committee has concluded that unusual blood clots with low blood platelets should be listed as very rare side effects of Vaxzevria (previously COVID-19 Vaccine AstraZeneca).
April 7, 2021 - The European Medicines Agency (EMA) found a possible link to very rare cases of unusual blood clots with low blood platelets. People who have received the vaccine should seek medical assistance immediately if they develop symptoms of this combination of blood clots and low blood platelets. The EMA is reminding healthcare professionals and people receiving the vaccine to remain aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within 2 weeks of vaccination. So far, most of the cases reported have occurred in women under 60 years of age within 2 weeks of vaccination. Based on the currently available evidence, specific risk factors have not been confirmed.
April 7, 2021 - Reuters reported the European Commission confirmed that delivery shortfalls of AstraZeneca's COVID-19 vaccine were a global issue, not something to be addressed only in talks between the EU and Australia.
April 6, 2021 - The WSJ reported the University of Oxford said it has paused administering doses of the Covid-19 vaccine it developed with AstraZeneca PLC in a small U.K. study to test the shot in children and teenagers, pending further information about rare blood-clotting issues in adults who have received it.
April 3, 2021 - Seven people in the United Kingdom have died from unusual blood clots after getting the Oxford-AstraZeneca COVID-19 vaccine, the UK medicines regulator has confirmed to the BBC.
March 31, 2021 - The EMA’s safety committee met on Wednesday, March 31st, in the context of its ongoing review of very rare cases of unusual blood clots associated with low numbers of platelets in people vaccinated with AstraZeneca’s COVID-19 vaccine (now called Vaxzevria). 'At present, the review has not identified any specific risk factors, such as age, gender, or a previous medical history of clotting disorders, for these very rare events. A causal link with the vaccine is not proven but is possible, and further analysis is continuing. As communicated on 18 March, EMA is of the view that the benefits of the AstraZeneca vaccine in preventing COVID-19, with its associated risk of hospitalization and death, outweigh the risks of side effects, stated the EMA's press statement.
March 30, 2021 - The Lancet published the results of a phase 2/3 study: Efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine against the SARS-CoV-2 coronavirus variant of concern 202012/01 (B.1.1.7): an exploratory analysis of a randomized controlled trial. Interpretation - ChAdOx1 nCoV-19 showed reduced neutralization activity against the B.1.1.7 variant compared with a non-B.1.1.7 variant in vitro, but the vaccine showed efficacy against the B.1.1.7 variant of SARS-CoV-2.
March 30, 2021 - The AP reported Germany's health authorities are suspending the use of AstraZeneca’s COVID-19vaccine for people under age 60 due to new reports of unusual blood clots in people who recently received the experimental vaccine.
March 29, 2021 - Prince Edward Island (PEI) Chief Public Health Officer Dr. Heather Morrison announced that PEI would pause the administration of the AstraZeneca vaccine for those under 55 years of age. The Chief Public Health Office contacted the Island pharmacies administering this COVID-19 vaccine and asked them to hold further administration of the vaccine, pending additional information. A total of 1,680 doses of the AstraZeneca vaccine have been administered in PEI. As part of Health Canada’s continuing commitment to openness and transparency on all information relating to COVID-19 vaccines, the Department issued an update on March 29, 2021, on new actions it has taken. 'As Chief Medical Officers of Health, we take vaccine safety very seriously. There are mechanisms to investigate and share reports of serious adverse events following COVID-19 vaccination in Canada to determine if they are causally linked to COVID-19 vaccines.'
March 26, 2021 - The EMA posted Vaxzevria as the new name for COVID-19 Vaccine AstraZeneca in Europe.
March 26, 2021 - The EMA announced a new manufacturing site had been approved to produce AstraZeneca’s COVID-19 vaccine active substance. The Halix site is located in Leiden, the Netherlands, and will bring the total number of manufacturing sites licensed to produce the active substance of the vaccine to four.
March 25, 2021 - AstraZeneca announced 'Positive high-level results from the primary analysis of the Phase III trial of AZD1222 in the US have confirmed vaccine efficacy consistent with the pre-specified interim analysis announced on Monday 22 March 2021. The primary endpoint, vaccine efficacy at preventing symptomatic COVID-19, was 76% (confidence interval (CI): 68% to 82%), occurring 15 days or more after receiving two doses given four weeks apart. Also, results were comparable across age groups, with vaccine efficacy of 85% (CI: 58% to 95%) in adults 65 and older. A key secondary endpoint, preventing severe or critical disease and hospitalization, demonstrated 100% efficacy. There were eight cases of severe COVID-19 observed in the primary analysis, with all of those cases in the placebo group.
March 23, 2021 - The Data and Safety Monitoring Board (DSMB) notified NIAID, BARDA, and AstraZeneca that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial. The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data. We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible. Authorization and guidelines for using the vaccine in the United States will be determined by the Food and Drug Administration and the Centers for Disease Control and Prevention after a thorough review of the data by independent advisory committees.
March 22, 2021 - AstraZeneca announced the interim safety and efficacy analysis of its US Phase III trial of the AZD1222 vaccine demonstrated statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalization. Vaccine efficacy was consistent across ethnicity and age. Notably, in participants aged 65 years and over, vaccine efficacy was 80%. The vaccine was well-tolerated, and the independent data safety monitoring board identified no safety concerns related to the vaccine.
March 18, 2021 - Thrombosis Canada announced it had reviewed recent reports from the United Kingdom and Europe relating to the SARS-CoV-2 prevention vaccine made by AstraZeneca and the development of a very rare type of thrombosis that is associated with thrombocytopenia. The view of Thrombosis Canada is that, based on evidence, people who receive the AstraZeneca vaccine are not at increased risk of developing blood clots compared with the general population.
March 18, 2021 - The European Medicines Agency (EMA) announced: COVID-19 Vaccine AstraZeneca: benefits still outweigh the risks despite possible link to rare blood clots with low blood platelets. The EMA's Committee believed that the vaccine’s proven efficacy in preventing hospitalization and death from COVID-19 outweighs the extremely small likelihood of developing disseminated intravascular coagulation or clots in the vessels draining blood from the brain. However, in the light of its findings, patients should be aware of the remote possibility of such syndromes. If symptoms suggestive of clotting problems occur, patients should seek immediate medical attention and inform healthcare professionals of their recent vaccination.
March 16, 2021 - The Africa CDC called for a special session of the African Taskforce for Coronavirus (AFTCOR), which includes experts from across Africa and the world, to review the AstraZeneca situation. From the evidence available and discussed during the AFTCOR special session, Africa CDC concluded that the benefits accruable from the AstraZeneca COVID-19 continue to outweigh its risks.
