Marty Makary pushes back on Biden vaccine mandate
Johns Hopkins Dr. Marty Makary joins 'Fox News Primetime' with analysis
The Food and Drug Administration has just simplified things by issuing a blanket recommendation for every adult in America to get a COVID-19 vaccine booster shot.
But this comes just eight weeks after the FDA’s external advisory panel voted down boosters for all adults by a 16-2 vote, due to concerns of insufficient data on younger people. So what’s the bottom line?
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For older Americans or those who have a risk factor for COVID illness, the medical case for boosters is now compelling. A recent study found the effectiveness of the mRNA vaccine’s in protecting you from getting COVID went down dramatically from 88 percent to 48 percent at six months, and J&J’s one-dose vaccine’s effectiveness declined to 13 percent.
Far more concerning, the vaccine’s effectiveness in protecting against death declined in people over 65, dropping to 76% with Moderna, 70% with Pfizer, and 52% with J&J.
FILE PHOTO: Walmart pharmacist holds a vial of the Moderna coronavirus disease (COVID-19) vaccine inside a Walmart department store in West Haven, Connecticut, U.S., February 17, 2021. (REUTERS/Mike Segar/File Photo)
But everyone has a different risk tolerance level. It can be helpful to quantify the risks of a breakthrough infection using the most recent data available.
According to the CDC, the risk of being hospitalized for a breakthrough infection among a person fully vaccinated is approximately 1 in 22,000 adults per week during the Delta variant. (This may or may not correspond to future risk in a post-pandemic era).
The one state that reports characteristics of breakthrough hospitalizations found that the average age of a fully-vaccinated person being hospitalized was 73 and the average age of a fully-vaccinated person dying was 80. That says a lot about just how skewed the risk may be in the population.
FILE PHOTO: Pfizer/BioNTech's new pediatric COVID-19 vaccine vials are seen in this undated handout photo. (Pfizer/Handout via REUTERS)
The decline of vaccine effectiveness against testing positive for COVID has been observed to a lesser extent in young people, but the case that young people are at increased risk of severe illness has not been established. Moreover, the reason both the FDA and CDC external experts voted down ‘boosters for all adults’ just eight weeks ago was that the side effects of a booster in younger people has not been elucidated.
It is thought that the side effect profile of a third dose is similar to that of the second dose, which for young men and boys includes a 1/7,000 risk of myocarditis, including the reported case of at least one vaccine-related myocarditis death, a 22-year old in a Israel, a country one-38th the population size of the United States.
A sign informs potential patients that "Pfizer COVID-19 Boosters Available, No Moderna" at a coronavirus disease vaccine clinic at La Colaborativa, in Chelsea, Massachusetts, U.S., November 9, 2021. REUTERS/Brian Snyder (REUTERS/Brian Snyder)
One important factor that plays into the need for a booster is natural immunity, a topic that has received little attention by public health officials despite overwhelming data. For those who have recovered from COVID, the calculus on needing a booster changes.
The largest study conducted worldwide on natural immunity found that vaccinated people were 27-times more likely to get COVID than those who had previously tested positive for COVID. But it’s clear that having had COVID illness, either before or after vaccination, adds to your body’s immunity to COVID. To date, there is not scientific support for COVID boosters among people who are vaccinated and also recovered from COVID.
One appeal of "boosters for all" is the simple messaging.
Maine Gov. Janet Mills recently told the Washington Post that simplified requirements for booster shots would help clear up confusion with the federal recommendations.
New Jersey Gov. Phil Murphy said "With the holidays coming up, we need as many people boosted as possible. It’s that simple."
The simple message of boosters for all may be easier to understand but it’s not supported by data.
Another factor in calculating COVID mortality risk is the advent of Merck's and Pfizer’s new pills that cut COVID deaths to zero in each of their phase three clinical trials. That is, no one who received the drug in the phase three trials died.
The first of these therapies, will likely be available the second week of December. These medications may mark the official end of the pandemic phase of COVID in the U.S. and a transition to the endemic phase.
One looming question is will everyone need a booster each year? It’s unlikely.
There is a magic number of doses at which the immune system builds up strong long-term immunity through memory B and T cells. It’s very rare for a vaccine to result in durable immunity after just one dose. It’s usually two or three. We are now recognizing that the first two mRNA doses given so close together may have resulted in them functioning as one primer dose.
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With any vaccine in medicine, the longer the interval between doses, the more durable the immunity. Research now shows that spacing out the first and second vaccine doses by three months (as I did for myself) confers much stronger immunity.
In fact, there is 3.5-times stronger immunity when studied with older people receiving the Pfizer vaccine. So it may be that your third dose may be the final boost needed to give you durable immunity against severe disease (the key outcome that is important).
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Finally, the vast majority of Americans dying from COVID today (approximately 1,000 people each day) are adults with a risk factor, such as being overweight, who are unvaccinated and who did not have COVID in the past.
As a reminder, anyone in that group should to go to local pharmacy today and get vaccinated in order to have protective immunity to downgrade any future COVID illness from a life-threatening infection to a non-threatening infection.
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