Значи во Израел се исплашиле затоа што 60% од сите тешки случаи му биле во вакцинирани и 45% од смртните. Затоа во паника почнаа да даваат трета доза.
WASHINGTON — A key advisory panel to the Food and Drug Administration overwhelmingly rejected recommending Pfizer booster shots for most recipients of the company’s coronavirus vaccine, instead endorsing them only for people who are 65 or older or at high risk of severe Covid-19, and received their second dose at least six months ago.
Committee members appeared dismissive of the argument that the general population needed booster shots, saying the data from Pfizer and elsewhere still seemed to show two shots protected against severe disease or hospitalization and did not prove a third shot would stem the spread of infection. Some also criticized a lack of data that an additional injection would be safe for younger people.
The committee of largely outside experts voted 16 to 2 against a Pfizer booster for people 16 and older after a tense daylong public discussion that put divisions in the agency and the administration on public display. Officials from the Centers for Disease Control and Prevention and the National Institutes of Health joined infectious disease experts and doctors in voting against additional shots for such a broad swath of the population.
In a statement about Friday’s vote, Kathrin U. Jansen, senior vice president and head of vaccine research and development at Pfizer, said, “We thank the committee for their thoughtful review of the data and will work with the F.D.A. following today’s meeting to address the committee’s questions, as we continue to believe in the benefits of a booster dose for a broader population.”
The meeting “put the F.D.A. back in the driver’s seat,” said Dr. Luciana Borio, a former acting chief scientist at the agency. The expert panel, she said, “was allowed to maintain its scientific independence. It understood there were significant limitations with the data presented and that the F.D.A. needs to review the data carefully before making a decision.”
The panel listened to hours of contradictory presentations by officials from Pfizer, the C.D.C., the Israeli government and independent experts about the waning effectiveness of Pfizer and other vaccines over time.
Dr. Sara Oliver of the C.D.C. presented data showing that vaccines continue to strongly protect against severe forms of Covid-19 in the United States, even in people 75 and older.
Jonathan Sterne, a professor of medical statistics and epidemiology in Britain, said he had analyzed 76 different studies on the vaccines’ real-world effectiveness and found that multiple factors could skew the results, including how many unvaccinated people in a study had natural immunity from prior infection. He also warned against drawing conclusions from short-term results from booster shots; data from Israel, for example, only included a follow-up period of several weeks for older adults.
Israeli experts made a different argument, telling the committee that they believed third Pfizer shots helped dampen a fourth wave of transmission as the Delta variant swept the nation this summer. The Israeli government, which has relied almost entirely on the Pfizer vaccine, began offering booster shots in late July, starting with the older adults.
Dr. Sharon Alroy-Preis, Israel’s head of public health services, said the summer’s rise in the number of hospitalized patients who had been fully vaccinated with Pfizer’s vaccine was “scary.” She said 60 percent of severely or critically ill patients and 45 percent of those who died during what she called the fourth surge had received two injections of Pfizer’s vaccine.
After offering boosters to the general population, she said, Israel was now averaging about half as many severe or critically ill patients as anticipated. She said boosters not only helped curb the spread of infection, but also “actually saved lives.”
Dr. William C. Gruber, a senior Pfizer vice president in charge of vaccine development, suggested that if the United States does not follow Israel’s lead, it could face more than five million more infections a year among people who received their second dose 10 months earlier, compared to those who got the second shot five months earlier.
“Israel could portend the U.S. Covid-19 future, and soon,” he said.
He said Pfizer’s data showed that a third shot elicited a robust antibody immune response that equaled or greatly exceeded the response after the second dose. Data also show, he argued, that breakthrough infections among vaccinated Americans are linked more to the ebbing power of the vaccine over time than to the Delta variant.
But committee members and some government officials appeared deeply skeptical. Dr. Philip Krause, one of the F.D.A. vaccine experts who wrote the medical journal review, criticized Pfizer’s presentation of data that had not been peer-reviewed or evaluated by the F.D.A., arguing that problems in the modeling in a study underpinning the company’s case understated the vaccine’s efficacy.
Dr. Oliver, the C.D.C. official, questioned attempts to draw a parallel between the United States and Israel, noting that Israel has only nine million residents and is less diverse than the United States. Notably, she also said that Israel
defines a severe case of Covid-19 more broadly than the United States does, which might help explain why Israel reports more serious breakthrough infections among its vaccinated residents.
Another C.D.C. official, Dr. Amanda Cohn, asked Israeli officials why the spread of the virus there had recently intensified, despite a broad rollout of boosters. Dr. Alroy-Preis said that the Jewish holidays, along with the start of the school year, had contributed to what she suggested would be a temporary surge in cases.
Committee members also said they were concerned about a paucity of safety data in younger recipients of a booster dose, since studies have shown a higher risk of myocarditis, an inflammation of the heart muscle, in young men who received Pfizer-BioNTech’s vaccine. Several asked whether it would be better to wait for a booster vaccine devised specifically to fend off the Delta variant of the virus.
One study apparently came too late for the discussion, underscoring the rapid flurry of changing data on vaccine potency. Released by the C.D.C. hours before the committee’s vote,
it found that the Pfizer vaccine’s level of protection against coronavirus hospitalizations dropped significantly four months after the second shot.
The study found that two weeks to four months after recipients got their second dose, the Pfizer vaccine was 91 percent effective in preventing hospitalization. After 120 days, though, its effectiveness fell to 77 percent. Moderna’s vaccine showed no comparable decrease in protection over the same time frame. The vaccinated patients in the study tended to be older; the Pfizer cohort had a median age of 68.
The New York Times: F.D.A. Panel Recommends Pfizer Boosters for Those Over 65 or at Risk.
The committee said there was insufficient evidence to recommend third shots for all adult recipients of the vaccine, as Pfizer had requested.
www.nytimes.com