The Biden administration is prepared to begin rolling out booster shots for many Americans the week of Sept. 20, the nation's top health officials announced Wednesday, citing data that show the effectiveness of Pfizer and Moderna vaccines against COVID-19 diminishes over time.
"Having reviewed the most current data, it is now our clinical judgment that the time to lay out a plan for COVID-19 boosters is now," US Surgeon General Vivek Murthy said at a White House briefing.
In a joint statement by the US Food and Drug Administration, the Centers for Disease Control and Prevention, Murthy and others, the officials cited the threat of the delta variant and noted "we are starting to see evidence of reduced protection against mild and moderate disease."
The recommendation will be that anyone who received Pfizer or Moderna vaccines should get a booster shot eight months after their second shot, with health care workers, nursing home residents and seniors first in line.
"Based on our latest assessment, the current protection against severe disease, hospitalization, and death could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout," the officials wrote. "For that reason, we conclude that a booster shot will be needed to maximize vaccine-induced protection and prolong its durability."
The CDC has maintained that vaccines still blunt the threat of becoming seriously ill. On Wednesday, the agency released data showing the vaccines still protect against hospitalizations. In one analysis involving 21 hospitals, the CDC found Pfizer and Moderna remained at least 84% effective against hospitalizations from March to July.
But that's just when it comes to keeping people out of hospitals. When it comes to more mild breakthroughs, data suggest vaccine effectiveness is already waning, particularly in the face of the delta variant.
This is especially true for the elderly, with a separate CDC analysis finding that Pfizer and Moderna vaccine efficacy dropped "significantly" among nursing home residents from March to July, as the delta variant became the predominant strain in the United States.
"It does appear overall vaccine effectiveness is declining from May to July. The good news is that vaccine effectiveness against hospitalizations has remained quite robust without much evidence of decline," said Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center.
A healthcare worker fills a syringe with Pfizer COVID-19 vaccine at a community vaccination event in Los Angeles, Aug. 11, 2021.
For now, the upcoming boosters will be aimed at people who received the Pfizer and Moderna vaccines only. But officials say they anticipate authorizing boosters for people who got the Johnson & Johnson vaccine too. The first J&J vaccines weren't administered until March, and the Biden administration says it expects more data on the effectiveness of that vaccine in a few weeks.
The administration says vaccines are still working and are the best assurances against severe illness or death. But the concern is that without a booster, breakthroughs infections could one day lead to more severe illness, even among the vaccinated.
Among those signing the statement were Murthy, CDC Director Rochelle Walensky, FDA Administrator Dr. Janet Woodcock, and Dr. Anthony Fauci, President Joe Biden's chief medical advisor and director of the National Institute of Allergy and Infectious Disease.
The plan to offer booster shots is contingent upon an official sign-off by the FDA on the safety and effectiveness of a third dose, although Wednesday’s statement suggested that was a foregone conclusion.
The CDC also has to sign off with specific recommendations. CDC advisers planned to meet Aug. 24 to discuss the matter. One issue likely to be discussed by CDC advisers is whether it will be advisable to opt for a different brand of vaccine as a booster. Studies on whether to "mix and match" vaccines have been ongoing.