The changes were driven by omicron and supported by Israeli data.
As the highly transmissible omicron type of coronavirus decreases in the United States, the Food and Drug Administration on Monday announced a series of sweeping changes to the availability of Pfizer-BioNTech booster doses.
The regulator has increased access to third doses by allowing their use in children 12 to 15 years of age. The agency also shortened the interval in which adults and children 12 and older can receive boosters after a second dose — from six months to just five months. Finally, the US Food and Drug Administration (FDA) made the third dose available for children 5 to 11 years old who were immunocompromised who might not respond well to only the first two doses. Which has more booster programs than the United States. Indeed, on Monday, Israeli authorities began offering a fourth dose (a second booster dose) of the Pfizer-BioNTech vaccine to people over the age of 60 in an effort to maintain high levels of protection in the population. The omicron variant, which is currently causing a vertical increase in cases in the United States, has been shown to neutralize protection with only two doses of the vaccine, but can still be overcome with booster doses.<"Based on FDA evaluation of currently available data, a booster dose for currently licensed vaccines may help provide better protection against both Delta and Omicron," said Peter Marks, director of the FDA's Center for Biological Research and Evaluation.Read More Slightly resistant to antibody levels produced in response to initial serial doses of current vaccines, the Food and Drug Administration has increased the range of eligible amplifiers for the third dose of prophylactic vaccine for some younger, more vulnerable people."
Supporting their decision to allow Using boosters for 12- to 15-year-olds, and the US Food and Drug Administration relied on Israeli data on more than 6,300 children in this changed age range in which they received the booster dose. . The data indicate that booster doses provide ongoing protection against existing species while not causing safety concerns. In particular, the Food and Drug Administration noted that there were no new cases of myocarditis or pericarditis (inflammation of the heart and surrounding tissues) in this age group.
The FDA also relied on Israeli data in its decision to bridge the gap between the second and third doses. According to data from more than 4.1 million people aged 16 and over in Israel who received booster doses at least five months after the first two doses, the agency found no safe reason to shorten this period. The FDA also cited reviewed laboratory data, which consistently found that booster doses significantly increased protection against omicron type.
"Therefore, booster vaccination may be permitted. Currently, the short time period applies only to the Pfizer-BioNTech vaccine, not to the booster doses of Moderna," the Food and Drug Administration said in a statement. However, the FDA said it would review the data. It will continue if other vaccines are available.
For immunocompromised children ages 5 through 11, the FDA said it does not rely on new data to allow the use of boosters. They were extrapolated from the older age groups and previously used safety data reviewed to allow two doses for younger children. It is restricted to those with weakened immune systems. Such as those who have undergone a solid organ transplant or have conditions that compromise the immune system to an equal degree throw. The agency says that children ages 5 to 11 who do not have a weakened immune system do not need a booster. But again, when the data is available, you will monitor it.
Vaccinations and boosters continued, FDA chief Janet Woodcock said in a statement that wearing masks and social distancing is to effectively combat Covid-19. The United States is higher than ever, with all-time highs on a daily basis. , with the current average of more than 400,000 new cases, an increase of more than 200 percent from the past two weeks.
The New York Times' Centers for Disease Control and Prevention's advisory committee plans to review FDA changes to speaker availability this week, and a meeting has been scheduled so far. The director of the CDC will likely quickly sign and endorse them as official federal recommendations. p>
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