MHRA welcomes today’s announcement by the JCVI
Our safety monitoring to date shows that COVID-19 vaccines continue to have a positive safety profile for the majority of people.
MHRA Chief Executive, Dr June Raine said:
We welcome today’s announcement by the JCVI, on the extension of the booster campaign to 40-49 year olds. This further strengthens our ability to ensure people are protected against COVID-19 and saves lives.
Our safety monitoring to date shows that COVID-19 vaccines continue to have a positive safety profile for the majority of people. The vast majority of reactions which are reported relate to expected side effects such as injection site reactions and flu-like symptoms, as was seen in our initial assessment. Our proactive monitoring of the safety of booster doses does not raise any new concerns.
We also welcome the recommendation for 16-17 year-olds to come forward and have a second dose of the Pfizer/BioNTech vaccine. People can be reassured that when we gave approval for the Pfizer vaccine for those 16 years and over in December 2020, we had thoroughly reviewed all the clinical trial data.
We have continued to carefully scrutinise all the data we have available to us and our robust surveillance programme includes monitoring all suspected reactions for adolescents as well as adults. We ensure all suspected reports are carefully followed up. The Expert Working Group of the Commission on Human Medicines has confirmed that reports of suspected myocarditis (heart inflammation) following COVID-19 vaccines are extremely rare and that the balance of risks and benefits overall remains favourable.