Vaxzevria COVID-19 Vaccine AstraZeneca Description
The Vaxzevria - AstraZeneca COVID-19 (AZD1222) (ChAdOx1 nCov-19) (C19VAZ) vaccine 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). The vaccine does not contain the virus itself and cannot cause COVID-19, says the European Medicines Agency (EMA).
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. Vaxzevria is made up of another virus (of the adenovirus family) that has been modified to contain the gene for making a protein from SARS-CoV-2.
Vaxzevria is a vaccine for preventing COVID-19 in people aged 18 years and older, says the ECDC.
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. The EMA authorized Vaxzevria in February 2021. On March 26, 2021, the EMA posted 'Vaxzevria' as the new name for COVID-19 Vaccine AstraZeneca.
AstraZeneca's Vaxzevria - AZD1222 (ChAdOx1 nCov-19) (C19VAZ) vaccine's Accession Number: DB15656. The UNII Preferred Substance Name: B5S3K2V0G8.
Vaxzevria COVID-19 Vaccine AstraZeneca History
Oxford University's Jenner Institute developed the Vaxzevria (AZD1222) vaccine, working with the Oxford Vaccine Group. AZD1222 was co-invented by the University of Oxford and Vaccitech. Vaccitech owns the rights to the viral vector technology ChAdOx, used in the Oxford vaccine, and was co-founded by Professor Sarah Gilbert, who has led the project.
A preliminary report of the COV001/2 phase 1/2 study published on July 20, 2020, showed a single dose of AZD1222 resulting in a 4-fold increase in antibodies to the SARS-CoV-2 virus spike protein 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 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.
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.
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’.
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. 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 recommended granting conditional marketing authorization for COVID-19 Vaccine AstraZeneca to prevent coronavirus disease 2019 (COVID-19) in 18 years of age.
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.
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.
Vaxzevria COVID-19 Vaccine AstraZeneca Side Effects
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.
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 considered all currently available evidence, including the advice from an ad hoc expert group.
UK and EU regulators requested their vaccine labels be updated to warn of these “extremely rare potential side effect(s).” The data suggest a slightly higher incidence reported in the younger adult age groups.
On May 5, 2021, the BMJ published a study: Arterial events, venous thromboembolism, thrombocytopenia, and bleeding after vaccination with Oxford-AstraZeneca ChAdOx1-S Denmark and Norway: population-based cohort study. Conclusions - Among recipients of ChAdOx1-S, increased rates of venous thromboembolic events, including cerebral venous thrombosis, were observed. For the remaining safety outcomes, results were largely reassuring, with slightly higher rates of thrombocytopenia/coagulation disorders and bleeding, which could be influenced by increased surveillance of vaccine recipients. However, the absolute risks of venous thromboembolic events were small, and the findings should be interpreted in light of the proven beneficial effects of the vaccine, the context of the given country, and the limitations to the generalisability of the study findings.
As of June 2, 2021, the United Kingdom Medicines & Healthcare Regulatory Agency had received 836 Yellow Card reports for the COVID-19 Vaccine AstraZeneca (Vaxzevria), in which the patient died shortly after vaccination.
On June 7, 2021, the EMA’s COVID-19 task force (COVID-ETF) began advising healthcare professionals in the EU to consider recommendations by learned societies when assessing people with signs and symptoms of thrombosis thrombocytopenia syndrome (TTS) following vaccination with Vaxzevria. TTS requires rapid identification and urgent clinical management. National and international recommendations have been updated with evolving experience from managing TTS and heparin-induced thrombocytopenia and thrombosis, a condition with some similarities to TTS.
The EMA’s safety committee concluded on June 11, 2021, that women who have previously had capillary leak syndrome must not be vaccinated with Vaxzevria (formerly COVID-19 Vaccine AstraZeneca). The committee also concluded that capillary leak syndrome should be added to the product information as a new side effect of the vaccine, together with a warning to raise awareness among healthcare professionals and patients of this risk.
