Monday, October 18, 2021

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    FDA panel to weigh boosters for Pfizer’s Covid-19 vaccine

    Covid-19 vaccine update

    Members of the US Food and Drug Administration’s Vaccine Advisory Board will meet on Friday to make a carefully watched decision on whether to accept an application to provide a wide range of booster shots of the BioNTech / Pfizer Covid-19 vaccine.

    Pfizer is seeking permission to provide adults with a double dose of mRNA jab booster approximately six months after receiving the second shot.

    If the Commission recommends approval of the application, the FDA may give final approval within a few days. With the US Centers for Disease Control and Prevention issuing guidelines on who is eligible, Americans should be able to start getting booster jabs next week.

    U.S. health authorities Announced last month They wanted to start giving people booster shots after the release of data suggesting that the effectiveness of mRNA vaccines such as Pfizer could decline within a few months after the second dose. ..

    In filing with the FDA Pfizer said The effectiveness of the vaccine decreased by about 6% every two months after the second dose. Data from IsraelScheduled to be submitted to the Advisory Board on Friday, it indicates that serious Covid cases began to decline sharply about 10 days after the booster program began.

    The FDA has already approved booster shots of the mRNA vaccine for people with weakened immunity. However, boosters are due to both the limited data available on the long-term efficacy of vaccines in the real world and the fact that many countries are still struggling to secure initial supply. The idea of ​​allowing shots more widely is controversial.

    In a report released Wednesday, FDA staff said the data on whether the vaccine’s ability to block symptomatic infections declined significantly over time was not conclusive and regulated whether boosters were needed. He said it was a sign of internal friction within the authorities.

    “Overall, the data show that the Covid-19 vaccine currently licensed or licensed in the United States still provides protection against severe Covid-19 disease and death in the United States,” officials said Wednesday. Said in a briefing document published in.

    Two senior FDA scientists who have already announced their resignation this week Co-authored a treatise With a lancet against the booster program. One of them, Marion Gruber, will speak at the beginning of the Advisory Board meeting on Friday.

    Others argue that US regulators should act swiftly to halt the surge in recent incidents.

    Arimokdad, a professor of global health at the University of Washington, said: We need to get a booster for everyone and move on. Once you have a booster, you can donate the vaccine. “

    Pfizer CEO Albert Bourla said in an open letter released Thursday prior to the FDA meeting that booster decisions should be based on scientific evidence, with people in high-income countries boosting boosters. He argued that making it available would not divert supply from low to medium prices. -Income country.

    “If the data indicate their need, safety, and efficacy, they should be approved. If not, they should not be approved. However, the introduction of booster doses is not possible for each country. I believe we shouldn’t change the number of doses we receive, “he writes.

    FDA panel to weigh boosters for Pfizer’s Covid-19 vaccine Source link FDA panel to weigh boosters for Pfizer’s Covid-19 vaccine

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