Pfizer-BioNTech COVID vaccine.Photo: Marcos del Mazo/LightRocket via Getty
Pfizer-BioNTech has requested approval from the Food and Drug Administration togive a fourth dose of their COVID-19 vaccineto people aged 65 and older, the companies said Tuesday.
The request asks that anyone in that age group who has already received a booster dose of any COVID-19 vaccine be allowed to get another dose of Pfizer’s vaccine toincrease their protection against the virus.
Pfizer-BioNTech included data from two large studies of people in Israel who had received four doses of their vaccine, and “both data sets showed evidence that an additional mRNA booster increases immunogenicity and lowers rates of confirmed infections and severe illness,” the companies said ina news release.
One study was an analysis of 1.1 million adults aged 60 and older and showed that people who received a fourth dose were half as likely to get infected and four times less likely to become severely sick than those who had three doses.
The other study, of 700 health care workers aged 18 and up, found that those who had a fourth dose had a ten-fold increase in antibodies two weeks after they received the shot, including against omicron.
The fourth dose was given three months after the third in both studies, and there were no safety concerns that came up. The studies have not yet been peer-reviewed.
“These early studies indicate that an additional booster dose of the Pfizer-BioNTech COVID-19 vaccine administered at least 4 months after an initial booster dose could restore antibody titers to peak post-third dose titer levels, improve protection against both infection and severe disease in individuals 60 years of age and older in Israel, and have a similar safety profile to that of previous doses,” the companies said.
RELATED VIDEO: Here are Some Myth-Busting Facts About COVID-19 Vaccines
The FDA has not yet planned to meet to discuss the possibility of authorizing a fourth booster dose. Currently, only certain immunocompromised adults in the U.S. are allowed to get a fourth dose.
Pfizer’s CEO Albert Bourla had said last week that “the way that we have seen, it is necessary” for people to get a fourth dose of a COVID-19 vaccine to protect against infection.
“The protection that you are getting from the third, it is good enough, actually quite good for hospitalizations and deaths. It’s not that good against infections,” he said.
Bourla’s statement is in line with a Centers for Disease Control and Prevention study released last month thatsupports the need for a fourth dose, finding that the mRNA shot’s protection begins to decline after about four months.
“There may be the need for yet again another boost — in this case, a fourth-dose boost for an individual receiving the mRNA — that could be based on age, as well as underlying conditions,“Dr. Anthony Fauci, the nation’s top infectious disease expert, said at the time.
As information about thecoronavirus pandemicrapidly changes, PEOPLE is committed to providing the most recent data in our coverage. Some of the information in this story may have changed after publication. For the latest on COVID-19, readers are encouraged to use online resources from theCDC,WHOandlocal public health departments.PEOPLE has partnered with GoFundMeto raise money for the COVID-19 Relief Fund, a GoFundMe.org fundraiser to support everything from frontline responders to families in need, as well as organizations helping communities. For more information or to donate, clickhere.
source: people.com