Vaxzevria COVID-19 Vaccine AstraZeneca Ingredients
Vaxzevria AstraZeneca COVID-19 Vaccine contains in one dose (0.5 ml) COVID-19 Vaccine (ChAdOx1-S recombinant) 5 × 10^10 viral particles (vp). ChAdOx1-S is a Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS CoV 2 Spike (S) glycoprotein. Produced in genetically modified human embryonic kidney (HEK) 293 cells.
Produced in the genetically modified human embryonic kidney (HEK) 293 cells and by recombinant DNA technology. This product contains genetically modified organisms. Vaxzevria - AstraZeneca COVID-19 Vaccine (AZD1222) (C19VAZ) full ingredients can be found at this University of Oxford website. Vaxzevria is made up of another virus (adenovirus family) that has been modified to contain the gene for making a protein from SARS-CoV-2. The vaccine does not contain the SARS-CoV-2 coronavirus itself and cannot cause COVID-19.
Vaxzevria COVID-19 Vaccine AstraZeneca 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.
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 procuring vaccines against COVID-19 for the countries in the Americas, via the COVAX Mechanism, was 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 version of the AstraZeneca COVID-19 vaccine.
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.
Vaxzevria COVID-19 Vaccine AstraZeneca Indication
The Vaxzevria - AstraZeneca (AZD1222) (ChAdOx1 nCoV-19) vaccine candidate is being tested to prevent infection of SARS-CoV-2, which causes COVID-19 disease.
On May 7, 2021, the UK's Joint Committee on Vaccination and Immunisation advised a preference for people aged 30 to 39 without underlying health conditions to receive an alternative to the Oxford/AstraZeneca vaccine.
Vaxzevria COVID-19 Vaccine AstraZeneca Dosing
Vaxzevria should be administered intramuscularly as two 0.5 mL doses given four to 12 weeks apart, with an interval greater than eight weeks being preferable to maximize its efficacy. This dosing regimen was shown in clinical trials to be well-tolerated and effective in preventing symptomatic COVID-19, with no severe cases and no hospitalizations more than 14 days after the second dose.
A non-peer-reviewed study published on April 13, 2021, found a single dose of the AZD1222/Covishield vaccine was shown to be highly immunogenic in previously naïve individuals inducing antibody levels greater than following natural infection.
On June 4, 2021, Ireland's Health Minister Stephen Donnelly confirmed that the interval between the two doses would be reduced by a third (12 weeks to eight) following advice from the National Immunisation Advisory Committee (NIAC).
Vaxzevria COVID-19 Vaccine AstraZeneca Storage Requirements
The Vaxzevria 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.
Vaxzevria COVID-19 Vaccine AstraZeneca CPT Code
The American Medical Association offers the appropriate CPT code combination for the type and dose of the COVID-19 vaccine.
Vaxzevria COVID-19 Vaccine AstraZeneca News
June 15, 2021 - AstraZeneca reported new data from Public Health England (PHE) demonstrated COVID-19 Vaccine AstraZeneca offers high levels of protection against the Delta variant (B.1.617.2; formerly the ‘Indian’ variant). Real-world data from PHE, published as a pre-print, demonstrated two doses of COVID-19 Vaccine AstraZeneca are 92% effective against hospitalization due to the Delta variant and showed no deaths among those vaccinated. The vaccine also showed a high level of effectiveness against the Alpha variant (B.1.1.7; formerly the ‘Kent’ variant) with an 86% reduction of hospitalizations and no deaths reported. The data suggest that vaccine effectiveness against milder symptomatic disease, although significant, was lower. Vaccine effectiveness against the symptomatic disease was 74% against the Alpha variant and 64% against the Delta variant.
June 11, 2021 - The EMA issued an advisory against use in people with a history of capillary leak syndrome.
