Top U.S. health officials have reportedly warned the White House to curtail its plans to offer COVID-19 booster shots to Americans later this month.
Leaders of the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention both told White House pandemic coordinator Jeffrey Zients in a meeting Tuesday that their agencies will not be able to fully assess the need for booster shots anytime soon, The New York Times reported.
President Joe Biden announced in mid-August that booster shots would be made available to the vaccinated starting the week of Sept. 20, pending approval by the FDA and CDC.
"The plan is for every adult to get a booster shot eight months after you got your second shot," Biden said on Aug. 18.
But FDA Acting Commissioner Dr. Janet Woodcock and CDC Director Dr. Rochelle Walensky informed Zients that under that timeline their agencies might only be able to rule on boosters for some people who have received the Pfizer vaccine, according to the Times.
A growing group of U.S. and international experts has pushed back against Biden's booster shot plans, arguing that the scientific evidence doesn't yet support an extra dose of vaccine.
People who have questioned the data include Dr. Camille Kotton, an infectious disease specialist with Massachusetts General Hospital in Boston. She serves on the CDC advisory panel that would review the need for booster doses prior to approval.
She noted that the vaccines now on the market continue to provide strong protection against severe illness and hospitalization due to infections from the now-rampaging Delta variant of COVID.
"Really, what we're seeing is higher rates of breakthrough disease, which is still generally mild symptoms," Kotton said in an interview with HealthDay Now.
Vaccinated people "aren't going to the hospital the vast majority of the time," she continued. "They just have a little bit of a viral syndrome."
Kotton's panel, the Advisory Committee on Immunization Practices (ACIP), recently approved a third dose of vaccine for people with compromised immune systems, but Kotton noted that the dose isn't a booster. Rather, people who are immune-compromised will receive a three-dose vaccine series rather than a two-dose series.
In that case, medical evidence showed that people with immune system deficiencies -- solid organ recipients, bone marrow transplant patients, folks fighting cancer -- needed three doses of vaccine to achieve sufficient protection against COVID, Kotton said.
"This is not actually a booster dose," she said. "This is a third dose that is considered part of their primary vaccine series."
Dr. Amesh Adalja, a senior scholar with the Johns Hopkins Center for Health Security in Baltimore, agreed that the current surge in COVID hospitalizations and deaths is being driven by the unvaccinated.
"That's what's in the hospital right now -- it's not vaccinated people that are the issue in this pandemic," he said.
"The whole debate over boosters needs to be framed by that, because putting third doses into highly vaccinated populations isn't going to change what's happening in the United States," Adalja told HealthDay Now.
Adalja said the vaccines are "still performing off the charts" when it comes to keeping people out of the hospital or the morgue.
"Vaccines are not bug zappers. They're not force fields. They're not meant to stop every breakthrough infection," he said. "Because the breakthrough infections are generally mild, I don't know that we want to be in the business of chasing them with booster shots when this is not a virus that's ever going to go away."
The FDA has scheduled an advisory board meeting Sept. 17 to review data from Pfizer-BioNTech regarding booster shots for its vaccine, the agency announced this week.
A key member of the FDA advisory panel has argued that it's too soon to approve COVID boosters, the Times reported.
"There is no compelling reason to get a third dose" now, Dr. Paul Offit, director of the Children's Hospital of Philadelphia's Vaccine Education Center, told the Times on Thursday.
The Advisory Committee on Immunization Practices has more on its COVID-19 vaccine recommendations.
SOURCES: The New York Times Amesh Adalja, MD, senior scholar, Johns Hopkins Center for Health Security, Baltimore; Camille Kotton, MD, infectious disease specialist, Massachusetts General Hospital, Boston