Full FDA approval of Pfizer COVID vaccine expected soon

OAKLAND, Calif. - Full FDA approval for the Pfizer vaccine is expected within days, possibly as early as Monday.

Previously the target date was Labor Day but regulators have accelerated their work, responding to surging illness  and death from the coronavirus.

"I think it's going to inspire confidence in some people who might have been on the fence," reacted Dr. Matt Willis, Marin County Public Health Officer.

"Here in Marin, we are seeing a 50 times higher risk of being hospitalized if you're unvaccinated."

The Pfizer two-dose vaccine was the first of three approved for emergency use last winter.

Vaccine skeptics called the process rushed, while supporters argued there was a lot of scrutiny, both then and now.

"There's nothing experimental about these vaccines," said Dr. Cameron Webb, a member of the White House Covid-19 Response Team.

"The authorization they already have and the evidence that we have tells us with real certainty they're very safe and very effective."

About 51.2 percent of Americans are currently vaccinated.

Among those who have shunned vaccinations, about 3 in 10 tell pollsters they’ve been waiting for the safety data to come in and that final stamp of approval.

FDA reviewers examined Pfizer's production, storage, side effects, and results.

"So they basically have to read over hundreds of thousands of pages of data about safety and efficacy," said Dr.Michael Teng, a virologist at the University of South Florida.

"And remember, in the beginning they had to do a very large Phase 3 trial," continued Teng.

"Thirty thousand or more participants, which Pfizer, Moderna and J & J had to do."

Moderna's full licensure is expected sometime in September.

Johnson and Johnson is still gathering data for submission.

In the Bay Area, and California generally, vaccination rates are higher than many other parts of the country.

"I got Moderna," said Carlos Paraza of San Rafael, who expects the FDA sign-off to encourage more people to get jabbed.

"They will, they will, because at the end of the day, you've got to go ahead and do it for your own safety and others."

Others wonder if vaccine resistant people will find other reasons to reject it.

"This is great news," said Robert Bloomberg of Lagunitas, "as long as people actually get vaccinated, but there are a lot of uninformed people out there."

Health officials hope a shift in vaccine hesitancy saves lives.

The delta variant has fueled a surge in caseloads with the unvaccinated at highest risk.  

"The vaccine is by far our most effective tool to prevent transmission, prevent infection, and prevent severe illness and death," said Willis.

He expects counties will have to regroup their vaccination clinics once demand goes up.

"Rebuild that team, that infrastructure, but it's a good problem to have if we're going to vaccinate more people," said Willis.

Marin County already has a 94 percent vaccination rate.

"If this adds more trust, then we're on the right track and I hope we can convince more people to feel confident," said Margaret Feil of Mill Valley.

Full approval is also expected to convince more employers and public agencies to mandate vaccines.

The trend has already emerged among many occupations, including teachers, first responders, health care and active duty military.

"One problem has been, without formally approval there were questions about whether it's appropriate to require it," said Willis, "so I think this is going to change the legal framework."

Willis notes there are varied reasons people hold-out against vaccination, and it's a conversation best navigated with their health care provider one on one.