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.”

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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Janet Woodcock (Greg Nash/Pool via AP Images)

'I re­al­ly don’t look back': Janet Wood­cock on her tran­si­tion away from drugs

Janet Woodcock may have one of the most historically long and drug-intense tenures in FDA history, but her new role is outside of all things pharma and the once-acting FDA commissioner isn’t looking back.

“No I really don’t look back,” Woodcock told Endpoints News via email on Monday morning. “Yes I will be transitioning. Longer discussion on infrastructure needed.”

Özlem Türeci, BioNTech co-founder and Uğur Şahin, BioNTech CEO

Third dose bumps up ef­fi­ca­cy of Pfiz­er-BioN­Tech's Covid-19 vac­cine in youngest group of chil­dren to 80%

Pfizer and BioNTech said Monday that they’re ready to approach the FDA this week with early data for their booster shot for Covid-19 vaccine in the youngest age group (6 months to under 5 years), which showed 80.3% efficacy based on 10 symptomatic Covid cases identified beginning seven days after the third dose.

“The study suggests that a low 3-ug dose of our vaccine, carefully selected based on tolerability data, provides young children with a high level of protection against the recent COVID-19 strains,” Uğur Şahin, CEO and co-founder of BioNTech said in a statement. “We are preparing the relevant documents and expect completing the submission process to the FDA this week, with submissions to EMA and other regulatory agencies to follow within the coming weeks.”

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Adar Poonawalla, Serum Institute of India CEO (Dhiraj Singh/Bloomberg via Getty Images)

Covid-19 roundup: Serum In­sti­tute eyes Africa for glob­al ex­pan­sion — re­port; Jun­shi an­tivi­ral hits pri­ma­ry end­point in late-stage tri­al

After Serum Institute CEO Adar Poonawalla announced last month that the world’s largest vaccine maker stopped producing doses of Covid-19 vaccines back in December, the institute is looking to expand.

The CEO told Reuters Monday that the company is considering establishing its first manufacturing plant in Africa in its next step toward global expansion after successfully mass producing and selling hundreds of millions of Covid-19 vaccine doses out of its India-based facilities.

Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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