John Nkengasong, Africa CDC director (Andre Pain/AFP via Getty Images)

Covid-19 roundup: Africa CDC to seek vac­cine do­na­tion pause — re­port; New study sug­gests blood clots from As­traZeneca shot are very rare

The Africa CDC is re­port­ed­ly seek­ing a pause in vac­cine do­na­tions as lo­gis­ti­cal chal­lenges and hes­i­tan­cy be­gin to out­strip sup­ply is­sues.

John Nken­ga­song, the agency’s di­rec­tor, told Politi­co on Tues­day that coun­tries are bet­ter able to pro­vide shots for their cit­i­zens. But con­cerns over get­ting shots in­to arms have mount­ed in re­cent weeks, and the con­ti­nent’s CDC will ask for a do­na­tions pause un­til the third or fourth quar­ter this year.

Nken­ga­song rea­soned the vac­cines would ex­pire if oth­er coun­tries and CO­V­AX con­tin­ued the pace of its cur­rent ship­ments.

“It’s like buy­ing a whole bas­ket of foods and just to put it on your kitchen counter,” he told Politi­co. “If you can­not use any, it will rot. But if you do that in small­er pieces, then you still get to the end goal with the same amount of food on your kitchen ta­ble — but at least you don’t have any waste.”

Most of the con­ti­nent’s vac­cine hes­i­tan­cy comes from young in­di­vid­u­als who don’t see the virus as much of a threat, he added. In ad­di­tion, he list­ed the fol­low­ing lo­gis­ti­cal chal­lenges: African coun­tries still need to build up their cold-stor­age ca­pac­i­ties, make more sup­plies like sy­ringes and nee­dles avail­able, and fig­ure out where to store un­used shots.

Thus far, CO­V­AX says it has shipped more than 500 mil­lion Covid-19 vac­cine dos­es to low-in­come coun­tries, many of which are in Africa. The Africa CDC’s strat­e­gy al­so comes as Pres­i­dent Joe Biden aims to boost US vac­cine do­na­tions to oth­er coun­tries as the Omi­cron wave sub­sides state­side.

New study shows blood clot risk is ex­treme­ly low af­ter As­traZeneca shot 

A new study from the UK is delv­ing deep­er in­to side ef­fects from the As­traZeneca vac­cine, sug­gest­ing events of rare blood clots may be more un­com­mon than pre­vi­ous­ly thought.

Re­searchers found the clots on­ly ap­peared in one case per three mil­lion vac­ci­na­tions, and on­ly af­ter in­di­vid­u­als re­ceived their first dose, ac­cord­ing to a pa­per pub­lished in PLOS Med­i­cine. The study an­a­lyzed health records of 46 mil­lion Eng­lish adults be­tween De­cem­ber 2020 and March 2021 to draw its con­clu­sions.

The pa­per’s au­thors looked specif­i­cal­ly at in­tracra­nial ve­nous throm­bo­sis (ICVT) and throm­bo­cy­tope­nia, or clots that are some­times ac­com­pa­nied by low platelet counts. Some coun­tries sus­pend­ed roll­outs of the As­traZeneca vac­cine when these is­sues first arose in ear­ly 2021.

Tues­day’s study showed no risk of blood clots for those old­er than 70, with younger pop­u­la­tions see­ing high­er risk. For all pop­u­la­tions, the au­thors said the risk of blood clots “are like­ly to be out­weighed” by the shot’s ben­e­fits in pro­tect­ing against Covid-19 hos­pi­tal­iza­tion and death.

It’s the same side ef­fect that in­duced a dis­tri­b­u­tion pause in the US for the J&J vac­cine last April. Though ad­min­is­tra­tion re­sumed a few weeks lat­er fol­low­ing a re­view clear­ing the shot, the pause damp­ened vac­cine up­take at the time, par­tic­u­lar­ly for the J&J shot. As­traZeneca and J&J used the same tech­nol­o­gy in de­vel­op­ing their vac­cines — ade­n­ovi­ral vec­tors.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Sergio Traversa, Relmada Therapeutics CEO

Rel­ma­da makes 'crit­i­cal changes' to PhI­II tri­al to try and save de­pres­sion drug

Relmada Therapeutics is making changes to its Phase III study of its lead drug for major depressive disorder, in an attempt to avoid problems with a prior trial that showed little difference between the drug and a placebo.

That failure in October wiped 80% from Relmada’s stock price, and was followed by another negative readout a few months later. In both cases, the company said that there had been trial sites that were associated with what it called surprising placebo effects that skewed the results compared with the drug, REL-1017.

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Paul Song, NKGen Biotech CEO

NK cell ther­a­py-fo­cused biotech eyes SPAC deal

A small, Santa Ana-based biotech created in 2017 is looking to enter a SPAC deal as it lays out plans to begin trials in its lead cell therapy candidates and bring on new executives.

Graf Acquisition Corp. IV and NKGen Biotech announced Thursday, with few other details, that the two companies signed a non-binding letter of intent to “pursue a business combination.” Graf Acquisition II and III withdrew their IPOs last year.

In­cyte hit by CRL on ex­tend­ed-re­lease JAK tablets, mud­dy­ing plans for Jakafi fran­chise ex­pan­sion

The FDA has rejected Incyte’s extended-release formulation of ruxolitinib tablets, in a surprise setback for the company’s plans to build on its blockbuster Jakafi franchise.

The ruxolitinib XR tablets are designed to be taken once a day, whereas Jakafi is indicated for twice daily dosage (although some patients can take it once daily).

According to Incyte, the FDA acknowledged in its complete response letter that the study submitted in the NDA “met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval.”

Peter Hecht, Cyclerion Therapeutics CEO

Hard pressed for cash, Cy­cle­ri­on looks for help fund­ing rare dis­ease drug

Cyclerion Therapeutics may have the design of a Phase IIb study ready to go, but it’s scrambling for a way to fund it.

The company said in a press release that it’s “actively evaluating the best combination of capital, capabilities, and transactions available to it to advance the development of zagociguat,” its lead candidate for a rare, genetic mitochondrial disease known as MELAS.

In a separate SEC filing, Cyclerion once again flagged “substantial doubt about (its) ability to continue as a going concern.” As of the end of 2022, it had cash and cash equivalents of only $13.4 million.

Three­'s a crowd as an­oth­er Kite ex­ec hits the ex­it; Surf­ing tough wa­ters, Celyad On­col­o­gy picks up new CEO

Kite Pharma is losing another exec, as Francesco Marincola leaves his post to join Flagship startup Sonata Therapeutics as CSO. Marincola served as Kite’s SVP and global head of cell therapy research, having joined the company in 2021 after a stint as CSO at Refuge Biotechnologies. Marincola has also served as a distinguished research fellow at AbbVie and spent more than two decades at the NIH and NCI. Marincola’s exit from Kite marks the third, following CEO Christi Shaw and Tecartus global program clinical lead Behzad Kharabi, who both left last month.

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