March 16, 2021 - EMA’s safety committee (PRAC) announced in a digital statement 'it made further progress today, Tuesday 16 March, in its detailed evaluation of cases of blood clots, some with unusual features such as low numbers of platelets, in recipients of COVID-19 Vaccine AstraZeneca. As previously stated, while its investigation is ongoing, EMA currently remains of the view that the benefits of the AstraZeneca vaccine in preventing COVID-19, with its associated risk of hospitalization and death, outweigh the risks of side effects.'
March 15, 2021 - The EMA issued a statement: Several authorities responsible for national vaccine campaigns in EU countries have temporarily paused vaccination with COVID-19 Vaccine AstraZeneca. Events involving blood clots, some with unusual features such as low numbers of platelets, have occurred in a very small number of people who received the vaccine. The EMA is working closely with the company, with experts in blood disorders, and with other health authorities, including the UK’s MHRA, based on its experience with around 11 million administered doses of the vaccine. Dr. Phil Bryan, MHRA Vaccines Safety Lead, stated, 'We are closely reviewing reports, but the evidence available does not suggest the vaccine is the cause.'
March 14, 2021 - The Company issued a press statement which stated: 'A careful review of all available safety data of more than 17 million people vaccinated in the European Union (EU) and the UK with COVID-19 Vaccine AstraZeneca has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia, in any defined age group, gender, batch or in any particular country. So far across the EU and UK, there have been 15 events of DVT and 22 events of pulmonary embolism reported among those given the vaccine, based on the number of cases the Company has received as of 8 March. This is much lower than expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines. The monthly safety report will be made public on the European Medicines Agency website in the following week, in line with exceptional transparency measures for COVID-19.'
March 12, 2021 - The International Society on Thrombosis and Haemostasis recommends that all eligible adults continue to receive their COVID-19 vaccinations, despite the recent decisions by Austria, Denmark, Norway, and Iceland to at least temporarily suspend the use of the AstraZeneca vaccine due to reports of thrombosis. 'At this time, the small number of reported thrombotic events relative to the millions of administered COVID-19 vaccinations does not suggest a direct link.'
March 12, 2021 - The European Medicines Agency stated it is reviewing all cases of thromboembolic events and other conditions related to blood clots, reported post-vaccination with COVID-19 Vaccine AstraZeneca. 'There is currently no indication that vaccination has caused these conditions, which are not listed as side effects with this vaccine.'
March 11, 2021 - The UK's Medicines and Healthcare products Regulatory Agency stated in a website statement regarding actions to temporarily suspend the AstraZeneca COVID-19 Vaccine: 'This is a precautionary measure by the Danish, Norwegian and Icelandic authorities. It has not been confirmed that the AstraZeneca COVID-19 Vaccine caused the report of a blood clot. People should still go and get their COVID-19 vaccine when asked to do so.' Separately, no adverse events related to the AstraZeneca COVID-19 vaccine, or the version manufactured by the Serum Institute of India, have been reported to Health Canada or the Public Health Agency of Canada.'
March 11, 2021 - Various media sources had reported the countries on Austria, Denmark, Iceland, Norway, Estonia, Lithuania, Luxembourg, Italy, and Latvia have temporarily suspended vaccination programs.
March 10, 2021 - The EMA reported Austrian's national competent authority had suspended using a batch of COVID-19 Vaccine AstraZeneca (batch number ABV5300) after a person was diagnosed with multiple thrombosis (formation of blood clots within blood vessels) and died 10 days after vaccination. Another was hospitalized with pulmonary embolism (blockage in arteries in the lungs) after being vaccinated. The latter is now recovering. As of 9 March 2021, two other reports of thromboembolic event cases had been received for this batch. There is currently no indication that vaccination has caused these conditions, which are not listed as side effects with this vaccine.
March 6, 2021 - The Lancet published a commentary: Single-dose Oxford–AstraZeneca COVID-19 vaccine followed by a 12-week booster. Overall, the value of this study is in providing evidence that a single dose of the ChAdOx1 nCoV-19 vaccine is highly efficacious in the 90 days after vaccination, that a longer prime-boost interval results in higher vaccine efficacy and that protection against symptomatic COVID-19 is maintained despite a longer dosing interval. It offers much-needed evidence for the UK policy of extending the dosing interval to 12 weeks and rapid mass immunization campaigns worldwide.
March 4, 2021 - Germany’s independent vaccine committee has formally approved the AstraZeneca vaccine for people age 65 and over, the health minister Jens Spahn told local media.
March 2, 2021 - The company announced the first of many millions of AstraZeneca’s COVID-19 vaccine doses have begun arriving in low and middle-income countries across the world through the multilateral COVAX initiative. Pascal Soriot, Chief Executive Officer, Astra Zeneca, said: “These first steps towards fulfilling our broad, equitable, and no-profit emergency response to the pandemic mean millions of people, irrespective of their country’s income level, will soon be protected against this deadly virus. This is a moment of great pride for us at AstraZeneca, and I am extremely grateful to our partners, including Gavi, CEPI, and Oxford University, for their hard work and dedication to make this humanitarian ideal a reality for many millions of people around the world.”
March 2, 2021 - The BBC reported French Health Minister Olivier Véran said people with pre-existing conditions - such as high blood pressure or diabetes - could get the Oxford-AstraZeneca vaccine from GP surgeries, hospitals, and "within days" from pharmacies. Those aged over 75 in age would be offered either Pfizer or Moderna vaccines.
March 1, 2021 - Canada's National Advisory Committee on Immunization announced new guidelines advising against vaccinating people 65 years and older with AstraZeneca's COVID-19 vaccine.
February 26, 2021 - The Honourable Anita Anand, Minister of Public Services and Procurement, announced that Canada had secured 2 million doses of the AstraZeneca COVID-19 vaccine through an agreement with Verity Pharmaceuticals Canada Inc./Serum Institute of India. AstraZeneca has licensed the manufacture of its ChAdOx1 vaccine to the Serum Institute. The first 500,000 doses will be delivered to Canada in the coming weeks and quickly distributed to the provinces and territories. The remaining 1.5 million doses will arrive by mid-May 2021.
February 26, 2021 - Health Canada authorized two vaccines, the COVID-19 vaccine manufactured by AstraZeneca and developed in partnership with Oxford University and the Serum Institute of India’s version of the AstraZeneca vaccine.
