🔒 FDA vaccine approval lifts share markets – With insights from The Wall Street Journal

“Today I’m calling on more companies in the private sector to step up with vaccine requirements that will reach millions more people,” President Biden said. “I call on you to do that—require it.”

The Pfizer-BioNTech vaccine was cleared by regulators last year on an emergency-use basis, as were subsequent clearances for Moderna Inc. MRNA 7.55% and Johnson & Johnson JNJ -0.43% vaccines.

Following Monday’s action by the FDA, the Pentagon said it would require all military service members to receive a Covid-19 vaccine. New York City Mayor Bill de Blasio said the city’s Department of Education will require vaccinations for all employees, and New Jersey Gov. Phil Murphy said the shots will be mandated for school employees.

The Pfizer-BioNTech vaccine was first cleared in December by the FDA on an emergency-use basis for people 16 years and older after the drugmakers showed it to be highly effective at preventing symptomatic Covid-19. The two-dose shot, resulting from the fastest vaccine development ever in the West, has since become the most received Covid-19 vaccine in the U.S.

Of the three authorized vaccines in the U.S., only Pfizer had submitted all the required information to the FDA for full approval, according to the companies, and analysts expected it to be the first to receive clearance.

Moderna, whose authorized two-dose shot uses similar mRNA technology as the Pfizer-BioNTech vaccine, has said it is still completing rolling data submissions. Johnson & Johnson, whose shot was authorized in February, has said it plans to file for full approval later this year.

The FDA’s action Monday came as U.S. hospitals are seeing a surge in cases tied to the contagious Delta variant, and as the government weighs when vaccinated adults should receive additional doses, putting pressure on the agency to act quickly.

The FDA said its review found the vaccine to be safe and effective in preventing Covid-19 as well as severe disease, hospitalization and death. The most common side effects by clinical trial participants who received the vaccine included fatigue, headache, joint pain, chills and fever.

“We have not lost sight that the Covid-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines,” said Peter Marks, director of FDA’s Center for Biologics Evaluation and Research. “The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”

The Pfizer-BioNTech shot was authorized for children as young as 12 years in May. Pfizer plans to request full approval for that group once it has collected and analyzed six months of safety data from clinical-trial subjects, according to the company.

The vaccine is now eligible for off-label prescriptions—or use beyond the approved populations. That could include booster doses, according to the FDA. Prescribing the vaccine off label for children wouldn’t be appropriate as there is no data on proper dosing or safety in youth, said acting FDA Commissioner Janet Woodcock.

“That would be a great concern that people would vaccinate children because we don’t have the proper dose or safety data,” she said. “We need to get the information and data on uses on younger children.”

After regulators approve a medical product, physicians often use off-label prescribing. Dr. Woodcock said, however, this is a different situation because Covid-19 vaccination providers have agreed with the Centers for Disease Control and Prevention to adhere to certain conditions, including those that cover the vaccines.

The age of the vaccine recipient must align with the FDA’s guidelines, according to the CDC website. The FDA doesn’t encourage off-label use, Dr. Woodcock said.

Uses outside of the authorization and recommendations raise issues like liability protections, compliance with the CDC provider agreement, and reimbursement for administration costs, according to a CDC spokeswoman.

Yvonne Maldonado, chair of the American Academy of Pediatrics Committee on Infectious Diseases, urged physicians to wait until the clinical trials are complete in children to give the vaccine to those under 12.

“We do not want individual physicians to be calculating doses and dosing schedules one-by-one for younger children based on the experience with the vaccine in older patients,” Dr. Maldonado said. “We should do this based on all of the evidence for each age group, and for that we need the trials to be completed.”

Pfizer, which will sell the vaccine under the name Comirnaty, is now permitted to market the vaccine to doctors, healthcare providers and the general public as it does with other approved products. Pfizer declined to share its marketing and advertising plans but said it seeks to take a thoughtful approach with such communications in hopes of increasing vaccine confidence.

The FDA is permitted to restrict such communications with emergency authorization.

“I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity,” said Pfizer Chief Executive Albert Bourla.

The Biden administration last week recommended that a third shot of an mRNA vaccine such as Pfizer’s be given to adults who have received the two-dose regimen. A critical element for broad boosting will be a recommendation from the Advisory Committee on Immunization Practices to the Centers for Disease Control and Prevention, as physicians often follow ACIP recommendations.

Pfizer has already submitted data to the FDA showing that a third dose of its vaccine boosts the immune system against the original virus and against the Beta and Delta variants to higher levels than the standard two-dose regimen. Pfizer plans to submit a request for booster authorization as an amendment to the full approval.

Full approval is expected to lead more businesses and institutions to require vaccinations because opponents of such measures have cited the emergency authorization as grounds for not requiring vaccinations. About 60% of eligible people in the U.S. are fully vaccinated, according to federal figures.

Dr. Marks, the FDA’s official, said the review showed an increased risk of myocarditis, an inflammation of the heart muscle, after the second dose, although he didn’t provide specific data on how frequently it occurs overall. He said it was mostly found in younger adult males.

Since April 2021, there have been more than a thousand reports to the Vaccine Adverse Event Reporting System of cases of inflammation of the heart happening after mRNA Covid-19 vaccinations in the U.S., according to the CDC. These reports are rare, the agency has said.

Dr. Marks said the FDA has heard false claims that Covid-19 vaccines cause infertility or contain microchips. “Let me be clear, these claims are not true,” he said.

Pfizer and BioNTech submitted some 340,000 pages as part of their approval application—more than three times the size of the emergency-use authorization submission—and included longer-term clinical trial data from more than 46,000 volunteers that showed the vaccine was 91.1% effective at preventing symptomatic Covid-19 up to six months after the second of two doses, according to Pfizer.

The emergency-use authorization issued last year was based on data from about 37,000 volunteers who were followed for a median of two months after the second dose. In the trial, about half the subjects received the vaccine, with the rest receiving a placebo.

The approval application also included information on manufacturing processes as well as the plants that produce the shots.

Researchers also found the vaccine to be highly effective against preventing severe Covid-19.

The shot was authorized last year on an emergency basis after the companies showed the vaccine was 95% effective in preventing symptomatic disease after two months. The emergency designation allows for products to be distributed during public-health crises based on the best available evidence.

The vaccine bested the agency’s standard that Covid-19 vaccines be at least 50% effective at preventing disease in a placebo-controlled trial to receive an emergency-use authorization, the same bar that must be cleared for full approval.

Eligible U.S. residents will continue to receive the vaccine at no cost, according to Pfizer.

Vaccination requirements have been accelerating in the U.S. despite some public resistance and efforts by states such as Arkansas to ban vaccine mandates. Some laws prohibiting vaccination mandates are tied only to vaccinations that have emergency-use authorization, so they may not apply since Pfizer has FDA approval.

Some employers such as Walmart Inc., WMT -0.66% Tyson Foods Inc. TSN -0.51% and Uber Technologies Inc. UBER 2.63% are requiring some employees to be vaccinated unless they have approved exceptions.

—Alex Leary contributed to this article.