KETTERING, Ohio (WDTN) – A recent New York Times article suggests that the Food and Drug Administration may fully approve Pfizer’s COVID-19 vaccine as early as Labor Day.
“We’re elated about it. There’s been a lot of pressure on the FDA from all kinds of constituents saying ‘Lets get this fully approved,'” said Dr. Jeffrey Weinstein, patient safety officer at Kettering Health.
Though the CDC has reported that over 192 million Americans have at least received their first vaccine dose, news of a Pfizer’s full FDA approval is positive.
Weinstein said the process to get to full FDA approval isn’t a short one. “They look at, you know, all the data that’s been accumulated in all the clinical trials from Phase 1 to Phase 3.”
Dan Suffoletto, public information supervisor at Public Health – Dayton & Montgomery County, said they hope this approval gets unvaccinated people in the county to rethink their decision. “This just goes to show how safe the vaccine is. So, it’ll put some peoples mind at ease and hopefully increase that vaccination rate.”
Nate Smith, communications coordinator for the Clark County Combined Health District, said the county is seeing an uptick in cases. “Approaching 70 cases already this week. We’re definitely seeing our numbers tick up. So, it’s kinda an all hands on deck approach towards education or vaccination right now.”
Smith is also excited for an earlier than expected approval so cases can hopefully go back down. Weinstein said many patients he’s seen who are unvaccinated have expressed concerns over vaccine emergency approval, and feels that an FDA approval might put people at ease.
“I suspect that there will be a population of people who will go out just on their own and get vaccinated now. Then, there will be those where it becomes a mandate and they have to get vaccinated for their job,” said Weinstein.
WDTN reached out to the FDA for comment on a specific timeline, and received this statement:
We cannot comment on specific timing. As we have said, our ongoing review of the biologics license application for the Pfizer-BioNTech COVID-19 vaccine is moving forward as rapidly as possible in keeping with the high-quality complete assessment that the public expects from the FDA. We recognize that for some, the FDA approval of COVID-19 vaccines may bring additional confidence and encourage them to get vaccinated. Acknowledging the urgency related to the current state of the pandemic, we have taken an all-hands-on-deck approach, including identifying additional resources such as personnel and technological resources from across the agency and opportunities to reprioritize other activities, in order to complete our review to help combat this pandemic surge.The U.S. Food and Drug Administration