After weeks of asking who will get Covid-19 booster vaccinations when and when – and confusing advice from a multitude of Officer– The Food and Drug Administration has made a decision.
On Wednesday, FDA regulators decided to change Pfizer-BioNTech’s emergency approval and allow a single booster shot of his Covid-19 vaccine, which is intended to be given to certain population groups. The groups are as follows: people aged 65 and over; People between the ages of 18 and 64 who are at high risk of developing severe Covid-19; and individuals between the ages of 18 and 64 in certain facilities or professions that put them at high risk of developing severe Covid-19 or severe complications.
Although the first two groups are pretty straightforward, the third group is less clear, which is why officials may have decided to give examples. Acting FDA Commissioner Janet Woodcock said the group included health workers, teachers, day care workers, food workers, people in prisons and people in homeless shelters, among others.
The agency’s decision only applies to Pfizer-BioNTech’s Covid-19 vaccine, which the vaccine only currently approved in the country. It should be noted that the booster dose is only a third dose of the Pfizer BioNTech vaccine. It is not another recording.
“This pandemic is dynamic and evolving, with new data becoming available every day on the safety and effectiveness of vaccines,” Woodcock said in a statement. “As we learn more about the safety and effectiveness of COVID-19 vaccines, including using a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed.”
As for timing, the FDA said the booster can be given to people in the specific groups at least six months after receiving their 2-dose series and anytime thereafter.
The safety and side effects of the booster dose were analyzed by Pfizer in a clinical study involving 318 people. Participants, of whom 306 were between 18 and 55 years old and 12 were over 65 years old, were followed for an average of two months. The side effects of the booster were similar to those after the first two doses and included pain, redness and swelling at the injection site; Fatigue; Headache; Muscle and joint pain; and chills. The FDA noted that participants were more likely to have swollen armpits lymph nodes after the booster.
The decision follows a meeting of the Advisory Committee on Vaccines and Related Biological Products, the agency’s external advisory body, held last week voted against Recommended booster vaccinations for Americans over the age of 16. However, the committee unanimously agreed to recommend a booster vaccination to people over 65 and others at high risk of Covid-19. The decision was ultimately left to the FDA – as well as the Centers for Disease Control and Prevention, who have not yet published their opinion – as the committee’s votes are not binding.
The FDA’s decision thwarted the Biden government’s plan to make booster vaccinations available to most Americans. The US is that newest wealthy country Approve booster vaccinations for its citizens and thus join the ranks of Germany, France, Great Britain, and Israel.
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