EMA finds link be­tween ‘very rare’ but some­times fa­tal blood clots and As­traZeneca vac­cine

The EMA said Wednes­day that very rare but some­times fa­tal blood clots should be list­ed as a side ef­fect for As­traZeneca’s Covid-19 vac­cine.

The EMA’s safe­ty com­mit­tee said the change to the vac­cine la­bel is part of an in-depth re­view of 62 cas­es of cere­bral ve­nous si­nus throm­bo­sis (CVST) and 24 cas­es of splanch­nic vein throm­bo­sis re­port­ed in the EU drug safe­ty data­base as of March 22. Eigh­teen of the cas­es were fa­tal.

De­spite the rare side ef­fects for the vac­cine, known as Vaxzevria, EMA ex­ec­u­tive di­rec­tor Emer Cooke said in a press con­fer­ence on Wednes­day that the ben­e­fits of the vac­cine still out­weigh the risks.

“The risk of mor­tal­i­ty from Covid is much greater than the risk of mor­tal­i­ty from these side ef­fects,” Cooke said.

The safe­ty com­mit­tee said it can­not make any rec­om­men­da­tions to re­duce the risk of the rare side ef­fects. Sabine Straus, chair of the EMA’s Phar­ma­covig­i­lance Risk As­sess­ment Com­mit­tee, said the re­port­ed rate of CVST is be­tween 1 and 2 per 100,000 peo­ple.

“One plau­si­ble ex­pla­na­tion for the com­bi­na­tion of blood clots and low blood platelets is an im­mune re­sponse, lead­ing to a con­di­tion sim­i­lar to one seen some­times in pa­tients treat­ed with he­parin,” EMA said.

As of April 4, EMA said a to­tal of 169 cas­es of CVST and 53 cas­es of splanch­nic vein throm­bo­sis were re­port­ed to the data­base, among 34 mil­lion peo­ple who have been vac­ci­nat­ed with in the EEA and UK. By com­par­i­son, Straus not­ed that for the J&J vac­cine, 3 CVST cas­es were found among 4.5 mil­lion vac­ci­nat­ed in the EU/EEA, for Pfiz­er, 35 CVST cas­es world­wide were found and 54 mil­lion re­ceived the vac­cine in the EEA, and for Mod­er­na, 5 CVST cas­es world­wide were among 4 mil­lion vac­ci­nat­ed in the EEA.

“EMA is re­mind­ing health­care pro­fes­sion­als and peo­ple re­ceiv­ing the vac­cine to re­main aware of the pos­si­bil­i­ty of very rare cas­es of blood clots com­bined with low lev­els of blood platelets oc­cur­ring with­in 2 weeks of vac­ci­na­tion. So far, most of the cas­es re­port­ed have oc­curred in women un­der 60 years of age with­in 2 weeks of vac­ci­na­tion. Based on the cur­rent­ly avail­able ev­i­dence, spe­cif­ic risk fac­tors have not been con­firmed,” the agency said.

Sep­a­rate­ly on Wednes­day, the UK’s med­i­cines reg­u­la­tor MHRA an­nounced that those un­der the age of 30 should not re­ceive the As­traZeneca vac­cine. As of March 31, 20.2 mil­lion dos­es of the As­traZeneca vac­cine had been ad­min­is­tered in the UK, mean­ing the over­all risk of these blood clots is ap­prox­i­mate­ly 4 peo­ple in a mil­lion who re­ceive the vac­cine, the MHRA said.

As­traZeneca said in a state­ment that it “has been ac­tive­ly col­lab­o­rat­ing with the reg­u­la­tors to im­ple­ment these changes to the prod­uct in­for­ma­tion and is al­ready work­ing to un­der­stand the in­di­vid­ual cas­es, epi­demi­ol­o­gy and pos­si­ble mech­a­nisms that could ex­plain these ex­treme­ly rare events.”

The World Health Or­ga­ni­za­tion added in a state­ment, “Based on cur­rent in­for­ma­tion, a causal re­la­tion­ship be­tween the vac­cine and the oc­cur­rence of blood clots with low platelets is con­sid­ered plau­si­ble but is not con­firmed. Spe­cialised stud­ies are need­ed to ful­ly un­der­stand the po­ten­tial re­la­tion­ship be­tween vac­ci­na­tion and pos­si­ble risk fac­tors.”

