FDA Approval of Pfizer Shot Opens Floodgates for Mandates
‘People who are unvaccinated are like a drunk driver out there’
Many hospitals and healthcare facilities are expected to mandate COVID-19 vaccination for healthcare workers now that the FDA has removed the emergency use authorization (EUA) label and fully licensed the Pfizer-BioNTech vaccine.
“I think full FDA licensure will open the floodgates for vaccine mandates in hospitals and nursing homes,” says Lawrence Gostin, JD, a law professor at Georgetown University in Washington, DC. “Although these facilities could legally mandate vaccines under an EUA, many have been waiting for full FDA approval. Now that it has come, it would be almost negligent not to require vaccines. Hospitals and long-term care facilities are very high-risk environments. Having a fully vaccinated workforce is vital to keeping patients or residents safe.”
Although some early adopters of mandates were successful in legal challenges, many healthcare facilities said they would move the day a vaccine received final approval. That day came Aug. 23 for the Pfizer mRNA vaccine, which will now be marketed as Comirnaty for the prevention of COVID-19 disease in individuals 16 years of age and older, the FDA reported.1
“The vaccine also continues to be available under EUA, including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals,” the FDA stated.
The FDA did not mention the booster shots that have been announced by the Biden administration to begin Sept. 20, but the landmark vaccine approval should give the booster effort more legitimacy and momentum.
Indeed, it is expected the full licensure will now encourage vaccine mandates and requirements beyond healthcare settings, says William Schaffner, MD, a professor of healthcare policy at Vanderbilt University, which previously mandated vaccination for all employees.
“I will think this will eliminate that [EUA] barrier to more institutions, healthcare facilities, colleges, [business] employers, entertainment venues — you name it,” he says. “Governmental agencies will be able to implement requirements for vaccination. I certainly think that healthcare workers, wherever they are located — including nursing homes — have a professional and ethical obligation to be vaccinated.”
Many hospitals waited for the EUA to be lifted so they could avoid legal challenges, but those who went ahead saw court rulings go in their favor. Now, it is a fait accompli that many healthcare workers will be mandated to take the COVID-19 vaccine or agree to frequent testing or other measures if their employers permit.
With the delta variant spreading all over the country and 90 million people unvaccinated but eligible, the real question is whether the FDA approval will convince some of the skeptics and anti-vaxxers to take the vaccine. Certainly a hardcore group will remain, but the full licensure and the call for booster shots might be persuasive to some of the vaccine-hesitant.
“The public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, MD.1
Under the Vanderbilt mandatory COVID-19 program, those who claim medical or religious exemptions must appear before a panel and make their case. Those who are approved under this system must agree to a frequent COVID-19 testing protocol to work.
“I am a strong advocate of mandates,” Schaffner says. “The analogy is that we are in a war with the coronavirus, particularly with this delta variant. So far, we have relied on a volunteer army. It is not sufficient. Now, we have to institute a draft.”
Monica Gandhi, MD, MPH, professor of medicine at the University of California, San Francisco, says her hospital waited a long time for the EUA to be lifted, intending to mandate the vaccine to healthcare workers. However, FDA approval was not immediately forthcoming as many expected, and the hospital proceeded with a mandate several weeks before the agency’s action.
“Yes, our hospital is now mandating the vaccine, but I am delighted the FDA at long last approved the Pfizer/BioNTech vaccine for other workplace settings,” Gandhi says. “This will go a long way in getting those who are hesitant to take the vaccine as well as allowing employers to issue vaccine mandates with limited exceptions. There is a Supreme Court ruling on the books in the U.S. since 1905 making compulsory vaccination legal and ethical.”
The 1905 case of Jacobson v. Massachusetts upheld the right of states to require smallpox vaccination for school attendance, setting a precedent that, with other case law, has seen hospital vaccine mandates upheld in court.2
Mandates for Nursing Home Staff
Citing the highly transmissible delta variant, President Biden ordered the Department of Health and Human Services (HHS) to mandate COVID-19 vaccinations for long-term care staff on Aug. 18. As a result, the Centers for Medicare & Medicaid Services (CMS) is moving to make nursing homes require all workers to be fully vaccinated against COVID-19 or risk losing federal reimbursement. The new requirements would apply to nearly 15,000 nursing home facilities, which employ approximately 1.6 million workers and serve approximately 1.3 million nursing home residents, the White House announced.3
“It is unclear if HHS needs to go through rule-making,” Gostin says. “I wholeheartedly support President Biden’s push for vaccine mandates. Nursing homes are extraordinarily high-risk settings with highly vulnerable residents. But it is on the edge of his authority. Congress can set conditions for receipt of federal funding, but not the president. Biden will likely rely on the flexibility in funding that Congress granted to HHS in the Medicaid and Medicare legislation. I believe he will act rapidly without a long rule-making process.”
Initially, long-term care companies said they would lose workers to other healthcare settings that do not mandate the vaccines, but with the FDA’s full licensure of Pfizer, that argument is becoming largely moot.
“I think they have to look reality right in the face,” Schaffner says. “Many healthcare workers and attendants at nursing homes come from minority and ethnic communities. They have a built-in reluctance — for a variety of reasons — to be vaccinated. I think the nursing home directors were very concerned that if they moved before full licensure, they would lose employees. I can understand that. Now that [the vaccine] is licensed, everybody who works in a nursing home is going to have to be vaccinated, or they can’t move from one [facility] to another. Also, I certainly expect every healthcare worker in the community would be vaccinated, and that includes doctor’s offices.”
