FDA gives green light to Pfizer for kids

At a meeting last week of the U.S. Food & Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee, unanimous agreement was given to recommend the Pfizer/BioNTech vaccine to be given to children in America aged five to 11, having already approved the vaccine for children aged 12 and over.

The FDA panel had to approve the question as to whether the benefits of the Pfizer vaccine outweighed the risks for children aged 5 to 11, with all panellists voting for the decision to allow the vaccine to be given to younger children and one abstaining. The decision was discussed via a 7-hour-long live YouTube broadcast, which eventually saw support in favour of the vaccine being given to children.

The next step is for America’s Centers for Disease Control and prevention (CDC) to give approval, which is expected on 2nd November, which could then kickstart vaccines in America for this young age group on Wednesday 3rd November.

If given the go-ahead by the CDC, children aged 5 to 11 will be give one third of the dose that adults have been receiving over two doses three weeks apart. Pfizer reported that this has been 90.7% effective in preventing symptomatic sickness.

The FDA regulators had to decide if the risks of a very rare side effect from the Pfizer vaccine (heart inflammation) were significant enough to stop the approval, but they decided it was so rare that the benefits of preventing children from getting seriously ill from Covid-19 far outweighed the risk of this rare side effect.

In America, 160 children aged five to 11 have died of Covid-19 and the country has one of the highest numbers of death anywhere in the world at about 740,000 deaths from the virus.

The UK has only just started to give 12- to 15-year-olds the vaccine, given in just one dose, and, as an Overseas Territory of the UK, the Cayman Islands will have to wait until the UK gives its own approval for children aged 5 to 11 before Cayman children can receive the vaccine.

On Monday last week, Moderna announced positive results from its tests on giving its vaccine to children aged 6 to 11 and said it showed “a robust neutralising antibody response after two doses of mRNA-1273 at the 50-µg dose level with a favourable safety profile.”

Moderna plans to submit this data to the FDA, the European Medicines Agency and other global regulators “in the near term”.

At a recent press conference, the Chief Medical Officer, Dr John Lee, said the move to vaccinate younger children was good news and it meant a lot of people would be very pleased as they could keep their children safe, as a result, however the decision as to whether children aged 5 to 11 would be vaccinated would be in the hands of the parents and their children.