June 9, 2021 - A study led by University of Edinburgh researchers and published today in Nature Medicine assessed the risk of bleeding-related events among 2.53 million people up to 27 days after the first dose of the AstraZeneca vaccine from December 2020 to April 2021. Interpution - Public health authorities should inform their jurisdictions of these relatively small increased risks associated with ChAdOx1. No positive associations were seen between BNT162b2 and thrombocytopenic, thromboembolic, and hemorrhagic events.
June 2, 2021 - The NEJM published a Correspondence that concluded, saying 'In South Africa the rate of adverse events with vaccination is low, and thromboembolic events have occurred mainly in persons with risk factors for thromboembolism. To date, no case of vaccine-induced immune thrombotic thrombocytopenia has been documented.
May 26, 2021 - The EMA published an update to its Safety Information page.
May 25, 2021 - According to the Central Epidemic Command Center, 302,698 Taiwanese have received at least their first dose since the rollout began on March 22, including 51,262 Taipei residents and 47,949 New Taipei residents. To date, only 687 adverse events have been reported among the 302,698 people who have received AstraZeneca vaccination, or around 0.23 percent.
May 21, 2021 - AstraZeneca announced Vaxzevria had been granted special approval for emergency use in Japan for active immunization of individuals aged 18 years and older to prevent COVID-19 caused by SARS-CoV-2.
May 18, 2021 - The ECDC published a technical report that provides a summary of the evidence available at the time of the publication and what will be required in the future to support EU/EEA countries taking decisions on the administration of the second dose, following the first dose of Vaxzevria. Since new evidence is being generated continuously and safety monitored regularly, it is essential for readers to consider the latest available information.
May 12, 2021 - The Lancet reported mixing COVID-19 vaccines may produce more frequent mild to moderate reactions than standard vaccine dosing schedules, University of Oxford researchers confirmed.
May 10, 2021 - Thierry Bretón confirmed the European Union has opted not to renew an order for AstraZeneca to supply its coronavirus vaccine after June 2021, reported local media.
May 7, 2021 - The Joint Committee on Vaccination and Immunisation (JCVI) has issued advice to the UK government on using the COVID-19 Oxford - AstraZeneca vaccine for people aged under 40. The JCVI has advised a preference for adults aged 30 to 39 without underlying health conditions to receive an alternative to the Oxford - AstraZeneca COVID-19 vaccine, where available, and only if this does not cause substantial delays in being vaccinated.
May 6, 2021 - The Australian Health agency reported five additional reports of blood clots and low blood platelets that have been assessed as thrombosis with thrombocytopenia syndrome, likely to be linked to the AstraZeneca COVID-19 vaccine.
May 6, 2021 - Reuters reported Germany will allow AstraZeneca’s COVID-19 vaccine to be administered to adults of all ages and aims to offer 12-18-year-olds a vaccine by the end of August 2021.
May 5, 2021 - BMJ reported: Arterial events, venous thromboembolism, thrombocytopenia, and bleeding after vaccination with Oxford-AstraZeneca ChAdOx1-S in Denmark and Norway: population-based cohort study. Conclusions Among recipients of ChAdOx1-S, increased rates of venous thromboembolic events, including cerebral venous thrombosis, were observed.
April 30, 2021 - AstraZeneca reported 18.4 million doses of AstraZeneca’s COVID-19 vaccine and 29.9 million of SII’s Covidshield vaccine had been sold.
April 27, 2021 - The Lancet published a new study: Vaccine side-effects and SARS-CoV-2 infection after vaccination in users of the COVID Symptom Study app in the UK: a prospective observational study. Results Interpretation - Systemic and local side-effects after ChAdOx1 nCoV-19 vaccination occur at frequencies lower than reported in phase 3 trials. And decrease the risk of SARS-CoV-2 infection after 12 days.
April 26, 2021 - The U.S. government announced it would supply 60 million vaccine doses to other countries, reported the AP.
