The Food and Drug Administration’s scientific advisory panel recommended against approving Pfizer/BioNTech booster vaccinations for the general population aged 16 and above. The boosters are currently only approved for immunocompromised individuals and patients in nursing homes—patients who are more vulnerable than the general population to get breakthrough infections that result in hospitalization or death.
Concluding that the vaccines offer the general adult population robust protection against severe disease that can possibly result in hospitalization or death, the committee decided the protection provided by the two-dose mRNA vaccine regimen is good enough for them.
The decision was not unanimous. For example, one panel member, Dr. Peter Marks, urged the committee to consider the spread of the disease, not just the severity of the illness.
As Michael F. Cannon and I have written here, the FDA often tramples on the fundamental right to self-medicate, and it looks as if it is about to do it again. I stated in an interview on The National Desk this morning that the FDA should stick to the question of whether a booster is safe and effective. The decision as to how much protection is good enough protection should be left up to patients, who are encouraged to consult with their health care providers.
Many people may be comfortable knowing that the vaccination protects them against severe illness and are willing to take their chances on a breakthrough infection that is likely to be mild to moderate. But others may make different risk/benefit assessments. For example, some may not want to risk giving it to their children and having to keep them home from school. Others may not be able to afford quarantining at home and missing work.
Alas, the FDA panel has made the decision for them.
This is one of the dangers of concentrating all decision-making authority in a government monopoly agency. It invites inevitable politicization of the process and violates individual autonomy.
The panel decision next goes to the FDA Commissioner, who is not obligated to follow the recommendations. Let’s hope the FDA overrules the panel and lets autonomous adults decide if they want to get a booster.
