Sanofi vaccine stalls due to manufacturing error

Sanofi Pasteur, one of the world’s leading vaccine manufacturers, has suffered a major setback in its efforts to develop a Covid-19 vaccine, STAT’s Helen Branswell reports. The shot’s efficacy was underwhelming in older adults in a Phase 1/2 trial, despite having prompted a strong immune response in younger people.

When Sanofi dug into these incongruous results, it found that an inadequate formulation of its vaccine had been given to trial participants, Su-Peing Ng, global medical head for Sanofi Vaccines, told STAT. This will push the timeline for the vaccine’s approval — if it’s approved at all — from the first half of 2021 into the second half of the year, the company said. Sanofi and its development partner, GSK, had been expecting to produce 1 billion doses of the vaccine next year.

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Expert panel endorses Pfizer/BioNTech vaccine

An advisory committee made up of outside experts voted yesterday to recommend the Food and Drug Administration authorize the Covid-19 vaccine developed by Pfizer and BioNTech. STAT staffers followed the daylong affair, hour by hour, and you can read their entire chronicle here.  

Over the course of the hearing, members of the committee dug into some of the major questions about the vaccine — such as whether people who have severe allergies should abstain from getting inoculated. They also discussed the issue of vaccination of people who are pregnant or lactating — since these populations were not included in clinical trials.

Barring major surprises, the next step is clear: An historic EUA from the FDA. 

The ever-evolving Covid-19 vaccine timeline

The Covid-19 vaccine timeline keeps getting pushed back — even before a rollout has begun, STAT’s Olivia Goldhill writes.

The Trump administration initially declared that 300 million vaccine doses would be available by January 2021, with the first distributed in October of this year. Currently, the plan is for 40 million vaccine doses to be distributed in December, but many are skeptical that goal can be met. The leading reason for delays: manufacturing.

“Manufacturing never goes 100%. There’s always issues and stock you have to throw out,” one pandemic response expert told STAT. “You bake a thousand cakes, you’re not going to get a thousand successful cakes.”

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Turning condensates into therapeutics

Cambridge startup Faze Medicines just launched with $81 million, with aims to develop condensate-based drugs to target diseases like amyotrophic lateral sclerosis and myotronic dystrophy. Condensates are membrane-less organelles, or clusters of molecules like proteins and nucleic acids, that help cells function. They’re increasingly becoming a focus in developing therapeutics: This past September, for instance, Boston’s Dewpoint Therapeutics raised $77 million for its own condensate work. 

“Enormous numbers of publications and companies are popping up, and we see that as fantastic recognition of what matters here,” Faze CSO Rachel Meyers said. “We are all about the idea that we need to translate this cool biology into drugs.”

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Supreme Court decision a blow to PBMs

The U.S. Supreme Court yesterday struck a blow against pharmacy benefit managers: It ruled that an Arkansas law can be used to regulate these controversial middlemen, STAT’s Ed Silverman writes.

The state law tasks PBMs with reimbursing pharmacies at or above the wholesale costs paid for generic drugs. It also prevents them from paying their own drug stores more than what is paid to other pharmacies — meaning that, for example, CVS Health’s PBM branch can’t favor its own pharmacies. 

“This is a historic victory for independent pharmacies and their patients,” National Community Pharmacists Association CEO B. Douglas Hoey said in a statement. “And it confirms the rights of states to enact reasonable regulations in the name of fair competition and public health.”

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More reads

• In a petition, Boehringer warns FDA its definition of ‘strength’ threatens biosimilar competition. (STAT)
• In biopharma mergers and acquisitions, managing regulatory compliance early protects return on investment. (STAT)
• Moderna doses adolescents in Covid-19 vaccine study (MarketWatch)