February 24, 2021 - UNICEF Representative in Ghana, Anne-Claire Dufay, said in a press statement, “This is a momentous occasion, as the arrival of the COVID-19 vaccines into Ghana is critical in bringing the pandemic to an end. The only way out of this crisis is to ensure that vaccinations are available for all. We thank all partners supporting the COVAX Facility to deliver safe and effective COVID-19 vaccines to all countries quickly and fairly. These 600,000 COVAX vaccines are part of an initial tranche of deliveries of the AstraZeneca / Oxford vaccine licensed to the Serum Institute of India, representing part of the first wave of COVID vaccines headed to several low and middle-income countries.
February 23, 2021 - Statement of Ruud Dobber, Ph.D. Executive Vice President BioPharmaceuticals Business Unit and President, North America AstraZeneca: Before the Subcommittee on Oversight and Investigations Committee on Energy and Commerce U.S. House of Representatives. 'AstraZeneca is fully committed to fighting the COVID-19 pandemic, helping to save lives through the expedited, science-based development and manufacture of AZD1222 and other potential prophylactic and therapeutic options. Our team is continuing to make progress in our development and manufacturing programs, and we fully intend to provide broad access to AZD1222, if approved or authorized under an emergency use authorization, in the U.S., and across the world.'
February 19, 2021 - The Lancet published a study that concluded: The results of this primary analysis of two doses of ChAdOx1 nCoV-19 were consistent with those seen in the trials' interim analysis confirm that the vaccine is efficacious, with results varying by dose interval in exploratory analyses. A 3-month dose interval might have advantages over a program with a short dose interval for the roll-out of a pandemic vaccine to protect the largest number of individuals in the population as early as possible when supplies are scarce, while also improving protection after receiving a second dose.
February 18, 2021 - The European Medicines Agency(EMA) published its overview of the COVID-19 Vaccine AstraZeneca, approved in the EU. The EMU also published its Product Information sheet.
February 18, 2021 - After reviewing all available data, the WHO Strategic Advisory Group of Experts concluded that ongoing research suggests that the Astra Zeneca vaccine is likely to protect people against severe COVID-19. However, this remains to be demonstrated in clinical trials and post-implementation evaluation. “Our priority must be to protect the most vulnerable from severe illness and death. Along with rolling out safe and proven vaccines, we must also work towards a diverse vaccine portfolio. At the same time, manufacturers must be prepared to adjust to mutations of the virus, including potentially providing booster shots and adapted vaccines,” said Dr. Moeti.
February 16, 2021 - The Therapeutic Goods Administration (TGA) has provisionally approved the Oxford/AstraZeneca COVID-19 vaccine for use in Australia. This registration means the AstraZeneca vaccine has met the TGA’s rigorous standards for safety, quality, and efficacy and will be provided for free to all Australian residents. It has been provisionally approved in Australia for people 18 years and older. Australia's priority groups can start receiving this vaccine in early March 2021.
February 15, 2021 - The World Health Organization (WHO) listed two versions of the AstraZeneca/Oxford COVID-19 vaccine for emergency use, giving the green light for these vaccines to be rolled out globally through COVAX. The vaccines are produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India (CoviShield). “Countries with no access to vaccines to date will finally be able to start vaccinating their health workers and populations at risk, contributing to the COVAX Facility’s goal of equitable vaccine distribution,” said Dr. Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products.
February 12, 2021 - The University of Oxford, together with three partner sites in London, Southampton, and Bristol, announced they are launching the first study to assess the safety and immune responses in children and young adults of the ChAdOx1 nCoV-19 coronavirus vaccine.
February 11, 2021 - AstraZeneca PLC published financial results, which included insights into AstraZeneca COVID-19 (AZD1222) (C19VAZ) coronavirus. Pascal Soriot, Chief Executive Officer, commented: “Despite the significant impact from the pandemic, we delivered double-digit revenue growth to leverage improved profitability and cash generation. The consistent achievements in the pipeline, the accelerating performance of our business, and the progress of the COVID-19 vaccine demonstrated what we could achieve." The company's guidance does not incorporate any revenue or profit impact from COVID-19 Vaccine AstraZeneca (C19VAZ) sales. In December 2020, AstraZeneca, through an advanced-purchase agreement with Gavi, the Vaccines Alliance, committed to enabling access to 170m doses of C19VAZ in up to 190 countries worldwide the COVAX Facility (COVAX).
February 10, 2021 - NPR reported the World Health Organization stated governments should continue rolling out the AstraZeneca Covid-19 vaccine, including in countries battling a new strain of the coronavirus that was first detected in South Africa. The WHO Strategic Advisory Group of Experts on Immunization had issued interim recommendations for using the Oxford/AstraZeneca COVID-19 vaccine (AZD1222) in adults aged 18 years and above. “Indirect evidence is compatible with protection against severe Covid-19,” the WHO said in interim recommendations. “However, this remains to be demonstrated in ongoing clinical trials and post-implementation evaluations.”
February 10, 2021 - AstraZeneca and IDT Biologika announced they are exploring options to accelerate COVID-19 Vaccine AstraZeneca's production in the second quarter of 2021 to support Europe’s immediate vaccination needs during the pandemic. Jürgen Betzing, CEO, IDT Biologika, said in a press statement, “We are proud that AstraZeneca has chosen us as a strategic partner for the manufacturing of their vaccines. The agreement underscores our expertise in the production of demanding vector-based vaccines and our ability to provide a one-stop solution, from creating drug substances through to “fill and finish” and secondary packaging. "
February 8, 2021 - Serum Institute of India (SII) announced a UK delegation led by Secretary of State for International Trade Liz Truss visited the SSI. Reuters reported that India’s government ordered 10 million additional doses of the AstraZeneca COVID-19 vaccine from the SSI following that meeting.
February 8, 2021 - Reuters reported Portugal's health ministry announced the AstraZeneca COVID-19 vaccine should preferably be used with seniors more aged than 65 years of age.
February 6, 2021 - AstraZeneca stated it believed its COVID-19 vaccine could protect people against severe disease caused by the South African variant of the SARS-CoV-2 coronavirus. However, AstraZeneca confirmed the Covid-19 vaccine does not appear to offer protection against mild and moderate disease caused by the viral variant first identified in South Africa, according to a study. In both the human trials and tests on the blood of those vaccinated, the vaccine showed significantly reduced efficacy against the 501Y.V2 viral variant, according to the randomized, double-blind study seen by the Financial Times.
February 4, 2021 - The University of Oxford is leading the first trial to explore alternating different COVID-19 vaccines, explore the potential for flexibility in delivery, and look for clues about increasing the breadth of protection against new virus strains.
