UPDATED: Pfizer, Eli Lilly and J&J roll out COVID-19 vaccination rules as delta makes case for mandates

COVID-19 vaccine
Some biotechs have been able to forego vaccine mandates because their entire workforce voluntarily got the shot. (solarseven/ iStock/ Getty Images Plus)

Editor's note: Fierce Biotech is also tracking employer vaccine requirements at companies like Ovid Therapeutics and Alector. 

Right as several countries seemed to be getting a handle on the COVID-19 pandemic, the delta variant crashed onto the scene, sending case counts soaring again and throwing re-opening plans into limbo. With cases expected to continue ticking up before Labor Day, the argument for vaccine mandates is growing.

For many drugmakers, several of whom led the charge on the therapeutics and vaccines taking aim at the pandemic, vaccination requirements are becoming the norm. That now includes two of the leading vaccine developers, Pfizer and Johnson & Johnson, as well as antibody maker Eli Lilly. 

Over the past few days, Fierce Pharma asked a range of biopharmas big and small about their evolving vaccination policies. While some companies have already gone public with their plans, others are deliberating how to approach the issue. Here's how several companies are handling it.

Mandate mavericks

Novartis has set the expectation among its U.S. workers that “everyone” coming to its campuses either needs to be vaccinated or have a negative COVID-19 test result within the last 14 days before each U.S. site visit, a company spokesperson said over email. Concerned about delta and other potential virus variants lurking around the corner, Novartis is “strongly” encouraging all of its U.S. staffers to get vaccinated as soon as possible. The company will keep tabs on the situation and update its policy as the pandemic continues to evolve, the spokesperson added.

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Gilead Sciences will also require all U.S. employees and contractors to be fully vaccinated. Its policy will take effect on October 1, the company said Monday, adding that the mandate will only be in place where legal and where vaccines are “readily available.” The company forged its policy after tracking the rise of COVID-19 cases in the U.S. and abroad, as well as analyzing the data available on the vaccines’ power to curb infections, hospitalizations and deaths.

Gilead says it polled its employees “extensively” on the issue and plans to accommodate staffers who can’t get a vaccine on medical or religious grounds. In places where vaccine mandates aren’t legal, the antiviral specialist says it will “strongly recommend” employees get the shot.

As for Pfizer, the company is also requiring all U.S. staffers and contractors get vaccinated or undergo regular weekly testing, a company spokesperson told Fierce Pharma. The company is “strongly encouraging” vaccinations for all ex-U.S. employees who can get one, she added.

Like Gilead, Pfizer says it will work with employees toward an alternative solution if they have medical or religious objections to the shot. That’s also in line with COVID-19 antibody developer Eli Lilly, which will require all of its employees in the U.S. and Puerto Rico to get vaccinated by Nov. 15. 

Johnson & Johnson has similarly matched those moves, requiring all of its U.S.-based employees and contractors to be fully vaccinated by Oct. 4. The single-shot vaccine developer says accommodations could be made for people with medical conditions or other reasons to not be vaccinated. 

Roche's Genentech has also jumped on the mandate bandwagon, San Francisco Business Times reports. The company has said about 80% of its staffers nationwide have self-reported as fully vaccinated. 

"However, with the rise of the delta variant, we believe we must do even more to guard against the spread of the virus at our sites and the serious risk this would pose to our people and operations," Genentech told the publication.

Globally, Roche said in an email that its policy is "highly dependent on the respective local situation and regulations." 

The company "is, and always has been, an advocate for vaccination," a spokesperson said. Roche believes measures like social distancing, facemasks and hygiene precautions, coupled with "robust testing," therapeutics and broad uptake of vaccines, are the best route to "contain and mitigate" the virus.

The perks of being a biotech

On the biotech front, many smaller companies are adopting a gentler tack. All of CAMP4 Therapeutics’ workers have been vaccinated, which CEO Josh Mandel-Brehm flagged in an email as one of the “benefits” of being a small company. The programmable therapeutics outfit isn’t requiring vaccines, but it does have a mask mandate for those who haven’t received the shot, Mandel-Brehm said.

It’s a similar story over at IM Therapeutics. The company hasn’t implemented a vaccine mandate and has “not needed to,” because all its current employees voluntarily received the shot, a spokesperson said over email.

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Double Rainbow Biosciences and Cellino reported similar moves, telling Fierce Biotech they hadn’t introduced an official vaccine policy. In Double Rainbow’s case, “100%” of the company’s employees are fully vaccinated, Grant Smith, director of corporate communications, said.

The company has also reintroduced a mask requirement for its in-office staff after the CDC released its updated delta guidance in late July.

Meanwhile, all Cellino staffers coming into the office have been vaccinated, CEO Nabiha Saklayen said in an email.

Working out a regimen

Other companies have bypassed shot mandates altogether or adopted more of a “wait and see” approach.

Alnylam told Fierce Pharma it hasn’t introduced a vaccine mandate yet, but it’s “moving in that direction.” The company believes “the science supports this and it’s the right thing to do for society,” a spokesperson said in an email.

Immuno-oncology specialist Agenus said in an email that it doesn’t have a vaccine mandate for its employees. Biogen, meanwhile, declined to comment on its policy.

GlaxoSmithKline lands somewhere in the middle. GSK currently requires that employees show proof of vaccination to enter "a number of [its] U.S. sites," a spokesperson said over email. It's entertaining some exemptions, the spokesperson added. GSK isn't demanding workers get the vaccine but "strongly" encourages it for employees and "complementary workers for whom it is appropriate."

Bayer isn't requiring the vaccine for its U.S. employees either, though it will continue to track the situation and adjust its policies accordingly, the company said over email. 

Boehringer Ingelheim isn’t mandating vaccines in Germany or the U.S., though it’s urging its workers get the shot on both sides of the Atlantic, the company said in an emailed statement. In Germany, where roughly 30% of the company’s workforce is based, Boehringer Ingelheim has administered some 9,000 vaccinations to its employees and their families on its sites.

Vaccines are voluntary for the company’s U.S. staffers, too, though Boehringer Ingelheim stated unequivocally that it believes the shots are “the most effective tool in the fight against the COVID-19 pandemic.”

Meanwhile, Takeda also ranks among the companies "strongly encouraging" its employees to get vaccinated when they can in the countries where they live and work. If an unvaccinated employee or contractor is working onsite, they'll need to undergo regular testing and produce a negative result before doing any work for the company, a company spokesperson said over email.

Takeda's also asking workers to re-don their face masks in parts of the U.S. and other regions where transmission rates are high, and says it has "shifted" the rollout of its new hybrid work model to respond to rising case counts and the spread of Delta. 

"This will help to alleviate some uncertainty on the part of employees, enable us to continue monitoring the epidemiologic data and allow time to consider if additional measures will be necessary to maintain a safe working environment," Takeda told Fierce Pharma.

Variants on the rise

With delta "dominating" and Lambda "lurking," RBC Capital Markets analysts wrote to clients Tuesday that they expect daily COVID-19 cases to rise steadily until the start of a "[meaningful]" decline right before Labor Day. They forecasted a peak of 250,000 to 300,000 daily cases in the U.S. some 25 to 27 days from now. 

The analyst team foresees another 115,000 COVID-related deaths in the U.S. between now and the end of the year, citing "higher than expected" case counts and stressed hospital bandwidth. 

Editor's note: This story has been updated with responses from Bayer, Boehringer Ingelheim, GlaxoSmithKline, Takeda, Pfizer, Roche, Johnson & Johnson and Eli Lilly. Fierce has sent inquiries about COVID-19 vaccination mandates to a number of pharma and biotech companies and will update this story as it develops.