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  • Pfizer Signals Time for COVID Booster; FDA and CDC Disagree For Now

  • The COVID-19 pandemic hasn't diminished despite the number of vaccines available

  • The coronavirus even spawned a more dangerous variant, the Delta, first discovered in India

  • However, a vaccine manufacturer claims its vaccine is waning, which requires a third dose to optimize the protection level

  • Pfizer said Thursday that its COVID vaccine is found with diminishing immunity

  • It is now working on a booster dose and will soon publish data about it

  • Once the data is available, it will also submit details to regulators, including the US FDA and European Medicines Agency

  • Pfizer plans to seek emergency use authorization for the booster in August

  • Though, two federal agencies in the US didn't agree with Pfizer

  • The agencies said that companies alone can't make decisions whether a booster dose is needed

  • Just hours after Pfizer made the announcement, the FDA and CDC released a joint statement

  • "Americans who have been fully vaccinated do not need a booster shot at this time," they said

  • The statement noted that fully vaccinated people are "protected from severe disease and death, including from the variants," currently invading the US like Delta

  • But those who aren't vaccinated remain at risk of severe symptoms, hospitalization, and premature death

  • Both two agencies explained that a "rigorous" process is required to determine if a booster is necessary

  • This process considers laboratory, clinical trial, and cohort data, yet not exclusively relying on those

  • The World Health Organization told CNN that no one knows whether boosters will maintain protection against COVID due to limited information

  • There's no concrete evidence yet on how long current doses will last

  • Plus, no sufficient data has determined if these boosters are truly beneficial or which groups will benefit the most

  • But why did Pfizer suddenly make an announcement without seemingly coordinating with federal agencies?

  • The company likely based its decision on the data released from the Israel Ministry of Health

  • That data suggested dwindling efficacy on preventing infection and symptomatic disease at 6 months after vaccination

  • While preventing severe disease remains high even at 6 months

  • The announcement can be a big deal worldwide

  • Not every nation has vaccinated at least 50% of its population

  • The booster dose may mean expanding protection among fully vaccinated but may restrict access of those unvaccinated due to limited resources

  • Right now, the best approach is to have as many people fully vaccinated against COVID-19

Pfizer Signals Time for COVID Booster; FDA and CDC Disagree For Now

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辉瑞为 COVID Booster 发出信号FDA 和 CDC 暂时不同意(Pfizer Signals Time for COVID Booster; FDA and CDC Disagree For Now)

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    joey joey 發佈於 2021 年 07 月 15 日
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