FDA significantly limits COVID-19 vaccine recommendations
Abandons strategy of prevention through widespread immunization
The US Food and Drug Administration (FDA) announced today
that it will only recommend COVID-19 vaccines for adults 65 and older and
people at risk for severe illness.
In a marked departure from
the current recommendations of seasonal vaccination for anyone 6 months and
older, the FDA will require manufacturers to conduct clinical trials
demonstrating the efficacy of COVID-19 vaccines for healthy children and adults
under age 65.
Writing in the New England Journal of
Medicine, FDA Commissioner Martin Makary, MD, MPH, and Vinay
Prasad, MD, MPH, director of the FDA's Center for Biologics Evaluation and
Research, said the move aligns the United States with other high-income nations
that have limited vaccine access to older and vulnerable populations.
But the announcement comes just 2 days before the FDA’s
Vaccines and Related Biological Products Advisory Committee (VRBPAC) meets for
the first time this year. VRBPAC was expected to address COVID-19 vaccines, as
was the Centers for Disease Control and Prevention’s (CDC's) Advisory Committee
on Immunization Practices (ACIP), which is set to meet in June.
Commenting to ABC News,
Paul Offit, MD, director of the Vaccine Education Center at Children’s Hospital
of Philadelphia, said, “The only thing that can come of this will make vaccines
less insurable and less available.”
Low uptake can hurt other vaccines
Makary and Prasad said uptake of the annual fall COVID-19
booster dose since 2023 has been low among healthy adults and children, at less
than 25% and 10%, respectively.
“The benefit of repeat dosing—particularly among low-risk persons who may have previously received multiple doses of Covid-19 vaccines, had multiple Covid-19 infections, or both—is uncertain,” Makary and Prasad wrote. “The American people, along with many health care providers, remain unconvinced.”
The low uptake contributes to vaccine hesitancy, they said,
“resulting in a reluctance to vaccinate that is affecting even vital
immunization programs such as that for measles–mumps–rubella (MMR) vaccination,
which has been clearly established as safe and highly effective.”
One third of US population likely eligible
The authors also noted that their approach uses an expansive
list from the CDC of health conditions that increase the risk of severe
COVID-19, including obesity, depression, asthma, pregnancy, and cardiovascular
disease.
“Estimates suggest that 100 million to 200 million Americans
will have access to vaccines in this manner,” they wrote. With adults over age
65, this is roughly one third of the US population.
The authors laid out a framework for testing the efficacy of
annual COVID boosters on those aged 6 months to 64 years, one that echoes
Operation Warp Speed, used to develop the first COVID vaccines in 2020. Adults
ages 50 to 64 without risk factors for severe illness are the ideal group to
study vaccine efficacy and endpoint, including infection, hospitalization, and
death in post-marketing, randomized placebo-controlled trials, they said.
“Sample-size calculations should aim to demonstrate that
vaccines reduce the incidence of the primary end point with a lower confidence
interval bound that is ideally above 30%,” they wrote. “People who have had
Covid-19 in the past year should not be excluded—since evidence is needed for
the average American.”
The authors said COVID-19 is different from influenza, which requires seasonal boosting, in several ways, most notably because natural immunity from previous COVID-19 infections against severe disease appears robust.
