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Food and Drug Administration advisers on Friday questioned a key claim by researchers in Israel and pharmaceutical company Pfizer: that its coronavirus vaccine is declining in terms of protection not only against infection, but against disease. serious and hospitalization.
The advisers met to assess Pfizer’s request for approval of booster doses of vaccine for all Americans over 16 years of age. Among the details that have surfaced during the heated debate: Israel and the United States define critical illness differently.
In Israel, anyone with an accelerated respiratory rate and an oxygen level below 94% is seriously ill. In contrast, the Centers for Disease Control and Prevention considers people sick enough to be hospitalized as seriously ill, CDC scientist Dr. Sara Oliver said at the advisory committee meeting.
The gap could help explain why the two countries reported very different results in people who were fully immune.
Israeli researchers said they had seen a large number of hospital patients who had received two doses months earlier. But in the United States, the CDC has reported that vaccinated patients represent only 2% of people hospitalized for Covid-19.
This is just one of many scientific differences that have come to light this week.
In the journal The Lancet on Monday, an international team of scientists analyzed dozens of studies and concluded that boosters are not yet needed by the general population, and that the world would be better served by using doses of the vaccine for protect the billions of people who remain unvaccinated.
FDA scientists on Wednesday released an assessment online suggesting that they are also not convinced that there is enough evidence that boosters are needed.
“Overall, the data indicates that the Covid-19 vaccines currently licensed or authorized in the United States still provide protection against serious Covid-19 illness and death in the United States,” according to their executive summary.
But some FDA officials have publicly approved the booster shots. “The need for an additional dose at six months to provide longer term protection shouldn’t come as a surprise, as it is likely necessary for the generation of a mature immune response,” said Dr Peter Marks, the ‘one of the agency’s top officials, said at Friday’s meeting.
Alarmed by the increase in cases, Israeli officials have offered third doses of the vaccine to anyone over the age of 12. Israeli researchers published the first results of the deployment in the New England Journal of Medicine on Wednesday – but few outside scientists found the study convincing.
Understanding the mandates of vaccines and masks in the United States
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- Vaccination rules. On August 23, the Food and Drug Administration fully approved Pfizer-BioNTech’s coronavirus vaccine for people 16 years of age and older, paving the way for increased tenure in the public and private sectors. Private companies increasingly require vaccines for their employees. Such warrants are authorized by law and have been confirmed in court challenges.
- Mask rules. The Centers for Disease Control and Prevention in July recommended that all Americans, regardless of immunization status, wear masks in indoor public places in areas affected by epidemics, a reversal of guidelines it offered in May. . See where the CDC guidelines would apply and where states have instituted their own mask policies. The battle for masks has become controversial in some states, with some local leaders defying state bans.
- College and universities. More than 400 colleges and universities require students to be vaccinated against Covid-19. Almost all of them are in states that voted for President Biden.
- Schools. California and New York City have both introduced vaccination mandates for educational staff. A survey released in August found that many American parents of school-aged children are opposed to mandatory vaccines for students, but were more in favor of mask mandates for students, teachers and staff who don’t. don’t have their vaccines.
- Hospitals and medical centers. Many hospitals and large healthcare systems are requiring their employees to be vaccinated against Covid-19, citing an increase in the number of cases fueled by the Delta variant and stubbornly low vaccination rates in their communities, even within their hand -work.
- New York City. Proof of vaccination is required from workers and customers for indoor meals, gyms, shows, and other indoor situations, although enforcement does not begin until September 13. Teachers and other education workers in the city’s vast school system will need to have at least one dose vaccine by September 27, with no possibility of weekly testing. Employees of the city’s hospitals must also get vaccinated or undergo weekly tests. Similar rules are in place for New York State employees.
- At the federal level. The Pentagon has said it will seek to make coronavirus vaccination mandatory for the nation’s 1.3 million active-duty soldiers “no later than” mid-September. President Biden announced that all federal civilian employees should be vaccinated against the coronavirus or undergo regular testing, social distancing, mask requirements and restrictions on most travel.
The team collected data on the effects of booster injections from the medical records of more than 1.1 million people over the age of 60. At least 12 days after the booster, infection rates were eleven times lower – and rates of severe illness nearly twenty times lower – among them. who received a booster compared to those who received only two doses, the researchers found.
The results are not surprising, according to experts, and do not indicate long-term benefit.
“We have known for some time that vaccines cause less robust immune responses in the elderly,” said Dr Celine Gounder, infectious disease specialist at Bellevue Hospital Center and former advisor to the Biden administration. “Recommending additional doses of vaccine for the elderly is not controversial. “
Vaccination remains powerfully protective against serious illness and hospitalization in the vast majority of people in all studies published so far, experts said. But the vaccines appear to be less potent against infections in people of all ages, especially those exposed to the highly contagious Delta variant.
Cumulative data so far suggests that only the elderly will need boosters, a view underscored by the FDA advisory committee, which voted Friday to approve the recalls only for Americans aged 65 and older and those who are at risk of serious illness.
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