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FDA greenlights Pfizer booster shots for elderly & those aged 18+ at ‘high risk’ from Covid-19, leaving room for interpretation | FDA greenlights Pfizer booster shots for elderly & those aged 18+ at ‘high risk’ from Covid-19, leaving room for interpretation |
(30 days later) | |
The US Food and Drug Administration has given its blessing to the use of Pfizer’s Covid-19 jab for booster doses. The move could impact millions of Americans, including teachers, grocery workers, and hospital staff. | The US Food and Drug Administration has given its blessing to the use of Pfizer’s Covid-19 jab for booster doses. The move could impact millions of Americans, including teachers, grocery workers, and hospital staff. |
Heeding advice from its special panel on vaccines, the FDA on Wednesday moved to approve a third dose of the US drugmaker’s Covid-19 vaccine to be used on seniors as well as “individuals 18 through 64 years of age and at high risk of severe Covid-19.” It has also been approved for adults “whose frequent institutional or occupational exposure” to the virus ostensibly puts them at a heightened risk of “serious complications of Covid-19, including severe Covid-19.” | Heeding advice from its special panel on vaccines, the FDA on Wednesday moved to approve a third dose of the US drugmaker’s Covid-19 vaccine to be used on seniors as well as “individuals 18 through 64 years of age and at high risk of severe Covid-19.” It has also been approved for adults “whose frequent institutional or occupational exposure” to the virus ostensibly puts them at a heightened risk of “serious complications of Covid-19, including severe Covid-19.” |
The announcement has left plenty of room for interpretation, with epidemiologist and senior fellow at the Federation of American Scientists Eric Feigl-Ding pointing out that it “gives enormous leeway for many people” to get the vaccine, and “not just elderly or healthcare workers.” | The announcement has left plenty of room for interpretation, with epidemiologist and senior fellow at the Federation of American Scientists Eric Feigl-Ding pointing out that it “gives enormous leeway for many people” to get the vaccine, and “not just elderly or healthcare workers.” |
Indeed, while the FDA fell short of approving booster shots for the US population as a whole – a view that has been championed by the administration of US President Joe Biden – acting FDA Commissioner Janet Woodcock signaled that the athorization could cover large portions of the population due to the nature of their work. | Indeed, while the FDA fell short of approving booster shots for the US population as a whole – a view that has been championed by the administration of US President Joe Biden – acting FDA Commissioner Janet Woodcock signaled that the athorization could cover large portions of the population due to the nature of their work. |
“The FDA amended the EUA for the Pfizer-BioNTech Covid-19 vaccine to allow for a booster dose in certain populations such as healthcare workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others,” Woodcock said. | “The FDA amended the EUA for the Pfizer-BioNTech Covid-19 vaccine to allow for a booster dose in certain populations such as healthcare workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others,” Woodcock said. |
The decision may still come as a disappointment for Biden, who has rallied behind the idea that everybody 18 and older should be able to get a booster shot within eight months of their second dose, promising to start rolling out the revaccination program as early as September. | The decision may still come as a disappointment for Biden, who has rallied behind the idea that everybody 18 and older should be able to get a booster shot within eight months of their second dose, promising to start rolling out the revaccination program as early as September. |
The FDA said that its decision was based on “scientific evidence,” “currently available data” on the effectiveness of the vaccine, and on its advisory committee’s recommendations. | The FDA said that its decision was based on “scientific evidence,” “currently available data” on the effectiveness of the vaccine, and on its advisory committee’s recommendations. |
Prior to voting in favor of booster shots, the advisory committee reviewed a number of studies submitted by Pfizer that showed the efficacy of the vaccine decreases with time. One study found that the jab’s efficacy plunged from 93% to 53% against the Delta strain after four months following the second dose. | Prior to voting in favor of booster shots, the advisory committee reviewed a number of studies submitted by Pfizer that showed the efficacy of the vaccine decreases with time. One study found that the jab’s efficacy plunged from 93% to 53% against the Delta strain after four months following the second dose. |
Doubts, however, have been raised about the accuracy of Pfizer’s observational studies. Even before the advisory board backed the proposed booster shots, FDA officials released a document stating that there were “known and unknown biases that can affect [the] reliability” of the findings. It also noted that available data "indicate" that vaccines “still afford protection against severe Covid-19 disease and death” in the US. | Doubts, however, have been raised about the accuracy of Pfizer’s observational studies. Even before the advisory board backed the proposed booster shots, FDA officials released a document stating that there were “known and unknown biases that can affect [the] reliability” of the findings. It also noted that available data "indicate" that vaccines “still afford protection against severe Covid-19 disease and death” in the US. |
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