The FDA has given the green light to Pfizer’s coronavirus vaccine, and Americans might get their first dose as early as Monday.
The emergency usage license comes at a time when the Covid-19 outbreak in the United States has claimed the lives of almost 294,000 people.
On December 11, the US Food and Drug Administration (FDA) approved the Pfizer-BioNTech Covid-19 vaccine for emergency use, allowing millions of very vulnerable people to receive the vaccination within days. Dr. Denise Hinton, the agency’s head scientist, wrote to Pfizer on December 11 to authorize the emergency use of the company’s vaccine.
“I’ve come to the conclusion that the known and potential advantages of the Pfizer-BioNTech Covid-19 Vaccine, when administered to prevent Covid-19 and in line with this Scope of Authorization, outweigh the risks. I am authorizing the emergency use of Pfizer-BioNTech Covid19 vaccine for the prevention of Covid-19, having concluded that the criteria for issuing of this permission under Section 564(c) of the Act are met,” it stated.
People aged 16 and up can receive the vaccine. “The vaccine covered by this authorization will be administered by vaccination providers and used only to prevent Covid in people aged 16 and up; and the Pfizer-BioNTech Covid-19 vaccine will be administered by vaccination providers without an individual prescription for each vaccine recipient,” according to the letter.
The approval comes at a time when the Covid-19 pandemic has claimed the lives of over 294,000 Americans and more than 15,834,960 cases have been documented across the country.
Following the FDA’s emergency use authorisation (EUA), the federal government will begin distributing potentially life-saving dosages to states and territories across the country. Officials from the federal government’s vaccine distribution program, Operation Warp Speed, have stated that the vaccine will be shipped to distribution centers across the United States within 24 hours following FDA approval. The government intends to release 2.9 million vaccine doses in the next 24 hours, followed by another 2.9 million doses 21 days later for patients to receive their second dosage.
While the EUA permits vaccine shipment, the vaccines cannot be administered unless the Advisory Committee on Immunization Practices (ACIP) of the US Centers for Disease Control and Prevention (CDC) recommends its use. The ACIP set a meeting for December 11 and plans to vote during a subsequent meeting on December 13.
The CDC had previously released guidelines based on ACIP recommendations that stated that healthcare workers and residents of long-term care institutions should receive the vaccination first, although states can distribute the vaccine as they see right.
On Friday, December 11, Alex M Azar, Secretary of the Department of Health and Human Services (HHS), also announced that the first Americans had arrived. Brinkwire News in a Nutshell