February 3, 2021 - The natural evolution of SARS-CoV-2: How science responds to these challenges, published by AstraZeneca.
February 2, 2021 - Oxford coronavirus vaccine shows sustained protection of 76% during the 3-month interval until the second dose.
February 2, 2021 - China-based Shenzhen Kangtai Biological Products Co. Ltd. announced that it had built a production workshop for the adenovirus vector vaccine developed by AstraZeneca and the University of Oxford. With a floor area of 2,200 square meters, the facility has an annual production capacity of 400 million doses. The Shenzhen drugmaker signed a deal with AstraZeneca in August 2020 to introduce the latter's COVID-19 vaccine into China, for which it is seeking clinical registration.
February 2, 2021 - Swissmedic announced it is currently reviewing two applications for the authorization of COVID-19 vaccines. Concerning the AstraZeneca vaccine, the data submitted and analyzed so far are not yet sufficient to permit authorization. Additional data from recent studies are needed to obtain more information about safety, efficacy, and quality.
February 1, 2021 - The Lancet preprint study: Single Dose Administration, And The Influence Of The Timing Of The Booster Dose On Immunogenicity and Efficacy Of ChAdOx1 nCoV-19 (AZD1222) Vaccine. Interpretation: ChAdOx1 nCoV-19 vaccination programs aimed at vaccinating a large proportion of the population with a single dose, with a second dose given after a 3 month period is an effective strategy for reducing disease and could be optimal for the rollout of a pandemic vaccine when supplies are limited in the short term.
January 31, 2021 - AP News reported UK-based AstraZeneca has agreed to supply 9 million additional doses of its experimental COVID-19 vaccine to the European Union during the first quarter of 2021. The new delivery target of 40 million doses is below previous commitments.
January 30, 2021 - The vaccine developed by AstraZeneca and the University of Oxford has been approved for use in Viet Nam's urgent situation, said Minister of Health Nguyen Thanh Long. This is the first COVID-19 vaccine approved by Viet Nam so far. Astra Zeneca pledged to supply 30 million vaccine doses for Viet Nam this year, said, Long.
January 30, 2021 - Media reported Germany would review the order of its coronavirus vaccine priority list following a recommendation from its vaccine authority not to give the AstraZeneca vaccine to individuals 65 and older. "We will now have to review the order of vaccination [because] of the age limitations of the AstraZeneca vaccine," said health minister Jens Spahn, according to AFP.
January 29, 2021 - The European Medicines Agency (EMA) recommended granting conditional marketing authorization for COVID-19 Vaccine AstraZeneca to prevent COVID-19 in people from 18 years of age. Combined results from 4 clinical trials in the United Kingdom, Brazil, and South Africa showed that the COVID-19 Vaccine AstraZeneca was safe and effective at preventing COVID-19 in people from 18 years of age. These studies involved around 24,000 people altogether. Half received the vaccine, and half were given a control injection, either a dummy injection or another non-COVID vaccine. People did not know if they had been given the test vaccine or the control injection. The safety of the vaccine has been demonstrated across the four studies.
January 28, 2021 - UPI reported Germany's Robert Koch Institute stated 'there are not enough data to determine how effective the vaccine is for the elderly, and it should be given only to people under age 65.'
January 27, 2021 - Reuters reported the Chilean Public Health Institute (ISP) approved the AstraZeneca-Oxford COVID-19 vaccine for emergency use by a unanimous vote of its advisory board. The approval is for use for Chileans over 18 and without an upper age limit.
January 27, 2021 - The US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices conducted a digital meeting to review the AstraZeneca COVID-19 vaccine candidate.
January 24, 2021 - Xinhua reported Ecuador's National Agency for Health Regulation, Control, and Surveillance had approved the emergency use of the Oxford-AstraZeneca vaccine against COVID-19. Ecuador's government said it has access to 18 million doses that will be used to vaccinate 9 million Ecuadoreans over 18 years old for free in 2021.
January 19, 2021 - Human trials of a coronavirus vaccine combining the Sputnik V Vaccine with the AstraZeneca and Oxford University co-developed vaccine are expected to start in early February, the chairman of r R-Pharm told Reuters.
January 16, 2021 - Gulf News confirmed the AstraZeneca’s COVID-19 vaccine had been approved for emergency use in Pakistan, making this experimental coronavirus vaccine the first authorization. Pakistan has announced to provide coronavirus vaccines free of charge to its citizens. Pakistan’s frontline healthcare workers would be at the top of the vaccine priority list. Initially, the vaccine would be administered to healthcare workers and people over 65.
January 12, 2021 - The European Medicines Agency (EMA) has received an application for conditional marketing authorization for a COVID-19 vaccine developed by AstraZeneca and Oxford University. An opinion on the marketing authorization could be issued by January 29, 2021, during the meeting of EMA’s scientific committee for human medicines.
January 7, 2021 - The AP reports South Africa says it will import 1.5 million doses of the AstraZeneca vaccine to inoculate its health workers. This is South Africa’s first announcement of a COVID-19 vaccine purchase. The first 1 million doses will be delivered later this month from the Serum Institute of India, followed by an additional 500,000 doses in February, Health Minister Zwelini Mkhize announced.
January 6, 2021 - AstraZeneca’s COVID-19 vaccine has been granted emergency use authorization in India and Argentina, the Dominican Republic, El Salvador, Mexico, and Morocco for adults' active immunization. India's approval is an important milestone as it will enable us to supply India and many countries worldwide. AstraZeneca has partnered with Serum Institute of India, the world's largest vaccine manufacturer, to deliver the Indian Government and many low and middle-income countries.
January 5, 2021 - Medicines and Healthcare products Regulatory Agency - Public Assessment Report Authorisation for Temporary Supply COVID-19 Vaccine AstraZeneca, solution for injection in multidose container COVID-19 Vaccine (ChAdOx1-S [recombinant]) Department of Health and Social Care.
January 2, 2021 - Brazil's Anvisa announced that it had approved a request for the exceptional import of vaccines by Fiocruz. On December 31, 2020, the approval took place the same day that Fiocruz filed the import order. The importation plan includes two million doses of the Oxford vaccine, AZD1222. As this is a vaccine import that has not yet been approved in the country, entry into the country must follow certain conditions established by Anvisa.
January 1, 2021 - India's Minister Prakash Javdekar said the AstraZeneca vaccine produced locally by the Serum Institute of India Ltd., CoviShield, was granted emergency approval. CoviShield has been identified as a more suitable vaccine for reaching people in India's remotes areas.
