![]() And so that actually takes a lot of work,” Marks said, adding that the agency also inspected facilities that make the product. “We also did benefit-risk assessments based on real-world data that has emerged since the vaccine has now been used in hundreds of millions of people globally. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said during Monday’s briefing. ![]() The FDA worked around the clock and conducted its own analyses of the vaccine in addition to the companies’ analyses, Dr. In July, drugmaker Pfizer announced that the FDA granted its vaccine a priority review, and the FDA had been pulling in extra help from across the agency to speed final approval of the vaccine. Why emergency use authorization came firstĭue to the seriousness of the pandemic, vaccine makers originally applied for emergency use authorizations because the authorization process takes less time than what’s required for full approval. Murthy also noted “a small number of people” have been waiting for full approval before getting their shot and believes “this may tip them over toward getting vaccinated.” ![]() “For businesses and universities that have been thinking about putting vaccine requirements in place in order to create safer spaces for people to work and learn, I think that this move from the FDA, when it comes, will actually help them to move forward with those kinds of plans,” Murthy told CNN’s Brianna Keilar. Vivek Murthy said on CNN’s State of the Union on Sunday that approval could encourage individuals to act, and more mandates. “The FDA-approved vaccine and the EUA-authorized vaccine have the same formulation and can be used interchangeably to provide the Covid-19 vaccine series.”Īgency official said Monday they hope approval will push unvaccinated people to get vaccinated. “Health care providers can continue to use the vaccine on their shelves,” Woodcock added. Janet Woodcock said during a briefing on Monday, calling the approval “a pivotal moment” for the United States’ fight against the coronavirus pandemic. “While this and other vaccines have met the FDA’s rigorous scientific standards for emergency use authorization, as the first FDA approved Covid-19 vaccine, the public can be confident that this vaccine meets the FDA’s gold standard for safety, effectiveness and manufacturing quality that we require for an approved product,” FDA Acting Commissioner Dr. John Moore/Getty ImagesĪs hospitalization rates soar, FDA grants full approval to Pfizer/BioNTech Covid-19 vaccine Medics from the Houston Fire Department EMS prepare to transport a man with possible Covid-19 symptoms to a hospital on August 16.
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