The regulatory signoff would remove a significant legal and public relations barrier to requirements, former government officials said.
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Vaccine mandates more likely once FDA grants full approvals, health experts say
The regulatory signoff would remove a significant legal and public relations barrier to requirements, former government officials said.
July 20, 2021, 8:30 AM UTC
By Shannon Pettypiece
WASHINGTON — The United States could see a wave of Covid-19 vaccine mandates as soon as the Food and Drug Administration grants full approval to one or more of the shots, public health experts predicted.
The three vaccines authorized by the FDA for emergency use against the coronavirus have proven safe and effective under that expedited review process and in the real world, and doctors and the nation's top public health officials have said there's no need for anyone to wait to get inoculated.
But as the pace of vaccinations lags and concerns about the highly-contagious delta variant grow, the official regulatory signoff would remove a significant legal and public relations barrier for businesses and government agencies that want to require vaccinations for their employees and customers, former health officials from the Biden and the Obama administrations said.
“I think once the vaccines go through full FDA approval, everything should be on the table, and I think that everything will be on the table at the level of municipalities, states, employers, venues, government agencies,” said Andy Slavitt, who stepped down as President Joe Biden’s Covid response coordinator last month and remains in close contact with administration officials.
Many institutions, including colleges and universities, have long required certain immunizations. Still, the suggestion of Covid vaccine mandates, whether by local governments for school children or by businesses for their customers, has so far been met with sharp resistance — primarily from conservative lawmakers and activists.
At least 20 state legislatures have passed bills or are considering measures that would ban businesses and state and local governments from placing restrictions on unvaccinated people. Even so, some colleges, concert venues and employers have already started requiring Covid vaccinations.
But the expedited review process for Covid vaccines has been cited as a safety concern by some people yet to get vaccinated and as a legal hurdle for organizations that have hesitated to put a mandate in place.
Institutions that have put vaccine requirements in place have already faced lawsuits, with opponents arguing that the statute creating the emergency use authorization indicates people should have the option to refuse a treatment. One such lawsuit by health care workers at Houston Methodist was thrown out last month.
But with the new delta variant spreading and hospitals once again filling up, there is a renewed sense of urgency by public health officials to find ways to reach the nearly 1 in 3 eligible Americans who have yet to get their first dose. Pfizer, maker of the first vaccine authorized for emergency use in the United States, said Friday it expects the FDA to grant full approval by January 2022 at the latest. Acting FDA Commissioner Janet Woodcock has said a decision should come well before then.
Health officials said they believe vaccine requirements could be that last push for people who haven't made getting vaccinated a priority or have been indifferent about needing it.
“Shame on us if we sit here in July and don't do something to increase the vaccination rates and then we can't open schools or have a situation where, God forbid, the economy takes another hit because businesses have to shut back down,” said Kathleen Sebelius, who served as health and human services secretary under President Barack Obama.
Biden's administration has so far resisted any vaccine requirements, opting instead to offer incentives. But Slavitt said he expects that to change with full FDA approval.
He said he believes some federal agencies should then begin requiring vaccinations for their employees, including members of the military, health care workers at Veterans Affairs hospitals and nursing homes, and other federal workers in close contact with the public, like airport security screeners.
“I think every government agency ought to rethink what's appropriate,” Slavitt said. “There are a number of people in surveys, by the way, who say precisely these words, ‘I'm not going to take it, unless it's required.’”
White House press secretary Jen Psaki declined to say Friday whether the administration was considering making the vaccine a requirement for the military or the federal workforce. The federal government already requires members of the military to get certain vaccinations. Immigration applicants must also be vaccinated against a range of ailments.
It is unclear how much authority the Biden administration could have as far as requiring vaccinations beyond the federal workforce. No federal vaccination mandate has ever been tested in court and none has ever been issued for the general population. Instead, much of the power to require vaccinations has rested with state and local governments following a Supreme Court ruling in 1905 that upheld a city board of health law requiring all adults get vaccinated against smallpox.
Just a handful of major companies, businesses and venues have put in place any vaccine mandates so far. Delta Air Lines and United Airlines are among the few companies requiring new employees to get vaccinated, but the policy doesn’t apply to current employees.
Several other companies, like BlackRock, have said only vaccinated employees can return to the office but have yet to say what will happen with unvaccinated ones. Madison Square Garden and Yankee Stadium have both limited their events to vaccinated attendees, but many other venues have only encouraged guests to get vaccinated.
Even hospitals and nursing homes have been hesitant about making vaccines compulsory for employees. Among nursing home employees, the rate of vaccination is below that of the general population and in some states, including Florida and Georgia, the vaccination rate is under 50 percent for workers, according to data from the Centers for Medicare and Medicaid Services.
“I do think it is a responsibility of employers and others that have the ability to mandate it at their sites,” Zeke Emanuel, a health adviser in the Obama administration, said of requiring vaccines for health care workers. “It is not like it is easy, but this is a moment of leadership and sometimes when you are a leader, you have to do hard things.”
Hundreds of colleges have required students to be fully vaccinated against Covid before returning to campus, but it’s unclear how those mandates will be enforced and there has already been pushback, including lawsuits. A federal judge on Monday upheld Indiana University's vaccine requirement. Most colleges already had vaccine requirements in place for other diseases.
Slavitt said one compromise employers could offer those who are firmly against getting vaccinated would be to requiring them to get tested several times a week.
Biden's administration has been supportive of private companies putting vaccine requirements in place and his chief medical adviser, Dr. Anthony Fauci, said July 11 he believes there should be more vaccine mandates at the local level.
The Biden administration's strategy has focused heavily on trying to make vaccinations more accessible, spreading information about the vaccines and warning about the risks of not getting the shots.
“We know that some employers, hospitals, health systems, colleges, universities and local leaders have chosen to take this step, and we expect others to do so as well," Psaki said regarding vaccine requirements. “But our role we're playing from here is continuing to go community by community, person to person, making sure we are meeting people where they are to get the vaccine out.”
Last week the White House turned to the pop star Olivia Rodrigo to try to reach younger people, who have the lowest vaccination rates. The surgeon general also released a report on the influence that misinformation on social media has had on vaccination efforts. Biden said Friday that those social media platforms, including Facebook, were “killing people” by allowing lies about the Covid vaccines to spread on their websites. Hewalked back the criticism Monday, saying those posting the false information were to blame.
The rate of vaccinations has fallen by half since June 1, when the administration declared a “month of action” to redouble efforts as the delta variant spread. By the end of last week, new cases had risen 70 percent over the past seven days with the bulk of infections in four states with relatively low vaccination rates, and the number of deaths had increased by 26 percent to 211 a day, according to the CDC.
“We've got a chance to really continue the progress, the incredible progress that's been made since January,” Sebelius said. “But we also have some real warning signs across the world that we should pay close attention to.”
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