Monday, April 4, 2022

Comment on the FDA and the CDC and Second Covid Boosters

Public health officials and agencies need to cultivate and maintain credibility in order to be fully effective. Unfortunately, there have been some missteps at the federal level. For example, remember the initial recommendation not to wear masks, which was subsequently changed. Also, recall the advice that the J&J vaccine was about as good as the mRNA vaccines, though anyone paying attention knew that this was likely not the case. Now the way the federal government has handled the approval of a second Covid vaccine booster makes one wonder what is going on in the federal health agencies.

On March 29, 2022, the FDA authorized the use of a second booster shot for individuals over 50. The CDC on the same day issued a media release, entitled “CDC Recommends Additional Boosters for Certain Individuals.”

The FDA took this action without consulting its Advisory Committee on Vaccines and Related Biological Products, even though the committee’s next meeting is on April 6. Why did the FDA not wait a few days and ask the committee for its advice on second boosters before taking regulatory action? Regardless of what the FDA officially says, my guess is that FDA officials thought they might get advice that was contrary to what they wanted to do. It is not clear that would have been the outcome, though, a prominent member of the committee, Dr. Paul Offit, has expressed skepticism of the need for second boosters for everyone over 50.

With regard to the CDC’s media release, its headline is misleading. The text of the statement does not recommend additional boosters. Rather, it says: “Following FDA’s regulatory action today, CDC is updating its recommendations to allow certain immunocompromised individuals and people over the age of 50 who received an initial booster dose at least 4 months ago to be eligible for another mRNA booster to increase their protection against severe disease from COVID-19. Separately and in addition, based on newly published data, adults who received a primary vaccine and booster dose of Johnson & Johnson’s Janssen COVID-19 vaccine at least 4 months ago may now receive a second booster dose using an mRNA COVID-19 vaccine.”

This wording is strange. It recommends that a broader group be "allowed" to get a second booster, though the CDC does not have the authority to do this. It reads as a recommendation to the FDA to do what it had already done a few hours previously.

The wording looks like a hasty bureaucratic compromise among government officials who probably are not in total agreement. There is disagreement in the medical community about this. The government's handling of this issue does not inspire confidence and is a further example of less than good public relations by public health authorities.

I do not know whether second boosters are necessary or a good idea for everyone over 50. I would like to see whether any consensus is achieved among the experts.

I also note that the attempt to manipulate press accounts on this subject have not been fully successful because of dissenting voices among experts. For example, here is an excerpt from a recent New York Times article, “Should you get another Covid booster”:

Many scientists are dubious about today’s decision.

The F.D.A.’s authorization allows anyone over 50 to receive a second booster. But experts pointed out that the limited research so far supports a fourth shot only for those older than 65 or who have underlying conditions that put them at high risk.

The most compelling data comes from an Israeli study that found that adults older than 60 who got a fourth dose were 78 percent less likely to die of Covid than those who got only three shots. The study was posted online last week and has not yet been reviewed for publication in a scientific journal.

“The Israeli study, in terms of mortality rate, is decisive,” said Dr. Robert Wachter, chair of the Department of Medicine at the University of California, San Francisco.

But that study, while it offers the only evidence, is deeply flawed. The participants all volunteered to get a fourth shot — and are likely to be people who are naturally careful about their health, said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and an adviser to the F.D.A.

It will be interesting to see what happens at the FDA advisory committee meeting on April 6.

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