Going it Alone, FDA Authorizes Second Booster for Adults 50 Plus
Without holding a meeting of its vaccines advisory committee, the U.S. Food and Drug Administration (FDA) authorized a fourth booster shot of the Pfizer-BioNTech and Moderna COVID-19 vaccines. The authorization is for everyone 50 years of age and older.
The decision to not hold a meeting of the advisory committee is controversial. The vaccines advisory committee is already scheduled to meet on April 6 to discuss booster shots in the U.S., although they were not expected to vote on specific recommendations.
In addition to the authorization of the fourth shot for people 50 and older, the agency authorized a second Pfizer-BioNTech shot for people 12 years and older who are immunocompromised, and Moderna’s for adults 18 and older who are immunocompromised.
Dr. Paul Offit, M.D., director of the Vaccine Education Center, professor of pediatrics in the Division of Infectious Diseases at the Children’s Hospital of Philadelphia and member of the FDA’s Vaccines and Related Biological Products Advisory Committee, criticized the agency over the decision.
“It’s just sort of fait accompli,” Offit said. “So is this the way it works? We talk endlessly about how we follow the science — it doesn’t seem to work out that way.”
The decision to authorize the fourth shot is questioned by many health and vaccines experts. Generally, they agree that for the elderly or immunocompromised, it’s probably a good idea. But for people who are younger, healthy or are less susceptible to severe COVID-19, they tend to question the need. Some of that thinking relates to the goal of the vaccine. If it’s to prevent hospitalization and death, then the fourth shot is probably not necessary for most healthy people. If the idea is to completely prevent infection over concerns about Long COVID, then perhaps the fourth dose is a good idea.
A study published in February by the U.S. Centers for Disease Control and Prevention (CDC) found that the third dose of the two vaccines resulted in emergency room visits dropping from 87% to 66% and 91% to 78% against hospitalizations four months after that third shot.
“That gives me pause for concern that the boosters are not necessarily holding up as well as we’d like,” said Dr. Peter Hotez, a vaccine expert at Baylor College of Medicine in Houston.
Hotez is one of those who strongly support a fourth dose, based largely on research out of Israel. A study there published last week indicated the death rate from the Omicron variant was 78% lower in people 60- to-100 years old who received a fourth shot of the Pfizer-BioNTech vaccine compared to people who only received three shots. This study has yet to be peer-reviewed.
Alternatively, John Moore, a professor of microbiology and immunology at Weill Cornell Medical College, questioned Moderna’s request for the fourth dose for all adults. “The old and frail person has much more need of an additional vaccine dose than a young, healthy athlete,” he noted.
The FDA’s authorization appears to be at least partly related to concerns over the Omicron subvariant, BA.2, which is about 30% more infectious than Omicron BA.1. It currently accounts for 30% to 50% of new cases in the U.S. However, it does not seem to be causing the same rise in hospitalizations seen with Omicron BA.1 and even Delta.
In the next few days, the CDC will follow with their own use recommendation for the fourth dose. It has previously been suggested that the agency will agree that it should be made available to those 50 and up, but they may not call it a recommendation. This is dubbed a permissive recommendation, which makes the information available, but leaves it up to individuals to take into consideration their own health and risk tolerance.
Dr. Eric Topol, a cardiologist and director of the Scripps Translational Research Institute in California, is largely in support of the fourth shot based on the Israeli data. He also pointed out to CNN that any Americans who wanted a fourth dose could already go to a pharmacy and get it by saying they were immunocompromised. The FDA’s decision, he says, just legitimized what many were doing anyway.