Covid-19 roundup: Pfizer licenses its pill to the Medicines Patent Pool; NYC joins states in authorizing boosters for all adults ahead of FDA

Fol­low­ing a sim­i­lar deal forged by Mer­ck for its Covid-19 drug mol­nupi­ravir, Pfiz­er on Tues­day agreed to al­low the UN-backed Med­i­cines Patent Pool to li­cense the com­pa­ny’s po­ten­tial treat­ment Paxlovid to make it more read­i­ly avail­able in 95 low- and mid­dle-in­come coun­tries.

The agree­ment al­lows MPP to grant sub-li­cens­es to qual­i­fied gener­ic drug man­u­fac­tur­ers to fa­cil­i­tate ad­di­tion­al pro­duc­tion and dis­tri­b­u­tion of the in­ves­ti­ga­tion­al an­tivi­ral, which has yet to be au­tho­rized.

Pfiz­er has not dis­closed a price for its treat­ment but ex­ec­u­tives have said they will price it sim­i­lar­ly to Mer­ck’s mol­nupi­ravir, which costs about $700 per treat­ment course in high-in­come coun­tries.

While the move to li­cense its drug, even be­fore its au­tho­riza­tion, may be viewed as a no­ble ef­fort, Doc­tors With­out Bor­ders said in a state­ment, ‘Li­cens­ing deals by phar­ma­ceu­ti­cal cor­po­ra­tions that cre­ate un­cer­tain­ties and seg­men­ta­tion for gener­ic pro­duc­tion and sup­ply con­tin­ue to be part of the prob­lem rather than part of a re­al so­lu­tion. There is no patent yet on the ex­per­i­men­tal can­di­date PF-07321332, and ri­ton­avir has been off patent since last year. In the ab­sence of patents on both com­pounds, able man­u­fac­tur­ers, par­tic­u­lar­ly those based in coun­tries ex­clud­ed from this li­cense, have an op­por­tu­ni­ty to ex­plore gener­ic pro­duc­tion di­rect­ly.’

NYC joins states in au­tho­riz­ing Covid-19 boost­ers for all adults ahead of FDA au­tho­riza­tion

New York City is join­ing Cal­i­for­nia, Col­orado, Arkansas, and New Mex­i­co in al­low­ing any adult to ac­cess a Covid-19 boost­er shot. Some, like car­di­ol­o­gist Er­ic Topol, called the de­ci­sion ‘ful­ly backed by the da­ta,’ as Pfiz­er and BioN­Tech main­tain that the wan­ing im­mu­ni­ty from the ini­tial 2-dose se­ries needs the boost to get back in­to the 90%+ range for pro­tec­tion.

Oth­ers seem con­cerned that such a de­ci­sion isn’t nec­es­sar­i­ly backed by ro­bust da­ta, or that such dos­es should be shipped abroad as ini­tial dos­es. Oth­ers still ques­tion the need for states to over­ride the FDA’s de­ci­sion to on­ly au­tho­rize the boost­ers so far for cer­tain groups of peo­ple, in­clud­ing those old­er than 65.

The FDA, how­ev­er, wasn’t keen to dis­cuss the is­sue. An agency spokesper­son told End­points News to con­tact the CDC for as­sis­tance with any ques­tions, adding, ‘It is im­por­tant to note that FDA does not make im­mu­niza­tion or clin­i­cal rec­om­men­da­tions.’

On whether states should be au­tho­riz­ing boost­ers ahead of an FDA de­ci­sion for the same age group, or if this was more an is­sue of off-la­bel use (be­cause Pfiz­er’s vac­cine is FDA ap­proved), the agency spokesper­son said, ‘We do not have any­thing ad­di­tion­al to add to our pre­vi­ous re­sponse.’

BREAK­ING: NYC Health Dept au­tho­rizes covid boost­er shots for *all* NY­ers aged 18+, as long as at least 6 months since 2nd Pfiz­er/Mod­er­na dose or 2 months since J&J dose.

This is a wel­come move at a time when cas­es are ris­ing in NYC.

Make an appt here: https://t.co/h2ivjx­U­Fu2

— Mark D. Levine (@MarkLevi­neNYC) No­vem­ber 15, 2021 Twist Bio­science re­veals an an­ti­body off­shoot with a start in Covid-19

Twist Bio­science un­veiled an off­shoot biotech this morn­ing — Rev­e­lar Bio­ther­a­peu­tics, which is work­ing on a po­ten­tial Covid-19 an­ti­body.

Ac­cord­ing to Twist, the in­de­pen­dent new biotech will be de­vel­op­ing and com­mer­cial­iz­ing an an­ti­body that has neu­tral­ized all known vari­ants of SARS-Cov-2 in pre­clin­i­cal tri­als.

That said, Rev­e­lar can lever­age Twist’s an­ti­body plat­form and li­cense ad­di­tion­al an­ti­bod­ies — up to five more tar­gets over the next four years, each of which will be sub­ject to ad­di­tion­al up­front, mile­stone and roy­al­ty pay­ments to Twist.

Twist CEO Emi­ly Lep­roust said in a state­ment that she hopes the an­ti­body will en­ter clin­i­cal stud­ies in 2022.

Twist is start­ing out with a $10 mil­lion seed in­vest­ment, based on Rev­e­lar’s de­vel­op­ment of the first an­ti­body and the po­ten­tial for suc­cess-based mile­stone pay­ments to­tal­ing over $100 mil­lion. In ex­change for the in­vest­ment and an­ti­body li­cens­ing, Twist got mi­nor­i­ty own­er­ship in Rev­e­lar — but at an un­spec­i­fied per­cent­age.

Rev­e­lar’s ex­ec­u­tive lead­er­ship team in­cludes Boehringer vet Glenn Ma­ri­na as CEO. Lep­roust and Twist CCO Patrick Finn are al­so part of the board of di­rec­tors.

‘We look for­ward to com­plet­ing pre­clin­i­cal and CMC de­vel­op­ment in sup­port of fil­ing an IND,’ said Ma­ri­na in a state­ment. — Paul Schloess­er

EU and EEA coun­tries agreed to do­nate 70+ mil­lion dos­es of Mod­er­na vax to low- and mid­dle-in­come coun­tries by year’s end

Mod­er­na to­day an­nounced an agree­ment that en­ables the EU and EEA coun­tries to do­nate dos­es of their Covid-19 vac­cine pur­chased un­der the EU Vac­cines Strat­e­gy to CO­V­AX for low and mid­dle-in­come coun­tries for the rest of the year.

The vac­cine dos­es will be head­ed to 92 coun­tries con­sid­ered as low- and mid­dle-in­come.

Ac­cord­ing to a Mod­er­na state­ment, the com­pa­ny ex­pects to see more than 70 mil­lion dos­es giv­en away by year’s end as part of the ini­tia­tive spear­head­ed by France, Swe­den and Nor­way. Ini­tial do­na­tions have in­clud­ed 15 mil­lion from France and 40 mil­lion from Ger­many.

‘We be­lieve that dose shar­ing, among oth­er strate­gies, will help en­sure an eq­ui­table glob­al dis­tri­b­u­tion of COVID-19 vac­cines,’ said Mod­er­na’s CEO Stéphane Ban­cel, who has come un­der fire re­cent­ly from the Biden ad­min­is­tra­tion for not help­ing enough on the in­ter­na­tion­al stage. — Paul Schloess­er
https://endpts.com/covid-19-roundup-pfizer-follows-merck-and-licenses-its-pill-to-the-medicines-patent-pool-nyc-joins-states-in-authorizing-covid-19-boosters-for-all-ahead-of-fda/