UP­DAT­ED: J&J to restart Covid vac­cine ship­ments to Eu­rope as EMA adds safe­ty warn­ing over rare blood clots

The Eu­ro­pean Med­i­cines Agency’s safe­ty com­mit­tee on Tues­day rec­om­mend­ed adding a warn­ing to the J&J Covid-19 vac­cine re­gard­ing the rare but some­times fa­tal blood clots with low blood platelets. Short­ly there­after, J&J said it would re­sume ship­ments of the vac­cine to the EU, Nor­way and Ice­land, and up­date its vac­cine’s Sum­ma­ry of Prod­uct Char­ac­ter­is­tics and Pack­age Leaflet to in­clude in­for­ma­tion on the di­ag­no­sis and man­age­ment of these very rare ad­verse events.

The com­mit­tee, which said the over­all risk-ben­e­fit of the vac­cine still re­mains pos­i­tive, re­viewed eight cas­es (in­clud­ing one that was fa­tal) of the rare side ef­fects among al­most 8 mil­lion Amer­i­cans vac­ci­nat­ed with the J&J vac­cine.

Emer Cooke, ex­ec­u­tive di­rec­tor of the EMA, said in a press con­fer­ence the vac­cine is due to be rolled out very short­ly in Eu­rope. In­ves­ti­ga­tions in­to the rare events are planned to con­tin­ue and J&J will con­duct ad­di­tion­al stud­ies. She not­ed that be­cause Eu­rope has a very good phar­ma­covig­i­lance sys­tem, very rare side ef­fects can be spot­ted ear­ly, which is a sign the sys­tem works, es­pe­cial­ly as the safe­ty com­mit­tee made its rec­om­men­da­tion pri­or to the vac­cine’s launch in Eu­rope.

The blood clots, which the com­mit­tee said were “very sim­i­lar” to side ef­fects linked to As­traZeneca’s Covid-19 vac­cine, oc­curred “most­ly at un­usu­al sites such as in veins in the brain (cere­bral ve­nous si­nus throm­bo­sis, CVST) and the ab­domen (splanch­nic vein throm­bo­sis) and in ar­ter­ies, to­geth­er with low lev­els of blood platelets and some­times bleed­ing.”

Pe­ter Ar­lett, head of the phar­ma­covig­i­lance and epi­demi­ol­o­gy de­part­ment at the EMA, not­ed that as of April 13, in ad­di­tion to the 8 to­tal cas­es for the J&J vac­cine, there have been 287 cas­es of the rare blood clots and low platelets fol­low­ing ad­min­is­tra­tion of the As­traZeneca vac­cine, in­clud­ing 142 in the Eu­ro­pean Eco­nom­ic Area, and 25 cas­es among those vac­ci­nat­ed with Pfiz­er and five for Mod­er­na. But in cas­es that oc­curred in the US, there was no low platelet count for Pfiz­er and Mod­er­na vac­cines, EMA clar­i­fied.

As far as why the blood clots with low platelets are oc­cur­ring, the EMA said the most plau­si­ble ex­pla­na­tion is an im­mune re­sponse lead­ing to a con­di­tion sim­i­lar to what can be seen some­times in pa­tients treat­ed with he­parin, called he­parin-in­duced throm­bo­cy­tope­nia.

Mean­while, J&J on Tues­day re­port­ed $100 mil­lion in Covid-19 vac­cine sales in the first quar­ter of 2021. CSO Paul Stof­fels said the com­pa­ny is try­ing to re­store pub­lic con­fi­dence in its vac­cine, and that the com­pa­ny re­mains com­mit­ted to re­sum­ing ship­ments to Eu­rope. The con­ti­nent has pur­chased 200 mil­lion dos­es.

In the US, where the gov­ern­ment signed a $1 bil­lion deal for 100 mil­lion dos­es (and the po­ten­tial for 200 mil­lion more), dos­es of the vac­cine have been paused since last Tues­day. The CDC will hold an­oth­er meet­ing of its ad­vi­so­ry com­mit­tee on Fri­day to dis­cuss the safe­ty is­sues fur­ther.

Man­u­fac­tur­ing is­sues at an Emer­gent site in Bal­ti­more al­so have raised ques­tions about whether J&J, which has tak­en con­trol of the fa­cil­i­ty, will be able to pro­duce enough vac­cines for the US. Emer­gent agreed not to ini­ti­ate the man­u­fac­tur­ing of any new ma­te­r­i­al at its Bayview fa­cil­i­ty last Fri­day. J&J said Tues­day that it’s pre­ma­ture to spec­u­late on any tim­ing is­sues with vac­cine de­liv­er­ies from the site, but it is work­ing with FDA to close the in­spec­tion this week and will work to ad­dress any ob­ser­va­tion­al find­ings.

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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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Ted White, Verrica Pharmaceuticals CEO

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The FDA has rejected Verrica Pharmaceuticals’ skin disease treatment for a third time — and once again the contract manufacturer is to blame.

The biotech emphasized that the only deficiency in the complete response letter is related to a general reinspection of the CMO, Sterling Pharmaceuticals, and has nothing to do specifically with its drug-device; the rest of the NDA is good to go.

CEO Ted White said the company is “extremely disappointed,” but will keep working toward approval.

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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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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 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.