April 23, 2021 - A non-peer-reviewed study published by the Nuffield Department of Medicine found 'Vaccination with a single dose of Oxford-AstraZeneca vaccine significantly reduced new SARS-CoV-2 infections in this large community surveillance study in the UK.
April 23, 2021 - The EMA stated, 'Vaxzevria (formerly COVID-19 Vaccine AstraZeneca) benefits outweigh its risks in adults of all age groups; however, very rare cases of blood clots with low blood platelets1 have occurred following vaccination.
April 19, 2021 - Researchers at the University of Oxford have launched a human challenge trial to look at what kind of immune response can stop people from becoming re-infected. They also want to see how the immune system reacts the second time around.
April 16, 2021 - The WHO published 'Global Advisory Committee on Vaccine Safety review of the latest evidence of rare adverse blood coagulation events with AstraZeneca COVID-19 Vaccine (Vaxzevria and Covishield).'
April 15, 2021 - Researchers at the University of Oxford in England reported the risk of the rare blood clotting known as cerebral venous thrombosis following COVID-19 infection is around 100 times greater than normal. And several times higher than it is post-vaccination or following influenza.
April 14, 2021 - Health Canada announced, 'Based on the review of available data from Europe and the United Kingdom and AstraZeneca, no specific risk factors have been identified. Therefore, Health Canada is not restricting the use of the vaccine in any specific populations at this time.'
April 13, 2021 - A limited, preprint study in the UK seniors (80+) found a single dose of the Oxford-AstraZeneca Covid-19 or Pfizer vaccines produced equivalent antibody responses five weeks after vaccination. The study, led by University of Birmingham researchers, found that antibodies specific to the SARS-CoV-2 spike protein were present in most people in both groups—93% after the Pfizer vaccine and 87% after the AstraZeneca vaccine.
April 9, 2021 - The NEJM published an Original Article: Thrombotic Thrombocytopenia after ChAdOx1 nCov-19 Vaccination. CONCLUSIONS: Vaccination with ChAdOx1 nCov-19 can result in the rare development of immune thrombotic thrombocytopenia mediated by platelet-activating antibodies against PF4, which clinically mimics autoimmune heparin-induced thrombocytopenia.
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.
April 7, 2021 - Reuters reported the European Commission confirmed that AstraZeneca's COVID-19 vaccine's delivery shortfalls 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).
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 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.
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 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 developing 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.
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.
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.
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.'
March 11, 2021 - Various media sources reported that countries in 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.
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.
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 Verity Pharmaceuticals Canada Inc./Serum Institute of India. AstraZeneca has licensed the manufacture of its ChAdOx1 vaccine to the Serum Institute.
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.
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).
February 12, 2021 - The University of Oxford and 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, including 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.
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.
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."
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 aged 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.
February 4, 2021 - The University of Oxford leads 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.
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.
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.
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 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.
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 producing 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.
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."
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 agreed 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 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).
December 8, 2020 - Netherlands-based HALIX B.V. announced 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 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.'
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.
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.
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.
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.
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.
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 University of Oxford’s potential COVID-19 vaccine's manufacturing and supply 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.
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, which 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.
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.
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 whether this candidate vaccine can prevent symptomatic COVID-19.
August 16, 2020 - Mumbai's KEM and Nair hospitals have begun testing India's vaccine candidates.
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 report.
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 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 that a single dose of AZD1222 resulted in a 4-fold increase in antibodies SARS-CoV-2 virus spike protein 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.
July 14, 2020 - IQVIA announced its collaboration with AstraZeneca to accelerate the development 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 collaborates 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, invests 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 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 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. 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 from SARS-CoV-2 coronavirus infections.
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.
Vaxzevria (AstraZeneca) COVID-19 Vaccine Clinical Trials
AZD1222 is undergoing late-stage clinical trials in Japan, Russia, South Africa, Kenya, and Latin America, in other European and Asian countries. Visit AstraZeneca for more sponsored trials.