How Pfizer’s FDA approval differs from its Emergency Use Authorization

National News

RALEIGH, N.C. (WNCN) – The Pfizer vaccine received full FDA approval on Monday morning. It could impact vaccine mandates for employers or schools.

The approval does not cover third doses for the immunocompromised, boosters for the general public or vaccines in children under 16. It does not apply to the Moderna or Johnson and Johnson vaccines either.

Emergency Use Authorization and not FDA approval was what many people have cited as their reason for not getting the COVID-19 vaccines. A survey from the Kaiser Family Foundation found 31 percent of people who are unvaccinated would get the shot if it moved from EUA to full approval. However, another 49 percent would still want to ‘wait and see’ after FDA approval.

Is there a real difference between the two?

Under the FDA approval process, testing and clinical trials happen first. That’s then followed by approval, mass production and distributions. EAU allows for testing and mass production to happen simultaneously. It is followed by authorization then distribution.

Before approving a drug, vaccine or other product, the FDA wants to see enough data to support it is safe and effective. EUA’s may be granted during emergency declarations. Under it, the FDA allows a product to be used based on the best available evidence rather than waiting on all the evidence to come in. With an EUA, the FDA weighs the risks and benefits associated with the product. An EUA still requires rigorous testing and clinical trials.

For EUA of the COVID-19 vaccines, the FDA asked for at least two months of safety data for at least 3,000 people in the clinical trials. That data included information about serious adverse events. Pfizer’s vaccine was based on a study that tracked 44,000 people 16 and older for at least two months.

For full approval, the FDA wanted to see six months’ worth of safety data. They also wanted to make sure the facility making the vaccines could manufacture the product with assurance of “product quality and consistency”.

In approving Pfizer’s vaccine, the FDA looked at real-world safety data following the vaccine rollout.

The FDA said they reviewed updated data from the clinical trials analyzing vaccine effectiveness data from about 20,000 vaccine and 20,000 placebo recipients. The vaccine was 91 percent effective in preventing COVID-19 disease. 

The FDA said more than half of the trial participants were followed for at least four months. About 12,000 recipients were followed for at least six months.

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