The Food and Drug Administration has approved the use of the COVID-19 vaccine developed by Pfizer and BioNTech, a milestone moment in the fight to eradicate a virus that killed almost 300,000 people in the United States and sickened tens of millions around the world.
“Today’s emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine holds the promise to alter the course of this pandemic in the United States,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release.
For persons over the age of 16, the vaccine is approved in the US. In clinical trials, it was shown to be 95 percent successful at preventing symptomatic COVID-19. “In a press conference at the end of November, Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, said That’s exceptional. This is much more than analysts would have dared to wish for. As long as it was at least 50 percent safe, the FDA was ready to approve a vaccine.
For persons over the age of 16, the vaccine is approved in the US. In clinical trials, it was shown to be 95 percent successful at preventing symptomatic COVID-19. In a press conference at the end of November, Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, said, “That is extraordinary.” This is much more than analysts would have dared to wish for. As long as it was at least 50 percent safe, the FDA was ready to approve a vaccine. “We were shocked,” Pfizer’s chief executive officer, Albert Bourla, told The New York Times. “We couldn’t believe it.”
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The shot tends to shield patients from the disease’s more severe manifestations. It is also highly beneficial in individuals over 65 years of age that are especially prone to COVID-19. Once it’s deployed, scientists will try to test the vaccine to see how well it performs in the real world.
Simultaneously, the news of the approval arrives as the FDA has faced public criticism from the White House to approve the vaccine. Chief of Staff Mark Meadows told the FDA Commissioner Stephen Hahn to resign if the vaccine was not supported by Friday and published the Washington Post. Initially, the department had intended to conclude the authorization by Saturday. An independent commission said on Thursday that it recommended permission.
The regulatory authorities in the United Kingdom, Canada, and Bahrain have also licensed the Pfizer and BioNTech vaccines.
The approvals for this vaccine, which came less than a year after production started, have set the record for the fastest vaccine to be produced. Previously, the mumps vaccine, which took four years, kept the paper.
Researchers were able to condense the usually years-long period of vaccine research into months by shortening the period between clinical trial stages and scaling up the production of new vaccines as trials were underway, among other steps. However, businesses have not missed steps in the course of safety testing. The FDA said it wanted to see two full months of safety data for every COVID-19 vaccine, and when the most severe side effects might occur, that’s the window.
The vaccine will be made available under an Emergency Use Permit. This certification requires the FDA to make drugs available because there are no other alternatives available during an emergency. The procedure helps the agency sidestep any of the more lengthy compliance procedures that a medication typically has to be officially approved or licensed. It usually takes a full year for the FDA to review vaccine data after businesses request it.
That was reduced to a few weeks for this emergency authorization; Pfizer and BioNTech presented their data on November 20.
The Pfizer and BioNTech vaccines are made using a gene-based technique that has never been used in an accepted human vaccine before. It contains a little bit of the coronavirus spike protein genetic material used by the virus to invade cells. From the genetic instructions, the body builds the protein spike and then produces defenses against it. The Moderna vaccine, which will be reviewed on December 17 by the FDA vaccine advisory committee, also uses this technology. Another explanation of why the vaccine was created so rapidly is the platform. When researchers have a virus’s genetic sequence, developing a gene-based vaccine to target is relatively straightforward.
A similarly challenging mission is now beginning: delivering the vaccine and vaccinating citizens. The Pfizer vaccine must keep at ultra-cold temperatures, making it more expensive to transport it across the country and the planet. By early 2021, doses of the vaccine will also be reduced.
The first to receive the vaccine would be health care staff and patients of long-term care homes, and vaccinations will be given within days. Next in line would presumably be other high-risk categories, including elderly adults and persons with chronic health problems. Vaccinations for the general public could begin in March or April on the most ambitious timetable, but hospitals claim that some of those dates appear impractical.
One hundred million doses of the Pfizer and BioNTech vaccines have been purchased in the US, enough to vaccinate 50 million individuals. The Trump administration allegedly rejected an attempt to secure an extra 100 million doses this summer. While they will obtain up to 500 million additional amounts, the refused bid means they will not be available until the autumn.
