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SILVER SPRING, Maryland: A panel of external advisers from the US Food and Drug Administration is expected to endorse the emergency use of Moderna’s coronavirus vaccine during a meeting Thursday (December 17), as the nation prepares to launch a second vaccine.
The panel’s vote on whether the vaccine’s benefits outweigh its risks is likely to come some time after 3 p.m. ET (4 a.m. Singapore time, Friday), with an FDA clearance expected on Friday.
This is the same committee of expert advisers that last week endorsed the COVID-19 vaccine from Pfizer and German partner BioNTech, clearing the way for the FDA’s emergency use authorization (US) a day later.
This vaccine is distributed throughout the country. On Monday, a mass vaccination program began in US hospitals.
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The Moderna vaccine uses similar messenger RNA technology but with less onerous cold storage requirements than the Pfizer-BioNTech vaccine, making it a better option for rural and remote areas. Both vaccines were 95 percent effective in preventing disease in pivotal clinical trials.
The FDA advisory committee is likely to discuss Moderna’s reports of side effects from its 30,000-person trial, which were more frequent than those reported by Pfizer. These are primarily reactions of relatively short duration to the vaccine rather than serious adverse events.
Analysts at SVB Leerink said that the Moderna vaccine appears less tolerable than the Pfizer-BioNTech injection, but noted that it is not an adequate comparison between trials and is unlikely to get in the way of an EUA.
FDA staff did not raise serious safety concerns in documents released Tuesday in preparation for the meeting. He said a link between Bell’s palsy, which causes temporary paralysis of the facial muscles, and the vaccine could not be ruled out after some cases were reported in trials of both vaccines.
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Pfizer and BioNTech said those cases occurred at the same rate as in the general population.
Moderna seeks authorization for people over 18 years of age. That could sidestep last week’s lively discussion among panel members about whether there was enough data to authorize the use of the Pfizer-BioNTech vaccine in teens ages 16 and 17. They finally voted in favor of the vaccine for those over 16 years of age.
The initial supply of Moderna vaccines would likely go to the United States, which has signed deals to secure up to 200 million doses and expects the first 20 million this month. The vaccine is given in two doses approximately four weeks apart.
The company has also signed supply agreements with Canada, the European Union and the United Kingdom. Regulators are conducting a “continuous review” of the vaccine for all three.
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