UK Regulator Approves Pfizer’s Infant COVID-19 Vaccine


The UK’s medicines regulator on Tuesday gave the go-ahead for Pfizer/Biontech’s COVID-19 vaccine, also known as The Cominity, to be used in British children aged 6 months to 4 years.

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

Medicines and Healthcare Products Regulatory Agency (MHRA) approval does not mean that a low-dose vaccine will be automatically included in the government’s COVID-19 vaccination program. Immunization and vaccination (JCVI).

The committee has not extended its one-time recommendation for jabbing children between the ages of 5 and 11, so it is unlikely that the JCVI will recommend using the product in healthy infants and toddlers.

Paul Hunter, professor of medicine at the University of East Anglia, told the Epoch Times that he would wait and see what the JCVI would decide about vaccination of infants. Given the short-lived efficacy against infection with HIV, he said he was “not sure” whether it would be appropriate to vaccinate this age group.

The approved dose for this age group is 3 micrograms, which is lower than the 10 microgram dose given to children in the lower grades of elementary school, and is designed to be injected three times into the upper arm, initially The two doses will be three weeks apart, followed by a third dose at least eight weeks after the second dose, MHRA said. statement.

The MHRA said the Pfizer/BioNTech COVID-19 vaccine “was found to meet UK regulatory safety, quality and efficacy standards, and no new safety concerns have been identified.” rice field.

MHRA experts also said they had “carefully reviewed data from an ongoing clinical trial involving 4,526 participants” and noted that “generally expected side effects (reactogenicity) It was consistent with what could be expected from a vaccine for 10,000 people,” he added.

The regulator also said the Committee on Human Medicines, which advises ministers on drug safety, efficacy and quality, upheld the decision after careful consideration of the evidence.

a More detailed documentation Announced the same day, it said the duration of protection the vaccine would provide “is still being determined by ongoing clinical trials.”

The document references a number of studies, including one identified as “Study 3”, which involved 1,776 infants aged 6-23 months and 2,750 children aged 2-4 years, the third was followed for a median of 1.3 to 1.4 months after administration of

Epoch Times photo
20 August 2022 Molly, a 7-year-old Labrador, was given to Jake Gregory of Cornwall while Jake was vaccinated against COVID-19 at the temporary NHS COVID vaccination center in Wadebridge, UK. I can caress you. (Hugh Hastings/Getty Images)

According to the documentation, the most frequent side effects in jab-treated infants aged 6-23 months were irritability, drowsiness, decreased appetite, injection site tenderness, and injection site redness and fever. On the other hand, her children aged 2 to 4 often experienced injection site pain and redness, fatigue and fever.

The document also states that limited data suggests that elementary school children aged 5 to 11 have a lower risk of myocarditis and pericarditis than middle school students.

In an email to The Epoch Times, Hunter said he was “unsure if vaccination against COVID is appropriate in these age groups” but would “wait to see the outcome of the JCVI’s recommendations”. Stated.

“Protection against COVID infection after vaccination does not last very long,” he said, noting that recent Pre-printed meta-analysis On the protective effects of pre-infection and hybrid immunity.

“Covid-19 vaccination greatly reduces the risk of severe illness, but serious illness in this age group is extremely rare,” said Hunter. “Also, almost all children in the UK have already had at least one COVID infection, and most have been infected multiple times, so they are already protected from much more serious illness than they were a year ago. It has been.”

low risk

Get the COVID-19 vaccine even for children over the age of 5 if they are at high risk for COVID-19 due to health conditions or a weakened immune system, or if they live with someone who has a weakened immune system I am eligible.

However, according to the MHRA summary of the product characteristics of the Comirnaty vaccine, its efficacy and safety have not been evaluated in immunocompromised persons, including those on immunosuppressive therapy. Regulators also say Comirnaty’s effectiveness may be lower in immunocompromised individuals.

A recent study conducted by researchers from the UK’s Health Security Agency found that deaths from COVID-19 remain “extremely rare” in children and adolescents (CYP), especially among healthy children. I understand.

According to the study, between March 2020 and December 2021, 81 CYPs under the age of 20 died of COVID-19.

Of the 81 deaths, 20 CYPs were otherwise healthy, but 61 were ‘critical’ including neuropathy, immunocompromised conditions, Down’s syndrome, Edwards’ syndrome, chronic heart disease, and 4 premature births. had an underlying disease. Mortality in otherwise healthy CYPs was 1.5 per million.

COVID-19 deaths were also concentrated among teenagers and young children, with more than half (47) between the ages of 16 and 19 and 22 under the age of 1.

Lily Zhou

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Lily Zhou is an Ireland-based reporter focusing on UK news. Lily said she attended the Chinese edition of The Epoch Times for the first time before she focused on the UK in 2020.