Focus on US vaccine rollout for youngsters

AUSTRALIA can use America as the perfect test case for Moderna’s Covid vaccine for children aged under five.

Sydney University paediatrician and immunisation expert Prof Robert Booy said we can judge how the rollout goes in America while our Therapeutic Goods Administration evaluates the MRNA vaccine.

“We can afford to wait and follow the US. If we follow them two to three months later, we have the safety experience in millions of children to fall back on, to say: ‘Yes, it is well tolerated in that age group’,” Prof Booy said.

“They will have millions safely vaccinated to follow their example.”

Since Covid tends to be less severe in children, the balance of risks in terms of side-effects versus benefit was closely considered. More than 1200 children and adolescents have died in the US since the beginning of the pandemic and hospitalisations have soared with the arrival of the Omicron variant.

In examining side-effects provided by the company from their trial, the FDA found adverse reactions in younger children were generally lower compared with those observed in adolescents and young adults. Fevers were found to be not “substantially different” to all other childhood vaccines.

The FDA found the Moderna data on safety, immune response and effectiveness had “a favourable benefit-risk profile in all age groups”.

The Moderna vaccine for children aged six months to five-year-old is half the usual dose for older children and given as two 25 microgram doses administered at least a month apart. There will also be a third dose for high-risk children.

Australia will likely follow suit after a strict evaluation of the safety data.

Pfizer was given a provisional determination last Thursday, which means it can now apply to use its vaccine in the under-fives.

There have been more than 420,000 cases of Covid in children under nine in Australia and nine deaths.

“There are a small number of children in Australia who died, who were previously healthy before Covid,” Prof Booy said.

“Children under five who have a chronic medical problem should be front of the list of getting vaccinated against Covid. Flu itself is a bigger risk to children under five than Covid and they should get their flu jab first.

“We can’t predict among healthy children who will be the unusual child who will get Covid severely and that is why we give universal vaccinations to cover off the completely health child getting a severe dose of whatever disease is being vaccinated against.”

If the TGA approves the Moderna vaccine, the safety data will then be thoroughly assessed by the Australian Technical Advisory Group on Immunisation before any recommendation is made.