Report: FDA Planning Big Announcement That Could Pave the Way for Vaccine Mandates
Vaccine mandates could have a firm regulatory footing after the Food and Drug Administration gathers next week to grant full approval to the Pfizer-BioNTech vaccine against the coronavirus.
The FDA is likely to approve the vaccine on Monday, according to The New York Times.
The Times reported the timeline was contingent upon approval of an assortment of paperwork, and noted that the Monday date was not set in stone. The agency previously said it was looking at approval sometime around Labor Day.
As noted by The Washington Post, moving from the vaccine’s status under an emergency authorization to full-fledged approval will be a critical point in the effort to vaccinate Americans because it is likely to trigger vaccine mandates from both private employers and governments.
This step is expected to trigger another round of approvals as Pfizer begins the process for getting federal approval to offer a third dose of the vaccine as a booster shot, for which the Biden administration has given its blessing.
The Times reported Moderna, which has been a step behind Pfizer throughout the regulatory process, is expected to hear back on its application for approval of its vaccine in the next few weeks. Moderna will reportedly be requesting approval for its own booster shot in September.
The issue of booster shots has triggered a debate within the scientific community, according to the Washington Post.
Calling for boosters “may be the right decision — let’s see the data — but if it were the [Trump] administration getting this far out ahead of FDA and CDC on something this significant, there’d be outrage. And appropriately so,” tweeted Jason L. Schwartz, Yale School of Public Health associate professor.
“Process matters, no matter which party is in power.”
It may be the right decision—let’s see the data—but if it were the _Trump_ administration getting this far out ahead of FDA and CDC on something this significant, there’d be outrage. And appropriately so. Process matters, no matter which party is in power. https://t.co/9VRDHqy69G
— Jason L. Schwartz (@jasonlschwartz) August 17, 2021
The decision on boosters “doesn’t make any sense to me at all,” said Vincent Racaniello, a professor of microbiology and immunology at Columbia University.
“I think it’s way premature because the science doesn’t say that we need to have a booster right now. It could be a year or two, depending on the data,” he said.
The crux of the issue is that in its rollout of data to show the need for a booster, the Biden administration showed that vaccine protection fades against a mild illness, but not against severe illness.
To some, that means any call for boosters is premature.
“The metric that matters is the protection against severe disease, hospitalization and death among people vaccinated,” said David Rubin, director of PolicyLab at Children’s Hospital of Philadelphia.
The booster decision “tends to portray that we’ve lost confidence in the ability of this vaccine to prevent severe infection. And I don’t think that’s the case,” he said.
Biden officials “got ahead of their skis” in announcing the plan, said Holly Fernandez Lynch, a bioethicist and lawyer at the University of Pennsylvania.
She said that “we are clearly seeing pressure” on the scientific community and FDA to do what political leaders want.
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