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). In addition, genetic material has been added to the ChAdOx1 construct, used to make proteins from the SARS-CoV-2 betacoronavirus called Spike glycoprotein (S).
The Vaxzevria vaccine does not contain the ChAdOx1 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 another virus (adenovirus family) modified to contain the gene for making a protein from SARS-CoV-2.
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.
Two versions of the Vaxzeria vaccine produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India have been listed for emergency use by WHO
On June 28, 2021, the University of Oxford published on the pre-print server of The Lancet a study that demonstrated that antibody levels remain elevated from baseline for at least one year following a single dose. In addition, a sub-analysis from the Oxford-led COV001 and COV002 trials with Vaxzevria found strong immune responses following either a prolonged second dose interval of up to 45 weeks or following a third boosting dose.
On August 8, 2021, the EMA published its latest Vaxzevria (COVID 19 Vaccine (ChAdOx1 S [recombinant])) safety information and EMEA/H/C/005675/0000 clinical data for professionals and consumers. Vaxzevria is a vaccine for preventing COVID-19 in people aged 18 years and older, says the ECDC.
The Vaxzevria COVID-19 vaccine was Authorized for booster dosing by the UK's MHRA approved on September 10, 2021. ‘We have in place a comprehensive safety surveillance strategy for monitoring the safety of all UK-approved COVID-19 vaccines, and this surveillance will include booster jabs,' Dr. June Raine, MHRA Chief Executive, commented.
The European Medicines Agency updated its Vaxzevria Safety overview on September 8, 2021, and general summary on September 15, 2021.
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 broader 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 complete 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. Furthermore, 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. Furthermore, in some cases, a combination of thrombosis and thrombocytopenia, accompanied by bleeding, has rarely been observed 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). The data suggest a slightly higher incidence reported in the younger adult age groups.
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. 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. The committee also concluded that capillary leak syndrome should be added to the product information as a new side effect of the vaccine and a warning to raise awareness among healthcare professionals and patients of this risk.
On June 29, 2021, Health Canada updated the product monograph for Vaxzevria to add capillary leak syndrome as a potential side effect, with a warning for patients with a history of capillary leak syndrome not to get the AstraZeneca or COVISHIELD COVID-19 vaccine.
The Lancet published a new study on July 27, 2021; the rates of TTS following the second dose of Vaxzevria are comparable to the background rate in an unvaccinated population.
The EMA's PRAC recommendation issued on August 6, 2021, includes a warning in the product information of Vaxzevria to raise awareness among healthcare professionals and people taking the vaccine of cases of Guillain-Barré Syndrome reported following vaccination. However, these side effects are very rare, and the benefit-risk balance of the vaccine remains unchanged.
As of September 2, 2021, the EMA confirmed a total of 184,679 cases of suspected side effects with Vaxzevria were spontaneously reported to EudraVigilance from EU/EEA countries; 1,149 of these reported a fatal outcome. By the same date, about 68.4 million doses of Vaxzevria had been given to people in the EU/EEA.
Australia's ATAGI noted on August 25, 2021, that International data continues to demonstrate the risk of TTS following the second dose of AstraZeneca (Vaxzevria) is much lower than the risk following a first dose (estimated internationally to be 1.8 per million-second doses). Accordingly, ATAGI reinforced the importance of completing a two-dose schedule with the same brand.
As of August 25, 2021, the United Kingdom Medicines & Healthcare Regulatory Agency (MHRA) had received 1,036 Yellow Card reports of suspected adverse drug reactions to the Vaxzevria vaccine in which the patient died shortly after vaccination; 97 reports of myocarditis, and 155 reports of pericarditis following use of the vaccine; 813 spontaneous adverse reactions associated with anaphylaxis or anaphylactoid reactions; and 415 cases of major thromboembolic events (blood clots) with concurrent thrombocytopenia (low platelet counts) following vaccination with COVID-19 Vaccine AstraZeneca. The nature and frequency of these reports are in line with that reported in previous updates, says the MHRA, the Executive Agency of the UK Department of Health and Social Care.
The EMA confirmed on September 17, 2021, the evidence to identify particular risk factors that make TTS more likely. Although spontaneous reports when put in relation to the exposure have suggested that the risk may be higher in women and in younger adults, and lower after the second compared to the first dose, the limitations of the way the data is collected mean that none of these differences could be confirmed.
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, including the EU, to ensure broad and equitable access to the vaccine at no profit for the pandemic duration. The Company is rapidly progressing 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 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.
As of July 29, 2021, the vaccine has been granted conditional marketing authorization or emergency use in more than 80 countries across six continents. More than 800 million doses of COVID-19 Vaccine AstraZeneca have been supplied to more than 170 countries worldwide, including more than 100 countries through the COVAX Facility.
