Albert Bourla, Pfizer CEO (Evan Vucci/AP Images)

Covid-19 roundup: Pfiz­er to sup­ply US with 200M more vac­cines as UK study finds high­er an­ti­bod­ies in 8-10 week in­ter­vals

The US gov­ern­ment has pur­chased 200 mil­lion more dos­es of the Pfiz­er/BioN­Tech vac­cine, the com­pa­nies an­nounced Fri­day morn­ing.

Pfiz­er and BioN­Tech ex­pect to de­liv­er 110 mil­lion of the ad­di­tion­al dos­es by Dec. 31, with the re­main­ing 90 mil­lion dos­es to be de­liv­ered no lat­er than April 30, 2022.

“Un­der this con­tract, the U.S. Gov­ern­ment is pay­ing ~$24 a dose for the Pfiz­er-BioN­Tech COVID-19 Vac­cine. The price for this or­der ac­counts for the ad­di­tion­al in­vest­ment nec­es­sary to pro­duce, pack­age and de­liv­er new for­mu­la­tions of the vac­cine, as well as the in­creased cost as­so­ci­at­ed with de­liv­er­ing the vac­cine in small­er pack sizes to fa­cil­i­tate de­liv­ery at in­di­vid­ual provider of­fices, in­clud­ing pe­di­a­tri­cians,” a Pfiz­er spokesman told End­points News.

The US gov­ern­ment has the op­tion to ac­quire an up­dat­ed ver­sion of the vac­cine to ad­dress po­ten­tial vari­ants, as well as new for­mu­la­tions of the vac­cine, if avail­able and au­tho­rized.

The Pfiz­er vac­cine is like­ly to con­vert its EUA in­to a full ap­proval some­time soon, po­ten­tial­ly in Au­gust or Sep­tem­ber, ac­cord­ing to FDA’s top vac­cine of­fi­cial Pe­ter Marks. Pres­i­dent Biden made a sim­i­lar time­line es­ti­mate dur­ing a CNN town hall on Wednes­day evening.

The US has now pur­chased 500 mil­lion dos­es of the Pfiz­er vac­cine for do­mes­tic use, and an­oth­er 500 mil­lion for do­nat­ing to the world’s poor­est coun­tries and oth­er al­lies.

El­i­gi­ble US res­i­dents will con­tin­ue to re­ceive the vac­cine for free, Pfiz­er said. — Zachary Bren­nan

Pfiz­er/BioN­Tech shots pro­duce high­er an­ti­bod­ies af­ter 8-10 week in­ter­vals — study

The UK is tout­ing the re­sults of a new study that it says vin­di­cates the coun­try’s de­ci­sion to space out Covid-19 vac­cine dos­es ear­li­er in the pan­dem­ic.

An in­ter­val of eight to 10 weeks be­tween Pfiz­er/BioN­Tech shots re­sults in high­er neu­tral­iz­ing an­ti­body lev­els than the three-week span test­ed in clin­i­cal tri­als, ac­cord­ing to a Bloomberg re­port. Though the find­ings have yet to be peer-re­viewed, re­searchers found dou­ble the an­ti­bod­ies af­ter 10 weeks com­pared to three weeks.

Fund­ed by the UK’s De­part­ment of Health and So­cial Care, the study looked at the im­mune re­spons­es of 503 British health­care work­ers. About three quar­ters of the par­tic­i­pants were women.

The find­ings come af­ter Britain orig­i­nal­ly ap­proved the Pfiz­er/BioN­Tech shot in ear­ly De­cem­ber 2020 ahead of the FDA and oth­er reg­u­la­to­ry au­thor­i­ties, and sub­se­quent­ly rolled out a plan to space out vac­cine dos­es in or­der to get as many peo­ple as it could their first shots.

Re­gard­ing the best in­ter­val be­tween dos­es, “eight weeks is prob­a­bly the sweet spot,” Uni­ver­si­ty of Ox­ford study lead Su­san­na Dunachie said at a news con­fer­ence, per Bloomberg. In ad­di­tion to boost­ing an­ti­body lev­els, the study al­so re­port­ed­ly found an im­proved re­sponse from helper T cells.

But the find­ings al­so re­lat­ed one sig­nif­i­cant draw­back as the UK and oth­er coun­tries face an­oth­er pan­dem­ic wave amidst the delta vari­ant’s surge: In­di­vid­u­als saw a de­cline in an­ti­body lev­els be­tween their first and sec­ond shots, par­tic­u­lar­ly against Delta. Re­gard­less, both the short and long in­ter­vals in be­tween dos­es lead to strong re­al-world pro­tec­tion against the virus, re­searchers said. — Max Gel­man

Japan’s prime min­is­ter press­es Bourla for more vac­cines

As the Sum­mer Olympics get un­der­way in Japan on Fri­day, the coun­try’s prime min­is­ter is press­ing Pfiz­er to speed up vac­cine de­liv­er­ies.

Japan leader Yoshi­hide Suga re­port­ed­ly met with CEO Al­bert Bourla ear­ly Fri­day in or­der to ask for an ac­cel­er­at­ed vac­cine sched­ule to the coun­try, per a Reuters re­port on Japan­ese me­dia. Suga is at­tempt­ing to se­cure shots that were orig­i­nal­ly sched­uled to ar­rive in Oc­to­ber, with lo­cal gov­ern­ments around the coun­try strug­gling with sup­ply.

Ac­cord­ing to the Reuters vac­cine track­er, on­ly 35% of Japan’s pop­u­la­tion has re­ceived their first vac­cine dose, a slow­er start com­pared to oth­er high-in­come na­tions.

The re­port comes with Japan kick­ing off the Olympics open­ing cer­e­mo­ny Fri­day amidst a swath of con­tro­ver­sies and lo­gis­ti­cal is­sues. Af­ter orig­i­nal­ly post­pon­ing the Games by a year due to the pan­dem­ic, Japan has seen a sig­nif­i­cant rise in cas­es re­cent­ly due to the Delta vari­ant. Though the coun­try had orig­i­nal­ly planned to al­low a lim­it­ed num­ber of spec­ta­tors, the Olympics are now tak­ing place in large­ly emp­ty sta­di­ums and are­nas.

More than 110 ath­letes and Olympics work­ers have al­so test­ed pos­i­tive in the days lead­ing up to the Games, ac­cord­ing to the New York Times, and Japan was forced to dis­miss its open­ing cer­e­mo­ny cre­ative di­rec­tor af­ter footage emerged of him mak­ing fun of the Holo­caust in a 1990s standup rou­tine.

A brouha­ha has al­so emerged over the card­board beds Japan has set up in the Olympic Vil­lage, in what it says is an ef­fort to lim­it in­ti­ma­cy be­tween ath­letes while the pan­dem­ic surges. — Max Gel­man

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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.

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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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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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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.

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.