Joe Biden (AP Photo/Susan Walsh)

Covid-19 roundup: Biden plans for ear­ly No­vem­ber roll­out of vac­cines for kids; EMA eval­u­ates Re­gen­eron's an­ti­body com­bo

The Biden ad­min­is­tra­tion on Wednes­day an­nounced plans for a quick roll­out of the Pfiz­er/BioN­Tech Covid-19 vac­cine to kids ages 5 to 11 ear­ly next month, pend­ing FDA au­tho­riza­tion.

The ad­min­is­tra­tion plans to ini­ti­ate com­mu­ni­ty part­ner­ships with clin­ics, phar­ma­cies and hos­pi­tal sys­tems if that EUA hap­pens.

The an­nounce­ment comes as Pfiz­er’s vac­cine has shown 93% ef­fec­tive­ness in pre­vent­ing hos­pi­tal­iza­tions among ado­les­cents aged 12 to 18, ac­cord­ing to the CDC analy­sis of re­al-world da­ta re­leased on Tues­day.

The analy­sis of da­ta from 19 US pe­di­atric hos­pi­tals, which was con­duct­ed while the Delta vari­ant was at its peak from June through Sep­tem­ber, showed that among the 179 chil­dren who were hos­pi­tal­ized for Covid-19, all but six were un­vac­ci­nat­ed. And of the 29 pa­tients hos­pi­tal­ized with se­vere enough Covid-19 to re­quire life sup­port, none were vac­ci­nat­ed. Two of those pa­tients died.

While the Pfiz­er/BioN­Tech vac­cine is cur­rent­ly au­tho­rized for chil­dren as young as 12, the FDA has sched­uled an ad­comm to eval­u­ate and weigh the da­ta on the younger chil­dren on Oct. 26. And the CDC’s in­de­pen­dent ad­vi­so­ry com­mit­tee will meet on Nov. 2-3.

EMA starts eval­u­a­tion of Roche/Re­gen­eron mon­o­clon­al an­ti­body com­bo

The Eu­ro­pean Med­i­cines Agency has be­gun eval­u­at­ing Roche’s ap­pli­ca­tion for mar­ket­ing au­tho­riza­tion for the mon­o­clon­al an­ti­body com­bo Ron­apreve from Roche and Re­gen­eron.

The agency will as­sess Ron­apreve, which has won an EUA in the US and brought in bil­lions in sales, on a short­er time­line and could is­sue an opin­ion with­in two months, the EMA says.

EMA’s safe­ty com­mit­tee al­so com­plet­ed its first as­sess­ment of Roche’s risk man­age­ment plan to iden­ti­fy, char­ac­ter­ize and min­i­mize Ron­apreve’s risks. There is al­so da­ta in the works on how the an­ti­body com­bi­na­tion can be de­vel­oped and stud­ied for use in chil­dren, ac­cord­ing to the EMA’s pe­di­atrics com­mit­tee.

The EMA al­so said it will work with the Eu­ro­pean Com­mis­sion to fast track mar­ket­ing au­tho­riza­tions in all EU and EEA mem­ber states.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

Covid-19 roundup: Ugur Sahin says new shots like­ly need­ed for Omi­cron; UK ful­ly ap­proves Vir/Glax­o­SmithK­line an­ti­body

Despite Ugur Sahin’s calls for calm over the Omicron variant — making a much more measured appeal than Moderna CEO Stéphane Bancel — the BioNTech chief is already predicting the potential need for new Covid-19 vaccines.

In comments made at a conference hosted Friday morning by Reuters, Sahin said that even though vaccinated individuals would likely still be protected from severe disease, Omicron could see greater numbers of breakthrough infections than other variants. The mutations mean Covid shots will probably become necessary every year, similar to the flu.