The Fall COVID19 Shot is already a US Public Health Disaster
The FDA, CDC, Pfizer and the Biden administration are practicing reckless medicine; Here is how I will advise instead
The Biden administration seems set on pushing out a fall booster for all age groups. The CDC director has alluded to it in recent videos, and hospitals are emailing staff to be prepared to receive it. Even David Leonhardt, writing for the Times, who is more balanced on COVID19 policy than his colleagues, say about the fall booster, “all adults should consider getting a booster shot. Many Americans have now gone more than a year without one, and immunity has waned.”
In contrast, the UK government disagrees. Here, is there fall guidance:
Ultimately the UK is more sensible, but everyone is wrong. The fall 2023 booster is essentially a widespread medical intervention made with zero data. It should not be offered with no ongoing or conducted RCTs.
Consider the spectrum of risk. Of course, older people might have more to gain than younger people. People who never had covid (not many left) might have more to gain than those who have had it (especially multiply), and young men have the most to lose. Every time you alter the spike sequence, you may have less myocarditis or more!
Walid Gellad notes that FDA has failed to enforce the post marketing commitment and as such pushing more doses in young men seems reckless. Why is FDA waiving this requirement?
Ultimately, however, only randomized controlled trials can tell us who has a net benefit. Yet, this administration does not want any. Pfizer made 100 billion in their peak year, and can afford to generate data, and yet the white house, which has now pushed Gruber and Krause out of FDA, has decided to generate no data.
Observational data will not help. B/c the people who seek boosters will be different than those who don’t. We explained that more in NEJM.
In the absence of data, and with no ongoing on planned RCTs, I have the following conclusions:
The Biden Administration is not science based. They are as ignorant as the anti-science fringe they decry. I would watch for conflicts of interest as Califf, Jha, Murthy and others move into private sector.
I will never get another COVID19 shot until someone shows it lowers the risk of severe disease for someone of (a) my age and (b) who already had 3 doses (2 against my will) and (c) COVID. Practically, given the anti-science admin, this will be never.
I would not advise anyone healthy <65 to get the vaccine.
I would not advise anyone healthy who had COVID already to get the vaccine.
For those >65 with medical problems, and no prior covid, there are no data. I suspect nearly none of these people will want the booster, and I won’t push back. I have no data to fight with.
I would discourage all COVID19 vaccination of anyone healthy <30 (this is most insane); Especially <18. At this point, all have had covid and no data show further doses help them.
Colleges & hospitals should NEVER mandate this booster
I will continue to oppose the universal booster program without data, and this anti-science administration.
My position of how to handle the fall booster is in line with longstanding principles of medicine, including ‘you can’t push things on healthy people without good data,’ ‘beware conflicts of interest and optimism bias’ and ‘all medicines have diminishing returns’— these principles have been forgotten.
The Biden administration’s handing of COVID19 vaccine policy was a disaster, which I detail here. The fall booster enriches Pfizer and does not generate data for 300 million people who may be curious. It looks like they will double down on their errors. The people driving the bus are ignorant of medicine, and worse: they want to keep the rest of us ignorant on boosters.
