COVID-19 Roundup: FDA Panel Recommends Pfizer Booster Shots for Adults 65 and older; Unvaccinated 10 Times More Likely to be Hospitalized; and More

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September 17, 2021


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FDA Advisory Panel Recommends Pfizer Third Doses to Those 65 & Older, and Those at High Risk

An advisory panel of experts for the U.S. Food and Drug Administration (FDA) has recommended a third dose, or booster shot, for recipients of the Pfizer-BioNTech COVID-19 vaccine who are 65 or older, or are at high risk of severe illness from the virus.

The recommendation from the experts is for third doses at least six months after the second shot. Panel members say healthcare workers, first responders and others who are exposed to the virus on their jobs qualify as being at high risk. Separately, the panel recommended, in a 16-2 vote, against approving a Pfizer booster for people 16 and older — at this time.

The experts, whose recommendation to the FDA is not binding, reviewed a large-scale, much-anticipated Israeli study of third doses of the Pfizer-BioNTEch vaccine. The study found that these booster shots reduced the rate of COVID-19 infection by a factor of 11 among adults 60 years of age or older, and lowered the rate of severe illness by a factor of 19.5. The study was published Wednesday in the New England Journal of Medicine.

Currently third doses of the Pfizer and Moderna vaccines are authorized only for immunocompromised individuals. The FDA will consider the expert panel’s recommendation with the next few days.

As the debate intensifies over whether booster shots for everyone are needed at this time, the FDA struck a markedly neutral tone in a post this week.

“Overall, data indicate that currently U.S.-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States,” the FDA stated in advance of today’s meeting of its advisory panel. “There are many potentially relevant studies, but FDA has not independently reviewed or verified the underlying data or their conclusions.”

Researchers in Israel derived data from July 30 through August 31, 2021 on more than 1.1 million people who are 60 and older. They all received a third dose of the Pfizer-BioNTech vaccine at least five months after being fully vaccinated with two doses.

However, the study has some key limitations. Among them: Researchers did not have enough time to follow up with participants, and they could not determine how long protection from boosters may last.

To meet the challenge from the more transmissible Delta variant, “and to reduce the load on the healthcare system, Israeli authorities approved the administration of a booster dose, first to high-risk populations, on July 12, 2021, and then to persons who were 60 years of age or older, on July 30, 2021,” the study confirmed.


Latest from CDC on COVID: Unvaccinated 10 Times More Likely to be Hospitalized, 11 Times More Likely to Die

The latest study to demonstrate how vitally vaccines prevent severe illness from COVID-19 finds that people who were not fully vaccinated over the past few months were over 10 times more likely to be hospitalized — and 11 times more likely to die — from the virus.

The findings published by the U.S. Centers for Disease Control and Prevention (CDC) confirm the continued efficacy of the three authorized vaccines from Pfizer-BioNTech, Moderna and Johnson & Johnson as the highly transmissible Delta variant has become dominant.

Across 13 U.S. jurisdictions from April 4 through July 17, 2021, the CDC stated that rates of COVID-19 cases, hospitalizations, and deaths were substantially higher in persons not fully vaccinated, compared with those in fully vaccinated persons — “similar to findings in other reports.”

Researchers also found that vaccinated persons accounted for 18 percent of observed cases — a finding that the study’s authors said “were consistent with a potential decline in vaccine protection against confirmed (COVID-19) infection.”

All studies have found that protection against hospitalization and death remains relatively high for those fully vaccinated. But the CDC also published new data showing further evidence of waning protection against severe disease in elderly adults.

In data shared by hundreds of hospitals and urgent care clinics on 32,000 patients, the CDC found that vaccine effectiveness against hospitalization in adults 75 and older “was significantly lower” than in younger patients through August.

In people up to the age of 75, the three vaccines were collectively 86 percent effective in preventing hospitalization, the CDC said. Protection against serious illness was higher among Moderna vaccine recipients (95 percent), compared to those who got Pfizer-BioNTech (80 percent) or Johnson & Johnson (60 percent).


FDA Cautions Parents Not to Administer COVID Vaccines to Kids Under 12

With the current spike in COVID-19 infections among children younger than 12, U.S. public health officials are cautioning parents not to get kids under 12 vaccinated until a vaccine is authorized.

The U.S. Food and Drug Administration (FDA) issued a special report to emphasize that the currently available vaccines, none of which have been approved for children under 12, may not be a safe or effective dose for young children. The agency did not say specifically when vaccines for younger children would become available under it’s “emergency use authorization.”  The FDA said last week that U.S. regulators are “working around the clock” in review data to support the approvals of vaccines for kids under age 12.

“We can assure the public we are working as expeditiously as possible to meet this critical public health need and we very much hope to have pediatric COVID-19 vaccines available in the coming months,” the FDA said.

In a special webpage, the FDA elaborates on the process, including clinical trials, involved to develop a safe and effective vaccine for those under 12.

“Just like every vaccine decision we’ve made during this pandemic, our evaluation of data on the use of COVID-19 vaccines in children will not cut any corners,” the FDA states. “Conducting clinical trials to determine an appropriate vaccine dose in children requires additional work over that done in the adult studies, including ensuring that the vaccine dosage and formulation strength used is the appropriate one from the perspective of safety and generating an immune response.”

Clinical trials involving children as participants are underway. Some vaccine manufacturers have stated that they are still enrolling, and some are still administering doses or following participants, the FDA said. “This process is expected to include a follow-up period of at least about two months, to allow for proper safety monitoring following the administration of vaccine doses for at least half of the clinical trial vaccine recipients,” the agency said.

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