December 30, 2020 - JCR Pharmaceuticals Co., Ltd.'s Chairman, and President: Shin Ashida announced that it had signed a provisional production master service agreement with AstraZeneca K.K. regarding the production of the bulk product in Japan for the adenovirus vector-based COVID-19 vaccine, known as AZD1222. The vaccine manufactured at JCR Pharmaceuticals will be sent to Daiichi Sankyo and Meiji's factories, both drugmakers, to be filled in vials and packaged. The finished products will then be shipped to hospitals.
December 30, 2020 - AstraZeneca announced the UK Medicines and Healthcare products Regulatory Agency (MHRA) had provided authorization for an emergency supply of COVID-19 Vaccine AstraZeneca, formerly AZD1222, for the active immunization of individuals 18 years or older. The approval recommends two doses administered with an interval of between four and 12 weeks. This regimen was shown in clinical trials to be safe and effective at preventing symptomatic COVID-19, with no severe cases and no hospitalizations more than 14 days after the second dose.
December 30, 2020 - Health Canada announced it is aware that the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) has issued an authorization for a COVID-19 vaccine manufactured by AstraZeneca. Health Canada has been reviewing AstraZeneca's vaccine since it was submitted on October 1, 2020, and is expediting the review of COVID-19 vaccines.
December 30, 2020 - Dr. Jeremy Farrar, Director of Wellcome, said: “Now begins the enormous task of scaling up vaccination to as many people as possible. It is much better to vaccinate as many people as possible with one dose than half that number of people with two doses in the next few months. It remains critical that groups most at risk, such as the elderly and frontline healthcare and essential workers, prioritize receiving the first doses. Still, we must not delay getting the vaccine to everyone in this country and worldwide. The dosing regimen announced today will allow a more rapid rollout.
December 27, 2020 - AstraZeneca's CEO Pascal Soriot said theCOVID-19 vaccine candidate AZD1222 had achieved a “winning formula” efficacy. Soriot stated the University of Oxford developed a vaccine that can provide ‘100 protection’ against severe COVID-19 after initially showing an average of 70% effectiveness.
December 21, 2020 - Russian Direct Investment Fund, N.N. N.F. Gamaleas, AstraZeneca, and R-Pharm signed an agreement on developing and implementing a clinical research program to assess the immunogenicity and safety of the combined use of one of the components Sputnik V vaccine of the Center. Hamalea and one of the parts of the AZD1222 vaccine, developed by AstraZeneca in conjunction with the University of Oxford.
December 17, 2020 - Researchers from the University of Oxford have published further data from the Phase I/II clinical trials of the ChAdOx1 nCoV-19 coronavirus vaccine, evidencing the decision to move to a 2-dose regimen in ongoing phase III trials and how ChAdOx1 nCov-19 is inducing broad antibody and T cell functions.
December 8, 2020 - Study published by The Lancet: Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomized controlled trials in Brazil, South Africa, and the UK. 'Interim results of the Oxford COVID-19 vaccine trials find that the vaccine protects against symptomatic disease in 70% of cases - with vaccine efficacy of 62% for those given two full doses, and of 90% in those given a half than a full dose (both trial arms pre-specified in the pooled analysis). The results are the first full peer-reviewed efficacy results to be published for a COVID-19 vaccine and are published in The Lancet. The vaccine was found to be safe, with only three out of 23,745 participants over a median of 3.4 months experiencing serious adverse events that were possibly related to a vaccine; one in the vaccine arm, one in the control arm, and one in a participant who remains masked to group allocation. All participants have recovered or are recovering and remain in the trial.
December 8, 2020 - Netherlands-based HALIX B.V. announced signed an agreement with AstraZeneca AB for large-scale commercial drug substance manufacture of AZD1222, the adenovirus vector-based COVID-19 vaccine.
November 27, 2020 - The UK government has formally asked the Medicines and Healthcare products Regulatory Agency to evaluate whether the Oxford/AstraZeneca vaccine supply can be authorized. The UK will be one of the first countries in the world to receive the vaccine, if approved, with AstraZeneca expecting to have up to 4 million doses ready for the UK by the end of the year and 40 million by the end of March 2021.
November 24, 2020 – Gavi, the Vaccine Alliance, issued a statement welcoming the release of interim efficacy data for the AstraZeneca/Oxford COVID-19 vaccine candidate.' Dr. Seth Berkley, CEO of Gavi, added, “Positive early data on any vaccine candidate is welcome news – even more so when it concerns a vaccine candidate that can be transported and delivered via traditional refrigeration and storage methods, and the manufacturer has committed to supply on a not-for-profit basis for the duration of the pandemic. As a vaccine candidate that can utilize standard 2-8 degree cold chain infrastructure for transport, storage, and delivery, the implications of this announcement for access to all countries – particularly lower-income ones – are significant.'
November 23, 2020 - AstraZeneca issues a press statement saying 'Positive high-level results from an interim analysis of clinical trials of AZD1222 in the UK and Brazil showed the vaccine was highly effective in preventing COVID-19, the primary endpoint, and no hospitalizations or severe cases of the disease were reported in participants receiving the vaccine. There were a total of 131 COVID-19 patients in the interim analysis. More data will continue to accumulate, and additional studies will be conducted, refining the efficacy reading and establishing the duration of protection.
November 21, 2020 - The Lancet published: Notice of addendum to Article reporting Oxford trial of ChAdOx1 nCoV-19 vaccine.
November 18, 2020 - A study published by The Lancet found ChAdOx1 nCoV-19 appears to be well tolerated in older adults and has similar immunogenicity across all age groups after a booster dose. Further assessment of this vaccine's efficacy is warranted in all age groups and individuals with comorbidities.
November 8, 2020 - Melbourne-based CSL Limited confirmed it would commence manufacturing the University of Oxford - AstraZeneca AZD1222 COVID-19 vaccine candidate at its advanced manufacturing facility in Broadmeadows, Victoria, on November 9, 2020. CSL has separate contracts with AstraZeneca and the Australian Government to manufacture approximately 30 million doses of the AZD1222 vaccine candidate, with the first doses planned for release in the first half of 2021, pending the outcome of clinical trials and regulatory approval. The TGA in Australia has granted the AZD1222 vaccine a provisional determination. AstraZeneca said it would manage the application for registration for the vaccine on the Australian Register of Therapeutic Goods.
November 7, 2020 - Article published by The Lancet: 'As a participant in the ChAdOx1 nCoV-19 vaccine trial, I was particularly excited to read the preliminary report by Pedro Folegatti and colleagues and congratulate the team on their promising results. However, glancing at the summary of adverse reactions in figure 1 of the Article, I was uncomfortably surprised to discover that I had unmasked myself. I self-reported moderate feverishness, which was experienced by 21% (12 of 56) of the ChAdOx1 nCoV-19 paracetamol group and none of the associated control group.
