Final approval for COVID-19 vaccine expected by September: NJ doctor explains
New Jersey Health Department data indicates the Delta variant is now accounting for 9 out of 10 new infections in the Garden State, and state officials continue to plead with residents who are not vaccinated to roll up their sleeves and get the shot.
But some individuals are still reluctant because the vaccines haven’t been given full approval by the U.S. Food and Drug Administration.
So far the Pfizer, Moderna and J&J COVID-19 vaccines have only received an Emergency Use Authorization, but Rutgers University infectious disease expert and epidemiologist Dr. Stanley H. Weiss, who is also a professor at the Rutgers New Jersey Medical School and the School of Public Health, said there’s a good reason for this.
The vaccines were approved months ago – why are they still being given under an emergency use authorization?
The usual timeframe for approval of a new vaccine is quite long with a lot of red tape and many layers of review to make sure it’s safe and it works.
“When you’re looking for efficacy you also want to have information from an extended period of time, and similarly with respect to safety, so you can’t instantaneously gather that information,” Weiss said.
Weiss said when an Emergency Use Authorization is granted, as was the case here, the FDA will require the pharmaceutical company producing the vaccine to submit a lot of follow-up data.
“It’s reviewed in-house at the FDA, it will then usually go to special advisory committees with experts, to help render and review opinions, and often with open hearings,” he said
How do we know the vaccines are really safe?
Weiss said there are multiple protocols in place to examine “what happens after people have been vaccinated, looking for any evidence of harm, those processes seem to be working well and show that the risk of side effects or serious illness is extremely low.”
Weiss noted more than 167 million Americans have been fully vaccinated so far, including 5.25 million Garden State residents, and the vaccines have an outstanding safety record.
“I don’t think there’s any reason for reluctance. I am fully vaccinated, I’ve encouraged all of my colleagues to be vaccinated including my friends and family,” he said.
He stressed it’s important to remember red tape was cut, but not safety requirements when the process to produce COVID-19 vaccines was accelerated.
“The Emergency Use Authorization was put in place so that with initial clinical trials there could be rapid review and approval for emergency use,” he said.
When will the FDA give final approval for the vaccines?
Dr. Weiss said he’s heard Pfizer is expected to submit a full application for approval within the next week or so and “once that is submitted then the FDA’s processes for rapid review and approval would go into effect.”
He noted that could mean final approval comes sometime next month for Pfizer, with Moderna and J&J following suit shortly after that.
“They know that everyone is interested in this issue and the FDA will very likely expedite every step the best it can,” he said.