President Joe Biden marked the milestone in an address to the nation Monday afternoon and used the news to urge more Americans to get their shots. “With today’s FDA full approval, there’s another good reason to get vaccinated,” Biden said. “Those who have been waiting for approval should go get your shot now. The vaccination is free. It’s easy. It’s safe and it’s effective, and it’s convenient.” In a separate statement, the FDA’s acting commissioner, Janet Woodcock, MD, underscored that the approval means the Pfizer vaccine meets the FDA’s high standards for safety, effectiveness, and manufacturing quality. “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,” she said. Because the pandemic has posed a public health crisis, the FDA had granted emergency authorization for the Pfizer vaccine, which allowed for the rollout of doses on the basis of initial data from a phase 3 clinical trial. The full approval has now been granted on the basis of a comprehensive data package that included longer-term follow-up data from the phase 3 trial. This trial established the vaccine’s high efficacy and favorable safety profile over the course of six months after the second dose. The Moderna vaccine may also soon follow suit — the company filed for full approval on June 1. Johnson & Johnson has yet to apply but said it plans to do so later this year. In his comments to the nation today, Biden also called upon more companies in the private sector to step up their vaccine requirements. He highlighted that these requirements are not new. “Vaccine requirements have been around for decades,” he said. “Most people in America don’t worry about polio, smallpox, measles, mumps, and rubella today because of vaccines, and it only makes sense to require a vaccine to stop the spread of COVID-19.” Biden directed the public to learn more about the vaccines and where to get the shot at Vaccines.com.
