Tuesday, 30 November, 2021
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Moderna interim results show that its low-dose vaccine works for 6-11-year-olds

A low dose of Moderna’s COVID-19 vaccine appears to be efficacious in 6- to 11-year-olds, says the manufacturer as it joins its rival Pfizer in expanding shots to children, reports STAT News.

Pfizer’s kid-size vaccine doses are closer to widespread use. They are undergoing evaluation by the US Food and Drug Administration for youngsters in nearly the same age group, 5 to 11, and could be available by early November. The company’s vaccine already is authorised for anyone 12 or older.

Moderna hasn’t yet been given the go-ahead to offer its vaccine to teens but is studying lower doses in younger children while it waits.

Researchers tested two shots for the 6- to 11-year-olds, given a month apart, that each contained half the dose given to adults. Preliminary results showed vaccinated children developed virus-fighting antibodies similar to levels that young adults produce after full-strength shots, Moderna said in a news release.

The study involved 4,753 children ages 6 to 11 who got either the vaccine or dummy shots. Moderna said that like adults, the vaccinated youngsters had temporary side effects including fatigue, headache, fever, and injection site pain. The study was too small to spot any extremely rare side effects, such as heart inflammation that sometimes occurs after either the Moderna or Pfizer vaccines, mostly among young men.

Moderna hasn’t submitted its data to a scientific journal but said it plans to share the interim results with the FDA and global regulators soon. The study is ongoing, and the company cannot calculate the vaccine’s effectiveness in actually preventing infections in children unless there are sufficient COVID-19 cases with which to compare rates between vaccinated and unvaccinated participants.

“We are encouraged by the immunogenicity and safety profile of mRNA-1273 in children aged 6 to under 12 years and are pleased that the study met its primary immunogenicity endpoints,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We look forward to filing with regulators globally and remain committed to doing our part to help end the COVID-19 pandemic with a vaccine for adults and children of all ages.”

The FDA hasn’t yet ruled on the company’s application to expand its vaccinations to 12- to 17-year-olds, although some countries have cleared Moderna’s shots for adolescents.

But the US is expected to begin vaccinating children under 12 some time next month, if the FDA clears low doses of the Pfizer vaccine for 5- to 11-year-olds. Pfizer reported last week that its kid-size doses proved nearly 91% effective at preventing symptomatic COVID-19 in that age group, even as the extra-contagious delta variant was spreading widely.

FDA’s advisers will weigh Pfizer’s evidence in a public meeting this week. If the agency authorises Pfizer’s kid shots, then next week, the Centers for Disease Control and Prevention is likely to recommend who should receive them.

Study details from Moderna

Results from the Phase 2/3 study, called the KidCOVE study, of mRNA-1273, the company’s vaccine candidate against COVID-19, in children 6 to under 12 years of age: this interim analysis showed a robust neutralising antibody response after two doses of mRNA-1273 at the 50 µg dose level with a favourable safety profile. Moderna plans to submit these data to the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and other global regulators in the near term.

KidCOVE is a randomised, observer-blind, placebo-controlled expansion study to evaluate the safety, tolerability, reactogenicity and effectiveness of two 50 µg doses of mRNA-1273 given to healthy children 28 days apart. The study population is divided into 3 age groups (6 to <12 years, 2 to <6 years, and 6 months to <2 years). Today Moderna reports on the 6 to under 12 years of age cohort.

This cohort enrolled 4,753 participants who were 6 to less than 12 years of age. In the trial, the SARS-Cov-2-neutralising antibody geometric mean ratio (GMR) comparing the response in children to the response in young adults from the Phase 3 COVE study was 1.5 (95% Cl: 1.3, 1.8), with a seroresponse rate of 99.3%, representing a difference of 0.6% (95% CI: -2.8%, 2.8%) to the Phase 3 benchmark. These results demonstrate strong immune response in this cohort of children one month after the second dose and met the co-primary immunogenicity endpoints for 6 to less than 12 years olds in KidCOVE.

mRNA-1273 was generally well tolerated with a safety and tolerability profile generally consistent with the Phase 3 COVE study in adolescents and adults. The majority of adverse events were mild or moderate in severity. The most common solicited adverse events were fatigue, headache, fever, and injection site pain.

Safety data continue to accrue, and the study continues to be monitored by an independent safety monitoring committee. All participants will be monitored for 12 months after their second injection to assess long-term protection and safety. These data are subject to change based on ongoing data collection. The Company plans to submit data from the KidCOVE study to a peer-reviewed publication.

The enrollment for the 6 years to under 12 years is complete, but the Phase 2/3 study continues to enroll children ages 6 months to under 6 years of age. The company has enrolled approximately 5,700 paediatric participants in the US and Canada in the trial as a whole. 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 Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.

 

STAT article – Moderna says its low-dose Covid vaccine works for kids 6 to 11 (Open access)

 

Moderna release – https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-positive-top-line-data-phase-23-study-covid-19

 

See more from MedicalBrief archives:

 

Healthy boys at greater risk from vaccination than COVID itself — US analysis

 

FDA authorises Pfizer vaccine for adolescents

 

Phaahla’s move on jabs for 12-year-olds without parental consent ruffles feathers

 

Pfizer vaccination linked to 3x high risk of myocarditis — Israel study

 

 

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