- Global Pharma News & Resources

EMA Committee for Medicinal Products for Human Use (CHMP) Adopts Positive Opinion Recommending Authorization for The Use of The Moderna Covid-19 Vaccine in Children (6-11 Years) In the European Union

EMA Committee for Medicinal Products for Human

Use (CHMP) Adopts Positive Opinion Recommending

Authorization for The Use of The Moderna Covid-19

Vaccine in Children (6-11 Years) In the European



Announcement follows CHMP's previous decision to adopt a positive opinion recommending marketing

authorization for Moderna's COVID-19 vaccine to include adolescents 12 years of age and older.

CAMBRIDGE, MA / ACCESSWIRE / February 24, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company

pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European Medicines

Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion

recommending a variation to the conditional marketing authorization (CMA) to include a 50 μg two-dose series of

Spikevax, the Company's vaccine against COVID-19, in children ages 6-11 years. Following the CHMP's positive

opinion, the European Commission will make an authorization decision on the use of Spikevax in children ages 6-11


"The CHMP recommendation to authorize the use of our COVID-19 vaccine in children ages 6-11 years in Europe is

an important milestone. It highlights the eéectiveness and safety of our vaccine in this age group and helps to keep

our children safe and able to experience a normal school and family life," said Stéphane Bancel, Chief Executive

Oìcer of Moderna. "We are grateful to the CHMP for their thorough review of our submission and look forward to

an authorization decision from the European Commission."

Moderna's vaccine was investigated in the ongoing Phase 2/3 "KidCOVE" study, a randomized, observer-blind,

placebo-controlled expansion study to evaluate the safety, tolerability, reactogenicity, and eéectiveness of Spikevax

(mRNA-1273) given to healthy children 28 days apart. Data submitted to the CHMP from over 4,000 children

demonstrated that vaccination of children ages 6-11 years with a 50μ g mRNA-1273 primary series is associated

with non-inferior anti-SARS-CoV-2 neutralizing antibody responses when compared to that in individuals 18-25

years old from the Phase 3 COVE study. Positive direct eìcacy of two 50μ g doses of mRNA-1273 was also

demonstrated and vaccination was generally well tolerated.

The study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID),

part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority

(BARDA), part of the Oìce of the Assistant Secretary for Preparedness and Response at the U.S. Department of

Health and Human Services (HHS). The identiêer is NCT04796896.

The EMA has also recommended updates to the summary of product characteristics (SmPC) for the use of Spikevax

in the European Union. The booster dose of 50 μg indicated for individuals 18 years of age and older, is now

recommended at least three months following the second dose. This timing has been shortened from the

previously approved timeframe of six months. The changes also include the possibility to administer a heterologous

(mix-and-match) booster dose, such as Spikevax, following completion of primary vaccination with another

authorized COVID-19 vaccine.

Moderna recently announced that the Therapeutic Goods Administration in Australia also granted provisional

registration for the use of the Company's mRNA COVID-19 vaccine for active immunization to prevent COVID-19

caused by SARS-CoV-2 in children ages 6-11 years.

Authorized Use

SPIKEVAX (elasomeran mRNA vaccine) has been granted Conditional Marketing Authorization by the European

Commission, based upon the recommendation of the European Medicines Agency and is indicated for active

immunization to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals six years of age

and older. A booster dose may be given at least three months after the second dose for people aged 18 years and


About Moderna

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing

programs in the êeld of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and

therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial

production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and

commercial collaborators, which has allowed for the pursuit of both ground-breaking science and rapid scaling of

manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval

of one of the earliest and most-eéective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology

and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases,

immuno-oncology, rare diseases, cardiovascular diseases, and auto-immune diseases. Moderna has been named a

top biopharmaceutical employer by Science for the past seven years. To learn more, viswit

Forward Looking Statements

This post contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of

1995, as amended, including regarding: development of the Company's COVID-19 Vaccine (mRNA-1273, or

Spikevax); the potential approval of the vaccine in children ages 6-11 by the European Commission following the

positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human

Use; and the safety, eìcacy and tolerability of the vaccine in children ages 6-11. The forward-looking statements in

this press release are neither promises nor guarantees, and you should not place undue reliance on these forwardlooking

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 diéer 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 êled with the U.S. Securities and Exchange Commission (SEC) and in subsequent êlings made by Moderna with

the SEC, which are available on the SEC's website atw 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.

Moderna Contacts:


Luke Mircea Willats

Director, Corporate Communications

Editor Details

Last Updated: 25-Feb-2022