Pfizer granted full approval of COVID-19 vaccine

FDA

The Food and Drug Administration announced Monday that it has granted full approval to Pfizer and BioNTech for their COVID-19 vaccine to be given to Americans as young as 16. The approval clears the way for a wave of moves that health officials say could reverse a nationwide slowdown in the pace of first doses.

The approval caps a monthslong effort by the FDA to clear the shot’s final remaining regulatory requirements, reviewing reams of the company’s latest safety data and conducting inspections at Pfizer’s vaccine factories around the world, according to the Centers for Disease Control (CDC).

“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.,” said the FDA’s Acting Commissioner Janet Woodcock said in a statement.

Pfizer completed its submission of a “biologics license application” for the shot in May, providing the extensive documentation required for full approval, and has told investors it plans to seek full approval for younger age groups and a booster shot.

Moderna said it plans to finish its application this month. Johnson & Johnson, which is currently gathering data from trials of two-dose regimens, also plans to file for full approval this year, according to news reports.

Pfizer’s vaccine has been available since December under an Emergency Use Authorization, which was expanded in May to include children ages 12 and up.

But the FDA had also faced growing pressure to speed the review as cases surged among mostly unvaccinated Americans from the fast-spreading delta variant of the virus. Though already allowed under federal law, full approval could open the door for more places that have waited to require the shots.

The California Department of Public Health (CDPH) issued a statement Monday from Dr. Tomás J. Aragón, CDPH director and state public health officer, following federal approval of the Pfizer BioNTech COVID-19 vaccine.

“Today’s announcement by our federal partners underscores the safety and efficacy of the COVID-19 vaccine and comes at a critical juncture as many of our communities are grappling with increasing cases fueled by the faster spreading delta variant,” said Dr. Aragón in a statement.

“For weeks we have watched cases go up at an alarming pace among individuals who are not vaccinated while the vaccinated are largely protected, especially against severe and long-term illness.

“We know the vaccines work. We know vaccines are safe. We know they save lives. If you are not vaccinated, let this be the milestone that gets you there. Get vaccinated to protect yourself and help put an end to this deadly pandemic.”