Moderna stock slips on FDA COVID-19 booster data uncertainty

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COVID vaccine manufacturer on booster shot plans

John Chiminski, the CEO of Catalent Pharma Solutions, which manufactures COVID vaccines for Moderna, Johnson & Johnson and AstraZeneca, says his his company is taking a 'go forward' approach by ramping up capacity to account for booster shots. 

Moderna shares kicked off the week lower over speculation its COVID-19 booster vaccine may not be ready in time for a planned push. 

"We were hoping that we would get the both the candidates, both products Moderna and Pfizer, rolled out by the week of the 20th, it is conceivable that we will only have one of them out, but the other would likely follow soon thereafter," said National Institute of Allergy and Infectious Diseases Director Anthony Fauci during an appearance on "CBS Face the Nation." "And the reason for that is that we, as we've said right from the very beginning, we're not going to do anything unless it gets the appropriate FDA regulatory approval." 

Pfizer is on track to meet the Sept. 20 deadline, a White House official told Fox News last week, while the company referred FOX Business to the FDA. 

Moderna began submitting data on its version to the FDA for review last week. 

"We are pleased to initiate the submission process for our booster candidate at the 50 µg dose with the FDA," Stéphane Bancel, CEO of Moderna, said in a statement. "Our submission is supported by data generated with the 50 µg dose of our COVID-19 vaccine, which shows robust antibody responses against the Delta variant."

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Moderna intends to submit the data to Europe’s regulatory agency and authorities worldwide in the days ahead. A third dose of Moderna's vaccine at the 0.5 mL dose recently became available to a small fraction of the U.S. adult population with weak immune systems, such as recipients of a solid organ transplant or those diagnosed with conditions considered to have a similar level of immunocompromise.

The nation’s top health officials on Aug. 18 said the U.S. is prepared to begin offering COVID-19 vaccine booster shots to Americans beginning Sept. 20, pending FDA review. The FDA intends to convene an advisory panel on Sept. 17 to weigh the Pfizer-BioNTech COVID-19 booster shot.

"We remain committed to staying ahead of the virus and following the evolving epidemiology of SARS-CoV-2," Bancel said. "We will continue to generate data and transparently share to support governments and regulators as they make evidence-based decisions regarding future vaccination strategies."

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The findings stem from a Phase 2 trial among 344 participants who received a booster dose six months after their second shot, which was said to result in a similar level of neutralizing antibodies across age groups under study, with a safety profile similar to the second dose. Moderna plans to submit the data to a peer-reviewed journal.

Another analysis indicated that the booster vaccine increased antibody levels against variants of concern, including a 42.3-fold increase against the highly transmissible delta variant behind the majority of new infections nationwide. Moderna previously announced it had been assessing three boosters in a Phase 2 trial: a 50 µg dose of mRNA-1273, a beta variant-specific shot, mRNA-1273.351 and another vaccine involving a "50-50 mix" of the previously authorized vaccine and the variant-specific booster shot.