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Fireside chat between Hal Barron and John Carroll, UKBIO19

It’s time we talked about bio­phar­ma — live in Lon­don next week

Zoom can only go so far. And I think at this stage, we’ve all tested the limits of staying in touch — virtually. So I’m particularly happy now that we’ve revved up the travel machine to point myself to London for the first time in several years.

Whatever events we have lined up, we’ve always built in plenty of opportunities for all of us to get together and talk. For London, live, I plan to be right out front, meeting with and chatting with the small crowd of biopharma people we are hosting on October 12 at Silicon Valley Bank’s London headquarters. And there’s a lengthy mixer at the end I’m most looking forward to, with several networking openings between sessions.

FDA+ roundup: Ad­comm date set for Cy­to­ki­net­ics heart drug; New gener­ic drug guid­ance to re­duce fa­cil­i­ty de­lays

The FDA on Wednesday set Dec. 13 as the day that its Cardiovascular and Renal Drugs Advisory Committee will review Cytokinetics’ potential heart drug, meaning regulators aren’t likely to meet the Nov. 30 PDUFA date that was previously set.

The drug, known as omecamtiv mecarbil, read out its first Phase III in November 2020, hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as the key to breaking into the market, failing to significantly differ in reducing cardiovascular death from placebo.

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Take­da to pull key hy­poparathy­roidism drug from the mar­ket af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024, but the entire inventory will be available until depleted or expired, a company spokesperson said via email.

Pfizer and BioNTech's original Marvel comic book links evolving Covid vaccine science to Avengers' evolving villain-fighting tools.(Source: Pfizer LinkedIn post)

Pfiz­er, BioN­Tech part­ner with Mar­vel for Avengers and Covid-fight­ing com­ic book

Pfizer and BioNTech are collaborating with Marvel to celebrate “everyday” people getting Covid-19 vaccines in a custom comic book.

In the “Everyday Heroes” digital comic book, an evolving Ultron, one of the Avengers’ leading villains, is defeated by Captain America, Ironman and others. The plotline and history of Ultron is explained by a grandfather who is waiting with his family at a clinic for Covid-19 vaccinations.

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Two CRLs lat­er, Illi­nois-based CD­MO hit with FDA warn­ing let­ter over 's­pore-form­ing' bac­te­ria and fun­gi

Dupo, IL-based contract manufacturer Sterling Pharmaceuticals has had a long, tough year.

Last September, partner Verrica Pharmaceuticals’ NDA for a potential skin disease treatment was hit with a second CRL, with the company pinning the problems on Sterling. Eight months later, Verrica was hit with a third CRL due to further issues at Sterling, following a February reinspection by FDA of the Sterling site.

David Cory, Eiger BioPharmaceuticals CEO (via MultiVu)

FDA re­jects Eiger's emer­gency use re­quest for re­pur­posed Covid-19 treat­ment

Eiger BioPharmaceuticals is no longer planning to submit an emergency use application to the FDA.

The Palo Alto, CA-based biotech had hoped to repurpose its hepatitis D treatment, peginterferon lambda, for mild-to-moderate Covid-19 — submitting a request to the FDA for a pre-EUA meeting back in September with data from a Phase III platform trial in hand.

However, that meeting was rejected by federal regulators because of “concerns about the conduct of the TOGETHER study,” per an Eiger statement.

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Af­ter Covid set­back, Val­ne­va lines up $100M for Pfiz­er-al­lied Ly­me dis­ease PhI­II

Valneva has secured €102.9 million (around $99.9 million USD) in a share offering to push forward its Pfizer-partnered Lyme disease vaccine and a jab for chikungunya that awaits an FDA decision.

The French vaccine maker largely snagged the near $100 million from Deep Track Capital and local state-owned Bpifrance, the company said Tuesday night. The capital injection is nearly equal to the amount Pfizer paid to nab equity in the company earlier this summer as part of the duo’s vaccine tie-up.