The decision is largely based on three studies.
On August 18, the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) issued a joint statement that starting on September 20, people who have received two shots of either Pfizer-BioNTech or Moderna’s mRNA COVID-19 vaccines would be able to receive a booster shot eight months after receiving their second shot.
Although the data is not as solid for the Johnson & Johnson one-shot vaccine and no decision has been made, it is anticipated that people who received the J&J shot will also be recommended for a booster shot. Also, people did not start receiving the J&J vaccine until March, three to four months after the initiation of dosing of the two mRNA vaccines in the U.S.
Surgeon General Vivek Murthy, M.D., said the plan was to “stay ahead” of COVID-19 and that the current vaccines are still effective in protecting against severe COVID-19, hospitalization and death, but the data to date suggests that protection wanes over time.
“We are concerned that this pattern of decline we are seeing will continue in the months ahead, which could lead to reduced protection against severe disease, hospitalization and death,” Murthy said in a White House briefing.
The decision is largely based on three studies. One was run in New York, which suggested that the vaccine efficacy against new COVID-19 strains dropped from 92% to 80% from May 3 through July 5. That research was published in the CDC’s Morbidity and Mortality Weekly Report (MMWR) yesterday.
The second study was performed by the Mayo Clinic and studied the effectiveness of both the Pfizer-BioNTech and Moderna vaccines in 80,000-plus people of all uses through July 16. The study showed that effectiveness dropped from 76% to 42% among people receiving the Pfizer-BioNTech vaccine and from 86% to 76% in the Moderna group.
The third, also published in the CDC’s MMWR, reported that the effectiveness in nursing home residents dropped from 75% in March to 53% in August. The researchers for that study, from the CDC and Lantana Consulting Group in Vermont, wrote that “an additional dose of COVID-19 vaccine might be considered for nursing home and long-term care facility residents to optimize a protective immune response.”
A fourth study, which was not the focus of yesterday’s discussion, came out of Israel, where the Pfizer-BioNTech vaccine is the only one deployed. Israel has begun vaccinating the elderly with a third booster based on reports that the vaccine’s efficacy dropped over time. In that study, the third dose decreased the risk of infection in people over the age of 60 by 86% and against severe infection by 92%. In addition, Pfizer and Moderna stated their own research demonstrated that a booster would improve protection.
The decision comes with some criticism. Some researchers questioned the need for boosters at this time. Others called out the morality of booster shots for the U.S. when numerous other countries are struggling to administer even a single shot. And yet another group has expressed concern that the decision was made by the Biden administration before the FDA and a vaccine advisory committee had made a decision or evaluated the data.
The government officials in their announcement, which included Murthy; Dr. Francis Collins, director of the National Institutes of Health (NIH); Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID); Dr. Rachel Levine, assistant secretary for Health; Dr. David Kessler, chief science officer of the COVID Response; Dr. Rochelle Walensky, CDC director; Dr. Janet Woodcock, acting FDA commissioner; and Dr. Marcella Nunez-Smith, chair of the COVID Health Equity Task Force, said the Pfizer-BioNTech and Moderna vaccines data “could” indicate a drop in protection against severe disease.
Dr. Norman Baylor, president and chief executive officer of Biologics Consulting and a former head of the FDA’s Office of Vaccines, told STAT, that “could is not a very strong word … especially to make a policy decision on.”
This was echoed by Dr. Anna Durbin, a vaccines researcher at Johns Hopkins University, who noted that the vaccines were still very effective at preventing hospitalizations, severe disease and deaths, and that preventing mild disease in the vaccinated didn’t necessarily mean the vaccines were failing. She does not think the decision to go ahead with boosters was based on science.
“I think there’s this tidal wave building that’s based on anxiety,” she told STAT. “And I don’t think it’s based on scientific evidence that a booster is needed.”
There are also questions about the timeline of the decision. The September 20 deadline was established, but the FDA hasn’t made a decision on Pfizer’s application for the booster, which was only filed on August 16. Moderna has yet to file for a booster approval.
Surgeon General Murthy said the booster program would only proceed if the FDA and the CDC’s ACIP advisory committee give a green light.
