The FDA and CDC Standards on the J&J Vaccine and the Immunocompromised are Unintelligible
Last week the FDA authorized and the CDC now recommends a third mRNA booster for the immunocomprimised. The CDC says:
Who Needs an Additional COVID-19 Vaccine?
Currently, CDC is recommending that moderately to severely immunocompromised people receive an additional dose. This includes people who have:
- Been receiving active cancer treatment for tumors or cancers of the blood
- Received an organ transplant and are taking medicine to suppress the immune system
- Received a stem cell transplant within the last 2 years or are taking medicine to suppress the immune system
- Moderate or severe primary immunodeficiency (such as DiGeorge syndrome, Wiskott-Aldrich syndrome)
- Advanced or untreated HIV infection
- Active treatment with high-dose corticosteroids or other drugs that may suppress your immune response
That’s very reasonable but the headline is inaccurate because the CDC then goes on to say:
The FDA’s recent EUA amendment only applies to mRNA COVID-19 vaccines, as does CDC’s recommendation.
Emerging data have demonstrated that immunocompromised people who have low or no protection following two doses of mRNA COVID-19 vaccines may have an improved response after an additional dose of the same vaccine. There is not enough data at this time to determine whether immunocompromised people who received the Johnson & Johnson’s Janssen COVID-19 vaccine also have an improved antibody response following an additional dose of the same vaccine.
So if you got one dose of J&J and are immunocompromised then you can’t get a second dose. But if you got two doses of an mRNA (which is already more effective than one dose of J&J) and are immunocompromised then the CDC recommends a third dose. None of this makes any sense. The weasel words there ‘isn’t enough data to determine’ indicate a typical failure to think in Bayesian terms and use all the information available and a typical failure to think in terms of patient welfare and expected cost and benefits.
Notice also the illiberal default. Instead of saying ‘we don’t have data on the J&J vaccine and the immunocompromised so we are not at this time recommending or not recommending boosters but leaving this decision in the hands of patients and their physicians’ they say ‘we don’t have data and so we are forbidding patients and their physicians from making a decision using their own judgment.’
Hat tip: Pharmacist CB.