After the recent cratering of COVID-19 vaccine demand, biopharma's pandemic superstars are looking to bounce back with private-market launches this fall.
Meanwhile, the evolving nature of the virus presents a need for vaccines that can offer protection against new variants. And even as Pfizer, Moderna and Novavax wait for the FDA to sign off on their tweaked vaccines, a new virus variant has taken hold.
EG.5, nicknamed "Eris," has taken over as the dominant variant in the U.S., causing 17.3% of COVID cases so far this month, according to the Centers for Disease Control and Protection (CDC).
Eris has spread to 51 countries and has been named as a “variant of interest” by the World Health Organization (WHO). It's an offshoot of another variant called XBB.1.9.2.
Pfizer, Moderna and Novavax's updated vaccines are set to target the XBB.1.5 variant and are expected to launch shortly ahead of the fall vaccination season.
Novavax expects its new vaccine to protect against Eris due to the new variant's similarities with XBB, a spokesperson told Fierce Pharma over email. The company, which makes the only non-mRNA COVID vaccine available in the U.S., is running studies testing its new shot against Eris.
Meanwhile, Pfizer is closely tracking emerging variants and testing its vaccine against them. Its team is ready to produce “variant-modified vaccine templates” if necessary and is still prepared to dole out its newest vaccine in the commercial market by the end of August, pending approval, a spokesperson said.
Moderna is evaluating its shot against the variant as well and has so far seen protection in preliminary testing, a company spokesperson told The Wall Street Journal.
How sales will play out in the private market is anyone’s guess, but Moderna has predicted around 100 million doses will be administered in the U.S. this fall, below the average of 150 million doses for a flu season.
It will be a make-or-break moment for the vaccines that once reaped tens of billions of dollars in sales. Moderna posted a whopping sales decline of 93% during this year’s second quarter, generating just $344 million compared to last year's $4.75 billion. Pfizer’s vaccine partner BioNTech is feeling the pressure, as well, and is “carefully watching” its spending, finance chief Jens Holstein said in the company’s second-quarter earnings release.
Pfizer, too, has eyes on its costs and is prepared to launch an “enterprise-wide cost improvement program” if full-year COVID sales disappoint, CFO David Denton recently said. Its sales declined 53% during the second quarter thanks to shortfalls for its COVID vaccine and antiviral.
As for Novavax, the small company may not survive if the new launch doesn’t go as planned and has already revealed a plan to lay off 25% of its staffers to cut costs.