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The United States Food and Drug Administration has approved emergency use authorization for a booster of Pfizer-BioNTech vaccine to be administered at least six months after the end of the second dose for people 65 years of age and older, people aged 18 to 64 at high risk of severe COVID-19; and those aged 18 to 64 whose occupational exposure puts them at high risk of serious complications from COVID-19.
The FDA today announced the modified EUA for Pfizer.
WHY IT IS IMPORTANT
The need for a recall continues to be debated.
On Tuesday, an 18-member FDA Vaccines and Related Biologics Advisory Committee overwhelmingly rejected whether a recall should be approved for everyone 16 years and older.
Members of the advisory committee voted unanimously to approve authorization for the emergency use of a Pfizer vaccine booster for people 65 years of age and older and for people 16 years of age and older at high risk of Severe COVID-19. Members said healthcare workers and other frontline workers such as teachers should be included in this group.
The FDA includes healthcare and frontline workers in its approval.
Only Pfizer has received emergency use authorization for a recall.
Studies submitted to the FDA have shown that the incidence of COVID-19 was higher in participants who completed their primary vaccine series earlier, compared to participants who completed it later. The FDA has determined that the COVID-19 breakthrough rate reported during this period resulted in a modest decrease in vaccine effectiveness among those vaccinated earlier.
Safety was evaluated in 306 participants aged 18 to 55 and 12 participants aged 65 and over who were followed for more than two months on average.
The most frequently reported side effects were pain, redness and swelling at the injection site, as well as fatigue, headache, muscle or joint pain, and chills. Of note, swollen armpit lymph nodes were seen more frequently after the booster dose than after the two-dose primary series.
THE BIGGEST TREND
This week, Johnson & Johnson said that a second dose of its single-shot vaccine given eight weeks after the first dose provided 94% protection against COVID-19, which is similar to the levels of Moderna and two-shot vaccines. Pfizer.
Pfizer received EUA for its two-dose vaccine in December. It received full FDA approval on August 23. Two days later, the FDA received a supplement from Pfizer requesting approval of a single booster dose to be administered approximately six months after the end of the primary vaccination series for people 16 years of age and older.
ON THE RECORD
“We are grateful for the advice of the doctors, scientists and leading vaccine experts on our advisory board and the important role they have played in ensuring transparent discussions on COVID-19 vaccines,” said Dr Peter Marks, director of the FDA Center. for evaluation and research on biological products. “We appreciate the robust discussion, including the vote regarding people over 65 and those at high risk for serious illness, as well as the committee’s views regarding the use of a booster dose for people with institutional or occupational exposure to SARS-CoV -2. The FDA has considered the committee’s comments and conducted its own in-depth review of the data submitted to reach today’s decision. We will continue to analyze the data submitted to the FDA regarding the use of COVID-19 vaccine booster doses and we will make further decisions, as appropriate, based on the data. ”
“Today’s action demonstrates that currently available science and data continue to guide FDA decision making for COVID-19 vaccines during this pandemic,” said Acting FDA Commissioner, on Dr Janet Woodcock, MD “After reviewing all of the available scientific evidence and the deliberations of our independent external expert advisory panel, the FDA has amended the EUA for the Pfizer-BioNTech COVID-19 vaccine to allow for a booster dose in some populations such as healthcare workers, teachers and daycare staff, grocers and those in homeless shelters or prisons, among others. This pandemic is dynamic and evolving, new data on safety and vaccine efficacy become available every day. As we learn more about the safety and efficacy of COVID-19 vaccines, including the use of a dose booster, we co We will continue to assess the rapidly evolving science and keep the public informed. “
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