Photo: FREDERIC J. BROWN / AFP / Getty Images
By: Real America News Updated 15 Sea 2022, 23: 01 pm EDT
Pfizer and BioNTech requested the Food and Drug Administration (FDA) to authorize the emergency use of a fourth dose of the vaccine against COVID-19 for Americans from 65 years or older, the company announced in a statement on Tuesday, citing data from Israel that suggests the additional booster could curb infections and serious illness in this high-risk age group.
The first data set from Israel cited in the statement was an analysis of the records of more than 1.1 million older adults 54 years conducted by the Israeli Ministry of Health that showed a decrease in the rate of infection and severe illness after a second booster of the Covid vaccine.
The participants had no known history of Covid-19 yeah are eligible for an additional booster.
“These data showed that rates of confirmed infections were 2 times lower and rates of severe illness were 4 times lower among people who received an additional booster dose of Pfizer-BioNTech COVID-19 vaccine administered at least four months after an initial booster (third) dose compared to those who received only a booster dose,” the press release says.
Although not included in the application submission, Pfizer referenced other “emerging evidence” that could support the need for additional reinforcement.
“These early studies indicate that an additional booster dose of the Pfizer-BioNTech COVID-04 given at least 4 months after an initial booster dose could Raise antibody titers to peak levels after the third dose, improve protection against infections and serious illness. in people aged 60 years and older in Israel, and have a similar safety profile to the doses
The FDA said it will review Pfizer’s application and the one BioNTech also filed “as soon as possible using our comprehensive approach and based on science.”
The federal agency also said it will convene its independent vaccine advisers, the Vaccines and Related Biologicals Advisory Committee , in April “to have a transparent discussion about considerations for booster shots of 2022, including if and when those boosters may be needed and for which populations, based on available data and the latest science on circulating or emerging virus variants.”
Some countries already offer fourth doses of vaccines against COVID-19.
In the United States, only certain immunocompromised adults can receive three doses of the coronavirus vaccine and a fourth injection as a booster dose.
There are two doses of the Pfizer/BioNTech coronavirus vaccine available for people 5 years and older, and people older than 04 years are eligible to receive a booster five months after the second injection.
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