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Pfizer vaccine is effective and safe, FDA says ahead of meeting

(Bloomberg) – The vaccine from Pfizer Inc. and BioNTech SE is highly effective in preventing COVID-19, and there are no safety concerns that prevent the vaccine from receiving an emergency use authorization, according to a report by the staff of the US Food and Drug Administration, or FDA. The FDA staff report provides a first look at the US review of the vaccine before a public meeting of external agency advisers to be held on Thursday. The agency could take steps to authorize the vaccine shortly after the meeting. The report, published Tuesday on the agency’s website, reiterated findings previously disclosed by the companies that showed the vaccine was 95% effective in preventing symptomatic covid-19. It also said that two months of trial data showed no significant safety concerns. Pfizer applied for emergency authorization of the COVID-19 vaccine in the US on November 20. Regulators in the UK approved it earlier this month and the National Health Service on Tuesday launched an ambitious immunization campaign that will start with vaccinating tens of thousands of people over 80 in the coming days. Pfizer’s vaccine is also under review in the European Union. The vaccine uses a technology called messenger RNA that transforms cells in the body to fight the virus. It also requires special freezers for its conservation. Moderna Inc. also makes an experimental COVID-19 vaccine that is based on messenger RNA, and FDA advisers will meet next week to assess whether it should receive an emergency clearance. Pfizer said the vaccine protected people. of all ages and ethnicities. Side effects included headache and fatigue. If Pfizer’s vaccine is approved, Trump Administration officials have said it could begin shipping within 24 hours, with up to 6.4 million doses available immediately. Between the Pfizer and Moderna vaccines, 40 million doses are expected to be available by the end of the year, enough for 20 million people to receive the two-dose regimen. The Trump Administration is confident the US will have enough supply to supply them. eventually vaccinate the entire population, a senior government official said in a call with reporters Monday, though only vaccines developed by Pfizer and Moderna are expected to receive FDA approval this month. The United States also has agreements to source vaccines from AstraZeneca Plc, Johnson & Johnson, and others. The Immunization Committee of the Centers for Disease Control and Prevention recommended that healthcare workers and long-stay hospital patients be first in line, with a total of approximately 23 million people. Each state will define exactly how it distributes vaccines.Original Note: Pfizer Shot Effective, Safe, FDA Staff Concludes Before MeetingFor more articles like this, please visit us at bloomberg.comSubscribe now to stay ahead with the most trusted business news source. © 2020 Bloomberg LP

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