UK Regulator Approves Pfizer’s COVID-19 Vaccine for Babies and Young Children

A vial labelled “Pfizer COVID-19 Vaccine” is seen in this photo taken on Jan. 16, 2022. (Dado Ruvic/Reuters)

The UK’s medicines regulator on Tuesday gave the greenlight for the Pfizer/BioNTech COVID-19 vaccine, also known as Comirnaty, to be used on children in Britain aged between 6 months and 4 years old.

The vaccine has previously been approved in Northern Ireland for the same age group.

The Medicines and Healthcare products Regulatory Agency (MHRA) authorisation doesn’t mean the low-dose vaccine will be automatically included in the the government’s COVID-19 vaccination programme, because the responsibility of making recommendations falls on a different body—the Joint Committee on Vaccination and Immunisation (JCVI).

It appears unlikely the JCVI will recommend the product to be used on healthy babies and toddlers as the committee has not extended a one-off recommendation to jab children aged between 5 and 11.

Paul Hunter, professor in medicine at the University of East Anglia, told The Epoch Times he would wait and see what the JCVI will decide on vaccinating the infants and toddlers. He said he’s “not sure” whether it’s appropriate to give the vaccine to this age group given the low risk COVID-19 poses to young children and the vaccine’s short-lived efficacy against infections.

The dosage approved for the age group—3 micrograms—is lower than that given to primary school-age children, which is 10 micrograms, and it’s designed as three injections in the upper arm, with the first two doses given three weeks apart, followed by a third dose given at least eight weeks after the second dose, the MHRA said in a statement.

The MHRA said the Pfizer/BioNTech COVID-19 vaccine had been “found to meet the UK regulator’s standards of safety, quality, and effectiveness, with no new safety concerns identified.”

It also said MHRA experts “carefully reviewed data from an ongoing clinical trial involving 4,526 participants,” adding, “The common, expected side effects (reactogenicity) were in-keeping with what can be anticipated from a vaccine in this age group.”

The regulator also said the Commission on Human Medicines, which advises ministers on the safety, efficacy, and quality of medicinal products, had endorsed the decision after a careful review of the evidence.

A more detailed document published on the same day said the duration of protection the vaccine provides is “still being determined by ongoing clinical trials.”

The document references a number of studies including one identified as “study 3” that involved 1,776 infants aged 6–23 months and 2,750 children aged between 2 and 4 who were followed for a median of 1.3–1.4 months after the third dose.

Molly, a 7-year-old labrador therapy dog, is stroked by Jake Gregory of Cornwall while Jake receives his COVID-19 vaccination at a temporary NHS COVID vaccination centre in Wadebridge, England, on Aug. 20, 2022. (Hugh Hastings/Getty Images)

According to the document, the most frequent adverse reactions in infants aged 6 to 23 months of age that received the jab were irritability, drowsiness, decreased appetite, tenderness at the injection site, and injection site redness and fever; while 2- to 4-year-olds commonly experienced pain or redness at the injection site, fatigue, and fever.

The document also said limited data suggested primary school aged children, aged 5 to 11, have a lower risk of myocarditis and pericarditis than secondary school aged children.

In an email to The Epoch Times, Hunter said he’s “not sure that vaccination against COVID in these age groups will be appropriate,” but would “wait to see the results of the JCVI recommendations.”

“The protection against COVID infection after vaccination does not last that long,” he said, referencing a recent pre-printed meta-analysis on the protection effectiveness of prior infection and hybrid immunity.

“COVID vaccination is much better at reducing the risk of severe disease. But severe disease in this age group is quite uncommon,” Hunter said. “Also almost all children in the UK have already had at least one COVID infection and most have had multiple infections so far and so are already protected against severe disease to a much greater extent than a year ago.”

Lower Risks

Children aged 5 or over are still eligible for COVID-19 vaccines if they are at high risk from COVID-19 owing to a health condition or because of a weakened immune system, or if they live with someone who has a weakened immune system.

But according to the MHRA’s summary on the product characteristics of the Comirnaty vaccine, its efficacy and safety were not assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The regulator also said the efficacy of Comirnaty may be lower in immunocompromised individuals.

A recent study carried out by researchers from the UK’s Health Security Agency found that deaths from COVID-19 remain “extremely rare” in children and young people (CYP), especially among otherwise healthy children.

According to the study, 81 CYP under the age of 20 died from COVID-19 between March 2020 and December 2021—an infection fatality rate of seven per million.

Of the 81 deaths, 20 CYP were otherwise healthy, while 61 had “significant underlying health conditions,” including neuro-disability, immunocompromising conditions, Down’s syndrome, Edwards’ syndrome, chronic heart disease, and four premature births, meaning the COVID-19 mortality rate for otherwise healthy CYP was 1.5 per million.

COVID-19 deaths were also clustered among older teens and infants, with more than half (47) occurring among those aged between 16 and 19, and 22 under a year old.