A clinical coordinator measures the exact dose of the COVID-19 vaccine before it is administered; Dec. 14, 2020. Credit: Helen H. Richardson/The Denver Post (pool)
UPDATE from The Washington Post:
“Expert advisers to the Food and Drug Administration voted unanimously Friday to recommend that the agency authorize a booster shot of the Pfizer-BioNTech coronavirus vaccine for people 65 years and older or who are at risk for serious disease.
A team of vaccine advisers to the U.S. Food and Drug Administration on Friday expressed concerns over limited data to justify a third COVID shot, and therefore, disapproved so-called booster shots to those aged 16 and older in the United States.
The group voted on this question: Do the safety and effectiveness data from a clinical trial support approval of the booster… “administered at least six months after completion of the primary series for use in individuals 16 years of age and older?”
Overall, the vast majority of members voted no. The vote came shortly after 3:30 p.m.
An advisory committee to the FDA began an all-day meeting Friday to consider Pfizer-BioNTech booster shots for people 16 years of age and older.
Earlier in the day, Dr. Michael Teng, associate professor of medicine at the University of South Florida and virologist, told the Florida Phoenix that it may be too early to determine the longevity of the third shots in protecting “against infection.”
“What’s not clear to me is how long that protection will last,” Teng said in a phone conversation.
“It looks like they have some data, mostly it seems to be that they’re relying on data from Israel to show that immunity to infection goes down overtime, although the immunity to hospitalizations and death still remains high.”
According to The New York Times, White House officials have expressed concerned about data from Israel, suggesting that vaccinated people are “seeing waning immune responses and higher rates of infection.”
Therefore, Israeli officials administered third doses to those 12 and older, according to The New York Times report.
The Biden administration’s recent proposal on booster shots for COVID-19 included a rollout of a third shot starting Monday. But authorization of booster shots will be dependent upon approval from the FDA and “recommendations” by the federal Centers for Disease Control and Prevention, according to Biden’s plan.
Health experts from Israel and around the world presented data and presentations during Friday’s meeting, while addressing whether benefits outweigh the risks associated with an extra dose that would be given at least six months after the second shot.
Dr. Sharon Alroy-Preis, who is Israel’s head of public health services, was questioned by a member about the booster shot offering “long-term durability” and if they would anticipate additional booster shots offered every six months.
“I think this is very early and we can’t really tell,” she said during the virtual meeting. “We know from other viruses that sometimes, like in Hepatitis, you get a dose…and you have protection for many years.
“We definitely don’t have any plans at the moment to boost every six months. We will continue to monitor to see if there is any waning effect.”
Ultimately, Teng said, the committee had to decide if the Pfizer booster shot is effective and safe. And when it comes to side effects from a third shot, Teng believes those are about the same as the original dose.
“One of the things Pfizer is presenting is some safety data. It shows that the side of effects are about the same as the second dose,” Teng said.
However, not all health experts have agreed with the idea to administer vaccine boosters right now.
Recently, a team of scientists analyzed studies and concluded “that boosters are not yet needed by the general population,” and focus should be placed on boosting vaccines to the unvaccinated population, according to a New York Times report.
Two of scientists are from the FDA and decided to resign “over what they felt was undue pressure from the Biden administration to approve booster shots,” The New York Times reported.
Dr. Sarah Oliver, from the CDC, said during her presentation Friday that “there have been over 380 million vaccine doses administered in the United States, to date” and discussed vaccine effectiveness against the Delta variant.
“Since the introduction of this Delta variant, VE [vaccine effectiveness] has ranged from 39 percent to 84 percent. VE against hospitalization, remained high from 75 percent to 95 percent,” Oliver said.
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