Boost­er bo­nan­za: FDA en­dors­es 'mix-and-match' scheme, and Mod­er­na and J&J too

The FDA late Wednes­day signed off on au­tho­riz­ing the use of het­erol­o­gous — or what FDA calls a “mix and match” of a pri­ma­ry vac­cine se­ries and dif­fer­ent boost­er dos­es — for all cur­rent­ly avail­able Covid-19 vac­cines, in ad­di­tion to sep­a­rate­ly au­tho­riz­ing Mod­er­na and J&J boost­ers.

On the mix-and-match ap­proach, which FDA of­fi­cials in­sist­ed isn’t too con­fus­ing in a press con­fer­ence, the agency of­fered the ex­am­ple of an 18-year-old who re­ceived the J&J shot at least two months ago and may now re­ceive a sin­gle boost­er of the J&J, a half dose of the Mod­er­na, or the Pfiz­er-BioN­Tech boost­er.

An­oth­er ex­am­ple would be some­one who re­ceived the ini­tial two-dose se­ries of Pfiz­er or Mod­er­na, and who is el­i­gi­ble to get a boost­er (i.e., 65 years of age and old­er, 18 through 64 years of age at high-risk of se­vere Covid-19, and 18 through 64 years of age with fre­quent in­sti­tu­tion­al or oc­cu­pa­tion­al ex­po­sure to SARS-CoV-2) may re­ceive a shot of the Mod­er­na, Pfiz­er or a J&J vac­cine, at least six months af­ter com­plet­ing their pri­ma­ry vac­ci­na­tion.

“Fol­low­ing a pre­sen­ta­tion of clin­i­cal tri­al da­ta from the Na­tion­al In­sti­tute of Al­ler­gy and In­fec­tious Dis­eases, the Vac­cines and Re­lat­ed Bi­o­log­i­cal Prod­ucts Ad­vi­so­ry Com­mit­tee’s dis­cus­sion of in­for­ma­tion sub­mit­ted for con­sid­er­a­tion, along with the agency’s eval­u­a­tion of the avail­able da­ta, the FDA has de­ter­mined that the known and po­ten­tial ben­e­fits of the use of a sin­gle het­erol­o­gous boost­er dose out­weigh the known and po­ten­tial risks of their use in el­i­gi­ble pop­u­la­tions,” FDA said in a state­ment.

Kirsten Lyke

At that VRB­PAC meet­ing, ex­perts re­viewed da­ta from a mix-and-match study where par­tic­i­pants who re­ceived J&J’s sin­gle shot fol­lowed by a Mod­er­na shot saw a geo­met­ric mean fold rise (the ra­tio of post-vac­ci­na­tion titer val­ue to pre-vac­ci­na­tion titer val­ue) of 76-fold, ac­cord­ing to Kirsten Lyke of the Cen­ter for Vac­cine De­vel­op­ment and Glob­al Health at the Uni­ver­si­ty of Mary­land School of Med­i­cine. That com­pared to a 4.2 GM­FR in those who re­ceived two dos­es of J&J’s vac­cine, and a 35 GM­FR in those who got J&J’s vac­cine fol­lowed by the Pfiz­er/BioN­Tech vac­cine.

“What I would note is that the neu­tral­iz­ing an­ti­bod­ies did in­crease in re­sponse to any boost re­gard­less of the pri­ma­ry vac­ci­na­tion se­ries,” she said, al­so not­ing that the mR­NA vac­cines re­sult­ed in high­er an­ti­body titers in the first 28 days af­ter the boost.

Oth­er ex­perts called for the EUA for mix-and-match boost­ers so that they can be tracked, as the het­erol­o­gous sec­ond and third shots are oc­cur­ring in the re­al world with or with­out an FDA au­tho­riza­tion.

Ofer Levy, di­rec­tor of Boston Chil­dren’s Hos­pi­tal’s pre­ci­sion vac­cines pro­gram, ex­pressed con­cern over re­cent re­ports that some Amer­i­cans are tak­ing mat­ters in­to their own hands, re­ceiv­ing unau­tho­rized boost­ers and mix­ing prod­ucts.

“In the re­al world, all these kinds of com­bi­na­tions or ex­tra boost­ers are al­ready hap­pen­ing,” he said. “So I think it’s a mat­ter of some ur­gency for FDA to help sort out what is ad­mit­ted­ly a com­pli­cat­ed and chal­leng­ing sce­nario. But we can’t hide from it, and I do think we need to give guid­ance to the pub­lic.”

Sep­a­rate­ly, the agency al­so of­fered an EUA for a sin­gle boost­er half-dose of the Mod­er­na vac­cine that may be ad­min­is­tered at least 6 months af­ter com­ple­tion of the pri­ma­ry se­ries to se­niors, those at high risk of se­vere Covid, and those who work in places where there’s a high risk of ex­po­sure to the virus.

For J&J, FDA said the boost­er may be ad­min­is­tered for any adult, at least 2 months af­ter com­ple­tion of the sin­gle-dose pri­ma­ry reg­i­men.

Pe­ter Marks

Both of those rec­om­men­da­tions for Mod­er­na and J&J boost­ers fol­lowed unan­i­mous votes from the FDA’s vac­cine ad­comm.

The CDC’s Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices will vote on a rec­om­men­da­tion to­day for which groups should re­ceive boost­ers. It will al­so dis­cuss new safe­ty up­dates. But as the Pfiz­er boost­er au­tho­riza­tion showed, the CDC di­rec­tor does not have to fol­low ACIP’s rec­om­men­da­tions.

“We will work to ac­crue ad­di­tion­al da­ta as quick­ly as pos­si­ble to fur­ther as­sess the ben­e­fits and risks of the use of boost­er dos­es in ad­di­tion­al pop­u­la­tions and plan to up­date the health­care com­mu­ni­ty and pub­lic with our de­ter­mi­na­tion in the com­ing weeks,” CBER di­rec­tor Pe­ter Marks said in a state­ment.

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

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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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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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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.

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Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

As first Omi­cron case in US crops up, re­searchers won­der: Which an­ti­bod­ies, vac­cines will hold up?

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

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Mod­er­na los­es lat­est bat­tle in key vac­cine de­liv­ery patent fight as fed­er­al ap­peal falls flat

The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.

For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ’069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.

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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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