Moderna has made the official request to the FDA to approve its COVID-19 for use in children ages 6 months to 5 years. Moderna also announced the location of its first non-U.S. mRNA manufacturing facility.
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Moderna has officially submitted a request to the U.S. Food and Drug Administration for its COVID-19 vaccine to be granted emergency use authorization (EUA) for children 6 months to 2 years, and for children 2 years to under 6 years of age. It has also submitted similar requests to other global regulators.
“We are proud to share that we have initiated our EUA submission for authorization for our COVID-19 vaccine for young children,” said Moderna CEO Stephane Bancel. “We believe mRNA-1273 will be able to safely protect these children against SARS-CoV-2, which is so important in our continued fight against COVID-19 and will be especially welcomed by parents and caregivers.”
The submission is for two shots of 25 micrograms. It is based on positive interim results from the Phase II/III KidCOVE trial, which was announced on March 23. It demonstrated robust neutralizing antibody response in the 6-month to 6-years age group and had a favorable safety profile. For the children 6 months to 23 months and 2 years to under 6 years, the antibody titers hit the statistical mark for similarity to adults in the COVE study, which was the primary objective of the trial.
That data included supportive preliminary efficacy analysis on cases that were primarily collected during the Omicron wave, including home testing. When data analysis was limited only to confirmed PCR testing, efficacy was 51% for 6 months to less than 2 years and 37% for 2 to <6 years.
KidCOVE is being conducted 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).
In related news, Moderna has reportedly chosen Montreal to build a manufacturing plant within the next two years, with vaccines to be produced by 2024. That timeline allows the factory to be built, inspected and approved by Health Canada. It’s designed not just for COVID-19 vaccines, but future mRNA vaccines for a variety of diseases that Moderna has in development. The facility will have a capacity of 30 million doses of vaccine annually.
Under the agreement with Canada, the country will receive priority access to the doses, as well as the ability to dictate what the factory manufactures. This allows for flexibility to respond to new or emerging threats.
At an August 2021 announcement of a memorandum of understanding, Bancel said, “The Government of Canada has the right at its own discretion to call the facility to make a product that it wants.”
This will be the first of Moderna’s manufacturing facilities outside the U.S. An official announcement is expected to be made on April 29 by Prime Minister Justin Trudeau and Quebec Premier Francois Legault.
The facility will include a research center and employ between 200 and 300 people. A specific site has not been announced, but it will be in the greater Montreal region. Due diligence is still being conducted on the site.
Bancel said they didn’t want to rush the decision. “You have to understand that these are decisions not for six months, one or two years, but it is a decision for 20, 30 or 40 years. It’s really important that we do it in a place where we have the right level of talent, who will become employees of Moderna.”
Since the beginning of the pandemic, the Trudeau government has invested $1.6 billion in approximately 30 projects associated with biomanufacturing, vaccines and therapies.
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