Local doctors and health officials hope FDA approval of Pfizer vaccine will raise vaccination rates

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Aug. 23—Local doctors and public health officials hope the Food and Drug Administration's full approval Monday of the Pfizer-BioNTech COVID-19 vaccine will convince more people to get vaccinated.

The FDA had granted an Emergency Use Authorization for the Pfizer vaccine on Dec. 11 and issued an EUA for the Moderna vaccine a week later. The full approval for the Pfizer vaccine, which will now be marketed as Comirnaty (koe-MIR-na-tee), is for people over 16. The vaccine is still available under EUA, including for kids ages 12 to 15.

"This is a milestone today, a monumental day," said Dr. Ajay Kumar, chief clinical officer for Hartford HealthCare, the parent company of Backus Hospital in Norwich. "Individuals who are still on the fence to get the vaccine hopefully can get a fresh or better reassurance about the vaccines as we go forward."

Kumar said Hartford HealthCare has 117 patients hospitalized for COVID-19, up from 10 or 12 in early July, and 70 or 74% are unvaccinated. Less than 28% of Connecticut residents haven't received any doses of a COVID-19 vaccine.

Kumar said breakthrough infections are generally occurring in people who are elderly and immunocompromised, and he's hoping the push for booster shots will help.

Ledge Light Health District Director Steve Mansfield said that although the vaccines approved under an EUA "were considered safe and effective, this FDA approval will likely persuade many individuals who have chosen not to get the vaccine up until this point."

The FDA said for its approval, it reviewed updated data from the clinical trial that supported the EUA, and included a longer follow-up period in a larger clinical trial population. The agency evaluated the safety of the vaccine in about 22,000 people over 16 who received the vaccine and 22,000 people who received a placebo.

More than half of trial recipients were followed for at least four months after the second dose, and about 12,000 recipients were followed for at least six months.

Moderna has applied for full approval for its vaccine, but it's unclear when the FDA will make a decision, and Johnson & Johnson hasn't yet applied.

Might this increase the likelihood of employer mandates?

The Connecticut State Medical Society said in a tweet that full approval "could bring more vaccine mandates — at employers, large venues, government facilities, etc. This will also help increase confidence and could encourage more people to get vaccinated."

Patrick McCormack, director of Uncas Health District, said his hope is that "rather than increase mandates, I'd like to see it increase confidence."

He thinks that knowing that this vaccine meets the same standards as other vaccines people typically receive "will hopefully sway at least some portion of people who have been hesitant." He said one of his nurses said the people she's hearing from the most who are waiting for FDA approval are pregnant women.

"We know there is a group of people that this won't impact them at all, that they may have other reasons why they don't feel comfortable, so we'll see," McCormack said.

Dr. Kevin Torres, chief medical officer at Lawrence + Memorial Hospital in New London, said he thinks we'll start to see more companies moving forward with a mandate. He said he knows some employers were concerned that mandating a vaccine under EUA could result in legal battles, and the full authorization "kind of does put that aside a bit more."

"I think there is some hesitancy out there," Torres said, "and hopefully for those that are waiting to get the vaccine, because they feel maybe it got rushed through or anything like that, this will give them a bit of confidence in it."

At a news conference in New London on Monday, Gov. Ned Lamont commented, "I think there are an awful lot of companies who are interested in being more aggressive in having all their employee vaccinated, either by incentive or even mandates. I think there was some hesitancy because they wanted to wait until the FDA gave final approval for the Pfizer vaccine. They have done that now."

Sen. Richard Blumenthal, D-Conn., said in a statement, "Full FDA approval after lengthy, detailed medical review should assure everyone of the safety and effectiveness of the vaccine. I am tremendously proud of Pfizer's scientists, researchers, and workforce—including many right here in Connecticut—who made this extraordinary scientific accomplishment possible."

e.moser@theday.com

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