Busi­ness­es and schools can man­date the use of Covid-19 vac­cines un­der EUAs, DOJ says

As pub­lic and pri­vate com­pa­nies stare down the re­al­i­ty of the Delta vari­ant, many are now re­quir­ing that their em­ploy­ees or stu­dents be vac­ci­nat­ed against Covid-19 pri­or to at­tend­ing school or to re­turn­ing or start­ing a new job. Claims that such man­dates are il­le­gal or can­not be used for vac­cines un­der emer­gency use au­tho­riza­tions have now been dis­missed.

Set­ting the record straight, the De­part­ment of Jus­tice on Mon­day called the man­dates le­gal in a new memo, even when used for peo­ple with vac­cines that re­main sub­ject to EUAs.

DOJ says that, con­sis­tent with the FDA’s in­ter­pre­ta­tion of sec­tion 564 of the Food, Drug, and Cos­met­ic Act, on­ly cer­tain in­for­ma­tion needs to be pro­vid­ed to po­ten­tial vac­cine re­cip­i­ents, such as the fact that FDA “has au­tho­rized the emer­gency use of the prod­uct,” “the sig­nif­i­cant known and po­ten­tial ben­e­fits and risks of such use,” and “the ex­tent to which such ben­e­fits and risks are un­known.” But it does not pro­hib­it im­pos­ing man­dates, DOJ says, adding:

Some have ques­tioned whether such en­ti­ties can law­ful­ly im­pose such re­quire­ments in light of the fact that sec­tion 564 in­structs that po­ten­tial vac­cine re­cip­i­ents are to be in­formed that they have the ‘op­tion to ac­cept or refuse’ re­ceipt of the vac­cine. In the past few months, sev­er­al law­suits have al­so been filed chal­leng­ing var­i­ous en­ti­ties’ vac­ci­na­tion re­quire­ments on the same the­o­ry. The on­ly ju­di­cial de­ci­sion to have ad­dressed this is­sue so far sum­mar­i­ly re­ject­ed the chal­lenge.

In one such ex­am­ple, an em­ploy­ee of the Durham Coun­ty Sher­iff’s Of­fice in North Car­oli­na sued his for­mer em­ploy­er in April af­ter he was fired for de­clin­ing to re­ceive a Covid-19 vac­cine. He ar­gued that he was “be­ing forced to take an ex­per­i­men­tal, un­ap­proved vac­cine against his will.” Late last month, the em­ploy­ee dropped his law­suit.

In Texas, Hous­ton Methodist was one of the na­tion’s first health sys­tems to im­pose a coro­n­avirus vac­cine man­date in April, lead­ing to Jen­nifer Bridges and 116 oth­er em­ploy­ees to file suit, ar­gu­ing they’re be­ing co­erced in­to tak­ing an un­ap­proved vac­cine.

“This is not co­er­cion,” Dis­trict court judge Lynn Hugh­es wrote in his opin­ion on June 12. “Methodist is try­ing to do their busi­ness of sav­ing lives with­out giv­ing them the Covid-19 virus. It is a choice made to keep staff, pa­tients, and their fam­i­lies safer. Bridges can freely choose to ac­cept or refuse a Covid-19 vac­cine; how­ev­er, if she re­fus­es, she will sim­ply need to work some­where else.”

A fed­er­al judge sim­i­lar­ly up­held the Uni­ver­si­ty of In­di­ana’s vac­cine man­date last week, and oth­er col­leges and uni­ver­si­ties’ vac­ci­na­tion man­dates are like­ly com­ing soon.

The US De­part­ment of Vet­er­ans Af­fairs on Mon­day be­came the first fed­er­al agency to man­date the use of the vac­cines.

“We’re man­dat­ing vac­cines for Ti­tle 38 em­ploy­ees be­cause it’s the best way to keep Vet­er­ans safe, es­pe­cial­ly as the Delta vari­ant spreads across the coun­try,” VA Sec­re­tary De­nis Mc­Do­nough said in a state­ment.

Ef­forts have trick­led down to states and cities now too. In Cal­i­for­nia start­ing in Au­gust, state em­ploy­ees and health care work­ers must show proof of vac­ci­na­tion or get test­ed reg­u­lar­ly. New York City in Sep­tem­ber will turn to a sim­i­lar pol­i­cy. Mean­while, more than 50 med­ical groups al­so called for manda­to­ry vac­ci­na­tions of all health care work­ers, the Wash­ing­ton Post re­port­ed.

And per the DOJ, the man­dates are en­tire­ly le­gal:

In­deed, if Con­gress had in­tend­ed to re­strict en­ti­ties from im­pos­ing EUA vac­ci­na­tion re­quire­ments, it chose a strange­ly oblique way to do so, em­bed­ding the re­stric­tion in a pro­vi­sion that on its face re­quires on­ly that in­di­vid­u­als be pro­vid­ed with cer­tain in­for­ma­tion (and group­ing that re­quire­ment with oth­er con­di­tions that are like­wise in­for­ma­tion­al in na­ture). Con­gress could have cre­at­ed such a re­stric­tion by sim­ply stat­ing that per­sons (or cer­tain cat­e­gories of per­sons) may not re­quire oth­ers to use an EUA prod­uct.

Why it Works: Man­u­fac­tur­ing a Vac­cine in a Mul­ti-Prod­uct Fa­cil­i­ty.

