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article imageFDA holds public meeting with advisory group on COVID-19 vaccines

By Karen Graham     Oct 22, 2020 in Health
With vaccines against COVID-19 inching closer, U.S. regulators took an unusual step Thursday in asking outside scientists: Are the government’s standards high enough to adequately judge the shots?
In what is probably the first of many meetings, the Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee, or VRBPAC, met on Thursday to consider Covid-19 vaccines.
The Associated Press is reporting that the FDA has a huge responsibility ahead of it in the next few months, and that is making a decision on whether to allow the use of the first vaccines against the coronavirus, amid growing public fears that politics is overriding science.
And this is one reason the meeting was heard, viewed, captioned, and recorded through an online teleconferencing platform today. Open for debate was whether the guidelines FDA has set for vaccine developers are rigorous enough. Interest is so high, FDA aired the meeting on YouTube.
“Vaccine development can be expedited. However, I want to stress that it cannot — and must not — be rushed,” Dr. Marion Gruber, director of FDA’s vaccine research office, told the advisers. Gruber explained that public scrutiny of the process “is critical to build trust and confidence” in whichever vaccines emerge.
One of the key questions the advisory committee took up was exactly how much data FDA needs to be sure a vaccine is safe and effective? And this is an important question to answer because Moderna announcing on Thursday it had reached full enrollment in its Phase 3 trials of the vaccine.
This now leaves another question to be answered: If the FDA allows emergency use of a vaccine before final testing is finished, will that destroy chances of ever learning just how well the vaccine - as well as their competitor's vaccines still under trial - really work?
“We can’t lose sight of the fact that it is in our societal interest to see these trials to completion,” said Dr. Luciana Borio, a former FDA acting chief scientist who planned to watch the advisers’ debate, reports NBC News.
VRBPAC will also need to look closely at a number of vaccines made with different technologies that each have pros and cons. “The first vaccine is not necessarily the best vaccine,” cautioned Dr. M. Miles Braun, a former FDA scientist now with Georgetown University School of Medicine. If the trials aren't allowed to finish, it may be difficult or impossible to ever know for sure.
But however one looks at it, this is a critical and you could say, historic time in the FDA's 114-year history. The Trump administration has spent billions of dollars to rush a coronavirus vaccine through a research process that usually takes years, and the FDA is now facing added pressure due to the Trump administration fueling public skepticism that politics could overrule science.
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