WASHINGTON — Federal authorities on Tuesday approved second booster shots of the Pfizer-BioNTech and Moderna coronavirus vaccines for everyone over the age of 50, describing the move as an attempt to bolster waning immunity to serious illnesses if the virus resurfaces in the coming months nation captured .
The Food and Drug Administration said people in the age group could get the extra injection at least four months after their first booster. The agency also approved a second booster shot for people 12 years and older with certain immune deficiencies.
The decision means tens of millions of Americans are now eligible for their fourth shot. And while the public may tire of repeated doses, the move is most likely a temporary one: federal health officials say it’s entirely possible Americans of all ages may need another shot in the fall to prepare for a winter surge. The hope is that by then the scientists will have reconfigured the existing vaccines so that they work better and last longer against the variants that have emerged since November.
Federal health officials initially considered restricting the second booster shot to people who are at least 60 or 65 years old. But at a press conference, Dr. Peter Marks, who oversees the FDA’s vaccines division, said a lower age limit makes more sense because so many Americans over 50 have chronic conditions that put them at risk.
While a single booster dose continues to protect most Americans from hospitalization and death from Covid-19, he said those over 50 who received their first booster more than four months ago should “seriously consider getting another one.” .
The Centers for Disease Control and Prevention was a little more cautious. In the fall, when the first round of boosters was approved, the agency cited a clear benefit of additional inclusion.
In contrast, the CDC updated its vaccine policy Tuesday to state that second booster shots are now allowed. dr Rochelle P. Walensky, the agency’s director, said the option of a different dose is “particularly important for people aged 65 and over and those aged 50 and over with underlying medical conditions that increase their risk of serious illness from Covid-19, since they are likely to benefit from an additional booster shot at that time.” About a third of people aged 50 to 65 have significant medical conditions, officials said.
The FDA made the decision with very limited data, mostly from Israel. Experts said there was fairly robust data showing the need for stronger protection after variants have compromised the effectiveness of the vaccines. There is significantly less data on whether and for how long a second booster dose provides this protection. Regulators said another dose didn’t raise any new safety concerns.
The notion that another booster shot is needed just six months after federal authorities approved the first round of boosters could increase public fatigue with Covid vaccines. Evidence now suggests that the government’s decision last autumn to authorize a first booster shot – the subject of much scientific debate at the time – saved lives over the winter. While the Omicron variant rose sharply, those who were boosted were 21 times less likely to die from Covid and seven times less likely to be hospitalized than those who were unvaccinated, according to the CDC
But at this point, “each additional dose offers marginal value,” said Dr. Eric Rubin, an infectious disease expert at Harvard TH Chan School of Public Health. At an event hosted by Columbia University this week, Dr. Kate O’Brien, the director of the Division of Vaccines at the World Health Organization: “We’re in a relatively weak position on the political front, on exactly that data are compelling decisions about fourth doses.”
The strongest data in support of a second booster dose comes from a newly published Israeli study that has not yet been peer-reviewed. During a 40-day period this year, researchers looked at Covid death rates in more than half a million adults aged 60 to 100 who had received at least one booster shot.
Of the 234,868 who only received a booster shot, 232 people died from Covid. Of the 328,597 people who received a second booster shot, 92 died from Covid. The mortality rate “was significantly lower in those who received an additional booster shot,” the researchers said.
Federal officials also examined statistical models that suggested that if the virus spikes again in late spring or summer, a second booster shot could save thousands of lives and prevent tens of thousands of hospitalizations.
The CDC has selected Johnson & Johnson recipients for special treatment. The agency has already recommended Moderna and Pfizer vaccines over Johnson & Johnson for safety reasons.
On Tuesday it said adults who received an initial dose plus a booster shot of the Johnson & Johnson vaccine at least four months ago – a group that could number more than 1.4 million people – were eligible for a second booster shot of one of the mRNA -Vaccines. The agency cited new data showing Johnson & Johnson’s vaccine was less effective than the other two.
Both Pfizer and Moderna have opted for a second booster. Pfizer and BioNTech said data collected during the Omicron wave showed the effectiveness of their first booster shot wanes within three to six months against both symptomatic infections and serious illnesses. Data from Israel suggests that a second booster dose restores protection, but researchers have not long followed recipients of this booster shot.
dr Paul Burton, Moderna’s chief medical officer, told CNN Monday that the virus’ mutations have weakened the vaccines’ protective shield. “The only way we’re going to get to a period of stability and ultimately endemic disease is to protect people and keep their antibody levels high, and I’m afraid that means regular boosters,” he said.
Both Pfizer and Moderna have an obvious financial incentive to promote more vaccines: They project tens of billions of dollars in Covid vaccine sales this year alone.
Neither the FDA nor the CDC convened their external committee of experts to discuss the new guideline, prompting criticism. dr Rubin, a member of the FDA panel, called the decision reasonable but said it was critical for the agency to release any data it relied on for others to review. The FDA’s decision memo is expected to be posted online soon.
Like other experts said Dr. Rubin, what is really needed now is a vaccine that works better than the existing ones against the new variants. Many studies are currently underway to find it, but the first results are not expected until later this spring.
“It’s not yet entirely clear what the optimal booster should be,” said Dr. Marks.
The FDA panel is scheduled to meet on April 6 to discuss how to move forward with the country’s booster strategy. Federal health officials have suggested vaccinations may be needed in the fall, just like with the flu. “Eventually,” said Dr. Marks, “we have to recognize that this is a virus that will be with us and that we have to come to terms with dealing with it on a regular basis.”
Another important decision may come next month, when the FDA can decide whether to approve a vaccine for the country’s youngest children — the only group not yet vaccine-eligible. Moderna plans to present data from a reportedly successful clinical trial of a two-dose regimen in children under the age of 6 in the coming weeks. Pfizer and BioNTech have said they expect results from their three-dose study in children under the age of 5 next month.
dr Marks said Tuesday that the FDA will seek advice from its advisory committee before making decisions about vaccinations for the youngest children.
For many of the roughly 3 percent of Americans with immunodeficiency, Tuesday’s decision essentially authorizes a fifth dose. Those 12 and older can get Pfizer’s Shot, while adults can choose between Pfizer’s and Moderna’s.
How big the public demand is for another booster is unclear. With the pandemic in the doldrums, the nation’s enthusiasm for gunfire has waned. Newly reported infections have been declining since the third week of January, when the Omicron wave peaked.
According to CDC estimates Tuesday, an even more contagious subvariant of Omicron, known as BA.2, now dominates among new US cases. The subvariant has led to a wave of new cases in Europe. However, some experts believe the United States could escape the brunt of its impact.
Cheryl Shell, a 71-year-old retiree from the southern Michigan town of Spring Arbor, said she’s not waiting to find out. She got her first booster shot in November, she said, and is anxious for a second because she’s worried about her potency diminishing. “I have to do whatever protection I can get,” she said.
Kate Bedingfield, White House communications director, said the new authorization was “a good thing and a straight forward thing.” She said the government has enough stocks to offer second boosters to those now eligible.
But she reiterated a point the White House had repeatedly made in recent weeks: if booster shots were recommended for the general population, Congress would have to allocate more money to pay for them.
Noah Weland and Adel Hasan contributed reporting.