Pfizer’s COVID-19 Vaccine Expected To Receive Full FDA Approval By Labor Day, Report Says


A health worker prepares a dose of Pfizer-BioNTech COVID-19 vaccine to inoculate a minor at a vaccination center in Asuncion, July 23, 2021. – Paraguay has started vaccinating children and adolescents aged 12 to 17 years with illnesses. (Photo by NORBERTO DUARTE / AFP via Getty Images)

KANSAS CITY, Kan. (WDAF) – Pfizer’s coronavirus vaccine may soon be the first to be fully approved by the Food and Drug Administration.

The New York Times reports that due to the delta variant and the growing number of COVID-19 cases, the FDA has accelerated the timeline to fully approve Pfizer-BioNTech’s COVID-19 vaccine. According to the New York Times, the agency wants to give full approval by Labor Day.

“I don’t think it’s too fast,” said Dr. Dana Hawkinson, medical director of infection prevention at the University of Kansas Health System. “I think what we’ve seen during this pandemic with anything, whether you look at the Remdesivir, the monoclonal antibodies, the vaccines, is that all of these steps were done diligently and carefully. The data was analyzed, it was collected, all the testing took place, it just sped up the way they did.

Millions of people have received the Pfizer version of the vaccine since the FDA granted the company Emergency Use Clearance (EUA) late last year. Moderna and Johnson and Johnson’s vaccines also have emergency clearance.

Under the EUA, the FDA cleared the coronavirus vaccines for use even though they were not fully approved because COVID-19 was considered a life-threatening emergency and there was no other alternative treatment available. .

Since the UAA was granted, the FDA has spent months evaluating vaccines and data from various studies and vaccine manufacturers. The administration considers all of these results before granting full approval to a drug.

So why is full approval important for something millions of people have already received?

Until full approval is granted, the three coronavirus vaccines currently offered in the United States are technically considered experimental treatments. Hospitals, universities and other businesses have said they don’t feel comfortable requiring employees to get vaccinated until the FDA gives their approval. Once this happens, the vaccine will no longer be considered experimental. They also hope it will prevent legal ramifications that could surface in forcing workers to take an experimental vaccine.

Health experts have also said that many unvaccinated people use the experimental status of vaccines as a reason they don’t want to be vaccinated. Once it is fully approved, experts hope it will convince people hesitant to vaccinate that vaccines are safe to get.

“I think this is a game changer. It will be fully authorized. I think you’ll see a lot of businesses and other places saying we’re going to require vaccination. I think it’s going to start happening earlier and earlier. And I think it’s probably in a lot of ways, if we’re going to protect ourselves as a society from COVID-19, it’ll be the right thing to do, ”Dr. Steve Stites, chief medical officer at the University of Kansas Health System, said Wednesday in an update with the hospital.

“There are very few other drugs, if any, that have (been given to people)… a billion times and studied around the world. I think there has been a lot of attention on these drugs. , and a lot of reports that that side effect or that side effect that people had to go and evaluate. And because there are so many people, we were able to eliminate all these side effects. So I’m very confident that , in particular, these messenger RNA drugs will be very safe, ”Stites said.

Moderna sought full FDA approval on June 1. The FDA said it needed the company to submit additional information before it was considered for full approval.

Johnson and Johnson has yet to seek full approval.

If you’ve decided it’s time to get your coronavirus vaccine, vaccines are widely available.

Just send a postal code to GETVAX (438829) for information on the nearest place to get the vaccine. The option is also available in Spanish by sending a postal code by SMS to VACUNA (822862).

You will get information on where to get vaccinated, what vaccines are available and how to make an appointment or if you can just go for an injection.


Comments are closed.