How the FDA's full approval could affect COVID-19 vaccinations
The rise of the highly transmissible Delta variant has put mounting pressure on the Food and Drug Administration to fully approve the COVID-19 vaccines under emergency use authorization.
Pfizer’s vaccine is expected to be the first to be granted such approval, possibly within weeks. Although it is unclear what impact this decision will have on the course of the pandemic, many public health experts believe it could make a difference in several ways.
One is that the full approval could persuade some unvaccinated Americans to get the shot.
About half of the total U.S. population has now been fully vaccinated, according to the Centers for Disease Control and Prevention. But that number, health experts believe, continues to fall short of the 70 to 90 percent mark they estimate is needed to control the spread of the virus.
Because the Delta variant is more contagious, infectious disease experts believe the immunity threshold is now on the higher end of that range. In other words, a great portion of the population remains vulnerable to infection. That includes children under the age of 12, who are not yet eligible to get the shots, but also more than 30 percent of people who do qualify yet remain unvaccinated.
Even though the COVID-19 vaccines have undergone rigorous safety protocols in order to be granted emergency use authorization by the FDA, and billions of people worldwide have now been vaccinated without any complications, many Americans continue to see the shots as “experimental.”
“That [FDA approval] will be the sign of confidence that the vaccine is safe to take. So there are some real important stakes here to get the full approval,” said Yahoo News medical contributor Dr. Kavita Patel.
According to a Kaiser Family Foundation poll, 3 in 10 unvaccinated adults — 31 percent — said they would be more likely to get the shots if a vaccine received full approval. The organization notes, however, that two-thirds of the adults polled were confused about the type of FDA approval category that these vaccines currently have. Some thought they were already fully approved, and others were unsure about whether they were fully approved or authorized for emergency use. The organization says these findings likely suggest that FDA approval is “a proxy for general safety concerns.”
In his recent column for Axios, Drew Altman, president and CEO of the Henry J. Kaiser Family Foundation and a leading expert on national health policy, said the FDA approval, among other things, will offer “an opportunity to clear up substantial public confusion.”
Both Pfizer-BioNTech and Moderna submitted a Biologics License Application, or BLA, to receive the FDA’s full approval of their mRNA vaccines. Pfizer began the process first, on May 7. Moderna applied later, on June 1, but the company is still submitting data and has not said when it will finish the process. Johnson & Johnson, which produces the third vaccine authorized for emergency use, has yet to apply for full approval but plans to do so later this year.
In a recent interview with the Washington Post, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, which regulates vaccines, said the agency was pursuing an “all hands on deck” approach in order to expedite approval of the Pfizer vaccine. Marks didn’t provide any information on when the decision may happen but said the FDA was “going to move with all due diligence to get the review done with our usual high quality, as rapidly as we can.” Some agency officials have said the decision could happen as early as next month.
Other experts, however, believe people who are still hesitant about the vaccines are probably not going to be swayed by FDA approval. Dorit Reiss, a professor of law at the University of California, San Francisco, Hastings College of Law, told Yahoo News that “it will make a larger difference to the legal situation.”
Reiss, whose current research focuses on legal and policy issues related to vaccines, said the approval could give businesses and government agencies more confidence to mandate COVID-19 vaccines. Across the nation these mandates have become more common, but they continue to be surrounded by controversy, in part because the COVID-19 vaccines have yet to be fully approved by the FDA.
“It will remove the argument that the vaccines cannot be mandated because they are under emergency use authorization,” Reiss said.
Whether vaccines under emergency use can be mandated or not, Reiss said, remains an “unanswered legal question,” mainly because this is the first time there has been a vaccine under an EUA for the entire population. However, Reiss said, there are growing indications that it is indeed legal to do so.
According to the Equal Employment Opportunity Commission, workplaces have the legal authority to mandate a COVID vaccine, even under an EUA. “Generally speaking, employers have the authority to set workplace conditions and the duty to keep the workplace safe,” Reiss said. “Some are saying, 'Vaccinate or you're fired.' Some are saying, 'Vaccinate, or test and mask.' Those are legal.”
Most recently a federal district court in Texas upheld Houston Methodist Hospital’s COVID-19 vaccination mandate, ruling that the hospital’s requirement broke no federal law. Additionally, Justice Department lawyers have determined that federal law doesn’t prohibit public agencies and private businesses from requiring the vaccines. In a detailed opinion, published last month, the department’s office of legal counsel said COVID-19 vaccine mandates are legal, “even when the only vaccines available are those authorized under EUAs.”
The full approval of the COVID-19 vaccines, Reiss said, will also have a direct legal impact on places where mandates can become operational only when the vaccines are granted FDA approval.
That is the case for states like Ohio, where Gov. Mike DeWine signed a bill prohibiting public schools and colleges from requiring individuals to receive vaccines not granted full approval by the FDA. Similarly, Louisiana Gov. John Bel Edwards said he would not consider requiring a vaccine for state employees unless the “FDA grants full licensure to one or more of the COVID vaccines.”
Reiss said that unless those laws are challenged and validated by a court, they are going to limit the ability to mandate vaccines, as states carry “the broadest public health power in the United States.”
Another implication of FDA approval is the ability for doctors to prescribe a medication "off label,” a common practice in which physicians are allowed to prescribe approved drugs for unapproved uses. Under FDA guidelines, this practice is legal as long as a doctor judges that "it is medically appropriate for their patient." But it does not apply to medications and treatments under emergency use.
Some health experts have cautioned that the full approval of a COVID-19 vaccine could open the door for doctors to use the off-label provision to prescribe the shots to those who are not eligible to get them yet but who could potentially benefit from the vaccines. On Thursday, the FDA authorized COVID-19 vaccine booster shots for people with weakened immune systems. But before that decision was made, experts were concerned that some doctors would prescribe these patients a booster shot without the proper authorization or data to support that move.
This has led to concerns among medical professionals that physicians may consider giving a vaccine off label to children under 12, which is a group that is still being studied.
“I expect those doctors to be very nervous about this one and to hesitate to do any off-label [prescription],” Reiss said, “but it's really going to depend on how things go. If you see a lot of children in the ICUs, the claim that it makes sense to prescribe it off label may become stronger. ... But doctors will hesitate, and they will be nervous, because if something bad happens they might find themselves sued, and they might have trouble defending themselves.”
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