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    Johnson & Johnson Asks FDA to Approve Covid-19 Booster

    Johnson & Johnson

    JNJ 0.82%

    Seeking approval from US health regulators Booster dose For the Covid-19 vaccine, we cite a study showing improved protection for previously single-shot adults.

    The Food and Drug Administration can determine J & J’s requirements within a few weeks. Authorities are planning a meeting of the Advisory Board on October 15 to review evidence of the need for boosters and recommend that authorities approve boosters.

    The advisor will also review data on whether people vaccinated by one company can receive boost immunization from another company. J & J’s request on Tuesday was to authorize a J & J booster for people who had previously taken the company’s single-dose vaccine.

    This requirement is broader, but controversial, to administer Covid-19 vaccine booster shots to address the potential weakening of immunity from the original vaccine and to combat the rapidly spreading delta variant of coronavirus. Is part of the promotion that has room for.

    The Biden administration has sought to deploy boosters widely based on studies showing weakened immunity. However, some infectious disease experts need a broad booster, citing data showing that the original vaccine continues to protect people from serious illness, even if the original vaccine does not stop all infections. Is questioning.

    September FDA Approved third dose Of the Covid-19 vaccine from

    Pfizer Ltd



    Many adult SEs are administered at least 6 months after people obtain the original two-dose series.

    Modana Ltd

    I also have Asked the FDA To approve a third dose of the vaccine, and the institution can immediately determine its requirements.

    Unlike the Pfizer and Modana double-dose vaccines J & J vaccine approved in late February A single dose to adults is based on a large international study showing that it is 66% effective in preventing symptomatic Covid-19 disease and 85% in severe to severe Covid-19 cases. increase.

    J & J then discovered that a second dose at various intervals could maintain protection and shared the data with the FDA.

    The company ran Another international study Subjects were vaccinated twice at 56-day intervals. The study found that the double-dose series was 75% effective overall for symptomatic Covid-19 disease and 94% effective in the US portion of the study. Also, according to J & J, the double dose series was 100% effective for severe to severe cases.

    J & J also tested a booster dose given 6 months after the first dose. The second dose was found to significantly increase the levels of immune system drugs known as antibodies in the weeks following booster immunization.

    Matamimen, Global Head of Research and Development at J & J’s Janssen Pharma Unit, said:

    The company said that single-dose vaccines continue to be effective against Covid-19, citing data showing that various measurements of the immune response are strong and stable up to 8 months after vaccination. Said.

    J & J’s Covid-19 vaccine has not played a significant role in the US mass vaccination campaign as initially expected. So far, according to the Centers for Disease Control and Prevention, only about 15 million doses have been administered, compared to more than 152 million Moderna doses and 229 million Pfizer doses.

    J & J faced manufacturing problems and a suspension of vaccination in April. Meanwhile, health officials have investigated rare but serious thrombotic disorders among vaccinated people.

    Write to Peter Loftus

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    Johnson & Johnson Asks FDA to Approve Covid-19 Booster

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    The post Johnson & Johnson Asks FDA to Approve Covid-19 Booster appeared first on Eminetra.

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