FDA's vac­cine ad­comm unan­i­mous­ly sup­ports Mod­er­na's boost­er in same pop­u­la­tions as Pfiz­er's boost­er

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.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Fireside chat between Hal Barron and John Carroll, UKBIO19

It’s time we talked about bio­phar­ma — live in Lon­don next week

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.

FDA+ roundup: Ad­comm date set for Cy­to­ki­net­ics heart drug; New gener­ic drug guid­ance to re­duce fa­cil­i­ty de­lays

The FDA on Wednesday set Dec. 13 as the day that its Cardiovascular and Renal Drugs Advisory Committee will review Cytokinetics’ potential heart drug, meaning regulators aren’t likely to meet the Nov. 30 PDUFA date that was previously set.

The drug, known as omecamtiv mecarbil, read out its first Phase III in November 2020, hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as the key to breaking into the market, failing to significantly differ in reducing cardiovascular death from placebo.

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Pfizer and BioNTech's original Marvel comic book links evolving Covid vaccine science to Avengers' evolving villain-fighting tools.(Source: Pfizer LinkedIn post)

Pfiz­er, BioN­Tech part­ner with Mar­vel for Avengers and Covid-fight­ing com­ic book

Pfizer and BioNTech are collaborating with Marvel to celebrate “everyday” people getting Covid-19 vaccines in a custom comic book.

In the “Everyday Heroes” digital comic book, an evolving Ultron, one of the Avengers’ leading villains, is defeated by Captain America, Ironman and others. The plotline and history of Ultron is explained by a grandfather who is waiting with his family at a clinic for Covid-19 vaccinations.

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Take­da to pull key hy­poparathy­roidism drug from the mar­ket af­ter years of man­u­fac­tur­ing woes

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.

Eli Lil­ly and Te­va pre­pare for court bat­tle over mi­graine med ri­val­ry

It looks like Eli Lilly and Teva Pharmaceuticals are going to trial.

A federal appeals court on Monday refused to invalidate three of Teva’s patents for its migraine treatment Ajovy, while also declining to issue a summary judgment in favor of either company, which would effectively end the case without a full trial.

Teva filed suit against Lilly back in 2018, alleging that the company infringed upon nine patents with its rival migraine drug Emgality. The rival drugs were both approved in September 2018 for the preventative treatment of migraine, and are designed to block calcitonin gene-related peptide (CGRP), a protein associated with the onset of migraine pain.

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Two CRLs lat­er, Illi­nois-based CD­MO hit with FDA warn­ing let­ter over 's­pore-form­ing' bac­te­ria and fun­gi

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.

David Cory, Eiger BioPharmaceuticals CEO (via MultiVu)

FDA re­jects Eiger's emer­gency use re­quest for re­pur­posed Covid-19 treat­ment

Eiger BioPharmaceuticals is no longer planning to submit an emergency use application to the FDA.

The Palo Alto, CA-based biotech had hoped to repurpose its hepatitis D treatment, peginterferon lambda, for mild-to-moderate Covid-19 — submitting a request to the FDA for a pre-EUA meeting back in September with data from a Phase III platform trial in hand.

However, that meeting was rejected by federal regulators because of “concerns about the conduct of the TOGETHER study,” per an Eiger statement.

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