Opinion: Pfizer’s vaccine is now fully approved by the FDA. Bring the money orders.
About the authors: Dorit R. Reiss is Professor of Law, James Edgar Hervey ’50 Chair of Litigation, at UC Hastings College of Law. Arthur L. Caplan is a professor of bioethics and founding director of the division of medical ethics at New York University School of Medicine.
Once again, ICUs in America are filling up with very sick Covid-19 patients. They fill the states where vaccination is poor and mostly with the unvaccinated. Delta now also takes care of our children. States, cities and hospitals are faced with unsustainable rationing choices. But today, things have just changed for the better. We now have a preventative: a licensed vaccine with another probably on the way soon.
Until today, all three vaccines used in the United States were available under a Food and Drug Administration standard called emergency use authorization. The EUA process allowed the FDA to move quickly to give Americans access to vaccines. The two
and Moderna have applied for a “full” license from the FDA, and today Pfizer’s application has been granted, making its regulatory status identical to that of any other vaccine approved by the agency. Due to the similarities between the vaccines, it is extremely likely that Moderna’s full approval will follow soon. A license for one shows that a license for all is possible.
Incredibly, we haven’t used the vaccines enough. With FDA clearance, the most plausible argument against Covid-19 vaccines that they are “experimental” completely collapses. Now is the time to act to save lives and prevent physical, psychosocial and economic harm. We need strong mandates.
For almost two years, we have been unable to contain Covid-19. Most of us hoped the vaccines would end the turmoil, but it still depended on sufficiently high vaccination rates. Many states are far from this. The Delta variant made matters worse. Delta is much more contagious than the previous variants, and the vaccines are less effective against the infection. Covid-19 vaccines are still incredibly effective against death or hospitalization from the Delta variant. They still, at least, greatly reduce transmission and offer some protection against infection. But what would have been sufficient vaccination rates with the previous variants is no longer sufficient.
Worse, we are not where we were. Delta is sending many more children to hospital, either because they are not yet eligible for the vaccine, or because Covid-19 is more severe in them, or because this variant is more contagious, and therefore, with the same level of severity, more children end up seriously ill. A disease that kills one in 10,000 children will kill more when it infects two million than when it infects a million; it’s simple math. In any case, the pediatric ICUs are filling up. Despite all this, in several states, the political environment discourages vaccines, which has led to the passage of laws that limit the ability of government and businesses to impose preventative measures, such as vaccine requirements.
Several states have decided to impose vaccines, as have some employers. But others have hesitated, in part because there is legal uncertainty about whether it is legal to require vaccines as part of an EUA. We believe – and the only court that has looked at this point has agreed so far – that it is legal to require vaccines as part of an EUA. But this is no longer relevant. With FDA clearance, this question is not applicable.
The vast majority of pending lawsuits challenging vaccine warrants have focused on the EUA status of those vaccines. Well, they’re not all under EUA anymore. Complaints against the mandates of universities and employers for licensed vaccines are few. Most of them focus on whether the denial of a specific exemption was legitimate, rather than the legality of the entire mandate. In some places, unions may be able to challenge vaccine mandates not negotiated with them, but not at all. Ultimately, licensure removes the strongest argument from opponents of the mandate.
It’s time to move. Delta is raging. People are dying. Vaccines are not the only tool we need to use, but are a key part of our arsenal. We have to use them. We need vaccination mandates for all professions working with a vulnerable population: retirement homes, inmates, hospitals, schoolchildren, disabled and daycare centers. If any of these workers are unwilling to be vaccinated, they should not be allowed to interact with their vulnerable loads. Political barriers are not a good reason for allowing staff to infect their charges. We applaud the decision of the federal government and several states to require vaccines for their employees. We hope other states will follow suit. Public servants should not allow themselves to be disease vectors because of misinformation. Vaccines against Covid-19 are safe, effective and now approved. We must deploy them quickly to support further measures and stop Covid-19 once and for all.
We need to solve the access issues for those who still have trouble getting vaccinated – we need to get people vaccinated. We have to bring back the masks. But mainly we need to impose vaccines in general and support all employers and government agencies that wish to do so. Lives depend on it. The absence of Covid demands it.
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