The FDA’s vac­cine ad­vi­so­ry com­mit­tee on Thurs­day vot­ed 19-0 in sup­port of ex­pand­ing Mod­er­na’s Covid-19 vac­cine EUA for boost­er dos­es for cer­tain high-risk in­di­vid­u­als. FDA is ex­pect­ed to au­tho­rize the Mod­er­na boost­er short­ly.

Sim­i­lar­ly to the Pfiz­er boost­er shot, Mod­er­na’s will like­ly be au­tho­rized for those old­er than 65, adults at high risk of se­vere Covid-19, and adults whose fre­quent in­sti­tu­tion­al or oc­cu­pa­tion­al ex­po­sure to SARS-CoV-2 puts them at high risk of se­ri­ous com­pli­ca­tions of Covid-19. But un­like the Pfiz­er ad­comm, where FDA had to scram­ble to get the com­mit­tee to vote in fa­vor of a boost­er, this com­mit­tee was unan­i­mous with the Mod­er­na shot.

Is­raeli sci­en­tists once again pre­sent­ed the lat­est in their ex­pe­ri­ence with boost­ers, which showed re­duced Covid-19 cas­es. Sev­er­al pan­elists praised how com­pelling the Is­raeli da­ta pre­sent­ed were.

Paul Of­fit

Paul Of­fit, a VRB­PAC pan­elist and pro­fes­sor of pe­di­atrics at Chil­dren’s Hos­pi­tal of Philadel­phia, called the da­ta clear for 70- to 79-year-olds, but said he was less im­pressed with the da­ta for those who are younger.

Oth­ers al­so ques­tioned the da­ta be­hind the boost­er, par­tic­u­lar­ly as for Mod­er­na is ap­ply­ing to ad­min­is­ter a half-dose of what was pro­vid­ed in the pri­ma­ry, two-shot se­ries.

“The da­ta we have is on­ly lim­it­ed to about 149 pa­tients on Mod­er­na. So I have some hes­i­ta­tion,” VRB­PAC mem­ber Jean­nette Lee, a pro­fes­sor of bio­sta­tis­tics at the Uni­ver­si­ty of Arkansas for Med­ical Sci­ences, said.

Pan­elist Er­ic Ru­bin, ed­i­tor in chief of the New Eng­land Jour­nal of Med­i­cine and an ex­pert on in­fec­tious dis­eases at Har­vard’s pub­lic health school, not­ed “the da­ta are not per­fect,” but these are “ex­tra­or­di­nary times.” He al­so re­it­er­at­ed the idea that the over­all ef­fect of a boost­er is much less than pri­ma­ry vac­cines, both here and abroad.

“We need to vac­ci­nate the un­vac­ci­nat­ed,” Ru­bin said.

Oth­er mem­bers of the com­mit­tee ex­plained how the Mod­er­na boost­er needs to win EUA as it wouldn’t make sense as a prac­ti­cal mat­ter to have a Pfiz­er boost­er and not one for Mod­er­na.

Pe­ter Marks

FDA’s top vac­cine leader Pe­ter Marks of­fered a sim­i­lar sen­ti­ment in not­ing that the CDC’s com­mit­tee, which is like­ly next up to re­view the Mod­er­na boost­er, may de­cide to fur­ther ma­nip­u­late the rec­om­men­da­tions from VRB­PAC, “but to the ex­tent that we can come to place that’ll be ac­cept­able for ACIP, that’ll be ap­pre­ci­at­ed.”

VRB­PAC pan­elist Steven Pergam, an ex­pert on in­fec­tious dis­eases at the Fred Hutchin­son Can­cer Re­search Cen­ter in Seat­tle, said he is “very sup­port­ive” of those with oc­cu­pa­tion­al Covid-19 risks re­ceiv­ing the boost­er, par­tic­u­lar­ly as the US seeks to pro­tect health in­sti­tu­tions from out­breaks.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Zoom can only go so far. And I think at this stage, we’ve all tested the limits of staying in touch — virtually. So I’m particularly happy now that we’ve revved up the travel machine to point myself to London for the first time in several years.

Whatever events we have lined up, we’ve always built in plenty of opportunities for all of us to get together and talk. For London, live, I plan to be right out front, meeting with and chatting with the small crowd of biopharma people we are hosting on October 12 at Silicon Valley Bank’s London headquarters. And there’s a lengthy mixer at the end I’m most looking forward to, with several networking openings between sessions.

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024, but the entire inventory will be available until depleted or expired, a company spokesperson said via email.

Dupo, IL-based contract manufacturer Sterling Pharmaceuticals has had a long, tough year.

Last September, partner Verrica Pharmaceuticals’ NDA for a potential skin disease treatment was hit with a second CRL, with the company pinning the problems on Sterling. Eight months later, Verrica was hit with a third CRL due to further issues at Sterling, following a February reinspection by FDA of the Sterling site.