“Current data suggest a reduction in protection over time from severe COVID-19 outcomes in older, immunocompromised individuals. “19 could help increase protection levels for those at higher risk,” said Dr Peter Marks, director of the FDA’s Center for Biological Assessment and Research, in a press release. crucial to help protect all adults from the potentially serious effects of COVID-19. Thus, those who have not received their initial booster dose are strongly encouraged to do so. “ The FDA said in its decision that it had determined that the known and potential benefits of secondary amplifiers outweighed the known and potential risks to these populations. The U.S. Centers for Disease Control and Prevention is expected to follow through on what is known as a permissible recommendation – a statement that vaccines can be used in this age group for anyone who wants them. However, the agency is not expected to formally propose the plans. If the CDC fails to issue a clear approval for second-hand boosters, it will burden the task of weighing the risks and benefits of another vaccine to individuals and has caused concern among some vaccine proponents who say marginal additional protection may not be available. will be worth the confusion created by the fourth installments. Dr Megan Ranney, an emergency physician who is the academic dean of Brown University School of Public Health, says throughout the pandemic, officials tackled policy-making before they had enough evidence to support it. Ranney sees this as another example. He says it is not clear if everyone needs a fourth dose at the moment, but having these approvals will provide flexibility for the rapid release of more amplifiers if needed. “I see this approval from the Biden government as an insurance policy on their part,” Ranney said. “It’s a way to get people to do the vaccine or the extra booster. But it also gives them the flexibility so that if BA.2 is worse than we expect, they can then release it quickly. Or God forbid, “If there is another variation in the next two months that requires another amplifier, they can launch it quickly. So I read it that way,” Ranney said. There is general scientific agreement that third doses help boost immunity to serious diseases caused by the Covid-19 virus. However, science is far from whether, or even when, fourth doses may be needed, as vaccines continue to provide a high degree of protection against the hospitalization and death of Covid-19, even when the protection against the disease is declining. . Much of the evidence for the safety and efficacy of a second booster dose comes from Israel, which is the fourth dose of coronavirus vaccine in adults 18 years of age and older in late January. The FDA said in its decision it looked at data from the Israeli Ministry of Health on more than 700,000 people aged 18 and over who had received second boosters of the Pfizer-BioNTech vaccine at least four months after their first booster dose. More than 600,000 of these people were over the age of 60. The agency said the data did not reveal any new safety issues related to the fourth dose. The FDA said the safety data for Moderna boosters, when used as a fourth dose, came from a study of 120 people aged 18 and over who received a fourth dose of the vaccine at least four months after their third dose of Pfizer. . No new safety concerns were identified three weeks after the last dose. Some of the data on which the FDA relied to make its decision come from previously published studies. In a large study of more than half a million adults over the age of 60, those who received a second booster or fourth dose of Covid-19 vaccine had a 78% lower chance of dying during the Omicron wave compared with those who had a third shot of at least four. months earlier. But the death tolls were relatively low in both groups. After 40 days of follow-up, there were 232 total deaths from nearly 234,000 people who had only received three doses of the Pfizer-BioNTech vaccine, compared with 92 deaths from 328,000 people. A smaller study of health workers, including younger adults, found that the fourth booster was safe and restored antibodies to the same levels achieved after the third dose. But the fourth doses were only moderately effective – about 30 to 40% – in preventing disease. And most of the workers who fell ill still had high viral loads, suggesting they were able to spread the infection to others. Additional studies from the United Kingdom show that boosting antibodies from a booster dose decreases very quickly, within a few weeks. Thus, some experts believe that given the resources available and the reduced appetite to continue receiving more and more aid, the United States will have to wait until there is a clear risk of a new wave of infections to release fourth installments. Some see that the possible time will be next fall. “If you only have one bullet in your gun to shoot, I’d rather keep it on fire until the fall, because then the cases can really start to increase,” said Dr William Schaffner, an infectious disease specialist at Vanderbilt University. As of January, Americans 12 years of age and older are eligible for a third dose of the vaccine, but only 46% of this demographic has received a third dose.
Schaffner says he is concerned that the fourth dose will simply confuse people who have not yet decided on a third dose. “I’m very worried about being divided and not being able to win, because the messages will be very, very confusing,” he said, “and so I think public health and clinicians should continue to focus on getting the third eligible individuals “. CNN’s Amanda Sealy contributed to this report.