US President Donald Trump said the COVID-19 vaccine by multinational pharmaceutical and biopharmaceutical company AstraZeneca has reached Phase 3 clinical trials in the US and is very close to being finalised for approval.
“I am pleased to announce that AstraZeneca’s vaccine has reached Phase 3 clinical trials and has joined various vaccines that are very close to the end. In the United States, we are doing things that people thought were not possible,” Trump said in a White House press conference.
Trump said that process could have taken years but his administration did in a matter of months.
Closer to a Cure: @POTUS announces Astrazeneca vaccine has reached its phase three clinical trial, joining other vaccines that are getting closer towards approval under Operation Warp Speed. #MAGA #AmericaFirst #Dobbs pic.twitter.com/3IgSuKyNtu
— Lou Dobbs (@LouDobbs) August 31, 2020
AstraZeneca also announced that its vaccine, developed by researchers at Oxford University, UK, will enroll approximately 30,000 adult volunteers at 80 sites in the US.
“Trial centres across the US are 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,” AstraZeneca said in a statement. The vaccine AZD1222 is already undergoing late-stage clinical trials in the UK, Brazil and South Africa, with additional trials planned in Japan and Russia. The trials, together with the U.S. Phase III study, aim to enroll up to 50,000 participants globally.
The phase 3 trial is being implemented as part of Operation Warp Speed in the US, which aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021.
US Food and Drug Administration Commissioner Stephen Hahn is willing to consider authorising a vaccine before the completion of Phase 3 clinical trials if the evidence shows the benefits of doing so outweigh the risks. Such an authorisation might only apply to certain groups for whom the vaccine is shown to be more effective, or safer, he told the Financial Review.
“Let’s say for example, that we have evidence that the vaccine is safe and effective in an elderly population. Well, we all know they’re the ones at risk for deaths related to COVID-19. Should we sit on those data and not act upon them?”
“We are going to apply the standard that’s appropriate for an emergency, just like a doctor would in the emergency room.”
AstraZeneca with partners Oxford University, and Pfizer with partner BioNTech, have said they could have data by October to support US emergency use authorization or approval of their respective vaccines.
The FDA has scheduled a public meeting of its vaccine advisory committee for 22 October, which is two weeks before the US election. If a vaccine developer applies for emergency authorisation, this will be the first chance for the committee to discuss it, although authorisation will not be announced until later.