A new age-appropriate formulation of the Pfizer BioNTech COVID-19
vaccine (Comirnaty) for use in children aged 5 to 11 years old
has been approved today by the Medicines and Healthcare products
Regulatory Agency (MHRA) after finding that it is safe and
effective. This approval was given following a robust review of
safety data that shows a positive benefit-risk profile for this
vaccine to be used in this age group.
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 5 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.”
Today’s approval is for a formulation specially designed for 5-11
year olds and given at a lower dose compared to that used in
individuals aged 12 and above (10 micrograms compared with 30
micrograms).
As with other age groups, it is given as two injections in the
upper arm. It will be for the Joint Committee on Vaccination and
Immunisation (JCVI) to make the final recommendation on the
dosing interval.
In coming to this decision, the MHRA has liaised closely with
other international regulators and public health bodies and
carefully considered global data on use in 5-11-year olds. These
data demonstrate a favourable safety profile compared with that
seen in other age groups. Over 5.5 million dosages of the vaccine
in 5-11s have now been administered in the US alone.
Notes to Editor
- This new authorisation to the Conditional Marketing
Authorisation (CMA) granted by the MHRA is valid in Great Britain
only and was approved via the European Commission (EC)
Decision Reliance Route. This is when the marketing
authorisation application made by the company references the
decision made by the EMA’s Committee for Medicinal Products for
Human Use (CHMP). The MHRA reviews this application, together
with due consideration of the EC decision, before making an
independent decision on the quality, safety, and effectiveness
of the vaccine.
-
The Medicines and
Healthcare products Regulatory Agency is responsible
for regulating all medicines and medical devices in the UK. All
work is underpinned by robust and fact-based judgements to
ensure that the benefits justify any risks.
- The Medicines and Healthcare products Regulatory Agency (‘the
agency’) has three centres. The MHRA, the National Institute for
Biological Standards and Control (NIBSC) and
the Clinical Practice Research
Datalink (CPRD). The agency is an executive agency of the
Department of Health and Social Care.
-
The Commission on Human
Medicines (CHM) advises ministers and the MHRA on the
safety, efficacy and quality of medicinal products. The CHM is
an advisory non-departmental public body, sponsored by
the Department of Health and
Social Care.
