Some­times, be­ing late can give you an ad­van­tage.

Thomas Tri­om­phe

That’s what Sanofi and GSK are try­ing to say as the Big Phar­ma part­ners re­port pos­i­tive re­sults from a late-stage tri­al of their next-gen bi­va­lent Covid-19 vac­cine, which was de­signed to pro­tect against both the orig­i­nal strain of the SARS-CoV-2 virus and the Be­ta vari­ant. Specif­i­cal­ly, against Omi­cron, they note, the vac­cine de­liv­ered 72% ef­fi­ca­cy in all adults and 93.2% in those pre­vi­ous­ly in­fect­ed.

“With the im­muno­genic­i­ty da­ta from our Be­ta-boost­er vac­cine, they sup­port our be­lief that, in a large­ly seropos­i­tive world, a next-gen­er­a­tion Be­ta boost­er vac­cine could pro­vide pro­tec­tion against vari­ants like Omi­cron,” said Thomas Tri­om­phe, Sanofi’s EVP of vac­cines, in a state­ment. “mR­NA has proven speed to mar­ket; we are demon­strat­ing here the ef­fi­ca­cy that our re­com­bi­nant pro­tein plat­form can pro­vide to the world.”

Roger Con­nor

The com­pa­nies are hop­ing to make this can­di­date avail­able by the end of the year, added Roger Con­nor, pres­i­dent of GSK Vac­cines.

Sep­a­rate­ly, Sanofi and GSK are wrap­ping up their reg­u­la­to­ry sub­mis­sions on a Be­ta-on­ly boost­er can­di­date and, armed with da­ta un­veiled re­cent­ly, say they will stand ready to roll out a boost­er cam­paign.

In Stage 2 of the Phase III VAT08 tri­al, which en­rolled 13,000 adult par­tic­i­pants, the bi­va­lent vac­cine can­di­date demon­strat­ed an ef­fi­ca­cy of 64.7% over­all against symp­to­matic Covid-19.

The 72% ef­fi­ca­cy in Omi­cron-con­firmed symp­to­matic cas­es was cal­cu­lat­ed based on se­quenc­ing per­formed for 71 cas­es out of 121 to­tal cas­es to date.

Fur­ther­more:

In pre­vi­ous­ly seropos­i­tive pop­u­la­tions, the Sanofi-GSK vac­cine can­di­date demon­strates an over­all ef­fi­ca­cy of 75.1% (95% con­fi­dence in­ter­val [CI, 56.3, 86.6]) against symp­to­matic in­fec­tion, and 93.2% (95% con­fi­dence in­ter­val [CI, 73.2, 99.2]) in Omi­cron-con­firmed symp­to­matic cas­es, ac­cord­ing to the se­quenc­ing analy­sis per­formed to date.

Sanofi and GSK had hoped ear­ly on that a com­bi­na­tion of their pro­tein-based vac­cine and ad­ju­vant tech­nolo­gies could bring a more tra­di­tion­al, even if slight­ly slow­er, op­tion to the ta­ble. But an ear­ly set­back de­layed their ef­forts, forc­ing them to shift strate­gies to fo­cus on a world that’s al­ready flood­ed with mR­NA and ade­n­ovirus-based shots.

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.