FDA issues emergency use authorization for Pfizer/BioNTech Covid-19 vaccine

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(CNN) The US Food and Drug Administration has authorized the first Covid-19 vaccine for emergency use in the United States. Millions of doses of the Pfizer and BioNTech coronavirus vaccine, which has been found to be 95% effective, will be soon shipped around the country so vaccinations can begin within days.

An emergency use authorization means what its name suggests: a medical product gets special authorization by the FDA to be used during an emergency — but it is short of a full approval. Pfizer would have to file a separate application for its vaccine to be fully licensed by the FDA.

Dr. Fauci explains importance of vaccine approval process 02:19″The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” FDA Commissioner Dr. Stephen Hahn said in a statement on Friday.

“Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization.

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  1. The U.S. federal government will continue to monitor occurrences of Bell’s palsy — a partial paralysis in the face — among people who receive Pfizer’s Covid-19 vaccine after four cases were reported among trial participants, though the vaccine doesn’t appear to cause the condition.

    Dr. Sara Oliver, an officer at the Centers for Disease Control and Prevention, said during the agency’s Advisory Committee on Immunization Practices on Friday that there is “no known or expected causal relationship between the vaccine and Bell’s palsy.” The ACIP develops recommendations on how to use vaccines to control diseases in the United States, according to the CDC.

    “Post authorization safety and effectiveness studies will be critical as well. Specifically, surveillance for Bell’s palsy could help determine any possible causal relationship,” Oliver said.


  2. EMA has received an application for conditional marketing authorisation (CMA) for BNT162b2, a COVID‑19 mRNA vaccine developed by BioNTech and Pfizer. The assessment of BNT162b2 will proceed under an accelerated timeline. An opinion on the marketing authorisation could be issued within weeks, depending on whether the data submitted are sufficiently robust and complete to show the quality, safety and effectiveness of the vaccine.

    Such a short timeframe is only possible because EMA has already reviewed some data on the vaccine during a rolling review. During this phase, EMA assessed data on the vaccine’s quality (such as information about its ingredients and the way it is produced) as well as results from laboratory studies. EMA also looked at results on the vaccine’s effectiveness and initial safety data emerging from a large-scale clinical trial as they became available.

    EMA will now assess the data submitted as part of the formal application for conditional marketing authorisation. The Agency and its scientific committees will continue working on the assessment over the Christmas period. If the data submitted are robust enough to conclude on the quality, safety and effectiveness of the vaccine, EMA’s scientific committee for human medicines (CHMP) will conclude its assessment during an extraordinary meeting scheduled for 29 December at the latest. These timelines are based on the type of data assessed so far in the context of the rolling review and may be subject to change as evaluation proceeds. EMA will communicate on the outcome of its assessment accordingly.

    During the review, and throughout the pandemic, EMA and its scientific committees are supported by the COVID-19 EMA pandemic task force, a group that brings together experts from across the European medicines regulatory network to facilitate rapid and coordinated regulatory action on medicines and vaccines for COVID-19.


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