Covid-19 roundup: Pfiz­er im­pos­es vac­cine man­date for US work­ers; WHO calls for mora­to­ri­um on boost­ers, while some coun­tries make plans any­way — re­port

As the US strug­gles to keep pace with the fast-spread­ing Delta vari­ant, big com­pa­nies like Wal­mart and Dis­ney are im­pos­ing vac­cine man­dates for some work­ers. It may come as no sur­prise that Pfiz­er — the Big Phar­ma be­hind the US’ first au­tho­rized Covid-19 vac­cine — is join­ing them.

Pfiz­er will start re­quir­ing all US em­ploy­ees and con­trac­tors to get vac­ci­nat­ed, or par­tic­i­pate in week­ly Covid-19 test­ing, spokesper­son Pamela Eise­le told Reuters. Work­ers out­side the US are strong­ly urged to get a vac­cine if they can, ac­cord­ing to the re­port. And those with med­ical con­di­tions or re­li­gious ob­jec­tions can seek ac­com­mo­da­tions.

The news comes about a week af­ter the De­part­ment of Jus­tice ruled that such man­dates are le­gal, even for Covid-19 vac­cines that have not yet been ful­ly ap­proved, and re­main sub­ject to emer­gency use au­tho­riza­tions. Genen­tech is al­so re­quir­ing its em­ploy­ees to get vac­ci­nat­ed against Covid-19 be­fore re­turn­ing to the of­fice.

Some Amer­i­cans con­tin­ue to op­pose the man­dates, ar­gu­ing that they’re be­ing co­erced in­to tak­ing un­ap­proved vac­cines. Back in April, when Hous­ton Methodist in Texas be­came one of the coun­try’s first health sys­tems to im­pose a vac­cine man­date, Jen­nifer Bridges and 116 oth­er em­ploy­ees filed suit.

“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.”

The vac­cine de­vel­oped by Pfiz­er and BioN­Tech could be ful­ly ap­proved by La­bor Day, the New York Times re­port­ed yes­ter­day. That timetable is in line with what Pe­ter Marks, the FDA’s di­rec­tor of the Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search, has said in pre­vi­ous in­ter­views.

WHO calls for a mora­to­ri­um on boost­ers, while some coun­tries make plans any­way — re­port

The World Health Or­ga­ni­za­tion has called for a mora­to­ri­um on Covid-19 boost­er shots un­til at least the end of Sep­tem­ber, to al­low low­er-in­come and large­ly un­vac­ci­nat­ed coun­tries to get ac­cess to the life-sav­ing shots.

But some coun­tries are ig­nor­ing that re­quest and mak­ing plans to ad­min­is­ter boost­ers any­way, in­clud­ing Ger­many, which says it will give third shots to vul­ner­a­ble peo­ple in Sep­tem­ber, Reuters re­port­ed.

“The pos­si­bil­i­ty of a boost­er vac­cine in Sep­tem­ber is in­tend­ed to en­sure that those who are par­tic­u­lar­ly at risk are ad­e­quate­ly pro­tect­ed,” the coun­try’s health min­istry said, per Reuters.

Oth­er coun­tries are jump­ing in line, in­clud­ing France, which said last month that the first wave of peo­ple to re­ceive the vac­cine would be el­i­gi­ble for boost­ers in Sep­tem­ber, the Wash­ing­ton Post re­port­ed. Britain’s al­so con­sid­er­ing plans for boost­ers next month, while Hun­gary (which has al­so au­tho­rized shots from Rus­sia and Chi­na) is al­ready of­fer­ing third shots to any­one who wants them, the Post re­port­ed.

“I un­der­stand the con­cern of all gov­ern­ments to pro­tect their peo­ple from the Delta vari­ant,” WHO di­rec­tor-gen­er­al Tedros Ad­hanom Ghe­breye­sus an­nounced on Wednes­day. “But we can­not ac­cept coun­tries that have al­ready used most of the glob­al sup­ply of vac­cines us­ing even more of it while the world’s most vul­ner­a­ble peo­ple re­main un­pro­tect­ed.”

The WHO hopes a mora­to­ri­um would al­low all coun­tries to vac­ci­nate at least 10% of their pop­u­la­tions, be­fore oth­ers be­gin ad­min­is­ter­ing boost­ers.

“We need every­one’s co­op­er­a­tion, es­pe­cial­ly the hand­ful of coun­tries and com­pa­nies that con­trol the glob­al sup­ply of vac­cines,” he said.

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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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.

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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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.

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.

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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President Biden in the East Room of the White House (Evan Vucci/AP Images)

Opin­ion: How the con­fus­ing boost­er shot de­ba­cle aligns Biden with Trump's pan­dem­ic re­sponse

When President Joe Biden took office, many public health advocates heaved a sigh of relief, assuming the US was back to following the science during this once-in-a-lifetime pandemic, and gone were the days of an American president touting ineffective treatments to the world.

But this latest debacle around the Pfizer/BioNTech booster shot has now not only led to the retirements of two top FDA vaccine officials, both of whom would’ve been key resources as the US soon reviews Covid vaccines for children, but also to question marks around conflicting FDA and CDC opinions and lingering debates on who exactly should receive a boost first and who should be the one that makes that decision.