Statement on COVID-19 Vaccine Clinical Studies in Children & Adolescents

01/12/2022

The U.S. FDA requested additional participants at a given dose level in pediatric cohorts after the VRBPAC review of requirements for pediatric EUA on June 10, 2021, and Moderna complied at that time. Outside the United States, Moderna has received regulatory authorizations in Europe, UK, Australia, and Canada for adolescents 12-17 years of age, and has submitted applications for 6-11 years of age.

In early December, Moderna also decided to evaluate the potential of lower doses to meet regulatory guidance for immunogenicity in children 6-11 years of age and in adolescents 12-17 years of age in our ongoing clinical trials. The Company is also evaluating a booster dose in adolescents 12-17 years of age. The Company is in the process of implementing those various protocol amendments.

We expect to report data in children 2-5 years of age in March. If the data is supportive and subject to regulatory consultation, Moderna may proceed with regulatory filings for children 2-5 years of age thereafter.


This post contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the Company’s development of a vaccine against COVID-19 (mRNA-1273); the Company’s evaluation of different doses for mRNA-1273 in adolescent and pediatric populations; the evaluation of booster doses of mRNA-1273 in adolescents; and the timing for anticipated results in pediatric trials for mRNA-1273 and subsequent regulatory filings. The forwardlooking statements in this press release 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, many of which are beyond Moderna’s control and 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 other 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 post 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.