After gathering data from more than 44,000 people, the FDA announced that the Pfizer Covid-19 vaccine has received full approval. Although the vaccination campaign began in the U.S after the vaccine received emergency authorization, many were skeptical and decided to wait for full approval. The news comes in handy to speed up the vaccination process in the U.S. A new infection wave with the Delta strain has hard hit the country, and the hospital system is overwhelmed.
FDA’s acting commissioner Janet Woodcock gave details
On August 23, the FDA released a statement explaining that the first Covid-19 vaccine has been approved. The vaccine will be marketed as Comirnaty, and it is fully approved for those 16 years old or more. The emergency authorization for the 12-15 age group still stands, and the recommendation is to vaccinate as many young people as possible.
The FDA acting commissioner, Janet Woodcock, M.D, explained that it is a major milestone for putting an end to the coronavirus pandemic. The approval means the vaccine is safe and it meets the high standards imposed by the FDA. She explains the mRNA vaccine trains our bodies to mimic a protein found in the SARS-CoV-2 virus. This way, the immune system will defend the body against infections caused by the virus. As further explanation, it is mentioned that the mRNA protein does not remain in the human body for long, and it does not alter our genetic material.
The Covid-19 vaccine is 91% effective against the new coronavirus
The FDA media release statement mentions that the vaccine has proven to be 91% effective in preventing the disease, and there have been minimal side effects reported. The most common ones included pain and redness at the injection area, headache, and fatigue, and sometimes fever or chills.