The Food and Drug Administration of the United States approved a booster dose from the Pfizer Inc and BioNTech Covid-19 vaccine for individuals 65 years and older, as well as all those who are at high risk of severe illness, and any individual who is routinely exposed to the virus.
The ruling sets the door for millions of individuals who had their second dose of the vaccine at least six months ago to receive booster doses as soon as this week.
The FDA acting Commissioner Janet Woodcock said in a statement that the modification to the vaccine's emergency use permission will allow boosts for groups such as health-care professionals, teachers and day care personnel, supermarket workers, and individuals in homeless shelters or jails.
Pfizer had requested the FDA to broaden its vaccination clearance to include boosters for all persons aged 16 and older and had submitted data to an independent FDA panel of advisors last week that it said indicated decreasing protection over time.
The panel ruled against the idea that boosters were necessary for everyone, although data demonstrated that they were beneficial to the elderly and those at high risk. more info
According to Dr. William Schaffner, medical director of the National Foundation for Infectious Diseases (NFID), the FDA's statement was more wide in terms of who was eligible for boosters than the panel's advice.
"Very broad indeed, especially that 'among others.' That could essentially give the green light for giving boosters to a very substantial proportion of the previously vaccinated adult population," said Schaffner, who serves as the NFID's liaison to the Advisory Committee on Immunization Practices (ACIP) at the U.S. Centers for Disease Control and Prevention (CDC).
According to an official of the agency speaking at a public meeting of the panel on Wednesday, the ACIP is could vote on the use of a third shot of the vaccine very soon.
"Tomorrow's ACIP meeting at the CDC will be focused on turning this into an official recommendation for implementation," said Dr. Amesh Adalja, senior scholar at the Johns Hopkins University Center for Health Security.
According to Dr. Jesse Goodman, an infectious disease expert at Georgetown University in Washington and former FDA top scientist, the FDA authorisation was "basically in line" with the advisory panel decision.
"These are pretty broad categories that give a fair amount of latitude to the judgment of healthcare providers and people providing immunizations," he added.
President Joe Biden and eight senior health officials, including Woodcock, revealed in August the government's plan to begin administering booster injections to anyone aged 16 and older this week, subject to FDA and CDC clearance.
However, the advisory council stated that there was insufficient evidence to warrant booster injections for that demographic and requested further safety data. The FDA is not required to adopt the advisory panel's suggestion, although it frequently does.
In the future, the agency may revisit the matter in order to get a larger authorization.
"This first FDA authorization of a COVID-19 vaccine booster is a critical milestone in the ongoing fight against this disease," said Pfizer chief Albert Bourla. The company had argued that boosters are needed for the general population.
Top FDA officials have been divided on the necessity for boosters for the general public, with Woodcock in favor and other of the agency's leading scientists arguing that existing research does not support them.
Some nations, notably Israel and the United Kingdom, have already launched COVID-19 awareness efforts. According to CDC data, the United States allowed additional injections for patients with weakened immune systems last month, and over 2 million people have already gotten a third shot.
(Source:www.thequint.com)
The ruling sets the door for millions of individuals who had their second dose of the vaccine at least six months ago to receive booster doses as soon as this week.
The FDA acting Commissioner Janet Woodcock said in a statement that the modification to the vaccine's emergency use permission will allow boosts for groups such as health-care professionals, teachers and day care personnel, supermarket workers, and individuals in homeless shelters or jails.
Pfizer had requested the FDA to broaden its vaccination clearance to include boosters for all persons aged 16 and older and had submitted data to an independent FDA panel of advisors last week that it said indicated decreasing protection over time.
The panel ruled against the idea that boosters were necessary for everyone, although data demonstrated that they were beneficial to the elderly and those at high risk. more info
According to Dr. William Schaffner, medical director of the National Foundation for Infectious Diseases (NFID), the FDA's statement was more wide in terms of who was eligible for boosters than the panel's advice.
"Very broad indeed, especially that 'among others.' That could essentially give the green light for giving boosters to a very substantial proportion of the previously vaccinated adult population," said Schaffner, who serves as the NFID's liaison to the Advisory Committee on Immunization Practices (ACIP) at the U.S. Centers for Disease Control and Prevention (CDC).
According to an official of the agency speaking at a public meeting of the panel on Wednesday, the ACIP is could vote on the use of a third shot of the vaccine very soon.
"Tomorrow's ACIP meeting at the CDC will be focused on turning this into an official recommendation for implementation," said Dr. Amesh Adalja, senior scholar at the Johns Hopkins University Center for Health Security.
According to Dr. Jesse Goodman, an infectious disease expert at Georgetown University in Washington and former FDA top scientist, the FDA authorisation was "basically in line" with the advisory panel decision.
"These are pretty broad categories that give a fair amount of latitude to the judgment of healthcare providers and people providing immunizations," he added.
President Joe Biden and eight senior health officials, including Woodcock, revealed in August the government's plan to begin administering booster injections to anyone aged 16 and older this week, subject to FDA and CDC clearance.
However, the advisory council stated that there was insufficient evidence to warrant booster injections for that demographic and requested further safety data. The FDA is not required to adopt the advisory panel's suggestion, although it frequently does.
In the future, the agency may revisit the matter in order to get a larger authorization.
"This first FDA authorization of a COVID-19 vaccine booster is a critical milestone in the ongoing fight against this disease," said Pfizer chief Albert Bourla. The company had argued that boosters are needed for the general population.
Top FDA officials have been divided on the necessity for boosters for the general public, with Woodcock in favor and other of the agency's leading scientists arguing that existing research does not support them.
Some nations, notably Israel and the United Kingdom, have already launched COVID-19 awareness efforts. According to CDC data, the United States allowed additional injections for patients with weakened immune systems last month, and over 2 million people have already gotten a third shot.
(Source:www.thequint.com)
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