Dr. Mendoza on FDA vaccine approval: Doesn’t change mandates, improves public confidence

Coronavirus

ROCHESTER, N.Y. (WROC) — The U.S. gave full approval to Pfizer’s COVID-19 vaccine on Monday, a milestone that may help lift public confidence in the shots as the nation battles the most contagious coronavirus mutant yet.

Monroe County Public Health Commissioner Dr. Michael Mendoza says the FDA approval won’t change anything as far as local mandates go, but it will help increase public confidence.

“The FDA approval doesn’t change anything as far as what we are able to mandate, but it does add credence to the fact that ‘hey this vaccine is safe and effective,'” Dr. Mendoza said during a virtual briefing with media Monday. “There are people who have some very legitimate concerns of the emergency use, this now puts it in the same league as our other vaccines.”

Per the health department’s latest update last week, 441,825 Monroe County residents were fully vaccinated, with 469,206 who have received at least one vaccine dose — 63.2% of the county population. The health commissioner says the FDA approval could help the unvaccinated realize the safety and efficacy of the vaccine.

“Our hope is that people will take this information, do their research, get their information from reliable sources and will come to the decision that it is in the best interest of them, their loved ones, and the community to get the COVID-19 vaccine,” Dr. Mendoza said. “I think the everyday person just wants to know what they are taking, in the form of medication or a vaccine, is safe and effective. All of the other medications that we prescribe, that are over the counter, are in the same category now as the Pfizer COVID-19 vaccine is.”

Dr. Mendoza reiterated that increasing vaccination is the best way to reaching herd immunity and ending this pandemic.

“Anything we do to get us more people in the community to get the vaccine that will push us closer to that herd immunity,” Dr. Mendoza said. “Our hope is that people will take this information and really do the research that they feel is necessary to come to the right decision.”

The health commissioner says Monday’s update doesn’t concern potential booster shots.

“We know that boosters are on the horizon, but I think we need to stick to the formal approval and make sure that when the time comes for boosters and other individuals to have access to the vaccine then we’ll readdress the practice at that time,” Dr. Mendoza said. “But I do think right now that we need to stay strictly within what has been approved by the FDA.”

Even with boosters on the horizon, the health commissioner says the vaccine is the best way to slow the recent delta surge.

“We’ve been saying all along that getting the vaccine is the most important step that you can take to stave off the delta or any subsequent variants that might be down the horizon,” Dr. Mendoza said.

And for anyone who is unvaccinated, the health commissioner said the normal mitigation efforts should continue to be implemented.

“The vaccine, even if you were to get it tomorrow, won’t fully give you the effect of the immunization for five weeks,” Dr. Mendoza said. “So taking the steps like wearing your mask indoors, wearing your mask when you’re in crowded areas, being mindful of who you are gathering with especially in private gatherings in your home, even though it’s not required and there’s no way that anyone can enforce that. We just want to encourage people to do the right thing. The vaccine is an important step, but it’s not the only thing that we need to help turn these numbers around.”

The U.S. becomes the first country to fully approve the shot, according to Pfizer, and CEO Albert Bourla said in a statement he hoped the decision “will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives.”

U.S. vaccinations bottomed out in July. As delta fills hospital beds, shots are on the rise again — with a million a day given Thursday, Friday and Saturday. Just over half of the U.S. population is fully vaccinated with one of the country’s three options, from Pfizer, Moderna or Johnson & Johnson.

A joint statement Monday from Monroe County Executive Adam Bello and Dr. Michael Mendoza:

“Today’s announcement by the Federal Drug Administration, giving full approval to the Pfizer COVID-19 vaccine, should help instill confidence among those in our community who have been hesitant to get vaccinated against this serious virus. Full FDA approval means this vaccine has undergone intense scrutiny by world class scientists, and the vaccine has proven to be safe and effective. It is no different than any other FDA approved vaccine that we take to prevent measles, mumps, chicken pox, the flu and numerous other preventable diseases. If you have been on the fence about getting vaccinated against COVID-19, now you can be sure that getting your shot is the right thing to do for yourself, your loved ones and our entire community.”

The FDA’s action also may spur more vaccine mandates by companies, universities and local governments. This month New York City, New Orleans and San Francisco all imposed proof-of-vaccination requirements at restaurants, bars and other indoor venues. At the federal level, President Joe Biden is requiring government workers to sign forms attesting that they’ve been vaccinated or else submit to regular testing and other requirements.

Anxious Americans increasingly are on board: Close to 6 in 10 favor requiring people to be fully vaccinated to travel on airplanes or attend crowded public events, according to a recent poll by The Associated Press-NORC Center for Public Affairs Research.

“Mandating becomes much easier when you have full approval,” said Dr. Carlos del Rio of Emory University. “I think a lot of businesses have been waiting for it.”

The FDA, like regulators in Europe and much of the world, initially allowed emergency use of Pfizer’s vaccine based on a study that tracked 44,000 people 16 and older for at least two months — the time period when serious side effects typically arise.

That’s shorter than the six months of safety data normally required for full approval. So Pfizer kept that study going, and the FDA also examined real-world safety evidence in deciding to fully license the vaccine for people 16 and older, those studied the longest. Pfizer’s shot still has emergency authorization for 12- to 15-year-olds.

Even after hundreds of millions of shots, serious side effects — such as chest pain and heart inflammation in teens and young adults — remain exceedingly rare, the FDA said.

As for effectiveness, six-month tracking of Pfizer’s original study showed the vaccine remained 97% protective against severe COVID-19. Protection against milder infection waned slightly, from a peak of 96% two months after the second dose to 84% by six months.

Those data came before the extra-contagious delta variant began spreading, but other data from the Centers for Disease Control and Prevention shows the vaccine is still doing a good job preventing severe disease caused by that mutant.

As for all the talk about booster doses, the FDA’s licensure doesn’t cover those. The agency will decide that separately.

The FDA already is allowing emergency use of a third dose of either the Pfizer or Moderna vaccine for people with severely weakened immune systems, such as organ transplant recipients who don’t respond as strongly to the usual two shots. For everyone else who got those vaccinations, the Biden administration is planning ahead for booster starting in the fall — if the FDA and CDC agree.

Also still to be decided is vaccination of children under 12. Both Pfizer and Moderna are studying youngsters, with data expected in the fall.


Check back with News 8 WROC as we will continue to update this developing story.

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