Supply Chain News

AstraZeneca to Supply 400M Doses of COVID-19 Vaccine to EU

This is the first European Commission COVID-19 vaccine agreement that enables all EU member states to access the vaccine at no profit during the pandemic.

COVID-19 Vaccine

Source: Thinkstock

By Samantha McGrail

- AstraZeneca recently announced an agreement with the European Commission (EC) to supply up to 400 million doses of its COVID-19 vaccine, AZD122.

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AZD1222 was co-invented by the University of Oxford and its spinoff company, Vaccitech. 

This agreement furthers an existing agreement with Europe’s Inclusive Vaccines Alliance, led by Germany, France, Italy, and the Netherlands, to give all EU member states the option to access the vaccine in an efficient manner at no profit during the pandemic.

EU member states may also redirect doses to other European countries as well, AstraZeneca explained.

“This first vaccine agreement with the European Commission will ensure that millions of Europeans have access to the AZD1222 vaccine following its approval. With production in our European supply chain soon to be started, we hope to make the vaccine available widely and rapidly, with the first doses to be delivered by the end of 2020,” Pascal Soriot, chief executive officer of AztraZeneca said in the announcement. 

“I would like to thank the entire European Commission, and especially the Commissioner for Health and Food Safety, Stella Kyriakides, for their swift response in ensuring Europeans may soon be protected with a vaccine against this deadly virus, enabling our global society and economy to rebuild.”

Results from the ongoing Phase 1/2 COV001 trial were published in the The Lancet in July. The trial showed that AZD122 was tolerated and generated robust immune system response against COVID-19 in all participants.

The single blind, randomized controlled trial enrolled 1077 healthy adults aged 18 to 55 years with no history of COVID-19 between April 23 and May 21, 2020, in the UK.

The participants received ChAdOx1 nCoV-19 at a dose of 5×10 viral particles or MenACWY as a single injection. And overall, the candidate prompted neutralizing antibody responses against COVID-19. 

Specifically, it was detected in 91 percent of participants after a single dose when measured in microneutralization assay and in 100 percent of participants when measured in plaque reduction neutralization assay.

Humoral responses to SARS-CoV-2 spike protein peaked by day 28-post prime, and cellular responses were induced in all participants by day 14. After two doses, notable cellular and humoral immunogenicity was present in all participants. 

These results support large-scale evaluation of this candidate vaccine in an ongoing phase 3 program, according to the study. 

Currently, clinical development of AZD1222 is progressing globally with late-stage Phase 2/3 trials ongoing in the UK and Brazil, a Phase 1/2 trial in South Africa, and trials planned in the US, Japan, and Russia, AstraZeneca said. 

Results from the trials are expected later this year, depending on the rate of infection within the clinical trial communities.

Back in May, AstraZeneca enhanced its response to the pandemic by making AZD122 widely available to multiple countries and organizations.

Specifically, AstraZeneca will provide at least 400 million doses of the vaccine to multiple countries and has already secured total manufacturing capacity for one billion doses. 

The first deliveries will begin in September 2020 and a Phase 3 clinical trial could begin in fall 2020, but this decision is subject to data from the previous two studies.

“This pandemic is a global tragedy and it is a challenge for all of humanity. We need to defeat the virus together or it will continue to inflict huge personal suffering and leave long-lasting economic and social scars in every country around the world,” Pascal Soriot, chief executive officer at AstraZeneca said in the announcement in May.

AstraZeneca and governments around the world will expand capacity further over the next months to ensure the delivery and increased access of a global vaccine.