Local expert on FDA’s Pfizer booster decision

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ROCHESTER, N.Y. (WHEC) — The U.S. Food and Drug Administration’s (FDA) advisory board voted Friday afternoon to reject the endorsement of the Pfizer COVID-19 booster shot for anyone over the age of 16. In a second vote they did approve a booster for people 65 and older, and those with a high risk of severe illness.

News10NBC took a look what the decision means.

When it comes to the Pfizer COVID-19 booster, the FDA says the drug manufacturer did not provide enough data, specifically on the safety of the extra doses that were to be given to younger people.

The rejection announcement by the FDA has some ties to our area. Rochester Regional Health, as well as other hospital systems in the city, helped in the development of the Pfizer COVID-19 vaccine.

Infectious Disease Specialist Dr. Emil Lesho tells us this booster would’ve been administered to the elderly, and front line workers who received their first Pfizer vaccine back in December.

"There’s some laboratory data that suggest the longer you go the lower your antibody levels are," Lesho said.

Scientists studied data from Israel which showed that for those who got the Pfizer vaccine, their first test of immunity was reduced leading to some hospitalizations. The FDA, not satisfied with those results.

"My understanding is they’re going to re-reviewing it starting with looking at sub-groups like elderly patients, or people that have high levels of exposure in their jobs," Lesho said.

An approval by the FDA was highly anticipated by state and county leaders who were planning on distributing thousands of booster shots as early as next week.

On Wednesday Governor Kathy Hochul said, "If they approve it we’ll be ready, and I wanted to make sure that all of our local health agencies knew that our expectation is very high, that they put the infrastructure in place."

Ontario County Public Health Director Mary Beer added, "We’re ready to go. We can pull it up. We’ve done so many clinics that my staff are experts at it."

Lesho said those who received their Pfizer vaccines eight months ago and are relatively healthy shouldn’t have any concerns after hearing today’s decision.

"The government agencies that are in place, and the public health agencies that are in place are doing their job at making sure there is sufficient data, and sufficient reason, and also sufficient levels of safety before they recommend going forward," Lesho said.

Although this isn’t the news Pfizer recipients were expecting, the advisory panel did approve booster shots for anyone over the age of 65, and those who are considered at high risk for COVID-19.