Covid-19 roundup: Ear­ly Is­rael da­ta show boost­ers may slow Delta; Fau­ci says Pfiz­er/BioN­Tech OK will spur man­dates

At the height of last win­ter’s Covid-19 surge, Is­rael launched one of the world’s fastest vac­ci­na­tion dri­ves thanks to sup­plies from Pfiz­er and BioN­Tech, but the coun­try re­cent­ly saw a surge in cas­es due to the high­ly con­ta­gious Delta vari­ant. To com­bat the new wave, the Is­raeli gov­ern­ment ini­ti­at­ed a boost­er shot dri­ve, and the first re­sults are com­ing back pos­i­tive.

The coro­n­avirus’ re­pro­duc­tion rate has dipped be­low 1 among the over-60 age group for the first time since the Delta surge be­gan, Reuters re­port­ed Tues­day, a sign of­fi­cials say the boost­er shots are work­ing. Such re­duc­tions mean peo­ple with Covid-19 are now, on av­er­age, in­fect­ing less than one oth­er per­son.

“The num­bers are still very high but what has changed is that the very high in­crease in the rate of in­fec­tions and se­vere cas­es has di­min­ished, as has the pace at which the pan­dem­ic is spread­ing,” gov­ern­ment ad­vis­er Er­an Se­gal told Reuters, adding, “This is like­ly due to the third boost­er shots, an up­take in peo­ple tak­ing the first dose and the high num­ber of peo­ple in­fect­ed per week, pos­si­bly up to 100,000, who now have nat­ur­al im­mu­ni­ty.”

Is­rael be­gan ad­min­is­ter­ing the third Pfiz­er/BioN­Tech dos­es on Ju­ly 30 to in­di­vid­u­als old­er than 60 and cas­es be­gan falling in that group around Au­gust 13. In the past 10 days alone, more than 1 mil­lion peo­ple over 60 have got­ten a boost­er ac­count­ing for more than half of that age group, per Is­raeli health min­istry da­ta.

The coun­try has since ex­pand­ed the el­i­gi­bil­i­ty for boost­ers for any­one old­er than 30 who is more than five months past their sec­ond dose. But about one mil­lion Is­raelis still have not been vac­ci­nat­ed and chil­dren un­der 12 re­main in­el­i­gi­ble for the shots.

De­bates over boost­er shots con­tin­ue to re­ver­ber­ate around the world, with the WHO crit­i­ciz­ing moves by wealthy na­tions to start hand­ing out third vac­cine dos­es be­fore many in low- and mid­dle-in­come have yet to re­ceive their first. The US re­cent­ly an­nounced plans to ad­min­is­ter boost­ers start­ing in the fall, with in­di­vid­u­als be­ing el­i­gi­ble start­ing eight months af­ter they re­ceived their sec­ond mR­NA vac­cine dose.

Though da­ta con­tin­ue to trick­le in from Is­rael, of­fi­cials are en­cour­aged by the ear­ly signs of boost­er ef­fec­tive­ness, par­tic­u­lar­ly for the Pfiz­er/BioN­Tech shot. A preprint of da­ta from the Mayo Clin­ic in­di­cat­ed the Pfiz­er vac­cine might be less ef­fec­tive at pre­vent­ing in­fec­tions, break­through or oth­er­wise, than its mR­NA coun­ter­part from Mod­er­na.

Fau­ci: Pfiz­er/BioN­Tech ap­proval will spur vac­ci­na­tions, man­dates

Ap­pear­ing on the TO­DAY Show on Tues­day morn­ing, NI­AID di­rec­tor An­tho­ny Fau­ci said he be­lieves the full FDA ap­proval of the Pfiz­er/BioN­Tech vac­cine will pave the way for more peo­ple to get in­oc­u­lat­ed soon.

Fau­ci high­light­ed a sur­vey show­ing that 30% of vac­cine-hes­i­tant in­di­vid­u­als said they were wait­ing on the FDA to give its full stamp of ap­proval, he said on the show. And on top of that, the FDA’s en­dorse­ment will like­ly spur pri­vate com­pa­nies to be­gin man­dat­ing their em­ploy­ees get vac­ci­nat­ed or face con­stant virus test­ing.

“There will now be much more en­thu­si­asm in man­dat­ing vac­cines,” Fau­ci said. “Be it in cor­po­ra­tions and places of em­ploy­ment, to uni­ver­si­ties, col­leges, the mil­i­tary, all of that will con­tribute great­ly to the num­ber of peo­ple get­ting vac­ci­nat­ed.”

The top in­fec­tious dis­ease ex­pert fur­ther said that be­cause Pfiz­er has now won the full OK, the com­pa­ny is al­lowed by law to start run­ning ad­ver­tise­ments for their vac­cine. Per CN­BC’s Meg Tir­rell, Pfiz­er doesn’t have any im­me­di­ate plans to launch a new ad cam­paign.

With­in hours of Pfiz­er and BioN­Tech ob­tain­ing their ap­proval Mon­day, sev­er­al man­dates be­gan rolling in. The Pen­ta­gon an­nounced Mon­day that it would re­quire all ac­tive mil­i­tary per­son­nel to re­ceive vac­ci­na­tions, and schools in New York City and New Jer­sey will re­quire all ed­u­ca­tion staff to get their Covid-19 shots.

Four oth­er states, Wash­ing­ton, Cal­i­for­nia, Con­necti­cut and Ore­gon, have al­so im­ple­ment­ed vac­cine man­dates, ac­cord­ing to a Wash­ing­ton Post re­port.

Lat­er Tues­day morn­ing, Fau­ci al­so ap­peared on MSNBC he ex­pects full ap­provals to come through for the Mod­er­na and J&J vac­cines “rel­a­tive­ly soon.” He al­so said it’s “rea­son­able” to ex­pect chil­dren un­der the age of 12 to be­come el­i­gi­ble be­fore the Christ­mas hol­i­days.

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.