There were also three cases of Bell’s palsy, which temporarily paralyzes facial muscles, among vaccine recipients, compared with just one among those getting a dummy shot. The FDA review said the role of the shot in the vaccine group “cannot be ruled out.”
An unanswered question is whether the vaccine also prevents people from symptomless infection – but Moderna found a hint that it may. Study participants had their noses swabbed prior to the second dose of either vaccine or placebo. At that one timepoint, swabs from 14 vaccine recipients and 38 placebo recipients showed evidence of asymptomatic infection, said Moderna’s Dr. Jacqueline Miller.
After the FDA acts, U.S. officials plan to move out an initial shipment of nearly 6 million Moderna doses. The vaccine needs to be stored at regular freezer temperatures, but not the ultra-cold required for Pfizer-BioNTech’s shot.
Hundreds of millions of additional shots will be needed to eventually vaccinate the general public, which isn’t expected until the spring or summer. The government’s Operation Warp Speed program has orders for 200 million doses of Moderna’s vaccine. That’s on top of 100 million doses of the Pfizer-BioNTech vaccine. Officials are negotiating to purchase more doses of that vaccine.
Like the first vaccine, Moderna’s vaccine will remain experimental as the company continues a two-year study needed to answer key questions, including how long protection lasts.
One of the trickiest issues panelists debated was how to keep study volunteers who received a dummy shot from dropping out to get the real shot once its authorized. Their participation is critical in order to have a comparison for long-term safety and effectiveness.
Moderna proposed immediately alerting all those volunteers of their status and offering them the vaccine. The company said more than 25% of its participants are health workers and some are already leaving to get the first vaccine.
But an invited expert from Stanford University urged Moderna to adopt Pfizer’s approach. Pfizer plans to gradually vaccinate people in its placebo group based on when they would have normally had access to the vaccine, as priority groups are established.
But most panelists acknowledged it will be hard to keep volunteers from leaving the Moderna study if they have to wait to get the vaccine.
“The reality may make that too difficult to do,” said Dr. Steven Pergam of the Seattle Cancer Care Alliance.
The only COVID-19 death in the 30,000 volunteers was in a placebo recipient, a 54-year-old man whose only risk factor was diabetes.
Knowing there could be more severe coronavirus in placebo recipients as the pandemic continues “weighs heavily on me,” said Moderna’s Miller.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
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