FDA releases promising review of Pfizer COVID-19 vaccine

Coronavirus Vaccine

A person gets a dose of the coronavirus disease (COVID-19) vaccination of BioNTech and Pfizer in this undated handout photo, as Britain became the first western country to approve a COVID-19 vaccine, in Mainz, Germany. BioNTech SE 2020, all rights reserved/Handout via REUTERS ATTENTION EDITORS – THIS IMAGE HAS BEEN SUPPLIED BY A THIRD PARTY. NO RESALES. NO ARCHIVES

WASHINGTON (NewsNation Now) — U.S. health officials have made a review of Pfizer’s COVID-19 vaccine public Tuesday, confirming that the shots are strongly protective against the virus.

The Food and Drug Administration posted its review online ahead of its Thursday meeting with outside experts to discuss whether the shot should be authorized for emergency use.

The U.S. is still vetting the Pfizer shot, along with a similar vaccine made by competitor Moderna Inc, as Britain administers its first doses Tuesday.

Pfizer’s vaccine, developed with its German partner BioNTech, is expected to be endorsed by a panel of FDA advisers as soon as this week.

The panel will pick apart the FDA’s first-pass review before recommending whether the vaccine appears safe and effective enough for millions of Americans.

Under its contract with Pfizer, President Donald Trump’s administration committed to buying an initial 100 million doses. Since the vaccine requires two shots, the first batch will cover 50 million Americans.

If the FDA gives the greenlight, the first recipients would be health care workers and nursing home residents, according to plans laid out by each state.

Pfizer and its German partner BioNTech previously reported the shots appear 95% effective at preventing mild to severe COVID-19 disease in a large, ongoing study. That’s based on the first 170 infections detected. Only eight of the infections were among volunteers given the real vaccine while the rest had received a dummy shot.

That was measured soon after study participants got their second dose. What is still unknown is how long that protection lasts.

“We’re looking at the best possible data,” Dr. Paul Offit of Children’s Hospital of Philadelphia and an FDA adviser recently cautioned. “People worry, reasonably, how about six months later?”

The other critical issue is safety. Pfizer has reported no serious side effects. Some recipients experience flu-like reactions — including fever, fatigue or muscle aches — especially after the required second dose. It’s a sign the immune system is revving up, able to recognize and fight back if the real virus comes along.

Other questions on the FDA advisers’ list include:

  • How well do the shots protect people at high risk such as those over age 65 or those of any age with additional health problems such as obesity or heart disease?
  • Were the shots adequately tested in Black, Hispanic and other communities hard-hit by the pandemic, to know how well the vaccine works in those populations?
  • Does the vaccine protect against asymptomatic infection, or could the vaccinated still unknowingly spread the virus?
  • What should pregnant women be told about vaccination, since they weren’t tested in Pfizer’s study?

Studies in children as young as 12 are just beginning.

Emergency vaccinations could begin before Pfizer’s 44,000-person study is complete, and answering some of those questions will require keeping that study going. Health authorities are wrestling with how to do so in a way that’s fair to placebo recipients who justifiably would want to get the real vaccine.

That access “is top of mind for many,” Pfizer and BioNTech recently wrote trial participants. The companies said they’re exploring ways to let placebo recipients switch to the vaccine group once they meet eligibility criteria for early access — if they’re health workers, for instance, or when the line opens for other essential workers or people over age 65.

On the safety front, study volunteers will be monitored for two years but even studies of tens of thousands of people can’t spot a complication that only strikes 1 in a million. So the government also is gearing up for unprecedented monitoring of recipients once emergency vaccinations get underway.

The Associated Press and Reuters contributed to this report. All reporting from Matthew Perrone and Lauran Neergaard of the AP, and Manas Mishra and Michael Erman of Reuters.

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