Dive Brief:
- Moderna is expanding production of the genetic backbone of its coronavirus vaccine, signing a multi-year deal with the new biotech manufacturing startup National Resilience.
- The agreement, announced by Resilience Wednesday, follows the company's recent application for FDA authorization of a half dose of its vaccine as a third, booster shot six months after initial vaccination. While Resilience's announcement did not specify how much the deal would boost Moderna's production, the vaccine maker forecast earlier this year it could make between 800 million and one billion doses in 2021 and up to three billion in 2022, depending in part on the booster dose authorized.
- Since launching in 2020 with backing from ARCH Venture Partners, Resilience has quickly built a manufacturing network through acquisitions of drug factories and other deals, including a recent alliance with Bluebird bio.
Dive Insight:
The spread of the delta variant across the U.S. and the world has driven case numbers among unvaccinated people, including children under 12, sharply higher. Global vaccine supply, therefore, remains a top priority for Moderna and its mRNA counterparts, Pfizer and BioNTech, which have been criticized for not widely sharing their production formulas with other drugmakers around the world.
"Uncontrolled spread globally that could result in new variants threaten control of the pandemic everywhere," Sara Oliver, an official at the Centers for Disease Control and Prevention, in an Aug. 30 meeting of federal vaccine advisers.
The U.S. has donated a relatively small number of doses to COVAX — the international effort to ensure low-income countries have access to vaccines — but the group remains hampered by inadequate supply as well as past missteps.
And while U.S. health officials grapple with how to ensure more global equity in vaccine access, they're also trying to rectify mixed messaging on when booster shots will be widely available to the general public in the U.S.
Currently, some immunocompromised people are allowed to receive a third dose of the Pfizer or Moderna vaccines. The FDA expanded its authorization for this population last month, and shortly after, the Biden administration said the general public could expect to start receiving booster doses the week of Sept. 20. While initial messaging indicated the extra dose should be given eight months after a person's first round of vaccination, Biden later suggested pushing the timeline up to as soon as five months.
However, federal health officials have reportedly asked the White House to scale back its plan to offer booster shots in late September, saying they need more time to review data, particularly for Moderna.
Should the FDA approve Moderna's lower, 50 microgram booster dose as a booster, the smaller dose could mean an increase in supply from the company, especially with the support from Resilience in manufacturing the mRNA component.
Moderna did not respond to a request for comment on updated supply projections as a result of the deal.