Statement on California Department of Public Health (CDPH) Report
Update January 20, 2021: The California Department of Public Health (CDPH) announced that it is advising providers that they can immediately resume the administration of lot 041L20A of the Moderna COVID-19 Vaccine, following an in-depth review of possible allergic reactions reported by some recipients. According to California State Epidemiologist Dr. Erica Pan in a statement issued by CDPH, “We convened the Western States Scientific Safety Review Workgroup and additional allergy and immunology specialists to examine the evidence collected. We had further discussions with the County of San Diego Department of Public Health, the FDA, CDC and manufacturer, and found no scientific basis to continue the pause. Providers that paused vaccine administration from Moderna Lot 41L20A can immediately resume. These findings should continue to give Californians confidence that vaccines are safe and effective, and that the systems put in place to ensure vaccine safety are rigorous and science-based. Members of my family who have qualified to receive the vaccine as health care workers or because of their age have already received the COVID-19 vaccine, and I encourage every Californian to get the vaccine when it's their turn."
January 19, 2021: Moderna acknowledges receiving a report from the California Department of Public Health (CDPH) that several individuals at one vaccination center in San Diego were treated for possible allergic reactions after vaccination from one lot of Moderna’s COVID-19 Vaccine. The Company is fully cooperating with CDPH in investigating these reported adverse events. Consistent with the statement from CDPH, at this point Moderna is unaware of comparable clusters of adverse events from other vaccination centers which may have administered vaccines from the same lot, or from other Moderna lots.
Moderna confirmed that a total of 1,272,200 doses were produced in batch number 041L20A, with nearly a million doses (964,900) already distributed to approximately 1,700 vaccination sites in 37 states. According to CDPH, that includes more than 330,000 doses from this lot distributed to 287 providers across the state of California. A total of 307,300 doses remain in storage and not yet distributed.
While Moderna said it does not know how many doses may have ended up in arms of people, it did report that the lot was shipped between January 4th and January 8th, and thus it expects that a significant portion of the distributed doses have been already used. This investigation is still ongoing and Moderna is working closely with FDA and CDC to understand the clinical cases and whether the broad pause in use of the lot is warranted.
Moderna said a detailed review of the manufacturing intermediates and final drug product was performed including raw materials, batch records, release and characterization testing results, and Moderna shipping and storage records. The review confirmed that all criteria for product release of lot 041L20A were met.
This statement contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: potential patient reactions to the Moderna COVID-19 Vaccine, the underlying cause of those reactions, and the process for assessing those reactions with the CDPH, FDA and CDC. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “could”, “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this statement are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this statement in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.