COVID-19 launched the pharmaceutical industry to the frontline in the battle against the fast-spreading global pandemic. The goal: distribute a safe, effective vaccine as quickly as possible. Major players in the vaccine market needed to partner with contract development and manufacturing organizations (CDMOs) to achieve the goal of mass vaccine quantities under expedited timelines. With CDMOs stepping up to play a critical role in the vaccine manufacturing process, multi-product CDMO facilities took the spotlight. Partnerships quickly formed as the race to save lives and fight a pandemic was on.

Alexander Lefterov/Endpoints News

The coro­n­avirus vac­cine that the world for­got could still help save it

Back at the beginning of the pandemic — back when we still called the virus “novel” and a single case in Washington state could make headlines — there emerged the story of the coronavirus vaccine that the world forgot.

It was an allegory for our pandemic ill-preparedness. At a time when the world had been caught so flat-footed, there were a pair of scientists who had seen the crisis coming, lab-coated Cassandras with an antidote if only the world had listened sooner.

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Habib Dable, Acceleron CEO

Days of heat­ed ru­mors cul­mi­nate in a re­port that Ac­celeron is in ad­vanced buy­out talks

Days of frothy rumors about possible M&A discussions at Acceleron were capped late Friday with a Bloomberg report asserting that the biotech company is in advanced talks for an $11 billion buyout deal.

Bloomberg was unable to identify any bidders in the deal, but speculation has been running rampant that the surging value of Acceleron stock had to be the result of leaks around the auction of the company. As of early Monday morning, we’re still awaiting the final word.

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Peter Marks (Jim Lo Scalzo/Pool via AP Images)

Tur­moil at CBER: Pe­ter Marks grabs con­trol of FDA's Of­fice of Vac­cines ahead of 2 key ca­reer leader de­par­tures

FDA’s top vaccine official Peter Marks is pulling the plug on a months-long transition for two top career vaccine officials who abruptly called it quits in late August.

Marion Gruber, director of the FDA’s Office of Vaccines Research & Review and 32-year veteran of the agency, her deputy director Phil Krause, announced their departures and then raised concerns with Covid-19 booster shots ahead of and during a recent Covid-19 booster vaccine advisory committee.

Albert Bourla, Pfizer CEO (John Thys, Pool via AP Images)

Covid-19 roundup: Pfiz­er/BioN­Tech sub­mit vac­cine da­ta to FDA for younger chil­dren; Doc­tors kept pre­scrib­ing hy­drox­y­chloro­quine

Pfizer and BioNTech said Tuesday they submitted to FDA positive data from a Phase II/III trial of their Covid-19 vaccine in children aged 5 to less than 12 years old.

A formal EUA submission for the vaccine in these children is expected to follow “in the coming weeks,” the companies said in a statement.

The trial of 2,268 healthy participants aged 5 to less than 12 years old showed the vaccine was safe and elicited robust neutralizing antibody responses using a two-dose regimen of 10 μg doses, which is one-third the dose that’s administered to adults.

Merck CEO Rob Davis

Mer­ck emerges as lead bid­der in po­ten­tial Ac­celeron buy­out with deal pos­si­ble this week — re­port

With rumors swirling about a potential buyout of biotech Acceleron and its lead PAH drug sotatercept, market watchers have been keeping close tabs on industry movers and shakers due up for an expensive bolt-on. According to a new report, it appears Merck may be the one.

Merck is in “advanced talks” on a deal to acquire Cambridge, MA-based Acceleron in what previous reports pegged as a potential $11 billion buyout, the Wall Street Journal reported Monday. A deal could come as early as this week, according to the Journal.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

Sanofi calls it quits on mR­NA Covid-19 shots, scrap­ping vac­cine from $3.2B Trans­late Bio buy­out

Sanofi is throwing in the towel on mRNA-based Covid-19 vaccines.

The French drugmaker will halt development on its unmodified mRNA Covid-19 shot despite what it said were positive Phase I/II results, a spokesperson told Endpoints News on Tuesday morning. Sanofi said the reason it’s stopping the Covid-19 mRNA program, developed in partnership with its new $3.2 billion acquisition Translate Bio, is because the market is too crowded.

Safe­ty fears force Pfiz­er to change piv­otal DMD gene ther­a­py tri­al pro­to­col

As one of the biggest players in an increasingly packed gene therapy space, Pfizer has taken an early lead over specialists like Sarepta in taking a Duchenne muscular dystrophy (DMD) candidate into late-stage testing. But new safety fears have led Pfizer to scale back that trial, cutting out patients with certain genetic mutations.

Pfizer has amended its enrollment protocol for a Phase III test for gene therapy fordadistrogene movaparvovec in DMD after investigators flagged severe side effects tied to specific mutations, according to a letter the drugmaker sent to Parent Project Muscular Dystrophy, a patient advocacy group.

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Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Ciaran McCrickard)

Seiz­ing Aduhelm prece­dent, Bio­gen, Ei­sai get the ball rolling on an­oth­er ac­cel­er­at­ed Alzheimer's ap­proval

Biogen — together with partners at Eisai — will be the first to breeze down that Alzheimer’s trail it blazed with the FDA’s historic and controversial accelerated approval of Aduhelm.

Eisai disclosed it’s initiated a rolling BLA submission for lecanemab, or BAN2401, the anti-amyloid beta antibody that Biogen has long touted as a follow-on to Aduhelm (then aducanumab). Following the precedent that the agency has now set, the two companies are gunning for an OK based on data suggesting that the drug could lower amyloid beta plaques.