[ad_1]
WASHINGTON — Pfizer and BioNTech on Tuesday asked federal regulators to allow coronavirus booster shots for those 18 and older, a move that will likely ensure every adult in America is eligible for an extra injection.
The Food and Drug Administration is expected to honor the request, perhaps before Thanksgiving and long before Christmas travel and gatherings. expectation of all 181 million fully vaccinated adults That’s a throwback from two months ago when an expert advisory committee came to the FDA with access to the extra shots in the country. overwhelmingly advice against Pfizer-BioNTech’s request to allow boosters for all adult recipients of this vaccine.
At the time, several committee members expressed doubts about whether young, healthy people needed boosters. But the Biden administration has been willing to offer additional footage widely since President Biden’s August. announced The “best way to protect ourselves” was for each adult to get a booster.
Mr Biden initially wanted the Americans to begin receiving reinforcements in late September, but the start of the campaign was delayed after regulators insisted they need more time to review safety and effectiveness data. Some global public health experts said it would be better to focus on getting the first vaccines to poorer countries with low vaccination rates than to distribute extra vaccines here so quickly.
If regulators approve Pfizer’s request, President Biden will have fulfilled his promise to give every adult a booster vaccine – but the choice will be limited to Pfizer’s vaccine for many.
For now, only people aged 65 and over and adults who are at special risk because of their medical condition or where they work or live can receive booster injections if they were initially vaccinated with the Pfizer-BioNTech or Moderna vaccine. The FDA has allowed boosters for all Johnson & Johnson recipients because this vaccine provides less protection. People are allowed to choose which of the three vaccines they want for their extra shot.
About 25 million Americans, including people who are immune-compromised and qualify in August, have received boosters so far. That’s about 14 percent of fully vaccinated people, and that number could rise sharply if all other adults qualify for a Pfizer-BioNTech booster. While the categories of eligibility are fairly broad, estimates still exclude at least 30 to 40 percent of vaccinated adults.
Moderna is expected to soon file the FDA’s request to expand eligibility for its booster. Some experts speculate that the agency may allow wider use of Moderna’s booster, but exclude young men due to concerns about a rare condition linked to the vaccine that appears to affect them disproportionately. condition called heart muscle inflammationis an inflammation of the heart muscle.
Some countries in Europe have already authorized booster shots for all adults; Israel offers them. For anyone aged 12 and over. Tuesday, Canadian authorities authorized A booster dose of the Pfizer-BioNTech vaccine for anyone 18 years of age or older.
In the United States, experts are fiercely divided. whether booster vaccines are necessary for the entire population. Many say that vaccines continue to provide strong protection against serious illness and hospitalizations, especially for young people without underlying medical conditions.
There is almost unanimous agreement that vaccinating the nearly 60 million Americans over the age of 11 who have not even had their first vaccination yet should remain the government’s highest priority.
A member of the FDA advisory board and assistant professor of immunology at the Harvard TH Chan School of Public Health, Dr. According to Eric Rubin, the benefits of a booster injection for younger, healthier people will be marginal.
Even so, some leading experts argue that the case for supporting shots is getting stronger. Director of the Center for Emerging Infectious Diseases Policy and Research at Boston University, Dr. Nahid Bhadelia said there was stronger data than in September when the FDA advisory committee rejected Pfizer’s initial request.
“I now think it looks like boosters can help prevent serious illness for many more people than we previously thought,” he added.
Dr. Rubin said he was comforted by the fact that when Israel began vaccinating young people, they “really didn’t see any important safety signals.”
Earlier this month, the federal government’s top infectious disease expert, Dr. Anthony S. Fauci said the latest data from Israel shows that Israel’s aggressive campaign of support is limiting the rates of serious illness, hospitalization and death there. He described the results as “pretty dramatic”.
Federal officials are watching Israel’s experience closely, as the vaccine campaign is getting started quickly and has a nationalized healthcare system that makes it easier to monitor results than in the United States.
An Israeli study published in the scientific journal The Lancet It compared nearly 730,000 people who received a booster dose in late October, August, or September, with people who had only received two doses of the Pfizer-BioNTech vaccine at least five months ago. Recipients aged 12 years and older were included in the study; The median age was 52 years.
The study found that compared with those who received two doses, those who received the supplement had a 93 percent lower risk of hospitalization, a 92 percent lower risk of serious illness, and an 81 percent lower risk of death. Supplemented recipients were evaluated one week to approximately two months after their third dose.
Pfizer and BioNTech said their claims were based on data from a clinical trial involving more than 10,000 volunteers in the US and elsewhere. They said the third injection counteracted the decreasing potency of the vaccine over time. After the third shot, they said, the vaccine’s effectiveness rate against symptomatic disease was up to 95 percent.
The FDA has the authority to replace Pfizer-BioNTech’s current emergency use authorization and is not expected to reconvene the advisory panel. Dr. Rubin said he was fine with that.
“The FDA had a good idea of what the panel was all about, and they’re in a good position to make a decision themselves right now,” he said.
Moderna may come with a request very similar to Pfizer’s. But gaining authorization can be more complicated Due to concerns about rare cases of myocarditis, especially in men under 30 who have received two doses of Moderna vaccine. Similar concerns have been raised about the Pfizer-BioNTech vaccine, but to a lesser extent.
If regulators approve Pfizer’s request, they will to some extent officially turn a blind eye to what health officials say they already see often. Some officials have said that many Americans seem to be filming boosters, regardless of whether they are officially eligible, so holding onto complex eligibility categories may be futile.
Maine’s top health official and president of the State Association, Dr. “This kind of move – if supported by data that I have not seen – is an acknowledgment of that fact,” said Nirav D. Shah. and Regional Health Authorities.
“If the data shows that the increase was worth it, that’s a good move,” he said.
[ad_2]
Source link