Booster

Booster

This past week, a panel of independent FDA advisors has voted to recommend booster shots of both the Moderna and Johnson & Johnson COVID vaccines. Boosters for Moderna and Pfizer were approved last month.

The decision shows some of the huge advantages of the booster but the limits of assessment.

Boosters were recommended for high-risk groups. These people are defined as people over 65, younger people at high risk for severe COVID, and those who work in high-exposure jobs, like nursing. This recommendation is quite specific.

The FDA panel relied on data from Israel, and small studies from the companies themselves. But Israel has largely vaccinated its population with Pfizer, not Moderna or J&J. And the panelists repeatedly raised concerns about the depth of drug company data, particularly on side effects.

As data reporter Betsy Ladyzhets noted in her COVID Data Dispatch Newsletter after the Pfizer booster authorization, there’s a serious lack of home-grown data underlying the entire booster process. Because the CDC doesn’t track all breakthrough infections—just serious ones—federal advisory bodies are relying on data gathered outside the US.

At the FDA presentation, the Israeli officials said that boosters not only reduced the rate of infections but cut the rate of severe disease by about 70 percent. In people older than 60, they said that boosters reduced deaths by 80 percent.

It seems clear that mRNA boosters will further protect their recipients against COVID. But when it comes to the larger questions—breadth of protection against varients, for example—the data is incomplete. This is not a criticism of the vaccine, it just means the information on them is not gathered or can't be. Much of this data is time-dependent and the meds have not been around long enough.

Regarding side effects, there are two main concerns. The first is blood clotting after the J&J vaccine, which primarily affects women in their 20s to 30s. The recognition of this rare but dangerous side effect led the United States to pause its distribution of the J&J vaccine this spring, breaking the momentum of some outreach campaigns. As of October 5, FDA officials reported 47 cases from J&J. The second is swelling of the heart muscle, known as myocarditis, which has most affected young men, and isn’t as dangerous. There have been 93 cases related to J&J, and 300 following Moderna shots as of June.

The Moderna booster dose, which is just half the 100 microgram primary doses, was only tested on 170 people. Instead, many panelists relied on Israeli data, which showed that out of 3.7 million full 100 microgram third doses delivered in Israel, there were only 44 events that required hospitalization or were life-threatening.

There are some serious problems here. There is a vaccine newsletter! This information is being disseminated to everyone and the concepts are sometimes difficult. Regulatory bodies are shy of using data from systems they don't control, especially when nationalism is involved. There is clearly a jump from the science eye to the political eye. The notion of 'high-risk groups' is an obvious one but not often heard in the public discussion.

Then there is 'context.' The dangerous complications are presented as isolated numbers. What does '44 events requiring hospitalization or were life-threatening' mean? Were the events that followed the vaccine directly related to the therapy? Was there a variation in severity? Is 44 out of 3.7 million a lot when compared to, say, penicillin reactions? Is a fever in a guy with leukemia seen as 'life-threatening' when it would be ignored in a healthy one? These kinds of questions are important when this information becomes so generally available.

Finally, there is the democracy of illness. The West is having a change in how it evaluates its population. The culture is having trouble with the Bell Curve.

The Bell Curve is contracting. Everyone is being mainstreamed. Pronoun reassessments are being made universally although gender identification problems are extremely rare. What in many fields is acceptable risk has become emblematic. A bad cop leads to banning cops. An outlier is not proof of the usual, it is brought under the big tent and personalized.

It may be impossible to make decisions with that mindset.