Children as young as five years old will be offered the Pfizer vaccine in the UK, advisers announced today as part of Britain’s fight against the Omicron variant.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) made the approval following a robust review of safety data that showed a specific formula of the company’s jab is more beneficial than harmful for those in the age group.
And the Joint Committee for Vaccination and Immunisation (JCVI) is now advising that children aged five to 11 who are in a clinical risk group or who are a household contact of someone who is immunosuppressed should be offered two doses.
Around 330,000 children are included in the groups, JCVI Covid chair Professor Wei Shen Lim said at a press briefing this afternoon.
They will be given two 10-microgram doses of the age appropriate Pfizer formulation — a third of the adult dose, with eight weeks between the first and second doses.
Advisers are expected to issue more recommendations for extending the rollout to other five to 11-year-olds in due course after looking at additional data, as well as on the Omicron variant more broadly.
Meanwhile, the JCVI also announced Britain’s booster programme is set to be extended to teenagers, with third doses set to be given to some over-12s.
The JCVI has advised that booster vaccinations should be offered to around 500,000 teens aged 16 to 17 years, and children aged 12 to 15 who are in a clinical risk group or who are a household contact of someone who is immunosuppressed.
Children aged 12 to 15 years who are severely immunocompromised and who have had a third primary dose will also be offered a booster.
Children as young as five years old will be offered the Pfizer vaccine in the UK, advisers announced today as part of Britain’s fight against the Omicron variant
What are the risks of Covid and vaccines to five-year-olds?
Covid
Most children only experience mild symptoms after being infected with Covid.
Just one in 300,000 children who test positive for Covid die, according to UK Government data.
And the risk of being hospitalised and getting admitted to ICU is similarly low.
But the risk is higher to children with serious underlying conditions.
The JCVI has yet to release its updated guidance on vaccinating children aged 11 and under.
But its latest advice on recommending first jabs to over-12s suggested one Pfizer dose only prevents 131 hospital admissions per million 12-15-year-olds.
And second doses only prevent nine hospital admissions for every million dished out to the age group.
The figures are likely to be less for five- to eleven-year-old, who are less vulnerable to the virus.
Vaccines
Myocarditis — an ultrarare form of heart inflammation — is the main side effect of the Pfizer vaccine that concerns experts.
Data shows the risk is slightly higher in adolescents than adults, particularly in boys.
The JCVI has not released data on how many cases are expected in children aged five to 11 but studies show children in younger age groups are less at risk than teenagers.
It found myocarditis cases in between 2.6 to 17.7 million first vaccine doses in children aged 12 to 15.
And the condition was found in between 20.9 to 42.2 children in the age group per million second doses dished out.
Dr June Raine, MHRA chief executive, said: ‘Parents and carers can be reassured that no new vaccine for children would have been approved unless the expected standards of safety, quality and effectiveness have been met.
‘We have concluded that the Pfizer/BioNTech Covid-19 vaccine is safe and effective for five to 11-year olds, with no new safety concerns identified.
‘We have carefully considered all the available data and reached the decision that there is robust evidence to support a positive benefit-risk for children in this age group.
‘Our detailed review of all side-effect reports to date has found that the overwhelming majority relate to mild symptoms, such as a sore arm or a flu-like illness.
‘We have in place a comprehensive safety surveillance strategy for monitoring the safety of all UK-approved Covid-19 vaccines and this includes children aged 5 to 11 years old.’
Boosters will be given to over-16s and some over -12 in the form of 30 micrograms of the Pfizer/BioNTech vaccine, given no sooner than three months after completion of the primary course.
Professor Lim said: ‘The majority of children aged five to 11 are at very low risk of serious illness due to Covid-19.
‘However, some five to 11 year olds have underlying health conditions that put them at higher risk, and we advise these children to be vaccinated in the first instance.
‘For children and young people who have completed a primary course of vaccination, a booster dose will provide added protection against the Omicron variant.’
More than 30million boosters have now been given in the UK, new figures show.
A record 968,665 booster and third doses were reported for the UK on Tuesday. The previous record was 940,606 doses on Saturday.
It means a total of 30.8million booster and third doses have now been delivered, with 6.1million in the past seven days. The figures have been published by the UK’s four health agencies.
Around 58 per cent of all adults in the UK have now had a booster or third dose of Covid vaccine, up from 46 per cent a week ago.
The decision to extend the rollout came after the world’s biggest study on myocarditis after the vaccine in children suggested there is not an increased risk of heart inflammation from the jab in British adults and older teenagers.
Analysis by the universities of Edinburgh and Oxford said myocarditis was occurring at a rate of three per million jabs administered in people aged 16 to 40.
They said this was not significantly different to the rate in the general population for the same age group.
Reports of myocarditis in young people and teenagers in other countries early in the rollout complicated the debate on whether British children should be jabbed. Data from Israel and US — where the dosage gap is only three weeks — suggested the condition was more common.
Experts believe Britain’s 12-week spacing has cut the risk of myocarditis and helped keep numbers low.
Scientists described the data as ‘reassuring’ to young people. But because the data did not look at young people specifically, questions on incidence in teenagers unanswered.
Vaccinating young children still makes many scientists uneasy due to the tiny risk the virus poses to them.
No10’s advisers were originally unconfident on approving them because the benefits did not clearly outweigh the risks, with youngsters unlikely to fall serious ill or die with the virus.
Revealed: What are other countries doing about Covid vaccinations for children
The United States starting rolling out Pfizer’s vaccines for children aged 5 to 11 at the start of November.
