Health & Fit Dr. Fauci Just Said These are the Vaccine Side Effects to Expect

05:10  24 october  2021
05:10  24 october  2021 Source:   eatthis.com

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  Surgeon General Just Issued This Dr. Vivek Murphy discussed on CNN why these vaccine mandates are necessary to save your life, and how you can stay safe. Read on—and to ensure your health and the health of others, don't miss these Sure Signs You've Already Had COVID. © Provided by Eat This, Not That! Vivek Murthy 1 Surgeon General Warned Delta is Dangerous: "We Have to Do Everything We Can" © Provided by Eat This, Not That! Doctor holding a syringe Why issue a mandate now, when Biden previously promised there would be none? One word: Delta. It's more transmissible and thus more dangerous.

a woman talking on a cell phone: A medical assistant administers a COVID-19 vaccine dose to a woman at a clinic in Los Angeles on March 25, 2021. Mario Tama/Getty Images © Provided by Business Insider A medical assistant administers a COVID-19 vaccine dose to a woman at a clinic in Los Angeles on March 25, 2021. Mario Tama/Getty Images
  • Johnson & Johnson applied to give COVID-19 booster shots 6 months after the first was administered.
  • But the FDA isn't convinced there's enough data yet to back a J&J booster shot.
  • An FDA expert panel will vote Friday on if the agency should OK J&J booster shots.

Johnson & Johnson wants to give people who received one dose of its COVID-19 vaccine a second dose, but it's unclear if the US Food and Drug Administration is onboard.

In documents released Wednesday, the FDA pointed out several key limitations in the evidence that J&J submitted for a booster shot. The agency is currently reviewing J&J's application to give an extra dose as early as two months after the single-shot jab. An FDA expert panel will meet Friday to discuss and vote on J&J's booster application.

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In particular, the agency highlighted the lack of robust clinical trial results supporting giving a booster six months following the first dose. J&J submitted results from a study that included just 17 volunteers who got a second dose after six months. While that data appeared to meet the FDA's goals for what a booster should do, the agency said the results are limited by the small sample size and were also impacted by the low sensitivity of a lab test J&J used.

J&J argued for a booster six months after the initial shot in its own report released Tuesday.

Video: J&J says second shot boosts protection (Reuters)

"A booster dose is recommended at 6 months or later, based on the strength of the immune responses," the company wrote, while adding it wanted to make a booster available as early as two months after the first shot.

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There's far more evidence supporting a second dose of J&J given two months after the first shot. But that dataset, which includes more than 16,000 volunteers, has yet to be independently reviewed and verified by by FDA scientists, the agency said.

Now, 15 million American who got J&J's vaccine are left wondering if and when a booster could be available. It's also unclear if the agency will consider authorizing Pfizer's or Moderna's shot for J&J recipients as well.

Despite the limitations highlighted by the FDA's review, it's still possible the agency will OK J&J's booster shot. Data has shown J&J recipients are less protected against hospitalization and death than people who got Moderna and Pfizer.

Read the original article on Insider

Covid-19 Pandemic Timeline Fast Facts .
Read CNN's Fast Facts about the coronavirus outbreak, declared a pandemic by the World Health Organization. The coronavirus, called Covid-19 by WHO, originated in China and is the cousin of the SARS virus. © Newsday/Getty Images Nurse practitioner Deborah Beauplan administers a COVID-19 swab test at a drive-thru testing site set up for Suffolk County employees and their families at Smith Point Park in Shirley, New York on December 19, 2020. Coronaviruses are a large group of viruses that are common among animals.

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