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.”

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.