Health officials, lawyer talk about Pfizer getting full FDA approval

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ROCHESTER, N.Y. (WHEC) — The U.S. Food and Drug Administration’s (FDA) approval of the Pfizer COVID-19 vaccine comes nearly nine months after the first Americans received their shots.

Health experts say they hope it encourages those that were on the fence on getting the vaccine to get it as soon as possible. They also hope it will negate some of the vaccine hesitancy we’re seeing.

“Now that we have full FDA approval it puts it in the same league as all of our other vaccines and all of our other vaccines and all of our medications in terms of it being safe and effective and having done all of the science necessary to this point,” Monroe County Health Commissioner Dr. Michael Mendoza said.

Mendoza said full FDA approval means this vaccine has undergone intense scrutiny by world-class scientists and it’s proven to be safe and effective.

“The full FDA approval process takes the initial authorization from the EUA [emergency use authorization] and goes that much further so we have the same individuals that were enrolled in the early studies and we’ve got more information about them and how they’ve done,” Mendoza said.

Health experts said approval is likely to open a new wave of vaccine mandates.

“In the past with influenza vaccine mandates this has been a struggle prior to essentially mandating flu vaccine in health care environments. Only about 75% of people would become vaccinated each year, once it was mandated we now exceed 90% often reaching 95% so it may allow us to move forward,” Dr. Ed Walsh, Head of Infectious Diseases at Rochester General Hospital said.

Both county and city leaders continue to push for the community to get the vaccine.

Rochester Mayor Lovely Warren said in a statement:

“Today’s announcement is another milestone in the effort to protect our communities and our country by putting an end to the COVID-19 pandemic. I certainly know firsthand the damage and loss this terrible disease can deliver. That’s why it is so important that all eligible Rochesterians get vaccinated. We all should trust the science and tremendous collective effort that was necessary to make these life-saving vaccines a reality. We should also think of the wellbeing of our friends, loved ones and neighbors then do the right thing to protect them by getting vaccinated.”

In a joint statement Dr. Mendoza and County Executive Adam Bello said:

“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.”

“Everybody is evaluating their options at this point and for schools and university and K-12 and schools,” Dr. Mendoza said. “From a public health standpoint, this is a really very simple question. You know we want to have as many people as possible getting the vaccine but of course, the devil is in the details and I think that’s what the next days and weeks are going to help us to illuminate."

“If you’re a private business person and interested in the safety and security of your employees then that’s a good reason to do that as well and I think a private business can do it without any restrictions as long as the vaccine is approved by the FDA,” Donald Chesworth, a Partner in the Rochester office of Tully Rinckey PLLC said.

Chesworth said if your boss does mandate the vaccine and you don’t want it, legally there’s nothing you can do.

“There’s nothing you can do unless you’re represented by a union and the union has some sort of understanding with the employer that they can negotiate that sort of thing and outside of that I think you need to take it or you need to be fired,” Chesworth said.

Dr. Mendoza said in terms of businesses and employers mandating the vaccine, it’s too early to tell what steps would need to be taken.

“The FDA approval of the Pfizer covid vaccine doesn’t actually change anything about what we in the health department or county are able to mandate or not but it certainly does add credence to the argument that the vaccine is safe and effective and all of the bodies, schools and stakeholders in the community now have additional information to mandate if they so choose,” Dr. Mendoza said.

Chesworth said, as far as school mandates, it’s always been a statewide mandate — but says it’s the best if it comes from the higher level of government.

“Once the vaccine is fully approved there shouldn’t be any objection other than the religious one or if you have some unique health issue that would prevent you from taking the vaccine,” Chesworth said. “Other than that I think the government, the schools can require it from anybody”

As far as schools go, Rush-Henrietta superintendent and President of the Monroe County Council of School Superintendents Bo Wright says right now, local school districts are not considering a vaccine mandate.