November 4, 2020 - The UK Vaccine Taskforce Chair Kate Bingham said that the target of 30 million doses of the vaccine by September had not been achieved. She estimated that Britain would get 4 million doses by the end of 2020.
November 1, 2020 - “We confirm the UK's Medicines and Healthcare Products Regulatory Agency rolling review of our potential COVID-19 vaccine,” an AstraZeneca spokesman said, according to Reuters. In rolling reviews, regulators can see clinical data in real-time and have a dialogue with drug makers to accelerate the approval process.
October 30, 2020 - Kenya announced it had joined the global efforts in search of an effective vaccine for COVID-19 with the start of a trial evaluating the ChAdOx1 nCoV-2019 Oxford coronavirus vaccine. The trial in Kenya will initially involve 40 frontline workers in Kilifi County. Once the vaccine safety is confirmed, a further 360 volunteers will be recruited with possible expansion of the trial to Mombasa County.
October 26, 2020 - “It is encouraging to see immunogenicity responses were similar between older and younger adults and that reactogenicity was lower in older adults, where the COVID-19 disease severity is higher,” an AstraZeneca spokesman told CNBC via email.
October 23, 2020 - The US Food and Drug Administration (FDA) authorized the phase 3 clinical trial. The FDA reviewed all safety data from trials globally and concluded it was safe to resume it. As part of the standard review process for trial safety events, a voluntary pause to vaccination across all global trials was triggered on September 6, 2020, to examine safety data by independent monitoring committees. The recommendations from these reviews have been supported by international regulators, who confirmed that the trials were safe to resume.
October 19, 2020 - Thailand Ministry of Public Health, Siam Bioscience, SCG, and AstraZeneca has signed a Letter of Intent on the manufacturing and supply of the University of Oxford’s potential COVID-19 vaccine AZD1222. To commence the Thai population's vaccination in the first half of 2021.
October 16, 2020 - The Swiss federal government signed an agreement with AstraZeneca to deliver up to 5.3 million doses of the ChAdOx1 nCoV-19 vaccine, provided it successfully passes the clinical trial phase and is approved by Swissmedic.
October 12, 2020 - Thailand's Ministry of Public Health, Siam Bioscience, SCG, and AstraZeneca signed a Letter of Intent on the manufacturing and supply of the University of Oxford’s potential COVID-19 vaccine AZD1222.
October 2, 2020 - The Phase, I/II clinical trial for the COVID-19 vaccine AZD1222 has resumed in Japan after discussions with the Japanese Pharmaceuticals and Medical Devices Agency. Their recommendations have been supported by international regulators in the UK, Brazil, South Africa, and India, who have deemed that the trials are safe to resume.
October 2, 2020 - Health Canada announced it received its first submission for authorization of a COVID-19 vaccine developed by AstraZeneca in partnership with the University of Oxford. In September 2020, the Minister of Health signed an Interim Order allowing companies to submit safety and efficacy data and information as they become available.
September 30, 2020 - The U.S. Food and Drug Administration is reported to have broadened its investigation of a serious illness in AstraZeneca's AZD1222 vaccine candidate study and will look at data from earlier trials of similar vaccines, developed by the same scientists, three sources familiar with the details exclusively told Reuters.
September 25, 2020 - Canada's Prime Minister, Justin Trudeau, announced an agreement with AstraZeneca to procure up to 20 million doses of its COVID–19 vaccine candidate.
September 15, 2020 - AstraZeneca Plc announced it has begun enrolling adults for a U.S.-funded, 30,000-subject late-stage study of its high profile COVID-19 vaccine candidate. Trial participants will receive either two doses of the experimental vaccine, dubbed AZD1222, four weeks apart, or a placebo, the company said. This phase 3 trial is being conducted under the U.S. government’s Operation Warp Speed program, aiming to accelerate the development, manufacturing, and distribution of vaccines and treatments for COVID-19.
September 12, 2020 - AstraZeneca announced clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed in the UK following confirmation by the Medicines Health Regulatory Authority that it was safe to do so. As the trial sponsor, AstraZeneca and the University of Oxford cannot disclose further medical information. According to the clinical trial and regulatory standards, all trial investigators and participants will be updated with the relevant information, and this will be disclosed on global clinical registries.
September 12, 2020 - Serum Institute of India announced phase 2 and 3 clinical trials of the Oxford COVID-19 vaccine candidate would resume after receiving the green signal from the Drugs Controller General of India.
September 10, 2020 - Pascal Soriot, AstraZeneca's CEO, told an online briefing organized by Tortoise Media that an independent safety committee was currently reviewing data on the AZD1222 vaccine candidates' reported adverse event. And 'the company should know before the end of 2020 whether this experimental vaccine protects people against the SARS-CoV-2 virus.'
September 9, 2020 - AstraZeneca announced, 'As part of the ongoing randomized, controlled clinical trials of the AstraZeneca Oxford coronavirus vaccine, AZD1222, a standard review process has been triggered, leading to the voluntary pause of vaccination across all trials to allow an independent committee to review the safety data of a single event of an unexplained illness that occurred in the UK Phase III trial. This is a routine action that has to happen whenever there is a potentially unexplained illness in one of the trials. At the same time, it is investigated, ensuring we maintain the trials' integrity.
September 3, 2020 - As part of the US's Operation Warp Speed goal to deliver safe and effective vaccines and therapeutics by January 2021, five DoD locations have been identified to participate in the Phase III trial evaluating the vaccine candidate AZD1222 under development by AstraZeneca. Honorable Tom McCaffery, Assistant Secretary of Defense for Health Affairs, said: “Now that vaccines have passed the first phases of testing for safety, dosing and response, we are ready to move into the next phase where volunteers are needed to join large clinical studies. We are excited to have several sites identified to support the next steps in the vaccine development process.”
September 1, 2020 - Oxford Biomedica plc announced that it had signed an 18 month supply agreement under a 3-year Master Supply and Development Agreement with AstraZeneca UK Ltd. for large-scale commercial manufacture of the adenovirus vector-based COVID-19 vaccine candidate, AZD1222. The Parties may extend the supply period into 2022 and 2023 by mutual agreement.
August 31, 2020 - The National Institutes of Health announced a multi-site, Phase 3 clinical trial evaluating AZD1222 has begun. The test will enroll approximately 30,000 adult volunteers at 80 sites in the USA to evaluate if this candidate vaccine can prevent symptomatic COVID-19 disease.
