British pharmaceutical firm AstraZeneca announced that it has begun Phase 3 trials of its ts experimental coronavirus vaccine in the US.
With the announcement, AstraZeneca became the third company to start Phase 3 trials of a coronavirus vaccine in the US. The vaccine, which is being developed in partnership with Oxford University, has US federal government support.
The other two drugmakers currently doing Phase 3 trials, Moderna and Pfizer/BioNTec, also received funding from the federal government.
Phase 3 trials
AstraZeneca stated that it is “recruiting up to 30,000 adults aged 18 years or over from diverse racial, ethnic and geographic groups who are healthy or have stable underlying medical conditions, including those living with HIV, and who are at increased risk of infection from the SARS-CoV-2 virus.”
In the trials, participants will be given two active or placebo doses, spaced four weeks apart. The firm is currently conducting Phase 3 trials in the UK, Brazil and South Africa and is eyeing to start similar trials in Japan and Russia.
The US trials receive funding from the federal government’s Biomedical Advanced Development Authority and the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
NIH director Dr. Francis Collins said: “NIH is committed to supporting several Phase 3 vaccine trials to increase the odds that one or more will be effective in preventing COVID-19 and put us on the road to recovery from this devastating pandemic.”
“We also know that preventing this disease could require multiple vaccines and we’re investing in those that we believe have the greatest potential for success,” Dr. Collins added.
AstraZenca is aiming to enroll over 50,000 volunteers globally, including 30,000 in the US, as well as participants in Latin America, Asia, Europe and Africa.
Vaccine and deployment
The experimental vaccine, named AZD1222, combines a weakened version of a common cold virus that infects chimpanzees and a protein from the virus that causes Covid-19 to induce an immune response.
Oxford University created the vaccine prior to being licensed to AstraZeneca for further development. According to the pharma giant, it will work with governments and other organizations to produce billions of doses and create broad and equitable access to the vaccine, once it’s approved.
In a statement, AstraZeneca said: “Recent supply announcements with Russia, South Korea, Japan, China, Latin America and Brazil take the global supply capacity towards three billion doses of the vaccine.”
The World Health Organization (WHO) has warned nations to avoid rushing to develop coronavirus vaccines and to be vigilant in granting emergency use authorization, which is a shorter way to getting a vaccine in wide use than full approval, which can take many months.
Both China and Russia have announced that they will start distributing vaccines prior to completion of late-stage clinical trials. US Food and Drug Administration (FDA) Commissioner Dr. Stephen Hahn mentioned that if the US gets enough data from advanced stage trials, it might be possible to authorize a vaccine before the trials are completed.
However, AstraZeneca emphasized that it is committed to science and safety and that the vaccine will meet the strict requirements set by by global regulators.