Timelines for F.D.A. Approval for Moderna and J.&J. Vaccines Remain Unclear
Attention turns to the other two Covid vaccines available in the United States after the Pfizer-BioNTech vaccine got full federal approval for use in people 16 and older. Moderna applied for full approval in June, a month after Pfizer, and Johnson & Johnson is expected to apply soon.,
The timelines for F.D.A. approval for the Moderna and Johnson & Johnson vaccines remain unclear.
The Covid vaccines made by Moderna and Johnson & Johnson have been available to the American public for months under federal emergency use authorizations.Credit…Bess Adler for The New York Times
Aug. 24, 2021, 5:57 p.m. ET
Now that the Pfizer-BioNTech coronavirus vaccine has been given full federal approval for use in people 16 and older, attention is turning to the vaccines made by Moderna and Johnson & Johnson.
Both vaccines have been available to the American public for months under emergency use authorizations from the Food and Drug Administration. Moderna applied for full approval in June, a month after Pfizer, and Johnson & Johnson is expected to apply soon.
When they might be fully approved remains unclear. Dr. Peter Marks, the F.D.A.’s top vaccine regulator, declined to specify a timeline for Moderna’s approval in a call with reporters on Monday.
Dr. Marks did note that the approval for Pfizer’s vaccine took only 97 days from the time the company submitted its data, less than half the time of a typical approval period. The exhaustive process was expedited by a “tireless team” that “worked day and night to get this done,” he said, adding that regulators were “highly rigorous” despite the short timeline.
Dr. Anthony S. Fauci, the nation’s top infectious disease expert, said in a series of interviews on Tuesday that he hoped the F.D.A. would soon be able to move forward to give full approval to the next vaccine.
“I don’t think it’s too far away,” Dr. Fauci said on the CBS program “This Morning.”
“I think it’s a temporal issue,” he continued. “I don’t think there’s anything different necessarily about the process, it’s just that they submitted or are submitting their material a bit later or after Pfizer did.”
Full federal approval could make vaccines more palatable to the more than 80 million people around the country who have not been vaccinated yet, Dr. Fauci said on “Morning Joe” on MSNBC, citing a survey that found that about a third of them were waiting for the F.D.A.’s imprimatur before getting a shot.
Dr. Fauci also said that he thought advertising for the vaccine, which is allowed now that it has been approved, might increase uptake, and that approval would spur more vaccine mandates from businesses, colleges and local governments.
President Biden encouraged such mandates in an address on Monday. The Pentagon announced that it would require all 1.4 million active duty troops to be vaccinated, New Jersey said that all teachers would need to get shots or weekly testing, and the State University of New York announced a vaccination requirement for its students.
Vaccine mandates and other protective measures have taken on greater urgency as the extremely infectious Delta variant has driven a surge in cases nationwide and overwhelmed hospitals in many states. The seven-day average of known deaths connected to the coronavirus has risen above 1,000 for the first time since March 2021, according to data collected by The New York Times.
Understand Vaccine and Mask Mandates in the U.S.
Vaccine rules. On Aug. 23, the Food and Drug Administration granted full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 and up, paving the way for an increase in mandates in both the public and private sectors. Private companies have been increasingly mandating vaccines for employees. Such mandates are legally allowed and have been upheld in court challenges.Mask rules. The Centers for Disease Control and Prevention in July recommended that all Americans, regardless of vaccination status, wear masks in indoor public places within areas experiencing outbreaks, a reversal of the guidance it offered in May. See where the C.D.C. guidance would apply, and where states have instituted their own mask policies. The battle over masks has become contentious in some states, with some local leaders defying state bans.College and universities. More than 400 colleges and universities are requiring students to be vaccinated against Covid-19. Almost all are in states that voted for President Biden.Schools. Both California and New York City have introduced vaccine mandates for education staff. A survey released in August found that many American parents of school-age children are opposed to mandated vaccines for students, but were more supportive of mask mandates for students, teachers and staff members who do not have their shots. Hospitals and medical centers. Many hospitals and major health systems are requiring employees to get a Covid-19 vaccine, citing rising caseloads fueled by the Delta variant and stubbornly low vaccination rates in their communities, even within their work force.New York City. Proof of vaccination is required of workers and customers for indoor dining, gyms, performances and other indoor situations, although enforcement does not begin until Sept. 13. Teachers and other education workers in the city’s vast school system will need to have at least one vaccine dose by Sept. 27, without the option of weekly testing. City hospital workers must also get a vaccine or be subjected to weekly testing. Similar rules are in place for New York State employees.At the federal level. The Pentagon announced that it would seek to make coronavirus vaccinations mandatory for the country’s 1.3 million active-duty troops “no later” than the middle of September. President Biden announced that all civilian federal employees would have to be vaccinated against the coronavirus or submit to regular testing, social distancing, mask requirements and restrictions on most travel.
Nearly 65 million people have been vaccinated with Moderna’s shot, and nearly 14 million with Johnson & Johnson’s, compared with more than 92 million people who have been vaccinated with Pfizer’s, according to data from the Centers for Disease Control and Prevention. Just over 60 percent of people eligible for the vaccine in the United States have been fully vaccinated.
Children ages 12 to 15 can still get Pfizer’s vaccine under the emergency use authorization; none of the vaccines have been authorized for children younger than 12.
In July, federal regulators pressed both Pfizer and Moderna to expand the sizes of trials in children ages 5 to 11 to detect rare side effects, including heart inflammation problems that have turned up in people younger than 30. Pfizer appeared to be on a faster track to secure an emergency use authorization for young children at the time.
Dr. Fauci said that pharmaceutical companies and federal agencies were still collecting data on using the vaccines in children younger than 12, and that he hoped the F.D.A. could at least authorize the vaccines for emergency use in children by early winter.
Speaking on “The Today Show” on NBC, Dr. Fauci said he thought that ending the pandemic in the United States would involve convincing the “overwhelming majority” of unvaccinated people to be inoculated.
“I believe we can see light at the end of the tunnel,” Dr. Fauci said. “When we reach a point where there’s enough of a veil of protection over the community that you see a dramatic diminution not only in cases, but in hospitalizations and, ultimately of course, in deaths.”