Pharmaceutical giant Johnson & Johnson to U.S. workers: Get vaccinated by Oct. 4

Pharmaceutical giant Johnson & Johnson is requiring its workers to get vaccinated against COVID-19 by Oct. 4, making it the latest major employer to forge ahead with a mandate as the U.S. nears full approval of the shots while other firms wait for a final regulatory decision to avoid legal headaches or workplace tumult.

The New Jersey-based drugmaker, which produces a one-shot vaccine against the disease, employs over 130,000 people.

The company said it will offer exemptions for religious or medical reasons, but its policy is more stringent than one from Pfizer. The rival vaccine maker said this month that workers must get vaccinated or face weekly testing, but it set no deadline. Pfizer said vaccination is an expectation of the workforce.

“As a global healthcare leader, Johnson & Johnson remains committed to following the science and to taking appropriate measures to support the health and well-being of our employees and contractors, as well as to uphold our responsibilities to the communities in which we live and work,” the company said. “As COVID-19 continues to devastate families and cause untold hardship, the data shows getting vaccinated is critical to helping end the pandemic.

“Effective October 4, all employees and contractors of the company in the United States will be required to be fully vaccinated against COVID-19,” it said.

J&J did not respond to queries about whether employees would be terminated for noncompliance or face other sanctions, though outside experts read it as a condition of employment.

The company said it would not steer employees toward its own vaccine and against the two-shot versions from Pfizer and Moderna. It said it supports “any one of the three authorized, available vaccines that an employee chooses.”

J&J joins the ranks of companies such as Walmart, Google and Tyson Foods in issuing mandates. The vaccines are administered under an emergency use authorization that says their benefits during the global crisis outweigh any risks.

Full licensure of at least one of the three vaccines Americans are using is expected this fall.

Some health care workers and other affected employees have protested the mandates in street demonstrations. Others are fuming online about being forced to choose between needle pokes and their jobs.

Hospitals from Maine to California are bracing for some vaccine holdouts to quit as the mandates take hold.

Others see an invasion of privacy.

Rep. Marjorie Taylor Greene, Georgia Republican, chided a journalist for asking whether she had been vaccinated. She cited the Health Insurance Portability and Accountability Act (HIPAA), which governs how medical providers, health insurers and other “covered entities” protect the flow of sensitive health information.

Dallas Cowboys quarterback Dak Prescott also cited HIPAA when asked about his vaccinated status.

Experts say HIPAA, passed in 1996, was designed to give insurers and vendors insight into the medical services that a patient receives while preventing people from disclosing health information to outside parties.

“It creates obligations for the hospital for what it can and cannot do with patient data. The rules just don’t apply to journalists, to ESPN,” said Kirk Nahra, a partner at the WilmerHale law firm who specializes in privacy and data security.

Experts say private companies are free to ask employees about their vaccination status.

“An employer asking for a person’s proof of vaccination is simply not a violation of privacy or HIPAA. Employers aren’t covered entities under HIPAA. They are private companies; they are not providing health care to the person. The person has a choice. They don’t have to answer. But if they don’t, they have to accept the consequences,” said Lawrence Gostin, a global health law professor at Georgetown University.

Employers are “not asking about something sensitive like a disability or what their sexual orientation or race is,” Mr. Gostin said. “It’s clearly not a privacy violation either legally or ethically.”

If an employer tries to pry vaccine information from a health care provider without the worker’s consent, however, “that would be a violation,” said Arthur Caplan, director of the division of medical ethics at the New York University Grossman School of Medicine.

The approval status of the COVID-19 vaccines is the other big sticking point.

The Food and Drug Administration is expected to fully approve the Pfizer vaccine next month. Approval of the Moderna version likely will follow. J&J has not requested full approval as it tests its two-dose regimen in clinical trials.

The Justice Department issued an opinion this month that supports mandates under the vaccines’ emergency status, or “EUA.”

It says the health and human services secretary is required to inform recipients about the benefits and risks of a product and their right to refuse the product, but that doesn’t bar public or private entities from inflicting consequences of a decision.

The opinion is just that — an opinion — and not binding on courts. Yet judges upheld mandates by Indiana University and a Houston hospital in early and high-profile legal fights over the rules.

Still, some companies are wary of getting tied up in court or employee revolts if they move forward with mandates before full approval.

The University of Minnesota said Friday that “once the FDA grants approval of the COVID-19 vaccine, all incoming and current university students will be required to be vaccinated against COVID-19.”

“Employers are on solid ground mandating it under an emergency use authorization. The courts have upheld that. The Department of Justice has ruled it is lawful,” Mr. Gostin said. “But many are waiting for full licensure. I can understand that just in terms of avoiding political backlash and having to defend lawsuits. By the early fall, we’re going to see more and more companies requiring vaccinations as [all of the vaccines] are given full approval.”

Some employers seem to be trying to sync their rules with full approval while not waiting too long because of fears of the fast-moving delta variant.

United Airlines said employers must upload a proof-of-vaccination card five weeks after full approval of a vaccine or five weeks after Sept. 20 (Oct. 25), whichever comes first.

“Some businesses understand the FDA will have their back and will soon grant full approval. Others are following Justice Department advice that it’s lawful right now,” Mr. Gostin said.

Mr. Nahra said employers do have room for alternatives to termination. They can require unvaccinated employees to wear masks, get tested or work from home if possible.

“It’s not that there is a single right or wrong answer,” he said. “There are a variety of solutions, and you have a lot of legal flexibility to choose among those options.”

The private sector is following a mix of mandates issued by federal, state and city officials across the country, particularly in blue states.

President Biden instructed the military to add COVID-19 to its list of required vaccinations and said federal workers must get vaccinated or face regular testing.

Pfizer said its policy, announced Aug. 4, wasn’t linked to any pending decision by regulators.

“Pfizer is requiring all U.S. colleagues and contractors to become vaccinated as a condition of work or participate in regular weekly COVID-19 testing. This is to best protect the health and safety of our colleagues and the communities we serve,” Pfizer said. “Outside the U.S., the company is strongly encouraging all colleagues who are able to do so in their countries get vaccinated. Colleagues who have medical conditions or religious objections will be able to seek accommodations.”

Mr. Caplan said J&J is likely responding to the business climate but is “being a good role model” with its more stringent rule that doesn’t allow for testing.

“I think it’s partly they’re operating in some states like New York that are extending mandates pretty quickly, partly because they are dealing with customers who might be looking for a vaccination authentication. And I think it’s partly because they’re putting their money where their mouth is,” he said. “I think it’s good. I think it’s being a good role model.”