The U.S. Food and Drug Administration (FDA) on Friday notified Moderna that the agency would require additional time to review and evaluate possible risks associated with the vaccine – particularly, a possible risk of myocarditis after vaccination.
The FDA delay could last several weeks, but the timing is unclear. The agency merely plans to further review data before making a final decision.
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However, that delay alone was enough to spook some investors into dumping their Moderna shares. The stock dropped 5% after trading started Monday morning. As of 10 a.m., the stock price had gone up and down again, and the value was down by about 6%.
In a press release Sunday, Moderna noted that an increased risk of myocarditis has been noted for COVID-19 vaccines, including the Moderna-produced vaccine. Moderna further noted that the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) have said the risk for this condition has been rare and generally mild.
The most notable example of cases occurred in four Nordic countries – Denmark, Finland, Norway and Sweden – that decided to recommend against the use of Moderna’s COVID-19 vaccine for younger age groups, The Wall Street Journal reported.
The European Medicines Agency (EMA) said Thursday that new preliminary data from those four countries supports a warning adopted in July that inflammatory heart conditions can occur in very rare cases. The EMA warning also applied to the Pfizer-BioNTech COVID-19 vaccine.
A Moderna spokesperson said Thursday that the company was aware of the decision in Europe and noted that COVID-19 itself increases the risk of these heart conditions.
Moderna estimated that around 1.5 million adolescents have received the Moderna COVID-19 vaccine and that the observed rate of myocarditis in adolescents under the age of 18 do not suggest an increased risk for the condition.
"Moderna is committed to conducting its own careful review of new external analyses as they become available," the company said in its statement Sunday. "The Company does not yet have access to data from some recent international analyses."
The movement of Moderna stock indicates that some shareholders are not confident that Moderna will receive approval and that the FDA may instead follow the EMA and Nordic examples.
Moderna did however confirm that it will now delay filing a request for Emergency Use Authorization (EUA) for use of its COVID-19 vaccine for an even younger group aged 6 to 11 years old.