Pfizer BioNTech is the first Covid-19 vaccine to overcome its ultimate regulation obstacle, given complete approval by the Food and Drug Administration, applying to people 16 and older.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the Covid-19 pandemic,” Acting FDA Commissioner Dr. Janet Woodcock said in a statement. “While millions of people have already safely received Covid-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
“I am hopeful this approval will help increase confidence in our vaccine,” Pfizer CEO Albert Bourla said in a statement. “Vaccination remains the best tool we have to help protect lives.”
The ruling of the FDA could open the road to new mandates for vaccines: Many companies waited for complete permission before requiring the vaccination of personnel.
“Full approval could not come at a more important time, as the highly contagious delta variant continues to drive up caseloads and deaths across the U.S.,” the president and CEO of the Robert Wood Johnson Foundation, Dr. Richard Besser, said in a statement. “I am hopeful that full approval will address any remaining concerns and will move many people to a ‘yes’ on vaccination.”
Nonetheless, Besser stated that the shortage of vaccines in middle- and low-income countries “represents a global failure,” adding, “Ensuring an adequate supply of vaccines in every country and community must be a health, economic, and moral imperative for the world.”
People who received the Pfizer vaccination will be eligible for third doses eight months after their second injections starting Sept. 20, according to federal health officials. Although the FDA has not yet approved the third dose in the general population, patients with impaired immune systems can receive the additional shot.
While this morning’s approval does not cover children aged 12 to 15, they can still acquire the Pfizer vaccination under emergency use authorization.
Covid vaccinations that have been licensed or recommended for use in children under the age of 12 are expected this fall and winter.
The vaccine developed by Pfizer is one of three now in use in the United States. Moderna has also submitted a Biologics Licensing Application for full approval. Johnson & Johnson hasn’t asked for full permission yet, so it’s still being used on an emergency basis.
In December, Pfizer’s product became the first Covid vaccination to receive emergency use authorization. According to the CDC, more than 204 million doses of the Pfizer vaccine have been administered in the United States as of today.
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