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July 13, 2021

Amid growing debate over booster shots, FDA adds warning label to J&J vaccine

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    Federal health officials on Monday met with representatives from Pfizer to discuss the potential need for Covid-19 booster shots, as the World Health Organization's (WHO) director-general called on wealthier countries to donate extra Covid-19 vaccines rather than using them as boosters.

    Your top resources on the Covid-19 vaccines

    Health officials meet with Pfizer regarding booster shots

    According to Politico, health officials in the Biden administration met with Pfizer representatives on Monday to discuss the company's plans for developing booster shots and to review Pfizer's data on the issue. The meeting was convened by HHS after Pfizer and BioNTech announced last week they would be seeking FDA authorization for a Covid-19 booster shot.

    Ultimately, sources told Axios that health officials agreed during the meeting that more data is needed before a decision can be made.

    "For those who are at risk, there may be a need for boosts … the real risk is, right now there are people who are not vaccinated," a person familiar with the meeting told Axios. "No one walked out of there and said boosters are needed imminently."

    Separately, an HHS official said of the meeting, "We appreciate the information they shared, and officials continue to engage in a science-based rigorous process to consider whether, when, or for whom a booster might be necessary."

    The official added, "At this time, fully vaccinated Americans do not need a booster shot."

    Meanwhile, sources told the New York Times that the final decision on booster shots will depend on data gathered by CDC regarding breakthrough infections leading to severe Covid-19 or hospitalization.

    "It was an interesting meeting. They shared their data. There wasn't anything resembling a decision," Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and chief medical adviser to the White House, said. "This is just one piece of a much bigger puzzle, and it's one part of the data, so there isn't a question of a convincing case one way or the other," he added.

    WHO director-general calls on wealthier countries to donate excess Covid-19 vaccines

    Separately, WHO director-general Tedros Adhanom Ghebreyesus on Monday called on wealthier countries to donate their excess Covid-19 vaccines rather than using them as booster shots.

    "We are making conscious choices right now not to protect those in need," he said. Instead of certain drug manufacturers "prioritizing the supply of vaccine as boosters to countries whose populations have relatively high coverage, we need them to go all out to channel supply to COVAX, the Africa Vaccine Acquisition Task Team, and low- and middle-income countries which have very low vaccine coverage."

    Ghebreyesus' statement comes as several countries— including the United States, the United Kingdom, and France—debate plans for booster shots. In addition, Israel recently announced it will start offering booster shots to those in the country with weakened immune systems. Israel made the announcement after its health ministry last week announced the effectiveness of Pfizer's vaccine had dropped to 64% against all coronavirus variants, down from 95% in May.

    Carlos del Rio, an infectious disease expert at Emory University, said Israel's decision "will help us answer some questions, but at the end of the day I don't agree with what they're doing. I think it's awfully premature."

    FDA adds warning label to J&J's Covid-19 vaccine

    Also on Monday, FDA announced it will add a warning label to the Covid-19 vaccine developed by Johnson & Johnson (J&J) saying the vaccine has been linked to Guillain-Barré syndrome (GBS).

    The condition is a rare nerve syndrome that occurs when the immune system attacks the nerves, leading to temporary paralysis, the Wall Street Journal reports. It affects about 3,000 to 6,000 people every year, and while its cause is unknown, it has been linked to other vaccines in the past, including some flu and shingles vaccines.

    There have been around 100 reports of Guillain-Barré syndrome in the more than 12 million people who have received J&J's vaccine. Most of the cases occurred in men ages 50 and older who developed symptoms about two weeks after getting vaccinated, CDC said. Overall, a person familiar with the matter told the Wall Street Journal the risk of developing Guillain-Barré is around three to five cases per million recipients.

    "Although the available evidence suggests an association between the Janssen vaccine and increased risk of GBS, it is insufficient to establish a causal relationship," FDA said in a statement. "Importantly, the FDA has evaluated the available information for the [J&J] COVID-19 vaccine and continues to find the known and potential benefits clearly outweigh the known and potential risks."

    In a statement, J&J said the absolute risk of developing Guillain-Barré syndrome is "very low," adding, "The safety and well-being of the people who use our products is our number one priority." (Cancryn et. al., Politico, 7/12; Owens, Axios, 7/13; Stolberg/LaFraniere, New York Times, 7/12; Sullivan, The Hill, 7/12 [1]; Chen, Axios, 7/12; Sullivan, The Hill, 7/12 [2]; Knutson, Axios, 7/12; Pruitt-Young, NPR, 7/12; Burton/Schwartz, Wall Street Journal, 7/12; LaFraniere/Weiland, New York Times, 7/12; Weixel, The Hill, 7/12; Anthes, New York Times, 7/12; George, MedPage Today, 7/12)

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