Statement on Myocarditis and Pericarditis
Moderna is aware of reports of myocarditis and/or pericarditis following administration of mRNA vaccines against COVID-19, including data presented by the U.S. Centers for Disease Control and Prevention on June 10, 2021 at the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee meeting.
After carefully reviewing the available safety data to date for Moderna COVID-19 Vaccine for cases of myocarditis and/or pericarditis, Moderna has not established a causal association with its vaccine. The company will continue to closely monitor these reports and is actively working with public health and regulatory authorities to further assess this issue.Forward-Looking Statements
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 lack of a causal relationship with the Moderna COVID-19 Vaccine, and the company’s ongoing efforts to monitor reports of myocarditis and pericarditis. 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 Annual Report on Form 10-K 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.