Vaccines will be more likely once FDA grants full approvals, health experts say

WASHINGTON – The United States could see a wave of Covid-19 vaccine warrants as soon as the Food and Drug Administration grants full approval to one or more of the shots, public health experts have predicted.

All three vaccines cleared by the FDA for emergency use against the coronavirus have been shown to be safe and effective under this expedited review process and in the real world, and doctors and most senior public health officials of the country said it was not necessary to wait to be vaccinated. .

But as the pace of vaccinations slows and concerns about the highly contagious delta variant increase, official regulatory approval would remove an important legal and public relations hurdle for businesses and government agencies wishing to require vaccinations for their employees. and clients, former health officials. of the Biden and Obama administrations said.

“I think once the vaccines are approved by the FDA, everything should be on the table, and I think everything will be on the table at the municipal, state, employer, site, government agency level,” he said. 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 vaccines. Yet the suggestion of Covid vaccine warrants, whether by local governments for schoolchildren or by businesses for their clients, has so far met stiff resistance – mainly from lawmakers and conservative activists.

At least 20 state legislatures have passed bills or are considering measures that would prohibit businesses and state and local governments from imposing restrictions on unvaccinated people. Even so, some colleges, concert halls and employers have already started requiring vaccinations against Covid.

But the Covid Vaccine Expedited Review process has been cited as a safety concern by some who have yet to be vaccinated and as a legal hurdle for organizations that have been reluctant to put in place a mandate.

Institutions that have vaccine requirements in place have already faced legal action, with opponents arguing that the law creating the emergency use authorization says people should be able to refuse a treatment. One such lawsuit brought by healthcare workers at the Houston Methodist was dismissed last month.

But with the spread of the new delta variant and the filling of hospitals, public health officials feel a renewed sense of urgency to find ways to reach nearly one in three eligible Americans who have yet to receive his first dose. Pfizer, maker of the first vaccine cleared for emergency use in the United States, said on Friday it expects the FDA to grant full approval by January 2022 at the latest. Acting FDA Commissioner Janet Woodcock said a decision is expected to be made well ahead of that date.

Health officials have said they believe vaccine requirements may be the latest push for people who have not made vaccination a priority or who have been indifferent to needing it.

Shame on us if we sit here in July and do nothing to increase immunization rates and we can’t open schools or have a situation where, God forbid, the economy takes another hit because that businesses need to shut down, ”said Kathleen Sebelius, who served as Secretary of Health and Human Services under President Barack Obama.

Biden’s administration has so far resisted all vaccine demands, choosing instead to offer incentives. But Slavitt said he expects that to change with full FDA approval.

He said he believed some federal agencies should then start requiring vaccinations for their employees, including members of the military, healthcare workers in veterans’ hospitals and nursing homes, and d other federal workers in close contact with the public, such as airport security officers.

“I think every government agency should rethink what’s appropriate,” Slavitt said. “There are a number of people in the polls, 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 on Friday whether the administration plans to make the vaccine a requirement for the military or the federal workforce. The federal government already requires the military to get vaccinated. Applicants for immigration must also be vaccinated against various diseases.

We don’t know how much authority the Biden administration could go so far as to require vaccinations beyond the federal workforce. No federal immunization warrant has ever been tested in court, and none has ever been issued for the general population. Instead, much of the power to require vaccinations rests with state and local governments following a Supreme Court ruling in 1905 that upheld a city health council law requiring all adults get vaccinated against smallpox.

So far, only a handful of large companies, businesses and sites have implemented immunization mandates. Delta Air Lines and United Airlines are among the few companies requiring new employees to be vaccinated, but the policy does not apply to current employees.

Several other companies, like BlackRock, have said that only vaccinated employees can return to the office, but have yet to say what will happen with the unvaccinated. Both Madison Square Garden and Yankee Stadium have limited their events to vaccine attendees, but many other venues have only encouraged guests to be immunized.

Even hospitals and nursing homes have been reluctant to make vaccines mandatory for employees. Among nursing home workers, the vaccination rate is lower than that of the general population and in some states, including Florida and Georgia, the vaccination rate is less than 50 percent for workers, according to The data from the Centers for Medicare and Medicaid Services.

“I think it’s a responsibility of employers and others who have the capacity to enforce it on their sites,” Zeke Emanuel, Obama administration health adviser, said of the vaccine requirement. for healthcare workers. “It’s not like it’s easy, but it’s a leadership moment and sometimes when you’re a leader you have to do tough things.”

Hundreds of colleges have demanded that students be fully vaccinated against Covid before returning to campus, but it is unclear how these warrants will be enforced and there have already been setbacks, including lawsuits. A federal judge confirmed Indiana University’s vaccine requirement on Monday. Most colleges already had vaccine requirements in place for other diseases.

Slavitt said a compromise employers could offer those who are strongly opposed to vaccination would be to force them to get tested several times a week.

Biden’s administration has backed private companies putting in place vaccine requirements and his chief medical adviser, Dr Anthony Fauci, said on July 11 that he believed there should be more mandates for vaccines at the local level.

The Biden administration’s strategy has focused heavily on trying to make vaccinations more accessible, disseminating information about vaccines, and warning of the risks of not getting the vaccine.

“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 of the requirements. vaccines. “But we play our part from there, we continue to go community by community, person to person, making sure we meet people where they are to get the vaccine out.”

Last week, the White House turned to pop star Olivia Rodrigo in an attempt to reach the youngest, who have the lowest vaccination rates. The surgeon general also released a report on the influence of misinformation on social media on vaccination efforts. Biden said on Friday that these social media platforms, including Facebook, were “killing people” by allowing lies about Covid vaccines to spread across their websites.. He returned to criticism on Monday, saying those who published the false information were to blame.

the rate vaccinations have halved since June 1, when the administration declared a “month of action” to redouble their efforts as the delta variant spreads. By the end of last week, new cases had risen by 70 percent in the past seven days with the bulk of infections in four states with relatively low vaccination rates, and the number of deaths had risen by 26 for one hundred to 211 a day, according to the CDC.

“We have a chance to really continue the progress, the incredible progress that has been made since January,” said Sebelius. “But we also have some real warning signs around the world that we should pay close attention to.”

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