US FDA experts approve Pfizer’s COVID-19 vaccine

Pfizer’s COVID-19 vaccine received a vote of confidence from US Food and Drug Administration (FDA) advisers late on Thursday (December 10, 2020, early Friday in the UAE), clearing the way for the agency to authorise its use.

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The agency is likely to do so within days, giving health care workers and nursing home residents first priority to begin receiving the first shots early next week.

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The FDA’s vaccine advisory panel, composed of independent scientific experts, infectious disease doctors and statisticians, voted 17-4, with one member abstaining, in favor of emergency authorization for people 16 and older. With rare exceptions, the FDA follows the advice of its advisory panels.

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With this formal blessing, the nation may finally begin to slow the spread of the virus just as infections and deaths surge, reaching a record of more than 3,000 daily deaths on Wednesday. The FDA is expected to grant an emergency use authorisation on Saturday, according to people familiar with the agency’s planning, though they cautioned that last-minute legal or bureaucratic requirements could push the announcement to Sunday or later.

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Highlights

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  • The panel of experts voted in favour of emergency authorisation for people 16 and older.
  • The FDA does not have to follow the advice, but it usually does.
  • The authorisation is expected within days, paving the way for healthcare workers and nursing home residents to begin getting shots next week.

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The initial shipment of 6.4 million doses will leave warehouses within 24 hours of being cleared by the FDA, according to federal officials. About half of those doses will be sent across the country, and the other half will be reserved for the initial recipients to receive their second dose about three weeks later.

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The arrival of the first vaccines is the beginning of a complex, monthslong distribution plan coordinated by federal and local health authorities, as well as large hospitals and pharmacy chains, that if successful, will help return a grieving and economically depressed country back to some semblance of normal, maybe by summer.

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“With the high efficacy and good safety profile shown for our vaccine, and the pandemic essentially out of control, vaccine introduction is an urgent need,” Kathrin Jansen, a senior vice president and the head of vaccine research and development at Pfizer, said at the meeting.

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The vote caps a whirlwind year for Pfizer and its German partner BioNTech, which began working on the vaccine 11 months ago, shattering all speed records for vaccine development, which typically takes years. It is also a triumph for the FDA, which has upheld its reputation as the world’s gold standard for drug reviews despite months of political pressure from President Donald Trump, who has sought to tie his political fortunes to the success of a vaccine. The Pfizer vaccine has already been given to people in Bahrain and Britain, where it was authorized on Dec. 2. Canada approved it on Wednesday.

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The US authorisation of Pfizer’s vaccine is expected to be followed soon by one for Moderna’s version, which uses similar technology and has also shown promising results in clinical trials. Operation Warp Speed, the Trump administration’s multibillion-dollar program to fast-track vaccine development, preordered 100 million doses of Pfizer’s vaccine in July and heavily backed the development and manufacturing of Moderna’s vaccine.

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More than 100 FDA employees have worked nearly round the clock to review the application Pfizer submitted on Nov. 20, compressing months of analysis into weeks as they pored over thousands of pages of clinical trial and manufacturing data.

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Earlier this week, career scientists at the FDA published an analysis showing the vaccine worked across a variety of demographic groups and that it was somewhat effective even after the first of two doses.

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During the daylong meeting on Thursday, panel members peppered company and agency experts with detailed questions about the safety and efficacy of the vaccine, which was found to be 95% effective in a late-stage clinical trial. Some members expressed concern that there was not enough data from 16- and 17-year-olds to know whether the vaccine would help them, but the committee decided the benefits for that group outweighed the risks.

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Some members asked about the likelihood for serious allergic reactions, given the news that regulators in Britain recommended this week that people with a history of anaphylactic allergic reactions to medicines and foods not get the vaccine while they investigate two cases of allergic reactions among health care workers. Pfizer officials said there were no cases of serious allergic reactions in the trial of 44,000 participants. People with a history of allergic reactions to vaccines were excluded from the study.

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Safety issues

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But advocates also asked regulators to be transparent about potential safety issues and to closely track the vaccine once it becomes available. Several said such measures were necessary to reassure a public that is hesitant to take a new vaccine, particularly Black and Native American people who have historically been mistreated by the medical community. “Before authorisation is granted, affected communities need to have confidence that the vaccine is safe and effective,” said Sarah Christopherson of the National Women’s Health Center.

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By insisting that the advisory committee vote on any vaccine, regulators created a shield against White House pressure to approve a product before the presidential election. When the panelists met in October to discuss the FDA’s guidelines for approving COVID-19 vaccines, they urged the agency to take its time and cautioned that rushing the process could risk missing vital safety data and further erode public trust.

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Oversight

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As part of its oversight, the FDA also had teams review company production facilities and clinical trial sites, where they verified that records corresponded to the accounts Pfizer had submitted to federal regulators.

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At the same time, regulators were evaluating an equally complex emergency authorization application submitted by Moderna, whose data will be examined publicly during another FDA outside advisory meeting next week.

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