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 (AZD2816) 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. AZD2816 has been designed using the same adenoviral vector platform as Vaxzevria, with minor genetic alterations to the spike protein based on the Beta (B.1.351, South African) variant.
The first participants in Phase II/III trial for the new COVID-19 variant vaccine AZD2816 were vaccinated on June 27, 2021, to assess its safety and immunogenicity in both previously vaccinated and unvaccinated adults. The trial will recruit approximately 2,250 participants across UK, South Africa, Brazil, and Poland. AZD2816 will be administered to individuals who have previously been fully vaccinated with two doses of Vaxzevria or an mRNA vaccine at least three months after their last injection. In non-vaccinated individuals, AZD2816 will be given two doses, four or twelve weeks apart, or given as a second dose following a first dose of Vaxzevria four weeks apart.
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. However, 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.
On August 19, 2021, Oxford University published a study that concluded by saying, 'SARS-CoV-2 vaccination still reduces new infections, but the vaccine's effectiveness and attenuation of peak viral burden are reduced with Delta virus variant.
Vaxzevria COVID-19 Vaccine AstraZeneca for Pregnant Wommen
While pregnancy puts women at higher risk of severe COVID-19, very little data are available to assess vaccine safety in pregnancy, wrote the WHO on September 2, 2021. Therefore, pregnant women may receive the vaccine if the benefit of vaccinating a pregnant woman outweighs the potential vaccine risks.
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.
The UK's MHRA approved the Vaxzevria COVID-19 vaccine for use in booster dosing on September 10, 2021.
On September 17, 2021, the EMA’s recommendation remains to continue giving the second dose of Vaxzevria between 4 and 12 weeks after the first, in line with the product information. There is no evidence that delaying the second dose has any influence on the risk of TTS. Where the second dose of Vaxzevria is not given, no definitive recommendations on the use of a different vaccine for the second dose can be made at present (see EMA/ECDC Joint Statement).
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
September 2, 2021 - The WHO published an updated safety review of the Vaxzevria vaccine. This article provides a summary of the interim recommendations; you may access the guidance document here.
August 25, 2021 - A non-peer-reviewed study found the Vaxzevria vaccine demonstrated overall effectiveness against severe COVID-19 up to 80 years of age. These results suggest that individuals aged 90 years or older may benefit from an expedited third booster dose.
August 24, 2021 - The Australian Therapeutic Goods Administration confirmed the Vaxzevria vaccine is authorized for people 18 years and older.
August 19, 2021 - The journal Nature published a study, 'AstraZeneca COVID-19 vaccines are effective against the highly infectious Delta variant of SARS-CoV-2 — but their protection drops away over time.'
August 17, 2021 - The Lancet published a new study that concluded by saying 'the statistical analysis in this small study does not account for potential confounding factors. However, the robust inhibition of variants, including the delta variant, further supports heterologous ChAdOx1-S/BNT162b2 vaccination. If confirmed in a large study, our data also support a heterologous boost vaccination of individuals with completed homologous ChAdOx1-S vaccination, once humoral immunity declines and patients become susceptible to infection.'
August 6, 2021 - The U.S. FDA announced that it had found certain lots of Astra Zeneca COVID-19 vaccine substance manufactured at the Emergent facility in Baltimore, Maryland, acceptable for use for potential export. The AstraZeneca vaccine is not authorized for use in the U.S., but FDA understands that these AstraZeneca lots, or vaccines made from the lots, will now be exported for use.
July 28, 2021 - AstraZeneca announced rates of the very rare clotting disorder, thrombosis with thrombocytopenia syndrome (TTS), following the second dose of Vaxzevria, comparable to the background rate in an unvaccinated population. In a large real-world study, data published as a pre-print on The Lancet server from over one million individuals assessed the incidence rates of blood clotting disorders of thromboembolism and thrombocytopenia, including the very rare thrombosis with thrombocytopenia following vaccination with an mRNA vaccine or Vaxzevria. They compared them with expected rates in a general population and people with COVID-19. Safety profiles of Vaxzevria and the mRNA-based vaccine were similar and overall favorable. Very rare clotting disorders were observed with both vaccines, but these were in line with what would be expected in the general population and lower than those diagnosed with COVID-19. Follow-up time was not sufficient to report rates after two doses of Vaxzevria, though other studies have shown rates of rare blood clotting events to be lower after a second dose.
July 28, 2021 - AstraZeneca announced, 'Rates of the very rare clotting disorder, thrombosis with thrombocytopenia syndrome, following the second dose of Vaxzevria are comparable to the background rate in an unvaccinated population.'
July 27, 2021 - The Lancet published a global safety database analysis: Very rare thrombosis with thrombocytopenia after second AZD1222 dose.
July 22, 2021 - Total antibody levels appear to start declining from as early as six weeks after complete vaccination. They can reduce by more than 50% over 10 weeks, according to new data from UCL’s Virus Watch study.
