FDA OKs COVID-19 vaccine boosters for all adults; potential COVID treatment on horizon

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By Michelle Tuccitto Sullo

The U.S. Food and Drug Administration announced Friday that it has amended the emergency use authorizations for both the Moderna and Pfizer-BioNTech COVID-19 vaccines to allow booster doses for all adults.

Previously, the boosters were authorized for individuals aged 65 and up and adults in high-risk categories. Now, all adults age 18 and older who got their last vaccine at least six months ago are eligible for a booster shot.

Acting FDA Commissioner Dr. Janet Woodcock said COVID-19 vaccines have proven to be the best defense against the disease.

The boosters, according to Woodcock, help provide continued protection against serious consequences such as hospitalization and death.

Gov. Ned Lamont’s office reported Thursday that 241 people were hospitalized statewide due to COVID-19, with 8,834 state deaths due to the virus to date.

As of Thursday morning, the Yale New Haven Health system had 72 inpatients with COVID-19. Of these, 16 were in intensive care, and nine were on ventilators. Of the total, 32 were at Yale New Haven Hospital, 13 at Bridgeport Hospital, four at Greenwich Hospital, 19 at Lawrence + Memorial Hospital in New London and four at Westerly Hospital in Rhode Island, according to system President Christopher O’Connor.

On Thursday, Pfizer announced an agreement with the U.S. government to supply 10 million treatment courses of its investigational COVID-19 oral antiviral candidate, Paxlovid, subject to FDA emergency use authorization.

Under the agreement, Pfizer, which has a facility in Groton, would begin delivering the treatment later this year, concluding in 2022, in exchange for $5.29 billion from the U.S. government.

If authorized or approved, Paxlovid would be administered in pill form for five days. According to Pfizer, the treatment is designed to block the activity of an enzyme the coronavirus needs to replicate.

Pfizer announced Tuesday that it was seeking emergency use authorization from the FDA for Paxlovid.

Albert Bourla, Pfizer’s chairman and CEO, said its Phase 2/3 interim analysis showed Paxlovid had “overwhelming efficacy” in reducing the risk of hospitalization and death from COVID-19.

According to Pfizer, in a study of adults with COVID-19, the data demonstrated an 89% reduction in risk of COVID-19-related hospitalization or death in patients treated with Paxlovid compared to a placebo within three days of symptoms starting. The company reported zero deaths in the treatment group.

Dr. Thomas Balcezak, executive vice president and chief clinical officer for Yale New Haven Health, said about 90% of the patients hospitalized in the Yale system due to the virus have never been vaccinated.

Balcezak said the new potential treatment for COVID-19 on the horizon is giving “hope,” and the Yale team will consider changing its treatment protocol upon FDA approvals.

He cautioned that the coming winter months could mean an uptick in virus cases, citing more people gathering indoors for the holidays and more travel.

“All of those things portend an increase in cases in the coming weeks,” Balcezak said.

The Yale New Haven Health system this fall ordered all of its employees to get vaccinated or face termination. Mark D’Antonio, a spokesman for the health system, said this week that ultimately 79 individuals were terminated out of nearly 30,000 employees for vaccine noncompliance. Back in October, the number was at 49. System leaders have said the employees may return if they get vaccinated.

Contact Michelle Tuccitto Sullo at msullo@newhavenbiz.com.