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UB med school doctor: FDA approval expected by September for COVID vaccines

"The FDA came out this week and said they were moving with all possible speed," said Dr. Nancy Nielsen, associate dean with the UB Jacobs School of Medicine.

BUFFALO, N.Y. — With reports last week that Erie County had shifted to a higher level "substantial" COVID infection rate and with general talk of more cases spreading around the country,  there may be more pressure than ever to get full FDA approval for the COVID vaccines.

You may recall that the vaccines for COVID, which are Pfizer-BioNTech, Moderna, and Johnson & Johnson have been used with the "EUA" or emergency use authorization tag for months now by doctors and public health officials to get the public to get their shots. 

Currently we're at about the 66 percent mark or two thirds of residents with vaccinations here in New York State. 

Now that push to go from that EUA, which came first for Pfizer in December, and then to ramp up to the full approval level may be accelerated. The STAT News medical news site reports that the Federal Food and Drug Administration was adopting an all hands on deck policy and putting a real priority on getting that full approval on a faster schedule. That is just like development of the vaccines in the first place. 

Dr. Nancy Nielsen, associate dean with the UB Jacobs School of Medicine, says that process is underway. 

"The FDA came out this week and said they were moving with all possible speed," Nielsen said. "Most experts who have watched this think that as early as early September the FDA could give full approval to Pfizer and probably to Moderna as well. Normally the process of going to full approval takes about 10 months and they originally said that they would accelerate it to six months. But they've had everything now and I think people who are FDA watchers say probably in September we could have full approval."          

NBC News and the Washington Post report there is substantial political pressure to get that full FDA approval beyond the EUA. 

Nielsen points out it may help to overcome that so-called vaccine hesitancy among some people who have yet to get the shots. 

"That will be helpful," Nielsen said. "Some people have been waiting for that. Frankly to me it's not a big difference, but there are those who think that they won't take the vaccine unless it's got full approval." 

And it may strengthen the legal basis for government and private businesses in making that case for vaccine mandates with employees who may have thought about legal action with just emergency use authorization. 

As we reported previously, the Hogan Willig law firm already said it was working on a lawsuit against a vaccine or testing mandate for state workers and that emergency use authorization could be at the core of their case as employees technically should have a choice.   

But some feel that factor may be gone in September with full FDA approval if it occurs. 

 

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