The United States is about to start firing booster shots in a matter of weeks, there is still one important point to resolve: it is still not entirely clear that third shots will be needed.
President Joe Biden recently pledged to begin deploying boosters the week of Sept. 20, pending a green light from federal regulators.
But health experts who advised the government on the decision said the August announcement by Biden politicians had come as a surprise. They said it was also unclear why that date was chosen.
Proponents of the impetus are still mixed and announcing a timetable, while likely to be popular with much of the public, puts independent government regulators in a corner suggesting they will sign the signature no matter what happens.
“That doesn’t mean you can’t get out (of the decision), but I think the public’s expectation is that drivers are needed now,” said Dr. Henry Bernstein, a pediatrician at Cohen’s North Medical Health Children’s Medical Center in New York who has advised vaccine disease control and prevention centers.
“There is a lot more data to review and work on to assess whether drivers are needed in multiple populations,” Bernstein added.
The question of whether U.S. immunity is declining has become an urgent issue in recent months with the rise of the delta variant and the country’s large unvaccinated pockets.
The latest analysis, released Monday by the CDC, found worrying signs about the ability of vaccines to prevent infections and to keep the elderly out of the hospital.
Although vaccines were 90% effective in June to prevent hospitalization in people over 75, that number dropped by about 80% in July.
But even with this drop, the data still suggest extraordinary protection against severe COVID-19 disease. It also raises more questions than it answers: Does immunity decrease over time? Is the delta variant making people sicker? Is this a problem especially for older Americans, whose immune systems are less robust to begin with?
Young people under the age of 49 are still 24 times more likely to end up hospitalized if they are not vaccinated. And the vast majority of people in the hospital are not vaccinated, suggesting that vaccines are kept in real-world settings.
“We don’t have much evidence of a reduction in the effectiveness of the vaccine against significant outcomes in the majority of the population according to our current data,” said Dr. Beth Bell, a professor at the University of Washington and an independent CDC advisor. that you help decide if you recommend boosters to Americans at a recent public meeting on boosters.
Dr. Yvonne Maldonado, who works with the CDC advisory panel on behalf of the American Academy of Pediatrics, was one of the people who said the September 20 date was a surprise and it is unclear why. was chosen.
During a meeting of CDC advisers, Maldonado said he was texting colleagues asking, “Why do we implement detailed plans for this when it looks like we don’t know yet?”
The Food and Drug Administration typically reviews the data before announcing any decision on whether a vaccine can be administered. Then, a CDC expert advisory group weighs in and the CDC director signs if he recommends the vaccine to the public.
In this case, the designated Biden politicians involved in the pandemic response, including the acting head of the FDA, Dr. Janet Woodcock, agreed on the September 20 date before this process would take place. And with the crisis in Afghanistan still unfolding, the president shifted to the pandemic and publicly revealed his commitment that all Americans would receive a booster shot eight months after his vaccination.
Pfizer and BioNTech, which partnered to develop the country’s first vaccine, have said they have early data suggesting a booster dose six to 12 months after the initial vaccination will help maintain a high level of protection. This data has not yet been publicly shared.
“The frustration is also due in part to the sense of urgency here, due to public pressure to get reinforcement. Everyone would like the data to still be evolving,” Maldonado said.
On Tuesday, the FDA confirmed that two former vaccine officials had planned to leave the agency. His departure, addressed in a note to staff, followed the news citing officials ’frustration with the process. Woodcock told colleagues he trusted the leadership of FDA vaccine chief Peter Marks, who planned to remain in his position.
“We have drawn up a plan that will allow us to continue to prioritize science, while meeting the deadlines that are important to ensure the end of this devastating pandemic,” he wrote in the staff email.
Other political leaders also defended the September 20 date on Tuesday. CDC director Rochelle Walensky told reporters during a White House press conference that there was international data to be presented and that it is likely to play a role in the regulators ’regulatory decision.
Jeff Zients, Biden’s COVID coordinator, noted that the FDA and CDC had signed the plan for the Sept. 20 launch.
“In short, this virus has proven to be unpredictable and we want to be ahead and plan every scenario, and this has been our approach from day one and we will continue to be,” he said.