July 16, 2021 - Real-world data from Canada suggested one dose of the AstraZeneca COVID-19 vaccine was protective against poor outcomes from the highly transmissible Delta variant.
July 15, 2021 - The Lancet published a new study: Spike-antibody waning after the second dose of the ChAdOx1 vaccine. A significant trend of declining S-antibody levels was seen with time for both ChAdOx1 (p<0·001), with levels reducing by about five-fold for ChAdOx1, between 21–41 days and 70 days or more after the second dose. This trend remained consistent when results were stratified by sex, age, and clinical vulnerability.
July 14, 2021 - The EMA published COVID-19 vaccine safety updates. They also indicate whether any safety information requires further investigation.
July 14, 2021 - The Government of Romania has decided to donate 100,000 doses of the AstraZeneca vaccine to Vietnam.
July 7, 2021 - The NEJM published a study focused on three patients with vaccine-induced immune thrombotic thrombocytopenia after receiving the AstraZeneca vaccine who improved with therapeutic plasma exchange. Argatroban treatment was monitored closely before, during, and after the exchanges, and only minimal aPTT variation was found, with no attributable bleeding. Patients 1 and 2 recovered despite their severe presentation. Patient 1 received rituximab after the fifth therapeutic plasma exchange. The platelet count for Patient 2 did not improve until IVIG (0.5 g per kilogram of body weight) was given after therapeutic plasma exchanges 4 through 7. Patient 3 underwent above-knee amputation, but therapeutic plasma exchange most likely prevented more extensive resection. No further thromboses occurred. We suggest considering therapeutic plasma exchange for thrombocytopenia and thrombosis that does not begin to abate after 5 days, continuing until platelet normalization. Earlier intervention could be considered. The usefulness of additional treatment with IVIG, glucocorticoids, and rituximab requires further study.
July 7, 2021 - Reuters reported Germany would donate its AstraZeneca vaccine inventory to less developed countries in August 2021.
June 28, 2021 - AstraZeneca announced a sub-analysis from the Oxford-led COV001 and COV002 trials published by the University of Oxford on the pre-print server of The Lancet, demonstrating antibody levels remain elevated baseline for at least one year following a single dose.
June 18, 2021 - The Lancet published a new study: Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 in HIV infection: a single-arm substudy of a phase 2/3 clinical trial. Interpretation: In this study of people with HIV, ChAdOx1 nCoV-19 was safe and immunogenic, supporting vaccination for those well controlled on ART.
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; 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 high effectiveness against the Alpha variant (B.1.1.7; formerly the ‘Kent’ variant) with an 86% reduction in 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 continuously generated and safety monitored regularly, readers need to consider the latest available information.
May 12, 2021 - The Lancet reported that mixing COVID-19 vaccines may produce more frequent mild to moderate reactions than standard vaccine dosing schedules, as confirmed by University of Oxford researchers.
May 10, 2021 - According to local media, Thierry Bretón confirmed the European Union has opted not to renew an order for AstraZeneca to supply its coronavirus vaccine after June 2021.
May 7, 2021 - The Joint Committee on Vaccination and Immunisation (JCVI) has advised the UK government on using the COVID-19 Oxford - AstraZeneca vaccine for people 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 the COVID Symptom Study app users 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. As a result, 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. However, 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 had 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. In addition, 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. In addition, 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 Australia's Oxford/AstraZeneca COVID-19 vaccine. This registration means the AstraZeneca vaccine has met the TGA’s rigorous safety, quality, and efficacy standards and will be provided 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 that Portugal's health ministry announced that the AstraZeneca COVID-19 vaccine should preferably be used with seniors aged 65.
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, according to a study, AstraZeneca confirmed that 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.
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. Therefore, 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 EMA’s scientific committee meeting for human medicines.
January 7, 2021 - The AP reports that South Africa 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.
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.
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 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.
November 8, 2020 - Melbourne-based CSL Limited confirmed manufacturing the University of Oxford - AstraZeneca AZD1222 COVID-19 vaccine candidate at its advanced manufacturing facility in Broadmeadows, Victoria.
October 19, 2020 - Thailand Ministry of Public Health, Siam Bioscience, SCG, and AstraZeneca has signed a Letter of Intent on the manufacturing and supplying 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.
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.
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. The company said that trial participants would receive either two doses of the experimental vaccine, dubbed AZD1222, four weeks apart, or a placebo.
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.
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 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 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 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.
July 17, 2020 - Moscow unveiled an agreement with AstraZeneca to produce a coronavirus vaccine developed by the firm and Oxford University.
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 9, 2020 - Serum Institute of India, the world's largest vaccine manufacturer, invested USD100 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.
May 21, 2020 - AstraZeneca has received more than $1 billion from the U.S. Health Department’s Biomedical Advanced Research and Development Authority developed 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.
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 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.