FDA Greenlit The Emergency Use Of The Pfizer-BioNTech COVID-19 Vaccine In US
The United States Food and Drug Administration, on Friday (11th December 2020), given the EUA (emergency use authorization) to the Pfizer-BioNTech vaccine. It is the first vaccine with the capability of preventing COVID-19 approved in the US. According to the FDA, anyone aged 16 or above can take the Pfizer-BioNTech vaccine.
The approval of Pfizer-BioNtech Vaccine marks a crucial turning point in the ongoing COVID-19 pandemic, which has claimed than 30,000 people’s lives in the United States.
FDA’s commissioner, Hahn said, the FDA’s emergency use authorization of the first COVID-19 vaccine is a crucial milestone in the battle against this devastating pandemic that has disrupted the lives of every single person in the country and around the world.
Dr. Eric Wei of New York’s Elmhurst hospital said that we could not overstate the vaccine’s importance. Experiencing it first hand, Dr. Wei knows how essential this vaccine is in stopping the onslaught of this deadly pandemic. This vaccine is what we have been praying for, he added.
The FDA approval comes after countries, including Canada, Mexico, and the UK, authorized using the Pfizer-BioNTech vaccine for the public.
Peter Marks – director of the FDA’s Center for Biologics Evaluation and Research, said that this vaccine’s emergency use authorization holds promise to change the course of this pandemic in the United States. With scientific decision making, the available effectiveness and safety data support the Pfizer-BioNTech’s COVID-19 vaccine’s authorization. The FDA approved its use because the vaccine’s benefits outweigh the known and potential risks.
Vaccine Testing And Efficacy
The FDA’s approval of the emergency use of the Pfizer-BioNTech vaccine called BNT162B comes after a successful clinical trial involving 43,000 people. The data collected during the test reveals that the vaccine effectively prevents the SARS-CoV-2 infection 95% of the time.
How Does The Pfizer-BioNTech Vaccine Work?
The Pfizer-BioNTech vaccine uses the new and innovative technology of introducing RNA to the body. The vaccine contains the RNA of the spike protein found on the coronavirus’s surface that it uses to attach to the cells.
When taken, the vaccine prompts the body to make copies of the spike protein, triggering an immune response. This process will prep the body to fight against COVID-19. The researchers have also published the results of the trial in the New England Journal of Medicine.
Though the FDA has okayed using the Pfizer-BioNTech vaccine, scientists are still studying how long the immunization provoked immune response will last and the rate of asymptomatic disease among people who will get this vaccine. They are also looking at if this vaccine can prevent COVID-19 transmission.
States will initially receive an allotment of 2.9 million doses, sent from Pfizer. This initial installment of the vaccine is for the healthcare workers and long-term care residents, whom CDC deemed the highest priority for vaccination.
Pfizer will roll out an additional 2.9 million vaccine in the coming weeks for giving the 2nd shot to the people already received the first. The health authorities are aiming for 20 million vaccinations before the end of 2020. This number includes both healthcare workers and long-term care residents.
The distribution of the Pfizer-BioNTech vaccine is the most challenging aspect of this entire process. Because the vaccine requires storage temperatures of -94F or -70C, distributing it will be a logistical challenge for the already funds strained healthcare system.
Experts believe that it will take somewhere around mid-to-late 2021 for the vaccine to reach lower-risk individuals. They estimate that upto 80% of adults need to get vaccinated before the US could reach “herd immunity.”