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


“The FDA came out this week and said it was moving at full speed,” said Dr. Nancy Nielsen, associate dean of the UB Jacobs School of Medicine.

BUFFALO, NY – With reports last week that Erie County had moved to a “substantial” higher COVID infection rate and with general discussions about the spread of more cases in the country, there could be have more pressure than ever to get full FDA approval for COVID vaccines.

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

Currently we are about 66% or two-thirds of the residents vaccinated here in New York State.

Now that push to move from that EUA, which first happened for Pfizer in December, and then to move to the full approval level can be accelerated. The medical news site STAT News reports that the Federal Food and Drug Administration was adopting a general policy on the bridge and making it a real priority to get this full approval sooner. It’s exactly like developing vaccines in the first place.

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

“The FDA came out this week and said it was moving at any speed possible,” Nielsen said. “Most of the experts who have observed this believe that by early September the FDA could give full approval to Pfizer and probably Moderna as well. Normally the full approval process takes about 10 months and they initially have said they would speed it up. to six months. But they have it all now and I think FDA watchers are probably saying that in September we could have full approval. ”

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

Nielsen points out that it may help overcome this so-called vaccine hesitancy in some people who have not yet received the vaccines.

“It will be helpful,” Nielsen said. “Some people were expecting this. Frankly for me, it’s not a big difference, but there are those who think they will only take the vaccine if it is fully approved.”

And it can strengthen the legal basis for government and private companies by advocating for vaccine warrants with employees who may have thought about legal action with emergency use authorization only.

As we previously reported, law firm Hogan Willig has previously stated that it is working on a vaccine trial or testing warrant for state officials and that authorization to use emergency could be at the heart of their case as employees should technically have a choice.

But some believe this factor could go away in September with full FDA approval if it occurs.

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