| 30 May 2024, Thursday |

Pfizer to seek approval ‘in days’ for use of its vaccine in children aged 5 to 11

In few days, US medicines regulator might grant Pfizer the approval, for the use of its Covid-19 vaccine for children aged five to 11.

Chief executive Albert Bourla said it was a matter of “days, not weeks” before the company submits trial data to the Food and Drug Administration.

That will begin the process of applying for emergency use authorization for the vaccine, which could be completed in three to six weeks, experts said.

Pfizer recently said trial data suggested its vaccine – produced with German partner BioNTech – was safe and effective for children aged 5 to 11.

It is using a lower dose in the age group, which is a third of that given to adults and older children.

Mr Bourla told the ABC news network once the company submitted the data, it was up to the FDA to “determine whether the vaccine should be approved,” adding Pfizer will be ready “to provide this new formulation of the vaccine” if it is.

Pfizer said the vaccine provokes a strong immune response, comparable to older age groups, despite the lower dose.

Trials are continuing in younger age groups.

Data for Pfizer’s vaccine among children aged six months and older, which uses an even smaller dose than that for the 5-11 group, is expected at the end of October.

The company will then file for emergency use authorisation for the shot if the data is positive.

Pfizer’s vaccine has been available to children over the age of 12 in the US, UAE and many other countries since May.

The vast majority of children experience only mild symptoms, or none at all.

However, they can and do catch the coronavirus and transmit it, and a small number become very sick or die as a result.

Data from Public Health Scotland this month found unvaccinated under-16s had a hospital admission rate of seven per 100,000 compared to 66 per 100,000 for unvaccinated people aged 60 or older.

A recent study reported in the journal Pediatrics showed Covid-19 led to more symptoms and complications than the flu in children, with underlying health conditions such as asthma and obesity presenting bigger risks.

According to the research, pneumonia and hypoxia, or a lack of oxygen, occurred more frequently in Covid-19 than seasonal flu.

Children can also suffer from ‘long Covid”.

According to the British Medical Journal, a recent large study conducted in the UK found as many as one in seven children, 14 per cent, may still have symptoms 15 weeks later. They include headaches, tiredness and breathing difficulties.