UK regulator approves Pfizer vaccines for 12-15-year-olds

June 8th, 2021

The UK’s medicines regulator has approved the Pfizer-BioNTech Covid-19 vaccine for 12-15-year-olds.

The MHRA (Medicines and Healthcare products Regulatory Agency) conducted an extensive review of the vaccine and members have now confirmed that the jab is safe for use in children aged 12 and over. The vaccine had already been approved for over 16s in the UK. 

Dr June Raine, chief executive of the MHRA, said that safety would be monitored very carefully and indicated that extending the current age groups set out by the Joint Committee on Vaccination and Immunisation (JCVI) would not be approved unless rigorous safety standards were met. 

The government has now asked the JCVI to evaluate the data and determine whether or not to advise ministers to encourage children aged 12-15 to have the vaccine. At present, the aim is to offer all adults a first vaccine by the end of July. The vaccine has also been recommended for 16-18-year-olds who are more vulnerable to severe symptoms of Covid-19. There are currently no planned dates to extend the scheme to 12-15-year-olds and ministers said they would be guided by the science and recommendations from the JCVI. 

The health secretary, Matt Hancock, confirmed that the UK would have sufficient supplies of the vaccine if the JCVI did recommend vaccination for 12-15-year-olds but said that any decisions would be based on clinical data and guidance. 

The Pfizer vaccine had already been approved by the EMA (European Medicines Agency) and children are already receiving the vaccine in Canada and the US. Germany confirmed plans to start inviting children from June 7th and French ministers have also suggested that teenagers will be included in the vaccine rollout. 

Prof Adam Finn, a member of the JCVI, explained that there were a number of complex matters to consider in the UK, including the disruption caused by case numbers rising among unvaccinated children in schools and provision for adults who may not be able to access vaccines in different countries. 

There has been a great deal of debate about sending vaccines abroad, especially if the UK and other wealthier nations reach a point where the entire adult population is vaccinated long before other countries have got efficient programmes up and running. In Nepal, for example, where are concerns about the emergence of new variants, only 3% of the population has been vaccinated. The latest statistics suggest that more than 40 million people in the UK have had their first jab.

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