FDA approval of a vaccine is a welcome step
The Food and Drug Administration’s approval of the PfizerBioNTech vaccine for those 16 years and older is a critical milestone on the way to extinguishing the coronavirus pandemic. The agency’s finding that the shots are safe and efficacious should inject new confidence into the vaccination drive and help chase away fears of those who are hesitant. Still, much remains to be done.
The FDA reached its decision in about 40% of the usual timeline for such a review, but wisely refused to be browbeat into a hastier conclusion. The agency closely examined the manufacturing facilities, along with the real-world experiences of more than 40,000 people who participated in clinical trials. This gives the process real integrity and can help offset the misinformation and mischief spread by vaccine skeptics.
The FDA decision must now lead to expanded vaccine mandates. We hope the U.S. military — which has already announced plans to mandate immunizations for active-duty members — will press ahead with getting the National Guard and reserves vaccinated as well, and that businesses, governors, universities and other organizations will feel secure in demanding their employees and others get the shot. Some people will have legitimate reasons to opt out, but they must agree to frequent testing to protect themselves and others.
As President Joe Biden said Monday, “We need to move faster.” Vaccines are the most powerful tool available to combat an enormous wave of the delta variant. According to the Centers for Disease Control and Prevention, nearly 90% of all U.S. counties are at a “high” level of community transmission, meaning 100 or more cases per 100,000 people in the past seven days. Florida is at 656 per 100,000, Texas at 397, Mississippi at 755 and Louisiana at 755. But about 30% of Americans 12 and older are still without at least one dose. Unvaccinated people largely account for the surge in COVID-19 hospitalizations. The daily vaccine uptake has been improving, but tens of millions more doses must still be given.
The FDA must also turn its attention to the other mRNA vaccine, Moderna, as well as to the Johnson & Johnson shot and pediatric coronavirus vaccines for children under 12. The agency has not given final approval to the Pfizer shot for those 12 to 15 years old, although the previous emergency use authorization remains in effect. Vaccine uptake in this age cohort has lagged, and a final approval will help speed it up. Also in the near future, the FDA and the CDC must weigh in on vaccine boosters, as the Biden administration has recommended for the fall.
The big picture in the United States is stark: The pandemic is once again claiming more than 1,000 lives a day; not enough people are getting the vaccine, even though it works well and is free and widely available. Uncertainty and anxiety grip the country, from classrooms to boardrooms. The FDA decision on the Pfizer vaccine is an important way station toward ending the pandemic, but there’s still a long journey ahead.