Biden told a town hall audience in Ohio on July 21 that he expected the FDA to "quickly" give final approval for COVID-19 vaccines.
"My expectation talking to the group of scientists we put together, over 20 of them plus others in the field, is that sometime maybe in the beginning of the school year, at the end of August, beginning of September, October, they'll get a final approval," Biden said.
The president also said he expected children under the age of 12, who are not currently eligible to receive the vaccine, would soon be able to get it on an emergency basis.
FDA's top drug evaluator comes from Big Pharma
Biden may yet get his wish for final approval for COVID-19 vaccines thanks to key personnel within the agency. The FDA's Center for Drug Evaluation and Research (CDER), which makes sure that safe and effective drugs are available in the U.S., is currently headed by Dr. Patrizia Cavazzoni who spent two decades with Big Pharma companies.
Biden's comments at the town hall came as the spread of the delta variant has led to a national rise in coronavirus cases. (Related: Fully vaccinated Americans are SPREADING covid's delta variant, health expert warns.)
Over the past week prior to his remarks, an average of roughly 41,300 cases had been reported each day across the country – an increase of 171 percent from two weeks before. The number of deaths reported had also gone up by 42 percent, to an average of 249 a day over the same period. New infections increased sharply in some states, such as Missouri, Arkansas, Louisiana and Florida.
In Ohio, Biden found himself fielding questions from audience members concerned about low vaccination rates in their communities.
"This is simple, basic proposition," he said. "If you're vaccinated, you're not going to be hospitalized. You're not going to be in an ICU. And you are not going to die."
Later, as reported by the New York Times, Biden exaggerated the efficacy of the vaccine. "You're not going to get COVID if you have these vaccinations," he said.
The Biden administration has apparently fixed its sights at forcing the FDA into fully approving COVID-19 vaccines, while completely dismissing evolving safety and efficacy concerns in the process. Fully authorizing the COVID-19 vaccines will allow for the government to hop over legal and regulatory hurdles that come from their current status under emergency use authorization.
Full approval will open door for vaccine mandates
Public health experts predicted that the U.S. could see a wave of COVID-19 vaccine mandates as soon as the FDA grants full approval to one or more of the vaccines.
Former health officials from the Biden and the Obama administrations said 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.
"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 Biden's COVID response coordinator last month and remains in close contact with administration officials.
The suggestion of COVID vaccine mandates, whether by local governments for schoolchildren or by businesses for their customers, has so far been met with sharp resistance
Many state legislatures pass bills protecting unvaccinated people
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. But those bills have not stopped some colleges, concert venues and employers from requiring COVID-19 vaccinations.
The expedited review process for COVID-19 vaccines has been cited 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 the plaintiffs arguing that the statute creating the emergency use authorization indicates people should have the option to refuse the vaccine. (Related: Indiana University students file a lawsuit over COVID-19 vaccine mandate.)
Delta variant gives government an opportunity to resuscitate vaccination campaign
But with the new delta variant spreading fast, there is a renewed sense of urgency by public health officials to find ways to reach the nearly one in three eligible Americans who have yet to get their first dose.
"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 former President Barack Obama.
Biden's administration has so far resisted any vaccine requirements, but Slavitt said he expects that to change with full FDA approval. "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.'"
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