Pfizer and BioNTech seek authorization for second booster shot for older Americans

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Pfizer and BioNTech seek authorization for second booster shot for older Americans

WASHINGTON – Pfizer and BioNTech said on Tuesday they had sought emergency authorization for a second booster shot of their coronavirus vaccine for adults 65 and older.

The companies’ request to the Food and Drug Administration was based heavily on data from Israel, where such shots are authorized for a somewhat broader group. His move could spark a heated debate among scientists about when, how and for whom the safety of vaccines should be increased.

Pfizer’s chief executive, Dr. Albert Boerla, has said repeatedly over the past week that he believes an additional dose will be needed to counter the declining safety after the third dose, which is now available to all Americans. Authorized for ages 12 and above. “The protection you’re getting from third is good enough, actually good enough for hospitalizations and deaths,” he told CBS’s “Face the Nation” on Sunday. “It’s not so good against infection.”

Previous requests for a booster shot sparked a fierce public debate. Some public health experts strongly opposed them to the general population last fall, only to change their mind after the Omicron version proved more agile at evading the shields of vaccines. Scientists continue to struggle over how long the safety of vaccines actually lasts and how many benefits added shots provide.

In an interview with Business Insider on Monday, Dr. Stephen Hoge, the president of Moderna, whose vaccine is the second most widely used vaccine in the United States, made a more cautious remark than Dr. Baurla.

“For people who are immune-compromised, who are older adults, over the age of 50 or at least 65, we want to strongly recommend and encourage” the fourth shot, he said. But he did not say how soon he felt it would be needed. Like many other experts, he suggested that most people would need an annual shot to protect themselves from the coronavirus, just like the flu.

In their justification, Pfizer and BioNTech cited two recent studies from Israel, both of which were published on preprint servers without any peer review. A study conducted in conjunction with Israel’s Ministry of Health reviewed the health records of 1.1 million people and concluded that they were less likely to be infected with the virus or develop serious illness after their fourth dose of Pfizer vaccine.

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But as Israel recently began its second booster program, researchers could not determine whether the additional protection was short-lived. Israel began offering a fourth dose to health care workers in late December, then quickly expanded eligibility to those 60 and older and other vulnerable groups.

A second study of Israeli health care workers showed that the fourth shots of the vaccine from Pfizer or Moderna raised antibody levels, but it was not very effective in preventing infection. The researchers said those findings underscore the urgency to develop vaccines that target either type of circulating.

In the United States the National Institutes of Health and various vaccine manufacturers are studying how vaccines can be updated.

Some senior administration officials say a fourth shot for all older Americans may make sense now, but the general population should probably wait until the fall. The FDA is expected to convene a meeting of its expert advisory committee next month to discuss the issue of the fourth shot. The developments were first reported by The Washington Post at the request of Pfizer.

Asked last month whether everyone would need another injection, the FDA’s top vaccine regulator, Dr. Peter Marks, said, “barring any surprises from the new variants, perhaps the best thing to do is to have an influenza vaccine.” It’s best to think of our booster strategy in conjunction with a fall, and then boost to as many people as possible.” White House Chief Medical Adviser Dr. Anthony S. Fauci suggests that any earlier recommendations would be aimed at those most at risk, possibly based on underlying conditions as well as age.

To date, nearly two thirds of Americans age 5 and older have been fully vaccinated with two shots of a vaccine. According to the Centers for Disease Control and Prevention, only half of those eligible for booster shots have received them, but the proportion rises to two-thirds for people 65 and older.

In a call with reporters on Tuesday, senior administration officials said the administration was lacking funds for vaccines. Officials said that assuming regulators authorize a fourth shot for people 65 and older, the administration has enough supplies to manage it. But he said it cannot extend that effort to everyone without more funding from Congress.

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The CDC recommends that many Americans with immune deficiencies get three shots as part of their initial series, followed by a fourth shot as a booster.

A study released last month by the agency found a reduction in protection after a booster shot of the vaccines from Moderna or Pfizer-BioNtech. Although they did not break down cases by age, underlying conditions or the presence of immune deficiencies, the researchers said the findings show the potential importance of a fourth shot.

The study analyzed hospitalizations and visits to emergency rooms and urgent care clinics in 10 states that received booster shots of either Moderna or Pfizer-BioEntech’s vaccines. It showed that the level of protection against hospitalization fell from 91 percent at two months after the third shot to 78 percent after four to five months. Effectiveness against visits to emergency rooms or urgent care clinics decreased from 87 percent to 66 percent.

Kaiser Permanente Southern California suggests that the effectiveness of a booster dose against both symptomatic and severe disease decreases over three to six months, while the fourth dose restores antibody levels to the peak levels triggered by the third dose.

But other recent studies have suggested that three doses of a COVID vaccine – or even just two – are enough to protect most people from severe disease and long-term death. Antibody levels drop, but other parts of the immune system can remember and destroy the virus over several months, according to at least four studies published in top-tier journals in recent weeks.

“We are now starting to see diminishing returns on the number of additional doses,” E. John Varys, director of the Institute of Immunology at the University of Pennsylvania, said in an interview last month.

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