The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee will hold a meeting Thursday morning in consideration of Pfizer’s coronavirus vaccine, which has already gotten authorization from officials in Canada and the UK.The committee will weigh the vaccine’s efficacy, and could issue an emergency use authorization of the vaccine by early next week.An emergency use authorization allows practitioners to administer a vaccine despite it not gaining full FDA approval. The EUA means that the vaccine is allowed to be used in non-clinical settings, which would allow Americans not in a trial or hospital setting to get the vaccine.Once it is authorized, it is expected that several million doses of the vaccine will immediately begin being distributed throughout the US to high-risk individuals. The first group of those expected to be inoculated includes health care workers and those who live or work in assisted living facilities.The panel's hearing will begin at 9 p.m. ET, and will be available on YouTube, Twitter and other social media platforms.“The FDA recognizes that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines. I want to assure the American people that the FDA’s process and evaluation of the data for a potential COVID-19 vaccine will be as open and transparent as possible,” said FDA Commissioner Stephen M. Hahn, M.D. “The FDA has been preparing for the review of EUAs for COVID-19 vaccines for several months and stands ready to do so as soon as an EUA request is submitted. While we cannot predict how long the FDA’s review will take, the FDA will review the request as expeditiously as possible, while still doing so in a thorough and science-based manner, so that we can help make available a vaccine that the American people deserve as soon as possible.”Pfizer says that the vaccine is showing a 95% efficacy against coronavirus infection. It is one of two vaccines that could be approved by the FDA in the next few weeks. Moderna also has a vaccine candidate that is showing an efficacy of 95%.“Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally. Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “We look forward to the upcoming Vaccines and Related Biological Products Advisory Committee discussion and continue to work closely with the FDA and regulatory authorities worldwide to secure authorization of our vaccine candidate as quickly as possible.”One concern over the Pfizer vaccine is possible side effects on those prone to allergic reactions. The UK’s National Health Service is advising those prone to allergic reactions to not take the Pfizer vaccine as it investigates two health care workers having apparent reactions after receiving the vaccine.Once given authorization, officials will be forced to confront two challenges: Public confidence in the vaccine and distribution. Both the Moderna and Pfizer vaccines are required to be refrigerated until use, complicating distribution methods.Also, polls are showing that a significant number of Americans are hesitant on getting the vaccine. Public health experts say getting the vast majority of Americans immunized is important in order to reach herd immunity against the virus, and to allow for normalcy to return to the US.In addition to a number of public health experts saying they’ll get the vaccine as a way to instill trust, former Presidents Bill Clinton, George W. Bush and Barack Obama said they would publicly take the vaccine in order to instill faith in the shot.
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