August 16, 2020 - Mumbai's KEM and Nair hospitals have begun testing India's vaccine candidate.
August 14, 2020 - AstraZeneca announced an agreement with the European Commission to supply up to 400 million doses of the AZD1222 COVID-19 vaccine. This new agreement will give all EU member states the option to access the vaccine equitably at no profit during the pandemic. It also allows EU member states to redirect doses to other European countries.
August 6, 2020 - Shenzhen Kangtai Biological Products announced it would produce AstraZeneca Plc's potential COVID-19 vaccine AZD1222 in mainland China. The Shenzhen-based company must have the capacity to make at least 200 million vaccine doses by the end of 2021 as part of the exclusive framework agreement.
August 1, 2020 - The Drugs Controller General of India has approved the Serum Institute of India, Pune, to conduct Phase II+III clinical trials of Oxford University-Astra Zeneca COVID-19 vaccine (COVISHIELD).
July 29, 2020 - Adar Poonawalla's Serum Institute had filed an application seeking permission from the Drugs Controller General of India for trials of Oxford-AstraZenca vaccine candidate, Covishield. The regulator has asked Serum Institute to demarcate Phase II and Phase III parts of the protocol and conduct Covishield trials all over India, the daily further reported.
July 27, 2020 - Emergent BioSolutions announced that it had signed an agreement to provide contract development and manufacturing services for AstraZeneca’s COVID-19 vaccine candidate, AZD1222. The agreement is valued at approximately $174 million through 2021 and follows an $87 million contract in June for development services, performance and process qualification, raw materials, and an initial capacity reservation.
July 23, 2020 - Between treating patients and researching the virus, Dr. Erdmann is also preparing to launch one of UAB’s most extensive clinical trials in years, testing whether a vaccine developed by Oxford University and drug manufacturer AstraZeneca will protect against COVID-19. Dr. Paul Goepfert, who is also leading the trial of AZD1222 at UAB, said, “We are going to do vaccinate at least 500 individuals locally.”
July 20, 2020 - The Lancet confirmed in a preliminary report of the COV001/2 phase 1/2 study a single dose of AZD1222 resulted in a 4-fold increase in antibodies SARS-CoV-2 virus spike protein in 95% of participants one month after injection. A T-cell response was induced in all participants, peaking by day 14, and maintained 2-months after vaccination. COV001 is a blinded, multi-center, randomized controlled Phase I/II trial with 1,077 healthy adult participants aged 18-55. It assessed a single dose of AZD1222 against a comparator meningococcal conjugate vaccine, MenACWY. Ten participants also received two doses of AZD1222 one month apart.
July 17, 2020 - Moscow unveiled an agreement with AstraZeneca to produce a coronavirus vaccine developed by the firm and Oxford University. Alexey Repik, R-Pharm’s board chairman, said his company had signed the deal. Kirill Dmitriev, head of the Russian Direct Investment Fund, said, 'Russia’s acquisition of the British-developed vaccine was designed to complement, not replace its own home-grown vaccine, which is the one that Moscow is focusing on.'
July 14, 2020 - IQVIA announced its collaboration with AstraZeneca to accelerate the development of a potential new vaccine for COVID-19. Is also part of the U.S. government’s recently announced Operation Warp Speed project. The specific IQVIA and AstraZeneca collaboration will drive faster delivery of clinical studies in the U.S. to demonstrate the efficacy of AstraZeneca’s potential COVID-19 vaccine, AZD1222.
July 1, 2020 - Speaking at a parliamentary hearing, Sarah Gilbert, professor of vaccinology at Oxford University, said 8,000 volunteers had been enrolled for the Phase III of its trial into the vaccine, AZD1222 was licensed to AstraZeneca. “We’re pleased that we see the right sort of immune response that will give protection, and not the wrong sort,” Gilbert said.
June 30, 2020 - AstraZeneca expects the first batch of 15.2 million doses to be produced by December 2020 and another, with the remaining 15.2 million doses, to be delivered in January 2021. After this production, it would still be necessary to go through registration and validation phases before a possible distribution.
June 28, 2020 - Brazil's Health Ministry executive secretary Elcio Franco said under the US$127 million deal, the Brazilian government’s public-health institute will acquire the technology and supplies to produce the AZD1222 SARS-CoV-2 vaccine, which is being tested in Britain and South Africa, as well as Brazil, reported SCMP. If the vaccine is demonstrated to be effective, 100 million doses will be available to the Brazilian population.
June 27, 2020 - Volunteers in Brazil have begun receiving a trial vaccine against COVID-19 in Latin America’s first phase 3 COVID-19 clinical trial. The trial officially began on Saturday 20th June and will enroll 5,000 volunteers across the country. Vaccinations will occur in Sao Paulo, Rio de Janeiro, and the northeast of Brazil.
June 23, 2020 - The first South Africa clinical trial for a vaccine against COVID-19 disease will vaccinate participants this week. Wits University is collaborating with the University of Oxford and the Oxford Jenner Institute on the South African trial.
June 20, 2020 - A recent study reported, 'Whilst a single dose induced antigen-specific antibody and T cells responses, a booster immunization enhanced antibody responses, particularly in pigs, with a significant increase. SARS-CoV-2 neutralizing titers.' Britain’s Pirbright Institute released this research suggests a 2-dose approach may be more effective in getting protection against COVID-19 disease, which SARS-CoV-2 causes.
June 13, 2020 - AstraZeneca has reached an agreement with Europe’s Inclusive Vaccines Alliance, spearheaded by Germany, France, Italy, and the Netherlands, to supply up to 400 million doses of the University of Oxford’s COVID-19 vaccine, with deliveries starting by the end of 2020. AZ's total manufacturing capacity currently stands at 2 billion doses.
June 11, 2020 - AstraZeneca Plc announced it selected Emergent BioSolutions to help produce the 300 million doses of the COVID-19 vaccine candidate pledged to the United States. Emergent is also working to boost the manufacturing of COVID-19 vaccines under development at Johnson & Johnson, Novavax, and Vaxart. Large-scale manufacturing will be done at the Baltimore Maryland Bayview facility.
June 9, 2020 - Serum Institute of India, the world's largest vaccine manufacturer, is investing USD 100 million in a potential COVID-19 vaccine developed at Oxford University. The Pune-based company has partnered with AstraZeneca, a British biopharma giant, to ensure an equitable supply of the AZD1222 vaccine doses to India and low-and-middle-income countries.
