Nuked The food and Drug Administration has authorized the use of a covid-19 vaccine developed by Pfizer and biontech. A landmark moment in the fight to suppress a virus that has killed nearly 300,000 people in the U.S. and sickened tens of millions around the world.
The emergency use authorization of the pfizer-biontech covid-19 vaccine holds the promise to alter the course of this pandemic in the United States.
The FDA was prepared to authorize a vaccine as long as it was at least 50 percent effective. Pfizer’s chief executive officer, Albert bourla, said’we could n’t believe it’.
The shot appears to protect people against the most severe forms of the disease. It is also highly effective in people over the age of 65, who are particularly vulnerable to covid-19.
Chief of staff Mark meadows told Stephen Hahn to resign if the vaccine was not cleared by Friday. The agency had originally planned to complete the authorization by Saturday. On Thursday, an independent committee said it recommended authorization.
The Pfizer and biontech vaccine has already been authorized by regulatory authorities in the United Kingdom, Canada, and Bahrain.
The authorizations of this vaccine have come less than a year after development began. The record was previously held by the mumps vaccine, which took four years.
Researchers were able to condense the normally years-long vaccine development process into months by, among other steps, shortening the time between clinical trial phases. Companies did not skip steps in the safety testing process, though the FDA said that it needed to see two full months of safety data on any covid-19 vaccine.
The vaccine will be made available under an emergency use authorization. It typically takes the FDA a full year to review vaccine data once it’s submitted by companies. Pfizer and biontech submitted their data on November 20th.
The Pfizer and biontech vaccine is made from a gene-based technology that’s never been used before in an authorized vaccine for people. It contains a tiny bit of the genetic material for the coronavirus spike protein, which the virus uses to enter cells. The body builds that spike protein from the genetic instructions and then generates defenses against it.
Pfizer’s vaccine has to stay at ultracold temperatures. Doses of the vaccine will also be limited through the start of 2021.
On the most optimistic timeline, vaccinations for the general population could start in March or April. Other high-risk groups, including older adults and people with underlying health conditions, will likely be next in line.
