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.

BY­OD Best Prac­tices: How Mo­bile De­vice Strat­e­gy Leads to More Pa­tient-Cen­tric Clin­i­cal Tri­als

Some of the most time- and cost-consuming components of clinical research center on gathering, analyzing, and reporting data. To improve efficiency, many clinical trial sponsors have shifted to electronic clinical outcome assessments (eCOA), including electronic patient-reported outcome (ePRO) tools.

In most cases, patients enter data using apps installed on provisioned devices. At a time when 81% of Americans own a smartphone, why not use the device they rely on every day?

UP­DAT­ED: J&J paus­es vac­cine roll­out as feds probe rare cas­es of blood clots

The FDA and CDC have jointly decided to stop administering J&J’s Covid-19 vaccine after reviewing data involving six reported US cases of a rare and severe type of blood clot in individuals after receiving the vaccine.

CDC will convene a meeting of its Advisory Committee on Immunization Practices on Wednesday to further review these cases and assess their potential significance. “FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research and Anne Schuchat, Principal Deputy Director of the CDC, said in a joint statement Tuesday morning.

Near­ly a year af­ter Au­den­tes' gene ther­a­py deaths, the tri­al con­tin­ues. What hap­pened re­mains a mys­tery

Natalie Holles was five months into her tenure as Audentes CEO and working to smooth out a $3 billion merger when the world crashed in.

Holles and her team received word on the morning of May 5 that, hours before, a patient died in a trial for their lead gene therapy. They went into triage mode, alerting the FDA, calling trial investigators to begin to understand what happened, and, the next day, writing a letter to alert the patient community so they would be the first to know. “We wanted to be as forthright and transparent as possible,” Holles told me late last month.

The brief letter noted two other patients also suffered severe reactions after receiving a high dose of the therapy and were undergoing treatment. One died a month and a half later, at which point news of the deaths became public, jolting an emergent gene therapy field and raising questions about the safety of the high doses Audentes and others were now using. The third patient died in August.

“It was deeply saddening,” Holles said. “But I was — we were — resolute and determined to understand what happened and learn from it and get back on track.”

Eleven months have now passed since the first death and the therapy, a potential cure for a rare and fatal muscle-wasting disease called X-linked myotubular myopathy, is back on track, the FDA having cleared the company to resume dosing at a lower level. Audentes itself is no more; last month, Japanese pharma giant Astellas announced it had completed working out the kinks of the $3 billion merger and had restructured and rebranded the subsidiary as Astellas Gene Therapies. Holles, having successfully steered both efforts, departed.

Still, questions about precisely what led to the deaths of the 3 boys still linger. Trial investigators released key details about the case last August and December, pointing to a biological landmine that Audentes could not have seen coming — a moment of profound medical misfortune. In an emerging field that’s promised cures for devastating diseases but also seen its share of safety setbacks, the cases provided a cautionary tale.

Audentes “contributed in a positive way by giving a painful but important example for others to look at and learn from,” Terry Flotte, dean of the UMass School of Medicine and editor of the journal Human Gene Therapy, told me. “I can’t see anything they did wrong.”

Yet some researchers say they’re still waiting on Astellas to release more data. The company has yet to publish a full paper detailing what happened, nor have they indicated that they will. In the meantime, it remains unclear what triggered the events and how to prevent them in the future.

“Since Audentes was the first one and we don’t have additional information, we’re kind of in a holding pattern, flying around, waiting to figure out how to land our vehicles,” said Jude Samulski, professor of pharmacology at UNC’s Gene Therapy Center and CSO of the gene therapy biotech AskBio, now a subsidiary of Bayer.

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Patrizia Cavazzoni, new CDER director

Pa­trizia Cavaz­zoni named per­ma­nent di­rec­tor of CDER, adding to ques­tions around where Wood­cock will end up

Patrizia Cavazzoni on Monday became the permanent director of the FDA’s Center for Drug Evaluation and Research, which puts to rest the idea that Janet Woodcock, Cavazzoni’s predecessor, might return to lead CDER if she isn’t made permanent commissioner.

