Covid-19 man­u­fac­tur­ing roundup: Rus­sia will pro­duce Sput­nik V in Pe­ru — re­port; CEPI calls for es­tab­lished vac­cine use in tri­als

Pe­ru will in­stall a man­u­fac­tur­ing plant in-coun­try to pro­duce the Sput­nik V Covid-19 vac­cine out of Rus­sia, its Pres­i­dent Pe­dro Castil­lo an­nounced Mon­day.

Just about 25% of the pop­u­la­tion is ful­ly vac­ci­nat­ed, while 33% has re­ceived at least one jab. Since Au­gust, the dai­ly in­fec­tion rate has hov­ered around the 1,000 mark.

Rus­sia and Pe­ru inked a deal for 20 mil­lion dos­es of Sput­nik V in Ju­ly.

Brazil just backed out of an agree­ment for the vac­cine, cit­ing a lapsed reg­is­tra­tion dead­line, de­spite bat­tling one of the tough­est out­breaks in the world. Sput­nik V is still await­ing emer­gency use au­tho­riza­tion from the World Health Or­ga­ni­za­tion. In June, the agency took is­sue with its vial-fill­ing pro­ce­dures at a plant. A re­port iden­ti­fied prob­lems sur­round­ing the risk of cross-con­t­a­m­i­na­tion and said that track­ing and iden­ti­fy­ing batch­es of the vac­cine was a con­cern.

An ap­pli­ca­tion for emer­gency use was sub­mit­ted to the WHO in Oc­to­ber 2020.

CEPI calls for es­tab­lished vac­cine use in tri­als

The Coali­tion for Epi­dem­ic Pre­pared­ness In­no­va­tions says that vac­cine mak­ers should make ap­proved shots avail­able for tri­als to pro­vide a new high bar for new jabs en­ter­ing de­vel­op­ment, Reuters re­port­ed Tues­day.

While tri­als typ­i­cal­ly study the vac­cine in com­par­i­son to a place­bo, that is prov­ing less and less eth­i­cal as time goes on, and in­fec­tion num­bers con­tin­ue to spike thanks to vari­ants.

To pro­vide the most wide­spread cov­er­age, new vac­cines could be test­ed against al­ready es­tab­lished vac­cines, the coali­tion said.

“We’ve made huge progress in the de­vel­op­ment of safe and ef­fec­tive COVID-19 vac­cines that are now sav­ing lives,” Melanie Sav­ille said in a state­ment, which was pub­lished in Na­ture. “But the pan­dem­ic is far from over: de­vel­op­ing the ‘next gen­er­a­tion’ of vac­cines now will re­duce in­equity by in­creas­ing glob­al sup­ply, and meet the chal­lenge of vari­ants.”

The lack of sup­ply of vac­cines, cou­pled with con­trac­tu­al agree­ments with gov­ern­ments threat­ens to bring vac­cine R&D “to a stand­still,” the state­ment says. It’s the re­spon­si­bil­i­ty of gov­ern­ments, de­vel­op­ers and man­u­fac­tur­ers to free up dos­es and al­low them for use in tri­als.

Roche en­lists In­di­an com­pa­ny to make gener­ic 

Drug de­vel­op­er Het­ero has re­ceived emer­gency use ap­proval in In­dia to make a gener­ic ver­sion of Roche’s Covid-19 drug, Reuters re­port­ed.

Het­ero has been li­censed Roche’s arthri­tis drug tocilizum­ab, which has been used to re­duce the risk of death in hos­pi­tal­ized pa­tients and cut down the need for ven­ti­la­tors. There’s been a short­age of tocilizum­ab, as the Delta vari­ant has run ram­pant through much of the world.

The drug will be made at Het­ero’s Hy­der­abad fa­cil­i­ty. The com­pa­ny al­so makes treat­ments Covid-19 treat­ments like remde­sivir, mol­nupi­ravir and favipi­ravir.

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.

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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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.

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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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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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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.

From left to right: Mark Springel, Kristina Wang, Lin Ao, Soufiane Aboulhouda

George Church, his stu­dents, and top VCs go na­tion­wide with a biotech train­ing camp

One night last fall, Floris Engelhardt sat down in her Boston apartment and logged onto a Zoom call, armed with a comic and a vague idea about starting a biotech.

Engelhardt was joining a student-run “match night.” A postdoc at MIT’s Bathe BioNanoLab, where researchers use DNA and RNA like Lego blocks for nanometer-sized structures, Engelhardt wanted to find real-world applications for her work. She sketched out — literally — a plan to use DNA origami, a decade-old technique for precisely folding DNA, to make therapies.

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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.