The US Food and Drug Administration (FDA) announced on Monday that the Pfizer-BioNTech COVID-19 vaccine has been formally approved for the prevention of the novel coronavirus in those aged 16 and up in the country.
The Pfizer-BioNTech vaccine - one of three available in the US - was previously granted emergency approval by the FDA. It will remain available for children, aged 12 to 15, via the aforementioned emergency use authorization.
The double-dose jab will be marketed as "Comirnaty," the FDA highlighted.
Shortly after the highly-anticipated FDA announcement, US President Joe Biden called on unvaccinated Americans to consider the Pfizer-BioNTech vaccine approval as reassurance of its safety and effectiveness in most individuals.
"If you're one of the millions of Americans who said that they will not get the shot until it has full and final approval of the FDA, it has now happened," Biden declared. "The moment you've been waiting for is here."
According to Biden, the COVID death toll is approximately 70% lower than the previous winter, and the US' overall weekly vaccinations are up 56% from the previous month. US states previously lagging in new vaccinations, including Arkansas, Louisiana, Alabama and Mississippi, have seen improvement.
Overall, the US' COVID-19 vaccine rollout saved some 279,000 lives and prevented 1.25 million hospitalizations, according to Yale School of Public Health research referenced by the US president. The study, published last month, also found that around 120,000 additional deaths and another 450,000 hospitalizations would have occurred if only half the amount of vaccines were administered.
As of today, more than 170 million individuals (51.5% of the total US population) have been fully vaccinated against COVID-19, and over 201 million individuals (60.7% of the total US population) have received at least one dose.
The full federal approval of a COVID-19 vaccine will likely be the catalyst for a new wave of vaccine requirements in both the public and private sectors.
Pentagon spokesperson John Kirby confirmed in a same-day announcement that the department will update vaccine requirements for US military personnel.
In this March 9, 2021, file photo, Army health specialists fill syringes with the Pfizer COVID-19 vaccine in Miami.
© AP Photo / Marta Lavandier
A timeline was not provided, but US Defense Secretary Lloyd Austin pledged earlier this month that he would "seek the president’s approval to make the vaccines mandatory no later than mid-September, or immediately upon" full licensure by the FDA. "Whichever comes first."
Several private companies, including the Walt Disney Company, Microsoft and Tyson Foods, took cues from the Biden administration's vaccine mandate and announced their own respective vaccine-related requirements.
Nevertheless, additional vaccine mandates will begin emerging after Monday, as many businesses were admittedly waiting on the FDA's full approval. US Surgeon General Dr. Vivek Murthy told CNN on Sunday that he believes the federal agency's announcement "would likely encourage [universities and businesses] and make them feel more comfortable in putting some requirements in place."
The urgency for such vaccine-related measures and mandates has been fueled by the exponential spread of the highly contagious Delta variant of COVID-19. US health officials have warned that the now-predominant strain of the disease is twice as contagious as its previous counterparts and may cause more severe illness than former variants - particularly in unvaccinated individuals.