Pfizer seeks approval for a second booster shot for older Americans

Washington — Pfizer and BioNTech said Tuesday they called for an urgent permit for a second booster dose of the coronavirus vaccine for adults aged 65 and over.

The company’s request to the Food and Drug Administration was largely based on data from Israel where such shots were allowed. For a slightly larger group..Their movements can burn even more A winding debate among scientists When and how to enhance vaccine protection, and for whom.

Dr. Albert Bourla, Pfizer’s CEO, reiterated that additional doses are needed to combat the decline in protection after the third dose over the past week, and all now 12 years and older. It is licensed by Americans. “The protection you are getting from the third, it’s good enough, it’s actually pretty good for hospitalization and death.” He told CBS’s “Face the Nation” on Sunday.. “Not very good for infectious diseases.”

Earlier demands for booster shots have sparked intense public debate. Some public health experts strongly opposed the general public last fall, but their thoughts after the Omicron variant proved to be more agile in avoiding the vaccine shield. I just changed. Scientists continue to clash about how long vaccine protection actually lasts and how much benefit additional injections can bring.

of Interview with Business Insider On Monday, Dr. Stephen Hoge, president of Moderna, the second most widely used vaccine in the United States, made a more cautious statement than Dr. Bourla.

“I highly recommend and encourage people with weakened immunity, older people over 50 or 65,” he said. But he didn’t say how quickly he thought it was needed. Like many other experts, he suggested that most people need annual shots to protect them from the coronavirus like the flu.

In its legitimacy, Pfizer and BioNTech cited two recent studies from Israel. Both are published to the preprint server without peer review. One studyIn collaboration with the Israeli Ministry of Health, reviewed the health records of 1.1 million people, and those who received four doses of Pfizer’s vaccine were more infected with the virus and had more serious illness than those who just received it. He concluded that he was unlikely to develop the disease. Administered 3 times.

However, because Israel has just launched a second booster program recently, researchers could not determine if the added protection was short-lived. Israel began offering a fourth dose to healthcare professionals in late December, after which it rapidly expanded its eligibility for ages 60 and older and other vulnerable groups.

Second study, One Israeli health care worker showed that a fourth dose of Pfizer or Moderna vaccine increased antibody levels, but was less effective in preventing infections. The researchers said these findings underscore the urgency of developing vaccines that target all circulating variants.

The National Institutes of Health and various vaccine manufacturers in the United States are researching ways to renew vaccines.

Some senior executives say the fourth shot for all older Americans may now make sense, but the general public should probably wait until the fall. The FDA will convene an expert advisory board next month to discuss the issue of force shots.Progress at Pfizer’s request Previously reported by The Washington Post..

Last month, everyone was asked if they needed another injection, Dr. Peter Markes, FDA’s top vaccine regulator, said:“Apart from the surprises from the new variants, perhaps the best thing is to come up with a booster strategy in combination with the flu vaccine next fall and give boosters to as many people as possible.” White House Chief Medical Advisor Dr. Anthony S. Forch, who is, suggests that earlier recommendations are likely to target the highest-risk people, probably based on underlying illness and age.

To date, about two-thirds of Americans over the age of five have been fully vaccinated with two vaccinations. According to the Centers for Disease Control and Prevention, only about half of the people targeted for booster shots received them, but that percentage rises to two-thirds of those over the age of 65.

In a phone call with reporters on Tuesday, senior government officials said the vaccine was underfunded. Assuming that regulators allow people over the age of 65 to shoot a fourth shot, officials said the government has sufficient supplies to control it. But they said the effort could not be extended to everyone without further funding from Congress.

CDC recommends the following: Many Americans with immunodeficiency get three shots as part of the first seriesFollowed by a fourth shot as a booster.

Survey Released by the agency last month, it showed that protection was weakened after a booster shot of either the Moderna or Pfizer-BioNTech vaccine. They did not classify cases by age, underlying condition, or the presence of immunodeficiency, but researchers said the findings indicate the possible importance of the fourth shot.

This study analyzed hospitalizations and visits to emergency rooms and emergency clinics in 10 states by people who received booster shots of the Moderna or Pfizer-BioNTech vaccine. The level of protection against hospitalization was shown to drop from 91% 2 months after the third shot to 78% 4-5 months later. Efficacy for visits to emergency rooms and clinics decreased from 87% to 66%.

Kaiser Permanente Southern California diminishes the effectiveness of booster immunity for both symptomatic and serious illness in 3-6 months, with a fourth dose returning antibody levels to peak levels caused by the third dose. I suggested that.

But Other recent studies suggestHe said that three or even two doses of the Covid vaccine are sufficient to protect most people from serious illness and death for a long period of time. While antibody levels decline, other parts of the immune system have been virus over months, if not years, according to at least four studies published in prestigious journals in recent weeks. It can be remembered and destroyed.

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