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?”

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.

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.

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: