MHRA authorises Pfizer Covid jab for 12-15-year-olds

The MHRA has authorised the Pfizer/BioNTech Covid vaccine for use in teenagers aged 12 to 15, the Government has announced.

The Department of Health and Social Care (DHSC) said it has now asked the Joint Committee on Vaccination and Immunisation (JCVI) for its advice on whether ‘routine vaccination’ should now be offered to the over-12s.

Announcing the extension to the vaccine’s approval in the UK, the MHRA today said that it has concluded a ‘positive safety profile’ for the jab in those aged 12 to 15 following a ‘rigorous review’ of its ‘safety, quality and effectiveness’ in the group.

It said that no new side effects were identified and that safety data was comparable with that seen in young adults, with the majority of adverse events being mild or moderate.

Professor Sir Munir Pirmohamed, chair of the Commission on Human Medicines, said that randomised placebo-controlled clinical trials involving more than 2,000 children aged 12 to 15 showed ‘extremely positive results’.

He said: ‘There were no cases of Covid-19 from 7 days after the second dose in the vaccinated group, compared with 16 cases in the placebo group. 

‘In addition, data on neutralising antibodies showed the vaccine working at the same level as seen in adults aged 16-25 years.’

MHRA chief executive Dr June Raine said: ‘We have carefully reviewed clinical trial data in children aged 12 to 15 years and have concluded that the Pfizer/BioNTech Covid-19 vaccine is safe and effective in this age group and that the benefits of this vaccine outweigh any risk.

‘We have in place a comprehensive safety surveillance strategy for monitoring the safety of all UK-approved Covid-19 vaccines and this surveillance will include the 12- to 15-year age group.’

A DHSC spokesperson added that it has asked the JCVI to ‘advise whether routine vaccination should be offered to younger people aged 12 to 17’.

‘We will be guided by the expert advisors and will update in due course’, they said.

The Pfizer vaccine has been approved for use in those aged 16 and above since December 2020.

However, there is currently no routine vaccination for under-18s in the UK, who should only be vaccinated if they have underlying health conditions are household contacts of someone who is immunosuppressed. 

It comes as NHS England has indicated that an announcement regarding vaccine rollout to the last remaining cohort – currently those aged 18 to 29 – is expected imminently.

Speaking in a GP webinar last night, NHS England director of primary care vaccination Caroline Temmink said: ‘All of cohort 11 are now eligible for their vaccine. 

‘We are working at the moment to look at capacity and vaccine supply to consider when it’s appropriate to open up cohort 12, but we are expecting an announcement on that very soon.’

Pfizer reported in March that early results of phase 3 trials showed its vaccine to be ‘100% effective’ in children aged 12-15.

Last month, Moderna also announced that its vaccine is effective in 12- to 18-year-olds after a study saw no cases of Covid-19 in those who had two doses. It is yet to be approved for rollout in this age group.

Meanwhile, a paediatric trial of the Oxford/AstraZeneca vaccine was launched in February but it later ‘postponed’ vaccinations ‘to allow further discussions with the MHRA’ following the reports of rare blood clots.

It follows reports earlier this year that the Covid vaccine will ‘almost certainly’ be rolled out to children later in the year and potentially as soon as August.