Vaxzevria receives full Marketing Authorisation in the EU for the prevention of COVID-19

Full Marketing Authorisation based on totality of efficacy and safety data
confirming the benefits of Vaxzevria

LONDON, UK I November 01, 2022 I AstraZeneca's COVID-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]), has been granted full Marketing Authorisation (MA) in the European Union (EU).

Vaxzevria was originally granted a conditional Marketing Authorisation (cMA) due to the urgency of the COVID-19 pandemic. As there continues to be sufficient evidence of safety and efficacy confirming the benefits of Vaxzevria, the European Medicines Agency (EMA) has now granted a full MA. This decision follows positive recommendation for a full MA by The Committee for Medicinal Products for Human Use (CHMP) of the EMA.

The MA covers the use of Vaxzevria in both a primary vaccination series, and as both a heterologous (with an approved mRNA COVID-19 vaccine) or homologous (all the same vaccine) third dose booster.

Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, AstraZeneca, said: “The move from conditional to full marketing authorisation for Vaxzevria is an important confirmation by the EMA of the safety and efficacy of Vaxzevria, demonstrating that the benefits continue to outweigh the potential risks. Vaxzevria is estimated to have helped save over six million lives in the first year of vaccination, which reflects the strength of the evidence showing Vaxzevria’s protection against severe disease and death caused by COVID-19.”

Vaxzevria has been demonstrated to be effective against all forms of COVID-19 from mild symptomatic to severe disease including hospitalisation and death, according to clinical studies and real-world evidence. These include an expert review of data from 52 real-world studies that showed that Vaxzevria and the available mRNA COVID-19 vaccines provide equally effective protection against hospitalisation and death from COVID-19 following three doses.1 There is also a substantial body of evidence supporting boosting with Vaxzevria following all primary vaccination schedules tested to date.2-14

AstraZeneca and its global partners have released over three billion doses of Vaxzevria to more than 180 countries, and approximately two-thirds of these doses have been delivered to low- and lower-middle-income countries. In the first year of its roll-out, it is estimated that Vaxzevria has helped save more than six million lives worldwide.15

Notes

Vaxzevria (ChAdOx1-S [Recombinant], formerly AZD1222)
AstraZeneca COVID-19 vaccine was invented by the University of Oxford. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

Vaxzevria is a ‘viral vector’ vaccine, which means a version of a virus that cannot cause disease is used as part of the vaccine, leaving the body knowing how to fight it if it is exposed to the real virus later. This vaccine technology has been used by scientists over the past 40 years to fight other infectious diseases such as the flu, Zika, Ebola and HIV.

Vaxzevria is estimated according to model outcomes to have helped save over six million lives in the first year of vaccination.15 Vaxzevria has an acceptable safety profile, according to clinical studies and real-world evidence from tens of millions of people globally.  Based on the millions of people vaccinated with Vaxzevria, very common adverse reactions reported included: headache, nausea, myalgia, arthralgia, injection site tenderness/pain/warmth/pruritus, fatigue, malaise, pyrexia, and chills. The majority of adverse reactions were mild to moderate in severity and usually resolved within a few days of vaccination. Vaxzevria is approved for COVID-19 primary vaccination schedule and first booster on top of a primary schedule in both homologous and heterologous settings.

Under a sub-license agreement with AstraZeneca, the vaccine is manufactured and supplied by the Serum Institute of India under the name COVISHIELD.

AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

References

1. Solante R, Alvarez-Moreno C, Burhan E et al. Expert Review of Global Real-World Data on COVID-19 Vaccine Booster Effectiveness & Safety during the Omicron-dominant phase of the pandemic. 6 September 2022, REPRINT (Version 1) available at Research Square. Including Supplementary Tables. https://www.researchsquare.com/article/rs-2015733/v1.  Accessed September 2022.

2. Munro APS, et al. Safety and immunogenicity of seven COVID-19 vaccines as a third dose (booster) following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK (COV-BOOST): a blinded, multicentre, randomised, controlled, phase 2 trial. The Lancet. 2021; 398, P2258-2276. Available at: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02717-3/fulltext. Accessed: September 2022.

