US authorises Pfizer vaccine for children as young as 12

The US has become the second country to authorise use of the Pfizer vaccine in children, in what has been hailed as a “watershed moment” in the battle to end the pandemic.

The Food and Drug Administration (FDA) has authorised Pfizer’s Covid-19 vaccine for children aged 12 to 15, but the decision must now be ratified by an advisory committee of the government’s Centres for Disease Control and Prevention (CDC).

If the CDC approves the decision at a scheduled meeting on Wednesday, vaccinations of children can begin immediately.

Until now, only those aged 16 and older have been permitted to receive the two-dose vaccine in the US. Canada is the only other country to approve the vaccine’s use in children as young as 12, but Pfizer has requested similar authorisation in the European Union.

The FDA’s decision comes after a trial of more than 2,260 volunteers in the US aged between 12 and 15 showed the vaccine was safe and offered strong protection.

The trial saw 18 cases of COVID-19 in the group that was given the placebo and none among those who were given the vaccine. It also found that the children developed higher levels of antibodies than earlier studies had seen in young adults.

Expanding vaccine availability to younger teenagers will make about 13 million additional Americans eligible for vaccination, a step that some see as critical to reaching herd immunity and improving safety as children return to school. 

Dr Bill Gruber, Pfizer senior vice-president, told the Associated Press: “This is a watershed moment in our ability to fight back the COVID-19 pandemic.”

While children are far less likely than adults to get seriously ill, the age group represents nearly 14 per cent of coronavirus cases in the US. At least 296 children have died in the US after contracting the virus and more than 15,000 have been hospitalised, according to the American Academy of Pediatrics (AAP).

The AAP said: “The known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks, supporting the vaccine’s use in this population.”

Pfizer has said it will have safety and efficacy data for children aged between two and 11 in September and it plans to ask the US to extend authorisation then.

The drive to vaccinate children could, however, be hampered by vaccine hesitancy. 

According to a US report published in May, only around 29 per cent of the parents surveyed said they would get their child vaccinated “right away” as soon as the child was eligible. 

According to the Kaiser Family Foundation Covid-19 Vaccine Monitor data, an additional 32 per cent of parents said they would wait to see how the jab is working before getting their child vaccinated. 

The remaining parents said that their child would either be vaccinated only if their school requires it (around 15 per cent) or definitely wouldn’t be vaccinated (around 19 per cent).