The U.S. Food and Drug Administration (FDA) just announced that the Pfizer Covid-19 vaccine officially has its full approval, so it’s no longer available solely through emergency use status.
What does that mean? Essentially, the FDA had decided that there’s enough conclusive testing and evidence to show that the vaccine meets the agency’s strict and long-term safety, effectiveness, and manufacturing standards for people ages 16 years and older. The FDA also found that after trials that included over 40,000 people, a full dose is 91 percent effective at preventing Covid-19.
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of [the] safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities.”
Moreover, scientists hope that this approval will give some Americans who are hesitant about Covid-19 vaccines the extra push to get them and protect themselves and those around them from the coronavirus. “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,” Janet Woodcock, MD, the acting FDA commissioner, told press. “Today’s milestone puts us one step closer to altering the course of this pandemic in the US.”
In addition to the Pfizer vaccine, the Moderna and Johnson & Johnson Covid-19 shots, which are already readily available and widely used in the United States, are also on their way to full FDA approval in the coming weeks and months. It’s an exciting development in the fight to eradicate Covid-19 — and there’s a lot of hope for the future!