Woodcock, who’s currently serving as acting commissioner and principal medical advisor to the commissioner, a position she was detailed to last year, may not make the move to permanent commissioner because of lingering questions from Senate Democrats. She previously served as director of CDER since 1994. Cavazzoni took over as acting director of CDER when Woodcock moved over to Operation Warp Speed to run the therapeutics side of the Trump-era program.

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Pascal Soriot (AstraZeneca via YouTube)

Af­ter be­ing goad­ed to sell the com­pa­ny, Alex­ion's CEO set some am­bi­tious new goals for in­vestors. Then Pas­cal So­ri­ot came call­ing

Back in the spring of 2020, Alexion $ALXN CEO Ludwig Hantson was under considerable pressure to perform and had been for months. Elliott Advisers had been applying some high public heat on the biotech’s numbers. And in reaching out to some major stockholders, one thread of advice came through loud and clear: Sell the company or do something dramatic to change the narrative.

In the words of the rather dry SEC filing that offers a detailed backgrounder on the buyout deal, Alexion stated: ‘During the summer and fall of 2020, Alexion also continued to engage with its stockholders, and in these interactions, several stockholders encouraged the company to explore strategic alternatives.’

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Anand Shah (FDA)

For­mer head of FDA’s med­ical and sci­en­tif­ic af­fairs on Covid: ‘FDA has nev­er been test­ed like this’

Anand Shah has served the American public in a unique way, crisscrossing over the last two administrations between serving as an attending radiation oncologist focused on prostate cancer at NIH, serving as CMO at the Center for Medicare and Medicaid Innovation, and most recently, leading the FDA’s operations on medical and scientific affairs from within the commissioner’s office.

Shah, who stepped down from the FDA in January, caught up with Endpoints News in a phone interview on Tuesday afternoon, offering his thoughts on the agency’s latest decision to pause the J&J vaccinations in the US, and reflecting on his time at an agency during this once-in-a-lifetime pandemic.

Barbara Weber, Tango Therapeutics CEO (Tango)

It takes two to Tan­go: The biotech us­ing CRISPR to dis­cov­er new can­cer gene tar­gets rides a $353M SPAC deal to Nas­daq

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

The latest biotech-SPAC deal has arrived, and it’s dancing its way to Nasdaq to the tune of several hundred million dollars.

Tango Therapeutics and its CRISPR-focused search for new cancer genes is reverse merging with Boxer Capital’s blank-check company, the biotech announced Wednesday morning. With a spotlight on three lead programs, Tango expects total proceeds to equal about $353 million in the deal, which includes the roughly $167 million held in the SPAC and an additional $186 million in PIPE financing.

Kristin Fortney, BioAge Labs CEO

An­ti-ag­ing biotech up­start plucks a drug from Am­gen's dis­card pile, piv­ot­ing from heart fail­ure to mus­cle con­di­tions

Back in April 2019, Amgen quietly shut down a Phase I trial for a drug named AMG 986. There was no safety concern; the molecule just didn’t hit the mark on helping the small band of heart failure patients who received it.

A small biotech, though, believes it would stand a chance in the burgeoning anti-aging field.

BioAge Labs has licensed AMG 986 — now renamed BGE-105 — with plans to parlay the existing IND into a quick Phase I trial teasing out the pharmacodynamic effects and set the stage for mid-stage tests focused on acute muscle indications.

Fifth Cir­cuit sides with FTC in ma­jor pay-for-de­lay set­tle­ment case

The US Court of Appeals for the Fifth Circuit on Tuesday upheld the Federal Trade Commission’s ruling that generic drugmaker Impax Laboratories should be charged with antitrust violations for accepting payments worth about $100 million to delay the entry of a generic opioid for more than two years.

The court’s opinion upheld the FTC’s anticompetitive findings on the deal between Impax (now owned by Amneal Pharmaceuticals) and Endo Pharmaceuticals, under which Endo committed to not market an authorized generic, which increased Impax’s projected profits by $24.5 million. Endo agreed to pay Impax credits for the shrunken market that Impax would inherit if, as expected, Endo made a successful hop to a reformulated Opana ER.