The FDA revised the Emergency Use Authorization for the Pfizer and Moderna vaccines to include a booster shot for persons that are immunocompromised on August 12. The CDC’s Advisory Committee for Immunization Practices met the next day (here are the meeting materials) and unanimously voted to recommend an extra dose of Covid-19 vaccine for some immunocompromised people. Director Wilensky immediately signed off on the recommendation. That recommendation will cover about 7 million Americans.
Last week, statements were leaking out of the White House suggesting that persons in the White House would like to see booster shots available to all Americans US to Advise Booster Shots for Most Americans 8 Months After Vaccination.
Those leaks were followed up by remarks made simultaneously by Surgeon General Murthy, Anthony Fauci, and Director Wilensky, suggesting that this is a coordinated effort to make vaccine recommendation policy at the top rather than the normal process of listening to the Advisory Committee for Immunization Practices and learning about the evidence base before recommending vaccines.
Recommendations for booster shots are supposed to start with an approval or EUA from the FDA followed by an in-depth review by the CDC’s Advisory Committee on Immunization Practices. That group is supposed to conduct a thorough evidence review including a GRADE assessment of the evidence, meet, deliberate, and vote on whether to recommend boosters for all. That recommendation would then go to the CDC director for consideration.
Top officials expressed their support for universal boosters before the ACIP met and before a full an evidence review was even done, basically making policy by press release rather than by using evidence.
It’s also critically important for them to consider the fact that the developing world has largely not had access to vaccine yet. In fact, 10% rich countries have administered 90% of all global vaccines. Administering 200M more vaccines to Americans that already have very good protection would take 200M doses out of the global supply chain that could be used in developing countries.
It also reinforces the feedback loop in which the vaccine manufacturers focus business model and manufacturing capacity on selling boosters to rich countries rather than ramping up production for COVAX.
Read this opinion piece in the Washington Post this week (which I agree with): Why the Biden administration’s recommendation on booster shots is a mistake:
This decision is a mistake. Not only does it risk depriving millions throughout the world of the vaccine, but there also is no evidence that additional shots meaningfully reduce death or hospitalization from covid-19 for healthy Americans. Far better would be to wait for solid trial data on booster shots.
High-income countries have used bilateral contracts with vaccine manufacturers to achieve vaccination rates as much as 50 times that of low-income countries. A campaign for boosters could lock in that apartheid. This profound global inequity would not only be a humanitarian disaster, but also a significant long-term risk for Americans, as scientists agree that accelerating global vaccination is the only way to prevent the formation of deadly new variants.
The booster for all Americans isn’t official policy yet. The CDC is at least officially waiting for ACIP to meet on August 30-31 to make the policy recommendation. Hopefully there will be a full evidence review by the 30th. But the fact that this policy was announced well in advance of ACIP means to me that this is a railroad job.