Covid-19 vaccine for children under six seeking approval

While protection against SARS-CoV-2 infection is not that good, the Moderna Covid-19 vaccine does strongly prevent young children from having severe disease, being hospitalised and dying from the disease. — AFP

American biotech firm Moderna is pursuing regulatory approval for its Covid-19 vaccine in children under six years of age after the two-shot regimen was found to be safe and produced a strong immune response, the company said on Mac 23 (2022).

Specifically, two doses of 25mcg given to babies, toddlers and preschoolers, generated similar levels of antibodies to two doses of 100mcg given to young people aged 18-25, indicating that there would be similar levels of protection.

Children under six are the only age group that have yet to gain access to a Covid-19 vaccine in the United States and most of the world.

Based on the data, Moderna said it would submit authorisation requests to the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and other global regulators in the coming weeks.

The results “are good news for parents of children under six years of age,” said CEO Stephane Bancel in a statement.

“We now have clinical data on the performance of our vaccine from infants six months of age through older adults.”

The company did however find relatively low vaccine efficacy against infection, with its clinical trial taking place during the SARS-CoV-2 Omicron viral variant wave.

Vaccine efficacy in children six months up to two years old was 43.7%, and efficacy was 37.5% in the two-to-five-years age group.

The majority of these cases were mild and the two doses still provided very strong protection against severe outcomes.

There were no hospitalisations or deaths.

Moderna said this was consistent with what had been observed among adults, and the company was evaluating a third dose as a booster, to increase efficacy against infection by the Omicron viral variant.

The trial included 4,200 children aged two to six years and 2,500 children aged six months to two years.

Side effects were generally mild and consistent with those seen in older age groups.

Rates of fever greater than 38°C were around the same as commonly-used and recommended paediatric vaccines: 17% in the six-months-to-two-years group, and 15% in the two-years-to-six-years group.

The company added that, after consulting with the US FDA, it is also applying to be authorised among children six to 11 for two doses of 50mcg, and updating its application for authorisation in teenagers aged 12 through 17.

The EMA and other regulators have already authorised the Moderna vaccine in these age groups.

Last month (February 2022), the US FDA postponed a meeting of a panel to consider the Pfizer-BioNTech Covid-19 vaccine for children younger than five, saying it required additional data on third doses.

The companies said they expected that data to be ready by next month (April 2022). – AFP Relaxnews