June 4, 2020 - AstraZeneca reached a $750m agreement with CEPI and Gavi to support the manufacturing, procurement, and distribution of 300 million doses of the potential vaccine, with delivery starting by the end of 2020. Also, AstraZeneca reached a licensing agreement with SII to supply 1-billion doses for low-and-middle-income countries, with a commitment to provide 400 million before the end of 2020.
June 4, 2020 - The Coalition for Epidemic Preparedness Innovations announced a partnership with AstraZeneca, which will support the manufacture of 300 million doses of the AZD1222 vaccine candidate ringfenced for the COVID-19 Vaccine Global Access Facility. Suppose the vaccine is proven to be safe and effective.
June 2, 2020 - The Brazilian Health Regulatory Agency (ANVISA) approved Brazil's inclusion in the clinical trials conducted by Oxford University and supported by AstraZeneca, considering 2,000 volunteers to be tested in the country.
May 23, 2020 - “It’s a race against the virus disappearing, and against time,” Professor Adrian Hill, director of the Jenner Institute, told the Telegraph. “We said earlier in the year that there was an 80% chance of developing an effective vaccine by September. But at the moment, there’s a 50% chance that we get no result at all.”
May 22, 2020 - University of Oxford researchers announced they have begun recruiting participants for the next phase in human trials of a COVID-19 vaccine in human volunteers. The phase II part of the study involves expanding the age range of people the vaccine is assessed to include a small number of older adults and children.
May 21, 2020 - AstraZeneca has received more than $1 billion from the U.S. Health Department’s Biomedical Advanced Research and Development Authority develops a coronavirus vaccine from the University of Oxford called AZD1222. AstraZeneca has agreed to initially supply at least 400 million doses of the vaccine and secured total manufacturing capacity to produce 1 billion doses, with first deliveries in September.
May 21, 2020 - Operation Warp Speed Accelerated AstraZeneca COVID-19 Vaccine to be Available Beginning in October 2020.
May 18, 2020 - The U.K. Business Secretary Alok Sharma indicated the government has an agreement with the Imperial College London and AstraZeneca to accelerate the production of the ChAdOx1 nCoV-19 vaccine candidate. The deal will see AstraZeneca manufacture up to 30 million doses by September 2020 as part of a commitment to deliver 100 million doses in total for people in Britain. Under the agreement, London pledged 65.5 million pounds in funding for the vaccine being developed at the University of Oxford and 18.5 million pounds for related work at Imperial College London.
May 16, 2020 - Canada’s Prime Minister Trudeau announced the first clinical trial of a potential COVID-19 disease prevention vaccine, called Ad5-nCoV COVID-19, approved by Health Canada.
May 14, 2020 - Everything you need to know about the Oxford University vaccine.
May 13, 2020 - A non-peer-reviewed study showed that a single vaccination in rhesus macaques with ChAdOx1 nCoV-19 effectively prevents damage to the lungs upon high dose challenge with SARS-CoV-2. Similarly, a recent study showed a triple vaccination regime of a high-dose of whole inactivated SARS-CoV-2 protected rhesus macaques from SARS-CoV-2 pneumonia.
April 30, 2020 - AstraZeneca and the University of Oxford announced an agreement for the global development and distribution of the recombinant adenovirus vaccine to prevent COVID-19 disease from SARS-CoV-2 coronavirus infections.
April 28, 2020 - The Serum Institute of India said it plans to produce up to 60 million doses of the vaccine against the new coronavirus under clinical trial in Britain.
April 24, 2020 - Vaccitech announces today that its scientific founders at the Jenner Institute, University of Oxford, have begun testing a COVID-19 vaccine in human volunteers.
April 23, 2020 - University of Oxford researchers have begun testing a COVID-19 vaccine in human volunteers in Oxford today. Around 1,110 people will participate in the trial, half receiving the vaccine, and the control group receiving a widely available meningitis vaccine.
AstraZeneca COVID-19 Vaccine Clinical Trials
AZD1222 is undergoing late-stage clinical trials in Japan, Russia, South Africa, Kenya, and Latin America, with planned trials in other European and Asian countries. Together with the U.S. Phase III study, these trials aim to enroll up to 60,000 globally.
Clinical Trial NCT04568031: Study of AZD1222 for the Prevention of COVID-19 in Japan - A Phase I/II Randomized, Double-blind, Placebo-controlled Multicentre Study in Participants Aged 18 Years or Older to Determine the Safety and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19
Clinical Trial NCT04540393: AZD1222 Vaccine for the Prevention of COVID-19. This study evaluates the safety and immunogenicity of AZD1222 for COVID-19 prevention in the Russian Federation. Suspended (Study has been suspended due to the occurrence of SUSAR at University of Oxford sponsored Phase2/3 study. Study will continue to be on hold until Russian MOH approval is received.)
Clinical Trial NCT04516746: Phase III Double-blind, Placebo-controlled Study of AZD1222 for the Prevention of COVID-19 in Adults.
On March 22, 2021, the AstraZeneca US Phase III trial of AZD1222 demonstrated a statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy in preventing severe disease hospitalization. This interim safety and efficacy analysis was based on 32,449 participants accruing 141 symptomatic cases of COVID-19. The trial had a 2:1 randomization of vaccine to placebo. Vaccine efficacy was consistent across ethnicity and age. Notably, in participants aged 65 years and over, vaccine efficacy was 80%. The vaccine was well-tolerated, and the independent data safety monitoring board (DSMB) identified no safety concerns related to the vaccine. The DSMB conducted a specific review of thrombotic events and cerebral venous sinus thrombosis (CVST) with the assistance of an independent neurologist. The DSMB found no increased risk of thrombosis or events characterized by thrombosis among the 21,583 participants receiving at least one dose of the vaccine. The specific search for CVST found no events in this trial. Estimated Completion Date: February 14, 2023.
Clinical Trial NCT04324606: A Study of a Candidate COVID-19 Vaccine (COV001). Last Update Posted: November 18, 2020. COV001 is a phase I/2 single-blinded, randomized, placebo-controlled, multi-center study to determine efficacy, safety, and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in UK healthy adult volunteers aged 18-55 years. Estimated Primary Completion Date: October 2021.
Clinical Trial NCT04684446: AZD1222 Vaccine in Combination With rAd26-S (Component of Gam-COVID-Vac Vaccine) for the Prevention of COVID-19. The objective is to evaluate the safety and immunogenicity of AZD1222 given in combination with (either before or after) rAd26-S to prevent COVID 19 in adults ≥ 18 years of age. Estimated Primary Completion Date: November 16, 2021.