Follow the Science. Whose Science?

Image by Katja Fuhlert from Pixabay

James Earl Biden. Yesterday was supposed to be the day when almost all American adults could start getting the first booster shot for the Pfizer vaccination. On August 18 the Biden Administration announced that a Pfizer booster shot would be available to Americans who received their second Pfizer dose at least eight months prior. At the time of the announcement, Biden said, “This will boost your immune response. It will increase your protection from COVID-19.  That’s the best way to protect ourselves from new variants that could arise.”

While the Biden announcement contained the usual boilerplate notation that approvals had to be secured from the FDA and CDC before the booster program could begin, it seemed obvious that the administration expected approval.

The scheduled date for broad based Pfizer booster shots came and went yesterday without a broad based booster program.

Follow the science? Health and Human Services “medical experts,” including CDC Director Rochelle Walensky, issued a statement on the same day Biden predicted booster shots starting on Sept 20 (yesterday). It read, in part: “Based on our latest assessment, the current protection against severe disease, hospitalization, and death could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout. For that reason, we conclude that a booster shot will be needed to maximize vaccine-induced protection and prolong its durability.”

Ready, set … stop! Per VerywellHealth, “On September 17, an advisory committee to the Food and Drug (FDA) Administration voted 16 to 2 against approving booster doses of Pfizer’s COVID-19 vaccine for all adults ages 16 and older. It did, however, recommend boosters for certain people — including those at high risk for serious illness and people over the age of 65.”

The FDA advisory committee’s decision is not binding on the FDA as a whole. However, a 16-2 vote against broadly providing booster shots at this time certainly sounds like an impediment to near-term FDA approval.

Who is on first? The CDC issues statements saying, in part, ” … we conclude that a booster shot will be needed to maximize vaccine-induced protection and prolong its durability.” President Biden described the booster program as, “the best way to protect ourselves from new variants that could arise.” The Israelis have implemented a booster shot program. They have also initiated studies on the effectiveness of the booster program. “What we discovered is that the vaccine’s effectiveness with respect to viral load gradually wanes over time, until after six months, [viral load] reaches a high level, similar to that of an unvaccinated person,” said Matan Levine-Tiefenbrun, a doctoral student at Tel Aviv University who is also affiliated with the Technion and was the lead researcher. “Nevertheless, we discovered that the booster shot brings the viral load back down by a factor of four, to what it was before.”

Follow the science? What science? The Israeli science? The CDC science? The science as summarized by Biden? The science of the FDA sub-committee.

But why?  To the layman it seems unclear why the FDA sub-committee voted 16-2 against a broad roll-out of booster shots. The explanations oscillate between needing more data and concerns about myocarditis, especially among young men and boys. However, other factors may be involved. A number of so-called western medical experts have begun claiming that booster shots in the West amount to a “vaccine nationalism.” In their estimation, any additional vaccines available should should be shipped to poor countries rather than used in the West for boosters. The U.N., through the World Health Organization, has called for a moratorium on booster shots until more of the developing world gets their first jabs. Could the FDA sub-committee be channeling Gen. Mark Milley with a bit of freelance foreign policy? Biden speaks at the U.N. today. Maybe his administration wanted to get past this speech before defying the WHO.

Fallout. As the Houston Chronicle reports, “State health officials are bracing for confusion as they manage expectations about coronavirus boosters that President Joe Biden announced last month would be widely available to adults this week.” Chaos and confusion seem to become the handmaiden of Biden’s statements and policies, from Afghanistan to a submarine deal with the Aussies that somehow has the French in fits. Now we have the booster bungle.

Michael Fraser, Executive Director of the Association of State and Territorial Health officials is feeing the pain. He said, ” … “the expectation has been set by the administration that we now have to manage. It puts the states in a difficult position.” Incompetence at the federal level often puts people in “difficult positions.”

As Chron reports, “Some states, such as Virginia, anticipating the interest in boosters, have posted online notices urging residents to be patient and to wait for further guidance once final recommendations have been provided by the federal government.”

The chief medical officer for Alaska wants to know if her state can start giving booster shots when they have vaccines nearing expiration and patients who understand the risks. Good question.

Finally, in a development that should surprise nobody, Americans are finding ways to get the booster with or without the federal government’s approval. As a pharmacist in New York’s East Village says, “We don’t ask for proof. If you think you are eligible, then we give a third dose.”  I guess that’s one way to “follow the science”.

— DJ Rippert