- Moderna tumbled as much as 7.2% on Tuesday even as FDA staff confirmed the company’s COVID-19 vaccine is safe and effective.
- The move sets up the shot for emergency use as early as next week.
- The staff’s report also pointed out that four of Moderna’s more than 30,000 trial participants had cases of Bell’s palsy, with three of the four having received the vaccine instead of a placebo.
- The FDA stopped short of directly linking the vaccine to cases of Bell’s palsy, but said a potential connection should be looked into.
- Watch Moderna trade live here.
Moderna fell as much as 7.2% on Tuesday despite the US Food and Drug Administration determining the company’s coronavirus vaccine is safe and effective at protecting against COVID-19.
The decision tees up Moderna’s vaccine for regulatory approval in a matter of days and emergency use as early as next week. The shot would be the second to be distributed across the US after deliveries of Pfizer’s vaccine began on Monday.
Staff also recommended hospitals observe vaccine recipients for possible cases of Bell’s palsy. The FDA’s report found that four of Moderna’s more than 30,000 trial participants had Bell’s palsy, with three of them having received the vaccine instead of a placebo.
The staff stopped short of directly linking the shot to the cases, but said the possible connection deserved to be looked into further.
“Currently available information is insufficient to determine a causal relationship with the vaccine,” the staff wrote.
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Pfizer’s vaccine, which also uses mRNA technology, showed similar links to Bell’s palsy cases in its own trials. Four Bell’s palsy cases emerged out of the roughly 43,000 Pfizer trial participants. All four cases received the vaccine over a placebo.
Bell’s palsy is a form of temporary facial weakness or paralysis that results from a dysfunctional cranial nerve, according to the National Institutes of Health. Steroids are highly effective at treating cases of new-onset Bell’s palsy and increase the chances of recovery of the affected facial nerve.
Two of the Bell’s palsy cases in patients who received Moderna’s vaccine have since been resolved, the FDA report said. Other than the Bell’s palsy cases, there were no “notable patterns or numerical imbalances” between Moderna’s vaccine group and placebo group for adverse reactions, the staff added.
Moderna traded at $144.89 as of 1:55 p.m. ET Tuesday, up about 655% year-to-date. The company has 18 “buy” ratings, six “hold” ratings, and two “sell” ratings from analysts.
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