It’s that time of year again when booster shots are soon to be available. We’ve been conditioned for years to get the latest flu vaccine booster to ward off influenza infection. Last year we added a Covid booster shot to the annual routine. Is it time to do that again?

Maybe. Maybe not. It’s really too soon to know for sure. But here is what we do know.

In a new article published in The Wall Street Journal, Dr. Marty Makary of Johns Hopkins University says President Biden declared last week that a new Covid booster shot “works” and is “necessary.” At least that’s what someone told him to say. He said he would ask Congress to fund it and “it will likely be recommended that everybody get it no matter whether they’ve gotten it before.”

Dr. Makary asks, “Is this our new approval process? There are no human-outcomes data on this new shot, which the Food and Drug Administration is expected to approve in the next two weeks.”

Undermining the normal scientific and regulatory process erodes public trust. Last fall the administration approved and recommended a novel Covid bivalent booster with no human data. Only 20.5% of American adults took it, and some were compelled to do so by employers or schools. The recommendation was based on mouse data and failed to recognize the 100,000-fold risk difference between a healthy young person and a comorbid elderly adult. The government paid $4.9 billion for 171 million doses, the vast majority of which went to waste.

Will this new booster mitigate against the severity of Covid infection?

Maybe. Maybe not. Dr. Makary says it’s possible a new booster will mitigate against the severity of Covid infection, but the variants it targets are fleeting. Press releases from Pfizer, Moderna, and Novavax state that their new boosters work on the two dominant variants in circulation today, known as EG.5 and FL.1.51. But we don’t know which variant will be dominant later this winter when it matters. A newer variant, for which the novel booster vaccine has unknown efficacy, has already been identified in Michigan and outside the U.S.

If flu shots get approved without a randomized trial, why not Covid boosters?

Advocates of the new Covid boosters point out that the annual flu shot gets approved without a randomized trial. But flu shots use a traditional vaccine platform that has withstood the test of time, and Covid vaccines have higher complication rates. The latter have a rate of serious adverse events as high as 1 in 556 doses, according to a study published last year in the journal Vaccine. They have also been found to cause myocarditis in young people at a rate six to 28 times the incidence after infection, according to a 2022 JAMA Cardiology study.

Dr. Makary says, “The novel Covid booster shot may be warranted for some high-risk patients. But pushing it hard for young and old alike without human-outcomes data makes a mockery of the scientific method and our regulatory process.”

I am generally a strong advocate of taking vaccines and I’ve taken the primary series of Covid shots plus one booster shot last year. But the track record for these shots has been less than great with many people still getting Covid infections (like my wife) despite taking the vaccines. It is likely these vaccines have reduced the severity of the illness and for that we should be grateful. But Dr. Makary makes some good points for consideration when it comes to the newest vaccines.

My advice is to wait and see before being the first to stand in line for the latest boosters unless you are in a high-risk category and your doctor strongly recommends you get the shot. Chances are we will learn more in the next few weeks to months that may influence our decision regarding the newest Covid boosters.

(Author’s Note: If you would like more information about each of the latest Covid vaccine boosters, click on the following link to Yale Medicine.)