3. AstraZeneca press release, 13 January 2022. New data from ongoing trial showed increased antibody response against Beta, Delta, Alpha and Gamma variants following third dose booster with Vaxzevria. Available at: https://www.astrazeneca.com/media-centre/press-releases/2022/new-vaxzevria-data-further-support-its-use-as-third-dose-booster.html. Accessed: September 2022.

4. Jara A, et al. Effectiveness of Homologous and Heterologous Booster Shots for an Inactivated SARS-CoV-2 Vaccine: A Large-Scale Observational Study. Available at SSRN: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4005130. Accessed: September 2022.

5. Vargas, L., Valdivieso, N., Tempio, F. et al. Serological study of CoronaVac vaccine and booster doses in Chile: immunogenicity and persistence of anti-SARS-CoV-2 spike antibodies. BMC Med 20, 216 (2022). Available at: https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-022-02406-0  Accessed September 2022

6. Ramasamy MN, et al. #04443 Immunogenicity and safety of AZD1222 (ChAdOx1 nCoV-19) and AZD2816 as third-dose boosters in adults previously vaccinated with AZD1222 or an mRNA vaccine. Results presented at a Late Breaking Abstract Session at ECCMID 2022; April 23-26, 2022; Lisbon, Portugal.

7. Liu X, et al. Persistence of immunogenicity after seven COVID-19 vaccines given as third dose boosters following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK: three-month analysis of the COV-BOOST trial. Including Supplementary Appendix. Journal of Infection. 2022; 84, P795-813. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8993491/ Accessed: September 2022.

8. Andrews N, et al. Covid-19 Vaccine Effectiveness against the Omicron (B.1.1.529) Variant. Covid-19 Vaccine Effectiveness against the Omicron (B.1.1.529) Variant. N Engl J Med 2022; DOI: 10.1056/NEJMoa2119451. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa2119451?query=featured_home. Accessed: September 2022.

9. Kirsebom F, et al. Knowledgehub 2022. Effectiveness of ChAdOx1-S COVID19 Booster Vaccination against the Omicron and Delta variants in England. Preprint available from: Effectiveness of ChAdOx1-S COVID-19 Booster Vaccination against the Omicron and Delta variants in England (khub.net). Accessed: September 2022.

10. Dejnirattisai W. et al. SARS-CoV-2 Omicron-B.1.1.529 leads to widespread escape from neutralizing antibody responses. 2022. Cell 185, 467-484. Available at:  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8723827/ Accessed September 2022

11. Costa Clemens SA, et al. Heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine in Brazil (RHH-001): a phase 4, non-inferiority, single blind randomised study. The Lancet. 2022; 399, P521-529. Available at: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00094-0/fulltext. Accessed: September 2022.

12. Chariyalertsak S, et al. Effectiveness of heterologous 3rd and 4th dose COVID-19 vaccine schedules for SARS-CoV-2 infection during delta and omicron predominance in Thailand. Available at: https://www.researchsquare.com/article/rs-1792139/v1. Accessed: September 2022

13. Flaxman A, et al. Reactogenicity and immunogenicity after a late second dose or a third dose of ChAdOx1 nCoV-19 (AZD1222) in the UK: a substudy of two randomized controlled trials (COV001 and COV002). The Lancet. 2021; 398, P981-990. Available at: https://www.thelancet.com/article/S0140-6736(21)01699-8/fulltext. Accessed: September 2022.

14. Intawong K, et al. Heterologous third and fourth dose vaccine to reduce severity and mortality in COVID-19 patients during delta and omicron predominance: A cohort study in Chiang Mai, Thailand. Research Square 2022. Preprint published online, not peer reviewed, available at: https://www.researchsquare.com/article/rs-1973470/v1. Accessed September 2022.

15. Data estimates based on model outcomes from separate analyses conducted by Airfinity and Imperial College, United Kingdom. AstraZeneca Data on File. DoF Ref – 156573, 11 July 2022. AstraZeneca UK Ltd

SOURCE: AstraZeneca

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