A panel of outside experts met on November 2 to vote on how broadly the shot should be recommended in the age group by the US Centers for Disease Control and Prevention (CDC).
The vaccine was authorized by the US Food and Drug Administration in the age group on November 29.
But with many parts of the world still awaiting doses for more vulnerable people, the World Health Organisation has urged countries and companies that control the global supply of the vaccines to prioritize supply to COVAX.
The following is a list of some countries that have approved or are considering vaccinating children:
EU COUNTRIES
- On November 25, the EU’s medicines regulator said it had approved the use of Pfizer and BioNTech’s Covid vaccine in five to 11-year-old children.
- In June, Denmark said it would offer Covid shots to children aged 12-15 to boost its overall immunity against the virus.
- France has started vaccinating those from 12 years upwards, provided they have parental consent.
- Germany in August agreed to make vaccination available to all children aged 12-17.
- Austria has started vaccinating children aged 12-15.
- Estonia could start vaccinating teenagers by the autumn, public broadcaster ERR reported, citing the head of the government’s Covid council.
- Hungary started vaccinating 16 to 18-year-olds in mid-May, according to Xinhua news agency.
- Italy on May 31 approved extending the use of Pfizer’s vaccine to 12- to 15-year-olds. On July 28, it also endorsed the use of Moderna’s vaccine for 12- to 17-year-old children.
- Lithuania’s prime minister said the country could start vaccinating children from age 12 in June, news site Delfi reported.
- Spain begun vaccinating children between 12 and 17 years old around two weeks before the academic year in September, the health minister said.
- Swedish PM says children aged 12-15 will be offered Covid vaccine later this autumn.
- Greece in July said children aged 12-15 could be vaccinated against Covid with Pfizer/BioNTech and Moderna shots.
- Finland’s capital Helsinki in June said it will begin giving Covid vaccines to children aged 12 to 15 who are at risk of contracting a severe coronavirus infection.
- On July 27, Ireland lowered the age for Covid vaccination to 12 years.
- Poland started offering Covid vaccines to children of ages 12 to 15.
EUROPE (NON-EU)
- On October 19, UK said it will open up COVID vaccine booking service to those aged 12 to 15.
- Switzerland approved on June 4 vaccinating 12- to 15-year-olds with Pfizer’s shot, while Moderna’s shot was approved in August for the age group.
- In September, Norway started to offer one dose of Pfizer and BioNTech Covid vaccine to children aged 12 to 15.
MIDDLE EAST
- In August, Israel began offering a Covid booster to children as young as 12.
- The United Arab Emirates said in August rolled out China’s Sinopharm vaccine to children aged three to 17. On November 1, UAE approved Pfizer-BioNtech shot for children aged five to 11 for emergency use.
- Bahrain approved Sinopharm Covid vaccine for children aged three to 11 from October 27, while on November 2, the Gulf state approved the Pfizer vaccine for emergency use for children aged between five and 11 years.
ASIA-PACIFIC
- Indonesia on November 1 authorised China’s Sinovac vaccine for children aged 6 and above.
- Malaysia on October 29 said it would procure the Pfizer/BioNTech vaccine for children aged five to 11, following a US expert panel’s recommendation
- Vietnam will begin inoculating children aged 16 and 17 with parental consent from next month using the Pfizer-BioNTech vaccine.
- An advisory committee to the Indian regulator recommended emergency use of Bharat Biotech’s Covid shot in the two to 18 age group. The regulator’s nod is awaited.
- New Zealand’s medicines regulator in June provisionally approved use of Pfizer’s vaccine for 12- to 15-year-olds.
- Australia said on September 12 it will expand its COVID-19 vaccination drive to include around one million children aged 12 to 15.
- China on June 5 approved emergency use of Sinovac’s vaccine for those between three and 17.
- Hong Kong said on June 3 it would open its vaccine scheme to children over the age of 12.
- Singapore opened up its vaccination programme to adolescents aged 12 to 18 from June 1.
- Japan on May 28 approved the use of Pfizer’s vaccine for those aged 12 and above.
- The Philippines on May 26 decided to allow the Pfizer-BioNTech’s vaccine for emergency use in children aged 12 to 15.
- Jordan in July begun vaccinating children aged 12 years and older against Covid.
AMERICAS
- The Covid vaccine by Pfizer-BioNTech will be the only one used in Mexico for at-risk children aged 12 to 17.
- Brazil on June 11 approved use of Pfizer’s vaccine for children over 12.
- On September 6, Chile approved the Covid vaccine produced by China’s Sinovac Biotech Ltd for use in children over 6 years of age.
- US FDA has authorized the Pfizer vaccine for children aged five to 11 years. CDC Director Rochelle Walensky must make her recommendations before it can be rolled out.
- Canada in early May approved use of Pfizer’s vaccine for use in children aged 12 to 15 but the decision for children between 5 an 11 years is not likely to come before mid- to end-November.
- Cuba’s vaccination campaign includes children as young as two.
- On September 13, El Salvador cleared the use of COVID-19 vaccine in 6 to 11-year-old children.
- Argentina is vaccinating children as young as three with Sinopharm COVID-19 vaccine.
- Ecuador’s vaccination includes kids as young as six with the China’s Sinovac vaccine
- Columbia is offering Pfizer, AstraZenenca, Moderna, Sinopharm and J&J’s Covid vaccines for children 12 years and above.
- Costa Rica is vaccinating 12 years and above.
AFRICA
- South Africa will start vaccinating children between the ages of 12 and 17 next week using the Pfizer vaccine.
Reporting by Reuters