Q&A: When will Covid vaccines for primary age children be approved?

EMA expected to approve the Pfizer vaccines for children aged 5-11 in the coming weeks

Taoiseach Micheál Martin has said Covid-19 vaccines may be rolled out for primary school children early next year. What countries have approved the vaccines for children, and how will the process work here?

What age-groups is the State vaccinating now?

At the moment Ireland has approved Covid-19 vaccines for everyone aged 12 and above, which is in line with the rest of Europe.

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Which countries are vaccinating younger kids?

The United States approved the use of Pfizer Covid-19 vaccines for children aged 5-11 in late October, following the greenlight from the Food and Drug Administration (FDA). In recent days Canada has also authorised the use of the Pfizer vaccine on five- to 11-year-olds.

In China, the Sinovac vaccine has been approved for children as young as three-years-old in June, with Hong Kong following suit in recent days.


Chile became the first country in Latin America to approve the vaccine for young children in September, authorising the Sinovac shots for six-year-olds.

Is it approved in Europe?

Not yet, but last month Pfizer submitted an application to the European Medicines Agency (EMA), the EU’s medical regulator, seeking approval to extend its vaccine to five- to 11-year-olds.

Since then the EMA has been reviewing data from Pfizer, and results from ongoing trials examining how effective the vaccine is for younger children.

Initially the European regulator said the outcome of its evaluation would be announced in “a couple of months”. However on Monday, Mr Martin said the EMA decision was expected “within the next week or two”.

What happens then?

If the EMA issue approval for the vaccine, that decision will then be considered by the National Immunisation Advisory Committee (Niac).

Niac, an independent expert group of scientists and academics, will themselves review the data and trial results, before making a recommendation to Minister for Health Stephen Donnelly, who will bring it to Cabinet for approval.

The Niac process can take a number of weeks at a minimum, while the group considers its recommendation. So even if the EMA issue approval in early December, it would likely be January or February at the earliest before the vaccines were authorised for younger children.

What’s the evidence the vaccines work for children?

The results of trials of Pfizer’s vaccine on children aged 5- 11 were published in September, showing it produced strong antibody responses to the virus.

More than 2,000 participants were administered doses a third the strength of the standard two-shot vaccine given to adults.

The trial results showed the vaccine produced similar antibody levels to 16- to 25-year-olds given a full adult dose, with similar side effects. These included having a sore arm after the injection, as well as fatigue, muscle pain, headaches, or fever. The FDA said the vaccine had been found to be more than 90 per cent effective in preventing Covid-19 infection in five- to 11-year-olds.

Why would children need the vaccine?

Children aged 5- 12 accounted for 15 per cent of Covid-19 cases in the two weeks up to midnight last Thursday, according to latest Health Protection Surveillance Centre (HPSC) figures.

There were 8,870 cases among that age group, with teachers unions warning Covid-19 cases are “soaring” among primary school children.

While the chances of serious illness from Covid-19 is low, if children are not vaccinated they risk spreading the virus to others, or developing long Covid, as well as missing school and other activities.

How will the rollout likely work?

The vaccination programme for children would likely look much the same as the rollout of shots to those aged 12-15. It would require parents to give consent, and for children to be accompanied to vaccine appointments by an adult.

Jack Power

Jack Power

Jack Power is acting Europe Correspondent of The Irish Times