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.

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Lex­i­con slams FDA over hear­ing de­nial fol­low­ing a CRL for its SGLT2 in­hibitor can­di­date

Lexicon Pharmaceutical is not giving up on its Type I diabetes candidate, despite FDA’s repeated rejections. This week the company laid out is argument again for a hearing on sotagliflozin in response to the FDA’s most recent denial.

The issue goes back to March 2019 when the FDA made very clear to Lexicon and its now departed partner Sanofi that it would not approve their application for a potential Type I diabetes drug because it does not appear to be safe.

Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Digital render of CPI's Medicines Manufacturing Innovation Centre in Glasgow, Scotland (Image:

CPI opens the doors to a new $100M+ man­u­fac­tur­ing fa­cil­i­ty in Scot­land

A manufacturing site that has received interest and investments from large pharma companies and the UK government is opening its doors in Scotland.

The manufacturer CPI (Centre for Process Innovation) has opened a new £88 million ($105 million) “Medicines Manufacturing Innovation Center” in Glasgow, Scotland, to accelerate the development of manufacturing tech and solve longstanding challenges in medicine development and manufacturing.

Pro­tect­ing its megablock­buster, Janssen chal­lenges Am­gen's Ste­lara biosim­i­lar ahead of planned 2023 launch

Johnson & Johnson unit Janssen on Wednesday sued Amgen over the company’s proposed biosimilar to its megablockbuster Stelara (ustekinumab), after Amgen said it was ready to launch next May or as soon as the FDA signs off on it.

If Amgen carries through with that plan, Janssen told the Delaware district court that the Thousand Oaks, CA-based company will infringe on at least two Janssen patents.

Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Mer­ck sues Johns Hop­kins for li­cens­ing Keytru­da patents in se­cret and in con­flict with re­search col­lab­o­ra­tion

Merck filed a lawsuit against Johns Hopkins University in Maryland federal court on Tuesday, arguing that the storied university obtained illegal patents as part of its research collaboration with the company and related to its blockbuster cancer drug Keytruda (pembrolizumab).

Merck alleges that the Baltimore-based university obtained and licensed Keytruda-related patents in secret while claiming that Keytruda was developed before and independent of a 2013 research collaboration between the two organizations. Hopkins also sought “hundreds of millions of dollars” tied to Keytruda sales because of the patents, Merck contends.

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