The decision to give additional doses of COVID-19 Modern and Pfizer vaccines confronts federal health officials who say the shots may not protect people from serious illness in the future against public health experts who disagree with its logic.
“It just doesn’t make sense on the surface,” said Dr. Paul Offit, director of the Philadelphia Children’s Hospital’s Vaccine Education Center. “All this effort to give a third dose, frankly, will do little to put us at the forefront of this pandemic because the problem here is not to increase vaccination. The problem is to vaccinate the unvaccinated.”
Most hospitalizations and deaths from COVID-19 occur in people who are not vaccinated. Only about 60% of the U.S. population that qualifies for a vaccine is fully immunized, although vaccination rates are rising.
However, federal health officials, who have raised concerns about declining immunity, announced last Wednesday that the Biden administration plans to allow adults in the U.S. to be fully vaccinated with mRNA vaccines developed by Moderna Inc. MRNA or Pfizer Inc. PFE and its partner BioNTech SE BNTX,
to get a third dose starting September 20 with some warnings.
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“I don’t think it’s true that just because you start to see the discoloration of immunity defined as a growing incidence of asymptomatic or slightly symptomatic diseases, [waning] protection against serious illness is just around the corner. It could be three years from now. It could be four years from now. ”
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The additional dose should be given at least eight months after the second vaccination, only to those over 18 years of age, and is likely to be made available to those most at risk, including nursing home residents and workers. health workers or those who have been vaccinated again in December and January.
The White House plan appears to depend on authorization from the Food and Drug Administration, a recommendation from the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention, and a seal of self-approval. CDC. (These steps are part of the normal process of bringing vaccines to Americans during the pandemic).
That said, as the plan was announced and the reasons justifying the decision have baffled some doctors with infectious diseases.
Talking to Americans about a plan before the FDA or CDC weighs in seems like a “political decision, as opposed to a scientific decision that the right regulatory bodies are making,” said Dr. Celine Gounder, a disease specialist. infectious. and epidemiologist at the NYU Grossman School of Medicine who was a member of President Biden’s COVID-19 Advisory Board. “The process does not appear to be continuing.”
Beyond the optics of the ad, Gounder and other experts have questioned the science used to support the decision.
Health officials cited three studies that showed that advanced infections increase, but the risk of hospitalization and death among vaccinated people remains low. But in their public comments, they hinted at a different set of concerns for the future.
“We are concerned that the current strong protection against serious infections, hospitalization and death may decline in the coming months,” CDC Director Dr. Rochelle Walensky said Wednesday.
Experts interviewed for this story say it is not a logical leap to start offering boosters now, as protection against hospitalization and death could diminish in the future. Traditionally, science and data lead decision-making in medicine. (That said, no one argues 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 start to see decreased immunity defined as a growing incidence of asymptomatic or slightly symptomatic diseases, [waning] protection against serious illness is just around the corner, “Offit said.” It could be three years from now. It could be four years from now. “
That’s why Offit considered the highly publicized data that came out of the outbreak in Provincetown, Massachusetts, as a good thing. Your prey? 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, keep people out of the hospital, keep them out of the ICU and prevent them from dying,” Offit said.
A changing stance on COVID-19 reinforcement shots
The White House’s shift change against reinforcements is frustrating for many, in part because officials came 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, Biden’s chief medical adviser, said the same thing at the time, as did the director of the National Institutes of Health, Dr. Francis Collins.
Then, a week ago, officials said some people with weak immune systems, such as organ transplant patients, will be able to receive a third dose, but the general public did not need it. “Other people who are fully vaccinated are adequately protected and do not need an additional dose of COVID-19 vaccine at this time,” FDA Acting Commissioner Janet Woodcock said Aug. 12.
The next day, CDC Dr. Kathleen Dooling said that while some immunocompromised people may need a booster, “other people who are fully vaccinated don’t need an extra dose right now, according to the presentation slides.
Everything changed with Wednesday’s announcement.
For Gounder, it makes a lot of sense to give an extra opportunity to people over the age of 80 and those living in residences. These are individuals who are less likely to have robust immune systems and advanced infections for them are more likely to mean serious illness and possibly hospitalization.
Also, giving an extra dose to someone who is immunocompromised is a different strategy than “empowering” the general population, in part because some of these people never got an immune response 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 additional doses,” he said. “It’s when you start looking at the rest of the population that it’s not clear.”
Therefore, both Gounder and Offit say that the best value for COVID-19 vaccines is to make sure they reach people who are not vaccinated and are not protected against the delta variant.
“If you look at communities that have high vaccine rates, they have very low disease rates, and areas with low vaccine rates have very high disease rates. [rates]”The vaccine works. It doesn’t work if you don’t get it.”
Read the studies that reported the CDC’s decision on reinforcement features:
• New cases and hospitalizations of COVID-19 among adults, by vaccination status – New York, May 3 – July 25, 2021
• Sustained efficacy of Pfizer-BioNTech and Moderna vaccines against COVID-19-associated hospitalizations among adults – United States, March-July 2021
• Efficacy of Pfizer-BioNTech and Moderna vaccines in the prevention of SARS-CoV-2 infection among nursing home residents before and during the widespread circulation of SARS-CoV-2 B. Variant 1,617.2 (Delta ) – National Health Security Network, March 1 —August 1, 2021