BREAKING NEWS: FDA advisory committee votes to NOT recommend approval of booster shots for Pfizer’s Covid vaccine
- The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) has voted to not recommend approval of Covid vaccine booster shots
- Members said there was not enough evidence that a third dose was safe and effective for use in all Americans
- The committee is planning to discuss a potential second round of voting to recommend approval for specific groups at risk such as older adults
- Pfizer said data suggested efficacy of two doses declines from 96.2% to 83.7% after six months but that a third dose boosts antibody levels
- FDA officials have previously expressed doubt about the need for extra doses and say the vaccines are still highly effective against severe disease and death
An independent panel at the U.S. Food and Drug Administration (FDA) has voted 16-2 to not recommend approval of booster doses for the Pfizer-BioNTech COVID-19 vaccine.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) said there was not enough evidence that a third dose was safe and effective for use at least six months after the final dose.
The FDA is not bound to follow the advisory group’s recommendations but the panel advising against approval makes it harder for the agency to justify moving forward.
Pfizer has submitted data that the company claims shows that its vaccine’s efficacy falls by about six percent evert two months following the second and final dose.
But many scientists, including senior officials at the FDA, disagree and argue that the vaccines are still highly effective at preventing severe illness and death.
The committee is planning to discuss a potential second round of voting to recommend approval for specific groups at risk such as older adults.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) has voted to not recommend approval of the COVID-19 vaccine booster shots. Pictured: A nurse administers a COVID-19 booster shot to Lana Sellers in Altamonte Springs, Florida, August 18
Last month, boosters were approved for immunocompromised Americans who had received either the Pfizer or Moderna vaccine after data showed they were less likely to develop high antibody levels after two doses.
At the time, Pfizer said its early data suggested people who received booster doses between six and 12 months after their final dose had high levels of protection.
The company filed for emergency use authorization for booster doses in late August and submitted data, made public on Wednesday.
The documents suggest that protection from two doses of the Pfizer vaccine declines from 96.2 percent at seven days after dose 2 to 90.1 percent two months later to 83.7 percent up to six months later.
What’s more, they cited data from Israel showing people fully vaccinated in January 2021 had a 2.26-fold increased risk for breakthrough infections compared to those fully vaccinated in April 2021.
Another Israeli study noted in the documents showed that effectiveness against infection was 39 percent and against symptomatic disease was 40 percent from June 20, 2021 to July 17, 2021, when the Delta variant was the dominant strain.
Comparatively, between January and April, these rates were at 95 percent or higher.
In a separate document, FDA scientists wrote with a skeptical tone about the need for booster shots.
‘Overall, data indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States,’ the scientists wrote.
They added that studies on booster doses have presented conflicting findings and that ‘known and unknown biases that can affect their reliability.’
This is a breaking news story and will be updated.