FDA approves updated COVID-19 vaccine; shots should be available in days

Federal officials signed off on updated COVID-19 vaccines on Thursday, designed to better protect people from the variants that have helped fuel a summer wave of cases.

The U.S. Food and Drug Administration approved the vaccines by Pfizer and Moderna for people 12 years of age and older and issued an emergency use authorization for their vaccines designed for children between the ages of 6 months and 11.

The Centers for Disease Control and Prevention will outline its recommendations on the updated vaccines on Friday at its fall/winter virus media briefing. The CDC has recommended the COVID-19 vaccines for everyone over the age of 6 months.

Both Pfizer and Moderna issued statements on Thursday saying the vaccines are ready to be distributed.

“Shipping will begin immediately to ensure robust supply and rapid access of this season’s vaccine in pharmacies, hospitals and clinics across the country,” Pfizer said.

Moderna said its updated vaccine “is expected to be available in the coming days.”

The updated vaccines will be available earlier than in previous years, when it generally was released in mid-September. Experts hope this could give people more protection now as the summer wave of cases heads into the fall, when infections traditionally have increased as schools reopen.

They also hope it convinces more people to get vaccinated against COVID-19. Only 22.5% of adults reported receiving updated vaccines between Sept. 14, 2023, and May 11, according to the CDC. And just 14.4% of children 17 years of age and younger received it.

“Vaccination continues to be the cornerstone of COVID-19 prevention,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “These updated vaccines meet the agency’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality.”

Marks encouraged eligible people to consider getting the vaccine, pointing to waning immunity to COVID-19 from both previous vaccinations and infections. The vaccines were updated to better protect against the omicron variant KP.2 strain of SARS-CoV-2, the virus that causes COVID-19, FDA officials said.

New York State Department of Health data shows 54% of the COVID-19 cases in the state correspond to the KP.2 variant.

Cases of COVID-19 across the United States and on Long Island have continued to increase or remain steady, according to some indicators. There were 194 people hospitalized on Long Island on Wednesday for a 7-day average of 6.68. It's a drop from July, when that statistic reached 8.06, with 234 hospitalizations, but similar to Aug. 21, 2023, when it was 6.60 with 192 hospitalizations.

Positive test results are also in line with this time last year. On Monday, 483 people tested positive for a 7-day average of 13.1%. But that's down from the 18.9% 7-day average on July 25 with 545 positive cases. Since tests taken by people in their homes are not counted, officials said these numbers likely only represent a portion of positive cases.

“I like the fact that it's coming at a little bit of an earlier interval than in the past,” Dr. Alan Bulbin, infectious disease director at Catholic Health’s St. Francis Hospital, said of the updated vaccines. “If you are someone who hasn’t had COVID-19 yet this summer, you view yourself as high risk or you haven’t had a shot since last fall, this is available to you immediately to protect you from what's happening right now."

Getting vaccinated is worthwhile even if it doesn’t always prevent a COVID-19 infection, said Dr. Bruce Farber, chief of epidemiology and public health at Northwell Health.

“We need to be transparent with people,” Farber said. “This vaccine will hopefully prevent them from getting COVID for a relatively short period of time, eight to 12 weeks. But afterward, it will definitely prevent them from getting very ill with COVID and it will definitely make their COVID milder, and that's all we can expect. And that's a really good benefit.”

By Lisa L. Colangelo

lisa.colangelo@newsday.com@lisalcolangelo

Lisa joined Newsday as a staff writer in 2019. She previously worked at amNewYork, the New York Daily News and the Asbury Park Press covering politics, government and general assignment.