Can employers mandate Covid-19 vaccines under emergency authorizations? It’s complicated

As the US ramps up vaccinations to more than 3 million people daily, some employers are beginning to do what schools across the country do every year: mandate vaccinations.

One of the major differences between any Covid-19 vaccine mandate and others for childhood vaccines is that the three authorized Covid-19 vaccines — from Pfizer, Moderna, and J&J — have not been granted full FDA approvals yet.

That difference has already been the source of two lawsuits — one from employees of the Los Angeles Unified School District and another from a New Mexico corrections officer (who was not able to halt the mandate) — which claim that a Covid-19 vaccine mandate is not legal because the vaccines are still technically experimental.

Peter Marks

The section of the law addressing EUAs directs the HHS Secretary to inform individuals “of the option to accept or refuse administration of the product” under an EUA, which some (like those filing suit) have asserted to mean that any wider mandates are prohibited until the vaccines win full approval.

But some legal experts think the courts will consider not only the ramifications of the current pandemic, but the way in which the FDA signed off on the vaccines, which, as the FDA’s vaccines lead Peter Marks made clear in comments prior to the first EUA, was more of an “EUA-plus” than a typical EUA.

Wen Shen, legislative attorney at the Congressional Research Service, explained in a recent report on Covid-19 vaccine mandates, “In particular, courts will likely consider whether requiring vaccines subject to an EUA — including the specific steps taken by FDA in issuing the EUA — under the specified conditions of the mandate is reasonably related to a legitimate government interest given the nature of the pandemic.”

Dorit Reiss

The EUA statute also makes clear that the HHS Secretary should provide this option to refuse vaccines under EUAs, but it does not provide any instructions to employers or universities.

UC Hastings College of Law professor Dorit Reiss and co-authors recently explained in a Stat News op-ed, “Those arguing that the EUA statute prohibits mandates by at-will employers are claiming that this federal law is changing existing state employment law on the topic by mere implication. They are reading in a broad prohibition covering all employers and universities in the U.S. that is not, in fact, in the statute.”

In the New Mexico case, a corrections officer sought to immediately prevent the county from mandating Covid-19 vaccinations on the grounds that there is a lot the FDA doesn’t know about these experimental vaccines, but the judge said in March that the mandate will not be halted, at least initially, without providing the county with an opportunity to respond.

Both Pfizer and Moderna now have enough safety data to file for full approvals for their Covid-19 vaccines. A Pfizer spokesperson said the company’s filing will come either later this month or next month, and Moderna previously said its filing will come sometime later this year.

When the FDA approves both vaccines (even if the J&J vaccine is still under an EUA), the legal case against employers’ Covid-19 vaccine mandates may disappear.

“An employee can push back if they can make a case the only vaccine they can get is on EUA, but it’s a much weaker case,” Reiss told Endpoints News. “If employers want to avoid that, especially large employers, an easy out is to contract for BLA [biologics license application] vaccines and offer them on-site,” which she said is what Rutgers University is doing after mandating Covid-19 vaccinations.

But Reiss also said she thinks preliminary injunction hearings for the two lawsuits in Los Angeles and New Mexico will occur before any Covid-19 vaccines win full approval.

“A big step in those lawsuits is whether there will be a preliminary injunction — that will tell us a lot about the chances, since the main debate is a question of law, not facts,” Reiss said.

In addition to employer vaccination mandates, Shen notes in the CRS report that states can also enact vaccine mandates. And although Congress may not directly require states or localities to pass mandatory vaccination laws or implement federal vaccination laws, Congress can incentivize (but not coerce) states to create such mandates.

Adaptive Design Methods Offer Rapid, Seamless Transition Between Study Phases in Rare Cancer Trials

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Matt Gline (L) and Pete Salzmann

UPDATED: Roivant bumps stake in Immunovant with a $200M deal. But with M&A off the table, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

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UPDATED: Watch out GlaxoSmithKline: AstraZeneca's once-failed lupus drug is now approved

Capping a roller coaster journey, AstraZeneca has steered its lupus drug anifrolumab across the finish line.

Saphnelo, as the antibody will be marketed, is the only treatment that’s been approved for systemic lupus erythematosus since GlaxoSmithKline’s Benlysta clinched an OK in 2011. The British drugmaker notes it’s also the first to target the type I interferon receptor.

Mirroring the population that the drug was tested on in late-stage trials, regulators sanctioned it for patients with moderate to severe cases who are already receiving standard therapy — setting up a launch planned for the end of August, according to Ruud Dobber, who’s in charge of AstraZeneca’s biopharmaceuticals business unit.

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Sanofi preps a multibillion-dollar buyout of an mRNA pioneer after falling behind in the race for a Covid-19 jab — report

It looks like Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines for Covid-19, Sanofi is reportedly ready to close the deal with a buyout.

Translate’s stock $TBIO soared 78% after the market closed Monday. A spokesperson for Sanofi declined to comment on the report, telling Endpoints News that the company doesn’t comment on market rumors.

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Rick Pazdur (via AACR)

FDA's oncology head Rick Pazdur defends the accelerated approval pathway, claiming it is 'under attack'

The FDA is sounding the alarm over its accelerated approval pathway as backlash continues over the recent nod in favor of Biogen’s Alzheimer’s drug Aduhelm, and an ODAC meeting on six such approvals that could potentially be pulled from the market — two of which already have.

“Do you think accelerated approval is under attack? I do,” Rick Pazdur, head of FDA’s Oncology Center of Excellence, said at a Friends of Cancer Research webinar on Thursday.

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Covid-19 roundup: Regeneron's mAB gets expanded EUA; mRNA drugmakers spike price of vaccines in EU supply deal

The FDA has expanded the authorization for Regeneron’s Covid-19 treatment Regen-Cov in an announcement Friday.

The authorization now covers post-exposure prophylaxis for those exposed to an infected person or who are at high risk of exposure “in an institutional setting” like a nursing home or a prison, and are not fully vaccinated or expected to provide a sufficient immune response.

Regeneron experts predict that 3% of the US population may not be able to fully respond to Covid-19 vaccinations.

Not all mRNA vaccines are created equal. Does it matter?; Neuro is back; Private M&A affair; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As part of our broader and deeper drive, Endpoints has been pairing webinars with our special reports to cover more angles on a given topic. In conjunction with Max Gelman’s neuroscience feature, Kyle Blankenship moderated an insightful panel to discuss where the field is headed. You can register to watch it on demand here.

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Bristol Myers pulls lymphoma indication for Istodax after confirmatory trial falls flat

Amid an industrywide review of cancer drugs with accelerated approval, Bristol Myers Squibb had to make the tough call last month to yank an approval for leading I/O drug Opdivo after flopping a confirmatory study. Now, a second Bristol Myers drug is on the chopping block.

Bristol Myers has pulled aging HDAC inhibitor Istodax’s indication in peripheral T cell lymphoma after a Phase III confirmatory study for the drug flopped on its progression-free survival endpoint, the drugmaker said Monday.

FTC pulls remaining case against AbbVie; New EU clinical trials system coming in 2022; Abingworth bets big on CymaBay

The Federal Trade Commission on Friday withdrew its remaining case against AbbVie after the Supreme Court declined to review a lower court’s ruling.

The punt by SCOTUS means that while the Illinois pharma company illegally blocked patients’ access to lower-cost alternatives to its testosterone drug AndroGel, the FTC will no longer be able to return about $500 million directly to AndroGel consumers.