AstraZeneca and European Commission reach settlement agreement over vaccine supply, ending litigation

AstraZeneca and the European Commission have reached an agreement that ends legal proceedings over the execution of the Advance Purchase Agreement for the delivery of the COVID-19 vaccine Vaxzevria (ChAdOx1-S [Recombinant]).

Under the agreement, AstraZeneca commits to deliver 60 million doses of the vaccine by the end of the third quarter 2021, 75 million by the end of the fourth quarter 2021 and 65 million by the end of the first quarter 2022. Member States will be provided with regular delivery schedules, and capped rebates will apply in the event of any delayed doses.

Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said: “I’m very pleased that we have been able to reach a common understanding which allows us to move forward and work in collaboration with the European Commission to help overcome the pandemic. We are fully committed to manufacture Vaxzevria for Europe following the release for supply of more than 140 million doses to date at no profit. We are also looking forward to working with the European Commission in a joint effort to further support COVAX.”

Legal proceedings by the European Commission against AstraZeneca were initiated in Brussels on 21 April 2021. Court hearings were scheduled at end of September 2021.

To date, AstraZeneca and its partners have supplied more than 1.1 billion doses of vaccine to over 170 countries; approximately two thirds have gone to low- and lower-middle-income countries.

In clinical trials, Vaxzevria demonstrated 100% efficacy against severe disease and hospitalisation after two doses.1,2 Real-world evidence shows the vaccine is around 90% or higher effective against WHO-identified variants of concern.3 Vaxzevria has been shown to be generally well tolerated. Incidents of thrombosis with thrombocytopenia (TTS) have been reported in a small number of people. Early diagnosis allows appropriate treatment of these events4,5 and there is no elevation of the risk of TTS at the second dose, compared to the rates expected in the general population.6

Vaxzevria (ChAdOx1-S [Recombinant])

Vaxzevria was co-invented by the University of Oxford and its spin-out company, Vaccitech. 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.

The vaccine has been granted a conditional marketing authorisation or emergency use in more than 90 countries across six continents. More than one billion doses of Vaxzevria/COVID-19 Vaccine AstraZeneca have been supplied to more than 170 countries worldwide, including more than 129 countries through the COVAX Facility.

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.

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References

1 AstraZeneca PLC. AZD1222 US Phase III primary analysis confirms safety and efficacy. Available at: https://www.astrazeneca.com/media-centre/press-releases/2021/azd1222-us-phase-iii-primary-analysis-confirms-safety-and-efficacy.html [Last accessed: Aug 2021]

2. Vasileiou E, et al. Effectiveness of first dose of COVID-19 vaccines against hospital admissions in Scotland: national prospective cohort study of 5.4 million people. [Online]. Available at: https://www.ed.ac.uk/files/atoms/files/scotland_firstvaccinedata_preprint.pdf [Accessed: 24 Feb 2021]

3. Public Health England. Effectiveness of COVID-19 vaccines against hospital admission with the Delta (B.1.617.2) variant. Available at: https://khub.net/web/phe-national/public-library/-/document_library/v2WsRK3ZlEig/view_file/479607329?_com_liferay_document_library_web_portlet_DLPortlet_INSTANCE_v2WsRK3ZlEig_redirect=https%3A%2F%2Fkhub.net%3A443%2Fweb%2Fphe-national%2Fpublic-library%2F-%2Fdocument_library%2Fv2WsRK3ZlEig%2Fview%2F479607266  [Last accessed: July 2021]

4. NICE. COVID-19 rapid guideline: vaccine-induced immune thrombocytopenia and thrombosis (VITT). Available at: https://www.nice.org.uk/guidance/ng200/resources/fully-accessible-version-of-the-guideline-pdf-pdf-51036811744 Last accessed July 2021.

5. United Nations. Guidelines: Diagnosis and Management of Thrombosis with Thrombocytopenia Syndrome (TTS) following Adenovirus Vectored COVID-19 Vaccinations. Available at https://www.un.org/sites/un2.un.org/files/coronavirus_vipitguidance.pdf. Accessed August 2021.

6. P. Bhuyan et al. Thrombosis with thrombocytopenia after second AZD1222 dose: a global safety database analysis of rare cases. Lancet. Available at: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)01693-7/fulltext. Accessed July 2021.

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