Man­u­fac­tur­ing woes for No­vavax’s Covid jab bad­ly dis­rupt plans for roll­out to the poor — re­port

Pro­duc­tion prob­lems at a No­vavax fa­cil­i­ty in Mary­land have led to de­lays in the Co­v­ax vac­cine shar­ing pro­gram. Now, a short­age of 1 bil­lion dos­es is ex­pect­ed, as the sup­pli­er tries to nav­i­gate pro­duc­ing a shot up to reg­u­la­tors’ stan­dards, Politi­co re­port­ed Tues­day.

The com­pa­ny has run in­to trou­ble with the pu­ri­ty of the vac­cine. No­vavax has had trou­ble prov­ing it can pro­duce a shot con­sis­tent­ly up to stan­dards, and it has caused sig­nif­i­cant de­lays in the roll­out to low- and mid­dle-in­come coun­tries. This fol­lows sev­er­al de­lays at No­vavax that has put the ex­ec­u­tive crew on the de­fen­sive.

Three peo­ple be­tween No­vavax and the Biden ad­min­is­tra­tion con­firmed the de­lays to Politi­co, though they spoke on the con­di­tion of anonymi­ty. Pu­ri­ty lev­els have hov­ered around 70%, the source said, and low­er pu­ri­ty lev­els raise the chance of hav­ing con­t­a­m­i­nants or un­nec­es­sary sub­stances in the vac­cine. That’s dis­rupt­ing plans to get vac­cine sup­plies more broad­ly dis­trib­uted, and af­ter the US gov­ern­ment had in­vest­ed $1.6 bil­lion in 2020 alone.

No­vavax’s stock price plunged 21% ahead of the bell.

“In re­sponse to a re­cent news ar­ti­cle cit­ing anony­mous sources, No­vavax con­firms our con­fi­dence in our abil­i­ty to de­liv­er our high-qual­i­ty vac­cine,” the com­pa­ny said in a state­ment re­leased Wednes­day. “Fur­ther, we un­der­score our on­go­ing com­mit­ment to the strin­gent stan­dards of pro­duc­tion and man­u­fac­tur­ing for our re­com­bi­nant nanopar­ti­cle pro­tein-based COVID-19 vac­cine can­di­date with Ma­trix-M ad­ju­vant.”

In the state­ment, the com­pa­ny high­light­ed its part­ner­ship with the Serum In­sti­tute of In­dia, a man­u­fac­tur­ing site in the Czech Re­pub­lic and sev­er­al oth­er man­u­fac­tur­ing agree­ments in South Ko­rea, Japan and “around the world.”

Co­v­ax al­ready low­ered its 2021 vac­cine pro­duc­tion goal from 2 bil­lion dos­es to 1.425 bil­lion, and es­ti­mat­ed that a short­fall of up to 1 bil­lion dos­es is com­ing. If that is ac­cu­rate, hun­dreds of mil­lions of peo­ple could be left with­out pro­tec­tion from the virus and its vari­ants, fur­ther ex­tend­ing the pan­dem­ic.

“We are con­fi­dent that our vac­cine will soon play a sig­nif­i­cant role in the glob­al COVID-19 vac­cine ar­se­nal, dif­fer­en­ti­at­ed by its po­ten­tial to help ad­dress two ma­jor is­sues slow­ing the world’s abil­i­ty to end the pan­dem­ic: glob­al dis­tri­b­u­tion chal­lenges and vac­cine hes­i­tan­cy,” CEO Stan­ley Er­ck said in the state­ment.

Sil­via Tay­lor

No­vavax’s SVP of in­vestor re­la­tions and cor­po­rate af­fairs Sil­via Tay­lor told Politi­co that the com­pa­ny’s an­a­lyt­i­cal test­ing meth­ods have been val­i­dat­ed, but did not say whether or not the FDA signed off on them. No­vavax said it will still file for emer­gency use au­tho­riza­tion by the end of the year. No­vavax has nev­er man­u­fac­tured a vac­cine be­fore. The No­vavax jab us­es spike pro­teins, which can be more dif­fi­cult to man­u­fac­ture to scale.

The news comes at a tough time. Pres­i­dent Joe Biden and his ad­min­is­tra­tion are at odds with Cam­bridge, MA-based drug­mak­er Mod­er­na af­ter the com­pa­ny has been slow to pro­vide the 176.5 mil­lion dos­es to the vac­cine shar­ing pro­gram that have been pur­chased. The New York Times re­port­ed that on­ly about 1 mil­lion dos­es have gone to low-in­come coun­tries, com­pared to 8.4 mil­lion Pfiz­er dos­es and 25 mil­lion J&J dos­es. But much of that short­fall has been blamed on the op­er­at­ing pow­er of Mod­er­na, which dou­bled its work­force to around 1,600 em­ploy­ees in 2020, and still has far few­er staff than ei­ther of the oth­ers.

Mean­while, a mix­up at an Emer­gent plant in Bal­ti­more led to mil­lions of J&J dos­es be­ing quar­an­tined while the FDA in­ves­ti­gat­ed, and many of those were trashed.

In Sep­tem­ber, af­ter many de­lays, No­vavax sub­mit­ted its vac­cine to the World Health Or­ga­ni­za­tion for re­view. The com­pa­ny’s gone through some ups and downs dur­ing the pan­dem­ic, in­clud­ing man­u­fac­tur­ing strug­gles that led to oth­er com­pa­nies beat­ing them to the fin­ish line in the hunt for a vac­cine.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

One work­er at a Lat­vian man­u­fac­tur­er is dead af­ter a fire breaks out at fa­cil­i­ty

A press release referred to it as simply, “the incident.” But a fire at an Olainfarm site in Latvia last week has left one person dead, and injured another, the company announced Monday.

Just before midnight Nov. 26, a fire broke out in the production building of JSC Olainfarm,  as the result of an “accident,” a company spokesperson said in an email to Endpoints News. The two victims were both company employees, and the causes of the accident are still being determined.

Fu­ji­film Diosynth dumps an­oth­er $454M in­to its sup­ply chain, this time at a fa­cil­i­ty in the UK

Fujifilm Diosynth Biotechnologies is in the middle of a monumental point in the company’s 10-year history, and the CDMO is about to grow even more, as it sets out to be the “beating heart” of the UK’s North East Life Sciences ecosystem.

A site in Billingham, Teeside, UK will receive a $453.72 million investment package from the manufacturer to double the existing footprint and create the largest multi-modal biopharmaceutical manufacturing site in the UK, bringing another 350 jobs to the region by late 2023.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

As first Omi­cron case in US crops up, re­searchers won­der: Which an­ti­bod­ies, vac­cines will hold up?

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

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