FDA approves latest COVID shots

The Food and Drug Administration on Monday approved updated COVID-19 vaccines that experts say will more effectively fight against current versions of the virus.

Yet after relatively scant public interest in the last two COVID-19 vaccines, public health officials could face challenges in persuading people to get the new shot.

“People believe we are past the pandemic, despite the trends we are seeing” of increased COVID-19 hospitalizations and cases, said Perry Halkitis, dean of the Rutgers School of Public Health in New Jersey.

Despite the recent rises, hospitalizations remain far below what they were last summer, in part because of immunity from previous infections and vaccinations, experts said.

A Centers for Disease Control and Prevention committee on Tuesday is expected to recommend who should receive the vaccines. CDC Director Dr. Mandy Cohen then will make a final decision. The vaccines will be free for most people in the recommended groups, experts said.

The FDA approved the vaccines for anyone 6 months or older.

“The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “We very much encourage those who are eligible to consider getting vaccinated.”

If the CDC signs off on the vaccines, which are manufactured by Pfizer-BioNTech and Moderna, they will be publicly available in the coming days, pharmaceutical company, health system and pharmacy spokespeople said.

This is the third updated shot authorized by the FDA, after the original vaccine series.

“It will be one booster once a year, as things stand now,” said Dr. Bruce Farber, chief of public health and epidemiology for Northwell Health.

1 in 7 Long Islanders fully boosted

Updated vaccines are needed to “boost our immune system” because protection from previous vaccines and prior infections wanes over time, said Dr. Martín Bäcker, associate director of the NYU Langone Hospital – Long Island Vaccine Center.

Only about 1 in 7 Long Islanders obtained both previous updated shots.

In Nassau County, 85% of residents have received the primary series of vaccinations, but fewer than 14% are up-to-date on boosters, state Department of Health data shows.

In Suffolk, 77% got the first vaccination series; fewer than 14% have received at least both boosters.

Uptake varies greatly depending on age. On Long Island, 40% of residents 75 and older, and 37% of people 65 to 74, are up-to-date, compared with 5% of people 12 to 25 and 9% of residents 45 to 54.

Dr. Amesh Adalja, a senior scholar with the Johns Hopkins Center for Health Security in Baltimore, said he’s not worried about the low vaccination rates among young people.

“What's more important is the high-risk people,” he said. “One of the problems that's happened in the past is that some of the messaging has been diluted, in that, if everybody is told to get a booster, then a high-risk person doesn't think they're any different.”

Messaging for the new vaccine should be laser-focused on those most vulnerable to severe COVID-19, which is what the vaccine is most effective at preventing, he said.

But, Farber said, even children unlikely to get seriously ill could infect people who are more vulnerable.

“I encourage everyone to get” the new vaccine, he said.

Farber urged people at high risk to get their vaccines as soon as possible.

Those at lower risk may use a different calculus, he said. The vaccine’s protection against infection lasts roughly 12 weeks and decreases rapidly, so healthy, younger people may want to choose the three months when they want to be most protected, Farber said.

Protection against severe disease lasts longer than protection against infection, he said.

The vaccine is targeted at the XBB.1.5 variant, which has made up most New York COVID-19 cases this year, according to state data.

Yet two other omicron variants, XBB.1.9 and XBB.1.16, are now dominant, comprising nearly 72% of cases.

Halkitis said he’s concerned that people will mistakenly believe the vaccine is not effective against those variants and “doubt they actually need the [new] booster.”

Even though the most widely circulating variants are not the same as XBB.1.5, they are “very similar,” and the new vaccine will offer strong protection, especially against severe illness or death, Bäcker said.

Viruses mutate regularly, so it was expected during vaccine development that XBB.1.5 might lose its dominance, he said.

Insurance coverage depends on CDC

Farber expects the CDC to recommend the vaccine for everyone 6 months and older.

If that happens, the vaccine will be free in-network for most people with private insurance, Medicare and Medicaid, just as flu shots are free, said Jennifer Kates, senior vice president and director of the Global Health & HIV Policy Program at the San Francisco-based health-policy nonprofit KFF.

If the CDC only recommends the vaccine for certain groups, insurance coverage would depend on how the CDC recommendation is worded, she said.

The Affordable Care Act, known as Obamacare, mandates coverage of CDC-recommended vaccines, except for short-term insurance and certain “grandfathered” plans, Kates said.

There is no legal requirement for free vaccines for uninsured adults, although all uninsured and underinsured children are eligible for federally funded shots, Kates said.

Pfizer-BioNTech and Moderna are pricing the new vaccine at $110 to $130, which would dissuade many people from getting vaccinated if they can't get the shot for free, she said.

"If you're already reluctant to get vaccinated, or you're not sure, and someone says, 'Well, it's $130,' that's a huge barrier," Kates said.

A federal program will provide the uninsured with some free vaccines — some of which Pfizer-BioNTech and Moderna have promised to donate — but it’s unclear when it will start and how extensive it will be, Kates said.

CDC spokeswoman Belsie González on Monday said the agency is planning to release more details later this week.

Top officials with the federally qualified health centers that cover Long Island — Harmony Healthcare Long Island in Nassau and Sun River Health in Suffolk — said they plan on offering free vaccines, depending on availability from government programs. 

Suffolk County will offer the vaccine at its regularly scheduled immunization sites that rotate throughout the county, spokeswoman Marykate Guilfoyle said.

Nassau has no plans for county-operated vaccination sites “because of the vast availability of medical and clinical resources,” county spokesman Christopher Boyle said.

By David Olson

david.olson@newsday.com@DavidOlson11

David Olson covers health care. He has worked at Newsday since 2015 and previously covered immigration, multicultural issues and religion at The Press-Enterprise in Southern California.