Covid-19 roundup: Moderna notes higher myocarditis risk for young males when compared to Pfizer's vaccine; EMA signs off on Roche, Celltrion mAb treatments
Moderna’s new CMO Paul Burton spoke to reporters Thursday morning, attempting to defend his company’s vaccine against questions around heart-related risks that appear to be cropping up in very rare instances among younger men.
The media push comes as the Moderna vaccine has proven to be overwhelmingly safe in more than 155 million individuals. But countries like Finland, Sweden, Norway and Denmark have limited use of the Moderna vaccine to men over the age of 30, as it found the younger men who received the vaccine, known as Spikevax, had a slightly higher risk of developing myocarditis when compared to other vaccines.
“Some health authorities have noted a slightly increased risk of myocarditis when compared to the Pfizer-BioNTech vaccine and that equates to about 10 additional cases in every 100,000 people who would be vaccinated,” Burton said.
But he also noted that when myocarditis does appear, typically after the second dose with males, for the most part it resolves on its own. He also said the reason why men get myocarditis while women do not may be linked to testosterone.
Moderna did not respond to a question about further details for why the FDA has pushed back its review of the company’s vaccine for younger populations. The company previously said the FDA needs additional time to complete its assessment for the vaccine among adolescents 12 to 17 years old because the agency wants to “evaluate recent international analyses of the risk of myocarditis after vaccination,” Moderna said. The review could take until January.
EMA endorses first 2 mAb treatments from Roche and Celltrion
As Covid-19 cases continue to increase across Europe, the European Medicines Agency on Thursday signed off on two new monoclonal antibody treatments submitted by Roche (Regeneron developed the mAb) and Celltrion.
Although the US has authorized and distributes three mAb treatments to states (developed by Regeneron, Eli Lilly and GSK/Vir), these are the first two OKs from the EMA for mAb treatments.
EMA’s human medicines committee recommended authorizing Roche and Regeneron’s mAb treatment, known in the EU as Ronapreve, for treating Covid-19 in those who are 12 years of age and older, weigh at least 40 kilograms (88 pounds), and who are at increased risk of their disease becoming severe but do not yet require supplemental oxygen.
Ronapreve also won a nod as a prophylactic in the same population.
With regard to Celltrion’s Regkirona, the committee recommended authorizing the treatment for adults with Covid-19 who do not require supplemental oxygen and who are also at increased risk of their disease becoming severe.