Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP Images)

Up­dat­ing the Covid-19 vac­cine: FDA of­fers a qual­i­fied thumbs-up ahead of ad­comm

The FDA’s ad­comm of out­side vac­cine ex­perts will meet to­mor­row to dis­cuss how to pro­tect the US from a like­ly com­ing wave of Omi­cron cas­es in the fall and win­ter, and whether to de­ploy vac­cines that specif­i­cal­ly tar­get the Omi­cron vari­ant.

While the da­ta so far are lim­it­ed, the FDA sound­ed an up­beat tone in the brief­ing doc­u­ments on Pfiz­er/BioN­Tech’s can­di­dates, re­leased this week­end ahead of the VRB­PAC meet­ing.

“The cur­rent epi­demi­ol­o­gy of SARS-CoV-2, the ev­i­dence of wan­ing im­mu­ni­ty elicit­ed by cur­rent COVID-19 vac­cines, and the avail­able im­muno­genic­i­ty da­ta gen­er­at­ed from a lim­it­ed num­ber of vari­ant-spe­cif­ic vac­cine can­di­dates sug­gest that an up­dat­ed vac­cine com­po­si­tion may pro­vide added ben­e­fit against cur­rent­ly cir­cu­lat­ing virus vari­ants,” the FDA said in its brief­ing doc­u­ments, adding:

This may be par­tic­u­lar­ly im­por­tant as the 2022-2023 win­ter sea­son pro­gress­es and the risk of an­oth­er ma­jor COVID-19 out­break in­creas­es due to the com­bi­na­tion of wan­ing im­mu­ni­ty, fur­ther evo­lu­tion of vari­ants, and in­creased in­door ac­tiv­i­ty. Nev­er­the­less, as not­ed above, un­cer­tain­ties re­main, and there are po­ten­tial trade-offs as­so­ci­at­ed with var­i­ous op­tions for mod­i­fy­ing the com­po­si­tion of cur­rent vac­cines

How­ev­er, the po­ten­tial ben­e­fits of this up­dat­ed vac­cine will have to be weighed by the ad­comm against mul­ti­ple un­cer­tain­ties, in­clud­ing un­known fu­ture vari­ants, the dearth of clin­i­cal ef­fi­ca­cy da­ta for these boost­ers com­pared to the pro­to­type vac­cines, and po­ten­tial man­u­fac­tur­ing is­sues that might arise re­lat­ed to pro­duc­ing an up­dat­ed vac­cine for­mu­la­tion, FDA said.

Pfiz­er said on Fri­day that its Omi­cron-adapt­ed mono­va­lent can­di­date giv­en as a fourth boost­er dose elicit­ed a 13.5 and 19.6-fold in­crease in neu­tral­iz­ing geo­met­ric titers against Omi­cron BA. 1, while its bi­va­lent vac­cine can­di­date ex­hib­it­ed a 9.1 and 10.9-fold in­crease against Omi­cron.

“Based on these da­ta, we be­lieve we have two very strong Omi­cron-adapt­ed can­di­dates that elic­it a sub­stan­tial­ly high­er im­mune re­sponse against Omi­cron than we’ve seen to date. We look for­ward to dis­cussing these da­ta with the sci­en­tif­ic com­mu­ni­ty and health au­thor­i­ties so we may rapid­ly in­tro­duce an Omi­cron-adapt­ed boost­er as soon as pos­si­ble if au­tho­rized by reg­u­la­tors,” Pfiz­er CEO Al­bert Bourla said in a state­ment.

The agency of­fers the com­mit­tee six op­tions for mak­ing a strain rec­om­men­da­tion:

  1. Make no rec­om­men­da­tion and let the vac­cine spon­sors just work with FDA, al­though that may re­sult in dif­fer­ent com­po­si­tions that are dif­fi­cult to com­pare mov­ing for­ward.
  2. Stick with the cur­rent com­po­si­tion of the vac­cines – like­ly main­tains good ef­fi­ca­cy against se­vere dis­ease, but the com­po­si­tion be­comes in­creas­ing­ly dis­tant from the cir­cu­lat­ing virus.
  3. Rec­om­mend that the com­po­si­tion of all boost­ers be up­dat­ed to con­tain an Omi­cron com­po­nent that has been test­ed clin­i­cal­ly.
  4. Rec­om­mend that the com­po­si­tion of all vac­cines used for boost­er dos­es be up­dat­ed to con­tain a more re­cent Omi­cron com­po­nent with­out clin­i­cal ev­i­dence.
  5. Rec­om­mend that the com­po­si­tion of all COVID vac­cines used for both pri­ma­ry se­ries and boost­ers be up­dat­ed to con­tain an Omi­cron com­po­nent, which might elim­i­nate con­fu­sion but there’s no da­ta on the ef­fi­ca­cy of a pri­ma­ry se­ries.
  6. Rec­om­mend that the com­po­si­tion of some vac­cines used for boost­er dos­es be up­dat­ed to con­tain some­thing oth­er than an Omi­cron com­po­nent (e.g., Be­ta vari­ant vac­cine), which could pro­vide ad­di­tion­al choic­es but may be con­fus­ing for the pub­lic.

The vot­ing ques­tion al­so seems to steer the pan­elists to not just weigh in on the Pfiz­er vac­cine specif­i­cal­ly, but to think about this sit­u­a­tion holis­ti­cal­ly. The vot­ing ques­tion is, “Does the com­mit­tee rec­om­mend in­clu­sion of a SARS-CoV-2 Omi­cron com­po­nent for COVID-19 boost­er vac­cines in the Unit­ed States?”

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FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Benjamin Oakes, Scribe Therapeutics CEO

CEO of Doud­na spin­out: With­in five years, genome ed­i­tors will have a 're­al­ly big im­pact' on pa­tients' lives

“CRISPR-by-design” is the idea behind Scribe Therapeutics, a company spun out from Jennifer Doudna’s Nobel-winning lab that’s competing in a closely-tracked field of genome editor companies just starting to make their way to the clinic.

After nabbing $100 million last March for its Series B funding round, Scribe is taking a different tack from some of its competitors, crafting a new enzyme isolated from bacteria called CasX, which has now been tweaked extensively and may be targeted to a range of genome-related diseases, offering a plethora of therapeutic options.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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Check­point ends tri­al due to Russ­ian in­va­sion; Terns lines up more cash for NASH

You can count a Phase III program at Checkpoint Therapeutics as the latest collateral damage from Russia’s invasion of Ukraine.

The biotech $CKPT reported this morning that it has had to scrap the late-stage CONTERNO trial combining cosibelimab with pemetrexed and platinum chemotherapy for non-squamous non-small cell lung cancer after the conflict slowed enrollment for the study.

According to Checkpoint: