Not everyone agrees that COVID-19 booster shots are necessary for all vaccinated Americans and that the discord could slow down plans to deploy additional doses of mRNA vaccines later this month and change who can choose them.
Dr. Sara Oliver, who heads the COVID-19 vaccine working group and is an official with the Centers for Disease Control and Prevention, said Monday that the “priority for booster dose policy should be be the prevention of serious illness in a population at risk, ”citing nursing home residents and front-line health workers as examples.
The presentation was part of a meeting of the CDC Advisory Committee on CDC Immunization Practices, a group of independent public health experts who make recommendations on vaccines to the CDC after the authorization or approval of the CDC. Food and Drug Administration.
White House officials, including President Joe Biden, said last month that Americans vaccinated with BioNTech SE BNTX,
and Pfizer Inc. PFE,
or the MRNA of Moderna Inc.,
COVID-19 vaccines can get a booster dose starting Sept. 20, as long as eight months have passed since someone has been completely vaccinated, the FDA authorizes or approves the booster, and the CDC gives its blessing. They said the first drivers will likely go to groups of people most at risk for serious illness.
(The White House also said that the people who got Johnson & Johnson’s JNJ,
the single-shot vaccine is likely to need a second dose, although no further details have been shared at this time).
That said, U.S. regulators have yet to accept a booster dose for the general public, and this has become a point of discussion for some public health experts.
The Biden administration’s announcement “made everyone – led the doctors, made the public believe – that they had access to information about these vaccines and the need for boosters that had not yet been published publicly.” said Dr. Sandra Adamson Fryhofer, an assistant professor of medicine at Emory University School of Medicine, said Monday. “For me, that opened the door to a lot of confusion.”
Fryhofer serves as a liaison with ACIP for the American Medical Association.
Federal health officials have said they are concerned that vaccines will soon be less effective in protecting people from serious illness, hospitalization and death, and that is their main reason for booster shots.
When asked about the ACIP reinforcement discussion on Tuesday, CDC director Dr. Rochelle Walensky said the committee had only evaluated U.S. data so far.
“It is our own data, as well as international data, that has led us to worry that the decline we are seeing for infection will soon lead to the decline we would see for hospitalization and serious illness and death,” he said.
However, doctors with infectious diseases previously told MarketWatch that clinical decisions for COVID-19 booster shots should be based on available data, not on what is expected to happen.
What has changed in the COVID-19 reinforcement discussion
The national discourse around the drivers has intensified over the past two months, driven by the public promotion of Pfizer and Moderna, the sudden support of the Biden administration and the widespread use of additional doses in Israel, which scientists are watching closely to see how the virus behaves in the highly vaccinated country.
At the same time, cases have steadily increased in the United States since early July, as immunity has declined over time and the rapid spread of the most infectious delta variant has led to an increase in infections among vaccinated and the unvaccinated.
Oliver reiterated that at Monday’s meeting.
“All [COVID-19] vaccines continue to be effective in preventing hospitalization and serious illness, but may be less effective in preventing infections or mild illnesses recently, “he said.” These reasons for lower effectiveness are likely to include decreased time and variance. delta “.
However, most of the growing number of hospitalizations and deaths we are seeing right now occur in unvaccinated Americans.
“The data so far do not show a significant reduction in the effectiveness of vaccines in terms of preventing hospitalizations and deaths,” Dr. Beth Bell, a clinical professor at the University of Washington School of Public Health, said Monday. member of the ACIP. . “The most important thing we can do about vaccines is to keep working as hard as we can to encourage more people to get the main series.”
What exactly is a COVID-19 booster shot?
This is where things get complicated.
The CDC does not refer to additional doses for the immunocompromised as a booster shot. Instead, it is considered a third dose or an extra dose because many of these people never had an immune response to the initial vaccination, according to Oliver. (The only Americans currently eligible for an additional dose of BioNTech / Pfizer or Moderna intakes are some teens and adults with compromised immune systems, an authorization that was granted in August).
The agency defines a booster dose as one that “increases” the immunity of the “primary series” of a vaccine that has decreased over time.
There are also different types of boosters. A homologous booster uses the same vaccine, while a heterologous booster uses a different vaccine for booster than the one used in the primary series.
There are already several “mix-and-match” clinical trials around the world, including one conducted by the National Institutes of Health that is testing a Modern booster in people who received any of the three COVID-19 vaccines authorized or approved.
In addition, drug manufacturers are testing different doses of vaccines in booster trials.
There is one more idea to consider: perhaps two-dose COVID-19 vaccines will become three-dose vaccines. (Dr. Paul Offit, director of the Vaccine Education Center at Philadelphia Children’s Hospital, told me in August that this appears to be the White House plan. His view is that officials at the “We do not expect erosion against serious disease. Now we will only offer reinforcement, assuming it is a three-dose vaccine.”
Other vaccines, such as human papillomavirus (HPV) and hepatitis B vaccines, require three doses, spread over a year or so. For example, the third dose of the hepatitis B vaccine can be given up to 18 months after the first dose.
“In a pandemic environment, it may be important to achieve high early protection with a second dose given in a shorter interval, but it may mean that a later dose is also needed for this booster effect,” Oliver said. “That doesn’t necessarily mean an annual booster dose is needed.”
What comes next
BioNTech and Pfizer said last week that they had sent data to the FDA for a Comirnaty booster shot. These data examined antibody levels in adults who received a third dose four to eight months after the initial vaccination.
Moderna and J&J have said that booster doses may increase antibody levels among people immunized with their shots, although neither company has submitted that data to U.S. regulators at this time.
The ACIP is expected to meet in mid-September or if and when the FDA authorizes or approves a third dose of one of the vaccines, to then discuss how COVID- 19. At Monday’s meeting he focused on establishing a framework for U.S. BioNTech / Pfizer, J&J and Moderna booster intakes to be asked to present clinical data on booster doses at upcoming meetings.
“We read the timing of this meeting and the discussion on the additional dose (‘reinforcement’) as an indication that the increase in third doses may not come as quickly as investors expected,” Daina Graybosch, an analyst at SVB Leerink.
Jefferies analysts had a much closer view of the meeting, telling investors that they think the committee opts only to recommend booster doses for high-risk populations such as health workers and the elderly.
“The ACIP still seems to doubt itself [additional] doses are needed despite decreasing antibodies and increasing infections, ”they wrote.