FDA Allows Second Coronavirus Boosters for Anyone 50+


WASHINGTON — Federal regulators Authorized second booster shots of Pfizer-BioNTech and Moderna coronavirus vaccines For anyone 50 and older, he described the move on Tuesday as an effort to strengthen weakened immunity against serious illness should the virus sweep the country again in the coming months.

The Food and Drug Administration said people in the age group can get additional vaccinations at least four months after the first supplement. The agency also allowed a second booster for people 12 years and older. with certain immune deficiencies.

The decision means tens of millions of Americans are now eligible for their fourth inning. And while the public may be weary of repeated doses, the move is likely a temporary one: Americans of all ages may need another vaccine in the fall to prepare for any winter waves, federal health officials say. The hope is that by then scientists have restructured existing vaccines to work better and last longer against variants that have emerged since November.

Federal health officials initially considered limiting second supplements to those who were at least 60 or 65 years old. But in a news briefing, Dr. Peter Marks said a lower age limit makes more sense, as many Americans over the age of 50 have chronic medical conditions that put them at risk.

While a single booster dose continues to protect most Americans from hospitalization and death due to Covid-19, those 50 and older who took their first supplement more than four months ago “should seriously consider taking another supplement,” he said.

The Centers for Disease Control and Prevention was a little more cautious. In the fall, when the first round of support was confirmed, the agency clearly benefited from an additional shot.

On Tuesday, by contrast, the CDC updated the vaccine guide to indicate that second boosters are now allowed. The agency’s director, Dr. Rochelle P. Walensky said that another dose option is “especially important for those aged 65 and over with underlying medical conditions and those aged 50 and over. would likely benefit from taking an additional dose of the supplement right now.” About one-third of people aged 50 to 65 have significant medical problems, officials said.

FDA made the decision with very limited datalargely from Israel. Experts said there is fairly solid data showing that stronger protection is needed as variants reduce the potency of vaccines. There is significantly less data on whether a second booster can provide this protection and for how long. Another dose raises no new safety concerns, regulators said.

Just six months after federal regulators approves first round of boostersmay increase public fatigue with Covid vaccines if another booster is already necessary. Evidence now shows that the government’s decision to authorize the first promoter last fall – which was the subject of much scholarly debate at the time – saved lives over the winter. While the Omicron variant was on the rise, those who were supplemented were 21 times less likely to die from Covid and seven times less likely to be hospitalized than those without the vaccine, according to the CDC.

But at this point, infectious diseases specialist at the Harvard TH Chan School of Public Health, Dr. “Each additional dose offers marginal value,” said Eric Rubin. hour An event hosted by Columbia University This week, the director of the World Health Organization’s vaccine department, Dr. “We are in a relatively weak position on the kind of policy front that makes compelling decisions about exactly what data is,” said Kate O’Brien. fourth dose.”

Strongest data supporting a second booster came from a newly published Israeli study has not yet been peer-reviewed. Over a 40-day period this year, researchers looked at COVID mortality rates among more than half a million adults aged 60 to 100 who had taken at least one supplement.

Of the 234,868 people who only had one promoter, 232 died from Covid. Of the 328,597 people who received a second booster, 92 died from Covid. “The mortality rate was significantly lower among those who received an additional booster,” the researchers said.

Federal officials have also studied statistical models that suggest a second booster could save thousands of lives and prevent tens of thousands of hospitalizations should the virus re-emerge in late spring or summer.

CDC has selected Johnson & Johnson recipients for special treatment. The agency has already recommended vaccines from Moderna and Pfizer over Johnson & Johnson’s for safety reasons.

On Tuesday, adults who received a starting dose plus a booster Johnson & Johnson vaccine (a group that may include more than 1.4 million people) at least four months ago are eligible for a second booster with one of the mRNA vaccines. The agency cited new data showing that Johnson & Johnson’s vaccine is less effective than the other two.

Both Pfizer and Moderna have argued for a second booster. Pfizer and BioNTech said: Data collected during the Omicron wave showed that its initial potentiator effects diminish within three to six months against both symptomatic infection and severe disease. Data from Israel shows that a second booster restores protection, but researchers haven’t been tracking recipients of these boosters for long.

Moderna’s chief medical officer, Dr. Paul Burton told CNN on Monday that mutations in the virus have weakened the shield of vaccines. “The only way to achieve a period of stability and ultimately an endemic disease is to protect people, keep antibody levels high, and I’m afraid that means a steady increase,” he said.

Both Pfizer and Moderna have a clear financial incentive to encourage more shots: They predict tens of billions of dollars Only in Covid vaccine sales this year.

Neither the FDA nor the CDC convened a committee of outside experts to discuss the new policy, prompting criticism. An FDA panel member, Dr. Rubin found this decision reasonable, but said it was critical for the agency to publicly disclose any data it relied on for others to review. The agency’s decision note is expected to be published online soon.

Like other experts, Dr. What’s really needed right now is a vaccine against new variants that works better than existing vaccines, Rubin said. Many studies are now being done to find it, but the earliest results are not expected until this spring.

Dr. “It is not yet clear what the optimal booster should be,” Marks said.

FDA panel will meet on April 6 to discuss what the country’s empowering strategy should be. Federal health officials have suggested that a vaccine may be needed in the fall, just as with the flu. “At some point,” said Dr. “We’re going to have to understand that this is a virus that will be with us and we will have to deal with it on a regular basis,” Marks said.

Another key decision comes possibly next month, when the FDA may decide whether to allow a vaccine for the nation’s youngest children – the only group still not eligible for the vaccine. Moderna plans to present what it describes as a successful clinical trial of a two-dose regimen for children under 6 years of age in the coming weeks. .

Dr. Marks said on Tuesday that the FDA will seek advice from the advisory committee before making decisions about vaccines for the youngest children.

For most of the roughly 3 percent of immunocompromised Americans, Tuesday’s decision essentially allows for what the fifth dose will be. Those aged 12 and over can take the chance with Pfizer, while these adults can choose between those from Pfizer and Moderna.

It’s unclear how much public demand there is for another booster. With the pandemic in recession, the nation’s enthusiasm for shooting is waning. Since the third week of January, when the Omicron wave peaked, new infections reported have been falling.

According to CDC estimates On Tuesday, an even more contagious sub-variant of Omicron, known as BA.2, now predominant among new US cases. The subvariable resulted in an increase in new cases in Europe. But some experts think the United States may be spared the brunt of the impact, in part because the Omicron variant has infected large numbers of Americans.

Cheryl Shell, a retired 71-year-old from the town of Spring Arbor in southern Michigan, said she didn’t wait around to find out. She said she got her first booster in November, and she’s dying to get a second because she’s worried about the strength going down. “I should go for whatever protection I can get,” she said.

White House communications director Kate Bedingfield said the new authorization was “a good thing and a simple thing”. He said the government now has ample supply to offer second boosters to those who qualify.

But he reiterated a point the White House has made multiple times in recent weeks: If booster vaccines are recommended for the general population, Congress will need to provide more money to pay for them.

Noah Weiland and Adel Hassan contributing reporting.



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