CMS recently announced that, in conjunction with the CDC, it is developing an “emergency regulation” requiring staff vaccinations in nursing homes.
“Today’s action is in keeping with CMS’s authority to establish requirements to ensure the health and safety of individuals receiving care from all providers and suppliers participating in the Medicare and Medicaid programs,” CMS stated.3
As of Aug. 8, 62% of nursing home staff are vaccinated nationally, and vaccination among staff at the state level ranges from a high of 88% to a low of 44%. The emergence of the delta variant has driven a rise in cases among nursing home residents from a low of 319 cases on June 27, to 2,696 cases on Aug. 8. Many of the recent outbreaks occurred in facilities with the lowest staff vaccination rates.3
That is almost a ninefold increase in resident infections in 10 days, a staggering jump that will make it hard to argue against mandating the vaccine. Indeed, the combination of the delta variant and the FDA ruling means healthcare workers who refuse vaccines are “reckless,” Gostin says.
“We were already seeing the federal government mandating vaccine for federal workers and contractors,” he says. “California has done it and New York City has done it. More and more businesses are doing it every day, from Facebook and Google to Microsoft.”
The lack of a national identification system to verify vaccination status is a sore point with Gostin, who thinks the Biden administration should have moved on this issue long ago.
“You can’t set a guideline that sharply distinguishes between the vaccinated and unvaccinated and then give cities and states no guidance on how to make that differentiation,” he argues.
The HHS paper vaccine cards “are being procured, forged, and stolen,” Gostin adds. “It is not a credential within a system in any sense of the word. It should be reliable and confidential. A lot of countries have done this — Israel, France. Resisting it [in the United States] has no scientific or public health reason — it is purely political.”
Nurses, Vaccine, and Fertility
Although only 58% of nurses in a recent American Nurses Association (ANA) survey supported mandating the vaccine, the association signed off on a statement supporting the requirement.4,5 According to the survey’s findings, 90% of nurses said they are immunized against COVID-19 or plan to be. They also reported they are comfortable recommending COVID-19 vaccines.
“We signed on to a clinician statement with about 57 other organizations,” says ANA President Ernest Grant, PhD, RN, FAAN. “The reason being the safety of the public is at stake. Nurses are expected — from an ethical and professional standpoint — to model the safe behavior that we are expecting the public to do. People who are unvaccinated are like a drunk driver out there. You may think that you have the right to drive drunk, but when you injure someone else, you put that person or their family at risk. We are trying to minimize the risk of the delta variant.”
According to the survey results, about 10% of nurses are holding out. They are not immunized and have no plans to take the vaccine.
“We are finding that those nurses are on the fence, based on things that they have heard or read on social media,” Grant says. “We are answering their questions and concerns. A lot of the young, female nurses are clinging to the rumors that the vaccines affect their fertility. There is nothing — no research — that says that. But, unfortunately, they read something on social media without looking to see if it was in a peer-reviewed journal.”
According to the CDC, “No evidence shows that any vaccines, including COVID-19 vaccines, cause fertility problems in women or men. … Many people have become pregnant after receiving a COVID-19 vaccine, including some who got vaccinated during COVID-19 vaccine clinical trials. In addition, a recent report using the v-safe safety monitoring system data showed that 4,800 people had a positive pregnancy test after receiving a first dose of an mRNA COVID-19 vaccine.”6
On the other hand, COVID-19 infection is a serious threat to an unvaccinated pregnant woman, and the CDC recommends vaccination of this population. “If you get pregnant after receiving your first shot of a COVID-19 vaccine that requires two doses, you should get your second shot to get as much protection as possible,” the CDC stated.
In terms of male fertility, persistent misinformation on social media claims unvaccinated sperm is somehow pure and will be extremely valuable. The claim is the COVID-19 vaccine will ruin the sperm of immunized males. The truth is quite the opposite, with no reported detrimental effects on sperm count or quality in tested, vaccinated men in a recent study.7 On the other hand, an unvaccinated man who acquires COVID-19 is at risk of detrimental effects to his reproductive system, with researchers concluding “the male reproductive tract, specifically the testes, may be targets of COVID-19 infection.”8
- U.S. Food and Drug Administration. FDA approves first COVID-19 vaccine. Aug. 23, 2021.
- Jacobson v. Massachusetts, 197 U.S. 11 (1905).
- Centers for Medicare & Medicaid Services. Biden-Harris administration takes additional action to protect America’s nursing home residents from COVID-19. Aug 18, 2021.
- American Nurses Association. New survey data: Nurses recommend COVID-19 vaccines and support mandates and boosters if recommended. Aug 18, 2021.
- American Nurses Association. ANA supports mandated COVID-19 vaccinations for nurses and all health care professionals. July 26, 2021.
- Centers for Disease Control and Prevention. COVID-19 vaccines for people who would like to have a baby. Updated Aug. 11, 2021.
- Gonzalez DC, Nassau DE, Khodamoradi K, et al. Sperm parameters before and after COVID-19 mRNA vaccination. JAMA 2021;326:273-274.
- He Y, Wang J, Ren J, et al. Effect of COVID-19 on male reproductive system — a systematic review. Front Endocrinol (Lausanne) 2021;12:677701.
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