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Moderna and Pfizer’s decision to give additional doses of COVID-19 vaccines pits federal health officials who say injections may not protect people from serious illness in the future against public health experts who do disagree with their logic.
“It just doesn’t make sense at first glance,” said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia. “Frankly, all this effort to give a third dose will not help us bring this pandemic under control, because the problem here is not to stimulate the vaccinated. The problem is to vaccinate the unvaccinated.
The majority of hospitalizations and deaths related to COVID-19 occur in unvaccinated people. Only about 60% of the US population who qualifies for an injection are fully immune, although vaccination rates are increasing.
However, federal health officials, citing concerns about diminished immunity, announced last Wednesday that the Biden administration planned to allow adults in the United States fully vaccinated with mRNA vaccines developed by Moderna Inc. MRNA or Pfizer Inc. PFE and partner BioNTech SE BNTX,
to get a third dose from September 20 with a few caveats.
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“I don’t think it’s true that just because you’re starting to see the discoloration of immunity defined as an increasing incidence of asymptomatic or mildly symptomatic disease, so that means the [waning] critical illness protection is right at your fingertips. It could be in three years. It could be in four years. ”
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The additional dose should be given at least eight months after the second injection, only to people 18 years of age and older, and will likely be available to those at high risk first, including residents of nursing homes. and health workers or those who have been vaccinated. in December and January.
The White House plan appears to depend on clearance from the Food and Drug Administration, a recommendation from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, and a seal of approval from the CDC itself. same. (These steps are part of the normal process of getting vaccines to Americans during the pandemic.)
That said, the way the plan was announced and the rationale for the decision puzzled some infectious disease physicians.
Talking to Americans about a plan before the FDA or CDC weighed in, made it seem like a “political decision, as opposed to a scientific decision made by the appropriate regulatory bodies,” said said Dr. Céline Gounder, specialist in infectious diseases. and NYU Grossman School of Medicine epidemiologist who was a member of President Biden’s COVID-19 advisory board. “The process doesn’t feel like it’s being followed.”
Beyond the lens of the ad, Gounder and other experts questioned the science used to support the decision.
Health officials cited three studies that showed breakthrough infections on the rise, but the risk of hospitalization and death among those vaccinated remains low. But in their public comments, they hinted at another set of concerns for the future.
“We are concerned that the current strong protection against serious infections, hospitalizations and death will wane in the coming months,” CDC director Dr Rochelle Walensky said on Wednesday.
Experts interviewed for this story say it doesn’t make sense to start offering reminders now, as protection against hospitalization and death may wane in the future. Traditionally, science and data drive decision making in medicine. (That said, no one disputes that vaccines are less effective against the delta variant, which is believed to account for almost all cases in the United States)
“I don’t think it’s true that just because you’re starting to see a discoloration of immunity defined as an increasing incidence of asymptomatic or mildly symptomatic disease, so that means the [waning] critical illness protection is just around the corner, ”Offit said. “It could be in three years. It could be in four years. “
That’s why Offit viewed the high-profile data from the outbreak in Provincetown, Mass., A good thing. His opinion ? No one died, only four vaccinated people were hospitalized and most of the approximately 450 infections were mild or moderate.
“The goal has always been to prevent serious illness, to keep people out of the hospital, to keep them out of intensive care, to prevent them from dying,” Offit said.
A shifting stance on COVID-19 booster injections
The White House’s U-turn on booster injections is frustrating for many, in part because officials spoke out against them so strongly during the second week of August.
Six weeks ago, the CDC and the FDA said COVID-19 booster shots were unnecessary; Dr Anthony Fauci, chief medical adviser to Biden, then said the same, as did the director of the National Institutes of Health, Dr Francis Collins.
Then, a week ago, officials said some people with weakened immune systems, such as organ transplant patients, would be allowed a third dose, but the general public did not have one. need. “Other fully vaccinated people are properly protected and do not need an additional dose of COVID-19 vaccine at this time,” Acting FDA Commissioner Janet Woodcock said on Aug. 12.
The next day, CDC’s Dr Kathleen Dooling said that while some immunocompromised people may need a booster, “other fully vaccinated people don’t need an extra dose at this time, according to the slides in the. presentation.
Everything changed with Wednesday’s announcement.
For Gounder, it makes perfect sense to also give an extra boost to people over 80 and those living in nursing homes. These are people who are less likely to have strong immune systems and breakthrough infections for them are more likely to lead to serious illness and possibly hospitalization.
In addition, giving an extra dose to an immunocompromised person is a different strategy from “stimulating” the general population, in part because some of these people never developed an immune response at all with the first two doses. Gounder said. In some of these cases, the third dose only helped some, but not all, of these types of patients to develop an antibody response.
“These three groups, I think there is good evidence to give extra doses,” she said. “It’s when you start looking at the rest of the population that it’s not clear.”
This is why Gounder and Offit say the best value for COVID-19 vaccines is ensuring that they reach people who are unvaccinated and unprotected against the delta variant.
“If you look at communities that have high immunization rates, they have very low disease rates, and areas that have low immunization rates have very high disease rates. [rates]”Offit said.” The vaccine works. It doesn’t work if you don’t get it.
Read the studies that informed the CDC’s decision for booster shots:
• New cases of COVID-19 and hospitalizations in adults, by vaccination status — New York, May 3 — July 25, 2021
• Sustained efficacy of Pfizer-BioNTech and Moderna vaccines against hospitalizations associated with COVID-19 in adults — United States, March — July 2021
• Efficacy of Pfizer-BioNTech and Moderna vaccines in preventing SARS-CoV-2 infection in nursing home residents before and during widespread circulation of the SARS-CoV-2 B variant. 1.617.2 (Delta) – National Healthcare Safety Network, March 1 – August 1, 2021
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