How the Pfizer vaccine received quick approval

Local News

HARLINGEN, Texas (KVEO) — Less than a year after the first confirmed case of COVID-19 in the United States, a vaccine is already being given to frontline workers.

This rapid approval for the Pfizer vaccine might have some people concerned about side effects because the vaccines for COVID-19 were developed and tested at a speed far quicker than even the quickest vaccine trials in the past.

“At its most accelerated phase its been about two years,” said Dr. Christopher Romero, the medical director for Pan-American Clinical Research while discussing the previous quickest vaccine approval. “That’s kind of been the benchmark for success to date.”

The speed of the creation of the Covid-19 vaccine is thanks in part to the FDA granting first the Pfizer vaccine, and soon the Moderna vaccine, Emergency Use Authorization (EUA).

Romero explained that EUA “is pathway for approving vaccines and therapies for diseases of significant concern.”

The Emergency Use Authorization allows companies making these vaccines to shorten the time-frame of clinical trials, but the vaccines are still held to a strict standard.

“Emergency use authorization for approval of these vaccines does not mean they haven’t gone through any review or evaluation for safety or efficacy,” said Romero.

During trials, the Pfizer vaccine was determined to be 95% effective at preventing people from getting Covid-19. According to a memo released by the FDA, the vaccine has not yet shown if it stops people who do get the disease from spreading it.

In that memo, the FDA explains that research on the vaccine is ongoing, and will continue even as the vaccine is administered to frontline workers nationwide, and wider distribution takes place.

The goal is to have the vaccines fully approved under the normal approval process. The vaccine was only granted the EUA due to the severity of the pandemic, and positive initial outlook of the phase-three trials.

Excerpt from an FDA press release on the issuance of the Emergency Use Authorization for the Pfizer vaccine.

Like with other vaccines, people with drug allergies or immune diseases should consult with their primary care physician before getting the vaccine. But there doesn’t appear to be any major risks for the majority of people.

“Overall, for the general population, the emergency use authorization should be seen as a really positive development for our path out of the horror show we’ve seen with Covid-19,” said Romero.

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