Moderna Aiding California Inquiry Into Allergic Reactions

Moderna Inc. is cooperating with California’s investigation into several cases of possible allergic reactions among people who received its Covid-19 vaccine, the company said Tuesday.

California State Epidemiologist Erica Pan recommended providers withhold shots from one batch of Moderna’s vaccine “out of an extreme abundance of caution.” The recommendation came after the state received reports of several people experiencing serious allergic reactions following immunization from the same batch, a higher-than-usual number, Pan said in a statement.

About 1 in 100,000 people have had a severe allergic reaction to Pfizer Inc. and BioNTech SE’s vaccine, which uses similar technology as Moderna’s shot, the U.S. Centers for Disease Control and Prevention said earlier this month. That rate means the phenomenon is rare, though regulators are closely tracking the safety of Covid-19 vaccines.

Moderna shares fell 4% Tuesday in afternoon trading in New York.

Six possible allergic reactions were reported Jan. 13 at Petco Park, a baseball stadium in San Diego hosting a mass vaccination clinic, a county health official said at a press conference.

A county health department spokeswoman said the lot the state is referring to matches the one used at Petco Park when the possible reactions were observed. The county stopped using doses from the same batch at other clinics, resulting in about 30,000 doses being pulled from the county’s supply, she said in an email Tuesday.

Moderna in a statement Tuesday said about 1.3 million doses were produced in the batch in question. Of those, 964,900 doses already have been distributed to about 1,700 vaccination sites in 37 states, Moderna said. The batch was shipped between January 4 and January 8, and the company expects most of the doses already have been used.

Inquiry Continues

“This investigation is still ongoing and Moderna is working closely” with the U.S. Food and Drug Administration and CDC “to understand the clinical cases and whether the broad pause in use of the lot is warranted,” the company said in a statement.

The CDC and FDA currently do not recommend health departments stop administering this or any lots of Moderna’s Covid-19 vaccine, FDA spokeswoman Abby Capobianco said in an email. The FDA is working with the CDC, the California Department of Health and Moderna to investigate the potential adverse events reported at the vaccination clinic, she said.

CDC did not immediately respond to requests for comment.

The California Department of Public Health in its statement Sunday said more than 330,000 doses from the batch have been distributed to 287 providers in California. The state said it has not been notified of another cluster or similar reports of allergic reactions related to this batch.

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