‘Overwhelmingly positive’: Fauci says ‘independent board’ has authority to end vaccine trials early and roll out immunizations

unnamed file
Credit: AFP

Although two ongoing clinical trials of 30,000 volunteers are expected to conclude by the end of the year, [Anthony] Fauci said an independent board has the authority to end the trials weeks early if interim results are overwhelmingly positive or negative.

The Data and Safety Monitoring Board could say, “‘The data is so good right now that you can say it’s safe and effective,'” Fauci said. In that case, researchers would have “a moral obligation” to end the trial early and make the active vaccine available to everyone in the study, including those who had been given placebos — and accelerate the process to give the vaccine to millions.

In trials of this size, researchers will know if a vaccine is effective after as few as 150 to 175 infections, said Dr. Robert Redfield, director of the Centers for Disease Control and Prevention, in a call with reporters Friday.

Related article:  Even one can of soda a day could increase risk of heart disease, study says

“It may be surprising, but the number of events that need to occur is relatively small,” Redfield said.

Follow the latest news and policy debates on agricultural biotech and biomedicine? Subscribe to our newsletter.

Researchers will continue to follow vaccinated volunteers for a full year to look for long-term side effects, Redfield said.

And Fauci acknowledged that cutting a trial short could undermine public confidence in COVID vaccines. One American in three is unwilling to get a COVID vaccine, according to a recent Gallup Poll.

Read the original post

Outbreak
Outbreak Daily Digest
Biotech Facts & Fallacies
Talking Biotech
Genetics Unzipped
Infographic: What are mRNA COVID-19 vaccines and how do they work?

Infographic: What are mRNA COVID-19 vaccines and how do they work?

As of 1 December 2020, thirteen vaccines have reached the final stage of testing: where they are being given to ...
favicon

Environmental Working Group: EWG challenges safety of GMOs, food pesticide residues

Known by some as the "Environmental Worrying Group," EWG lobbies ...
m hansen

Michael Hansen: Architect of Consumers Union ongoing anti-GMO campaign

Michael K. Hansen (born 1956) is thought by critics to be ...
News on human & agricultural genetics and biotechnology delivered to your inbox.
glp menu logo outlined

Newsletter Subscription

Optional. Mail on special occasions.
Send this to a friend