FDA approves Pfizer coronavirus vaccine. First of all, healthcare workers will soon be vaccinated.
Vaccine approved by FDA in America
The US Food and Drug Administration has authorized the use of a COVID-19 vaccine developed by Pfizer and BioNTech, which is a milestone in the fight to suppress a virus that has killed nearly 300,000 people in the United States and made tens of millions sick worldwide.
“Authorizing the Pfizer-BioNTech COVID-19 vaccine for emergency use today carries the promise to change the course of this epidemic in the United States,” said Peter Marks, director of the FDA Biological Evaluation and Research Center, in a press release.
The vaccine has been approved in the United States for persons over the age of 16. This vaccine has been found to be 95 percent effective in preventing symptomatic COVID-19 in clinical studies. “This is extraordinary,” said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, at a press conference in late November. “Much better than the experts had hoped for.” The FDA has stated that it is ready to allow a vaccine as long as it is at least 50 percent effective. “We were shocked, we couldn’t believe it,” Albert Bourla, Pfizer’s chief executive officer, told The New York Times. said.
The Pfizer and BioNTech vaccine has already been approved by the governments in the UK, Canada and Bahrain.
Less than a year after development began, these vaccine approvals broke the record for the fastest vaccine ever developed. The latest record was broken by the four-year mumps vaccine. This is extraordinary!
The vaccine will be provided under an Emergency Use Permit from the FDA allowing products to be made available in an emergency when no other options are available. The process allows the FDA to bypass some of the long-term regulatory steps that have to be officially approved or licensed for a drug. It usually takes the FDA a full year to review vaccine data after submission by companies. Thanks to the emergency authorization, this process could be shortened to a few weeks. Pfizer and BioNTech submitted their data to the FDA on 20 November.
The Pfizer and BioNTech vaccine is made from a gene-based technology that has never been used in a vaccine that has been approved for humans before. The vaccine contains a small amount of genetic material from the coronavirus spike proteins that the virus uses to enter cells. The body builds up the protein from genetic instructions and then builds defense against it. The Moderna vaccine, which the FDA’s vaccine advisory committee will review on December 17, also uses this technology.
Vaccine approved, so what now?
Now he is on an equally daunting task: distributing the vaccine and vaccinating people! Pfizer’s vaccine needs to remain in extremely cold temperatures, making it more difficult to ship across countries and around the world. Vaccine doses will also be limited from the beginning of 2021.
Healthcare professionals and those staying in long-term care facilities will receive the vaccine first and doses can be given within days. Other high-risk groups will likely be in line, including older adults and people with underlying health problems. According to the most optimistic timeline, vaccines for the general population could start in March or April, but hospitals say some of these timelines are unrealistic.
The US purchased 100 million doses of Pfizer / BioNTech vaccine, enough to vaccinate 50 million people. The Trump administration reportedly rejected an offer to secure an additional 100 million doses this summer. While the US may receive up to 500 million more doses, it means that this may not happen until the summer, due to the rejected offer.