FDA panel recommends Moderna booster shot, but the process isn’t over

Coronavirus

A panel of medical experts affiliated with the Food and Drug Administration endorsed a COVID vaccine booster from Moderna on Thursday.

The panel recommended a half dose as a booster.  The move puts the vaccine closer to having emergency use authorization as a third dose, but, medical leaders warn, the process is not yet complete, and the booster is far less effective at protecting the general population than having many more people get their first dose.

The meeting of the FDA panel was done virtually, and lasted all day. The panel of about a dozen and a half immunologists, infectious disease experts and other public health professionals, asked questions, analyzed data, and deliberated over Moderna’s efficacy after a third dose.

Meanwhile, there’s no shortage of people wondering the same thing as people who were in line at the city’s office near Crotona Park in the Bronx where it distributes $100 debit cards to newly vaccinated residents.  

Person after person asked the same question about booster vaccines.

“Why do I need to get a third shot?” one man on line asked.

“I don’t  understand why we need a third shot,” a woman said.

Dr. Purvi Parikh, a specialist in respiratory illnesses, including COVID, provided answers, in an interview with PIX11 News.

“Basically ,what boosters are are additional augmentation of your immunity,” Parikh, a specialist at the Allergy and Asthma Network, said.  “It doesn’t mean the vaccine’s not working, in fact it’s still working extremely well. It’s to be proactive against any future issues.”

The FDA panel’s recommendation not only calls for a half dose of the vaccine to be used as a booster going forward, it also would limit its application to people 65 and older; residents of long-term care facilities; people with weakened immune systems; and people who work in high-risk jobs or at locations at high-risk for COVID exposure.

The list is very similar to one for the Pfizer vaccine booster, which has been fully approved by federal authorities.

Regarding Moderna, however, Dr. Mitchell Katz, the CEO of the city’s Health and Hospitals Corporation, pointed out that the approval process is not over.  The FDA has to decide whether or not to accept the panel’s recommendation — it very rarely does not.  

Also, the CDC has to decide whether to approve the booster. That decision is expected next week.
Katz said that the Pfizer booster approval process serves as a roadmap now.

“There was in fact a lot of debate between the CDC and the FDA,” he said about the Pfizer process.  
“But when it finally got approval,” Katz added, “we were ready the next day.

“We will see the same thing here,” he said.

He’s also said something that a number of other people, from Mayor Bill de Blasio to Dr. Parikh said, even as the Moderna booster is being considered:  boosters among vaccinated populations are less effective than basic vaccinations among people who have yet to get a shot.

“The first shot is the most important part of the equation,” the mayor said during his daily briefing on Thursday.

Dr. Parikh elaborated.

“That is actually the most important. That initial vaccination is key.  That is paramount,” she said.  

“Right now you’re very unprotected,” she continued, “and if you get sick, you may be in bad shape, because now we’re not seeing elderly people in the hospital anymore with tons of medical problems. We’re seeing young and healthy people who’ve not gotten vaccinated.”

“Over 90 percent of hospitalized patients are unvaccinated,” she said, “and over 99 percent of people dying are unvaccinated.  So it’s in your best interest to do so.”

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