The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved the Pfizer/BioNTech COVID-19 vaccine for 12- to 15-year-olds, following on from approval for this age group in the US and Europe, following a ‘rigorous review’.
MHRA chief executive, Dr June Rain 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.
‘No extension to an authorisation would be approved unless the expected standards of safety, quality and effectiveness have been met.’
It will now be up to the Joint Committee on Vaccination and Immunisation (JCVI) to advise on whether this age group will be included in the COVID-19 vaccination programme.
Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines (CHM) said: ‘We have been very careful to take into consideration the younger age group and the benefits of this population being vaccinated against any potential risk of side effects. There has been a thorough assessment and review of this data which was also looked at specifically by the CHM’s Paediatric Medicines Expert Advisory Group who are scientific experts within this age group.
‘Over 2000 children aged 12-15 years were studied as part of the randomised, placebo-controlled clinical trials. 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. These are extremely positive results.’
While the risk of becoming seriously ill with COVID-19 is very low in children compared with adults, there are concerns that, without vaccination, the number of cases in children may continue to rise due to the highly-transmissable Delta variant.
The US, Canada and Germany started vaccinating children in the 12-15 age group earlier this month.
More than 68 million doses of COVID-19 vaccines have been administered to date, with 53% of the adult population having received both doses. Four out of five adults in Wales have received at least one dose, compared with around seven out of ten in the other UK nations.
Queen’s Nurses call on G7 leaders to support vaccination campaign
To coincide with the G7 Summit this month, 140 Queen’s Nurses from across the UK have signed a joint letter to the Prime Minister, Boris Johnson, calling on him and the other G7 leaders to extend their support for the World Health Organization’s COVAX programme, which aims to vaccinate people in poorer countries that may otherwise not have access to the vital treatment.
The Director-General of the World Health Organization has warned that deaths due to COVID-19 in 2021 could surpass the levels reached last year: many countries are today struggling with high transmission rates, over-stretched intensive care units, and desperate shortages of medical oxygen.
Nurses have played an instrumental role in delivering the vaccination programme in countries around the world and will continue to do so as the effort expands. The success of the vaccination effort is heavily dependent on the skill and capacity of the nursing workforce.
However, as wealthy countries move towards coverage rates of 70% and above, coverage across sub-Saharan Africa remains less than 1% and the gap between rich and poor countries is growing by the day. Closing the gap is an ethical imperative; it is also a necessity if the virus is to be contained and to reduce the likelihood of further new variants emerging.
QNI chief executive Dr Crystal Oldman said: ‘The key message of this campaign is that none of us is safe until everyone is safe. That's why Queen's Nurses from across the UK are calling on the leaders of the G7 countries meeting in the UK this week to support the efforts of COVAX and invest now in the global vaccination programme.
‘COVAX plans to deliver two billion doses this year to more than 120 countries, but it is increasingly evident that the pace and scale of international cooperation must be stepped up. The costs of vaccinating the world will be dwarfed by the economic costs if global leaders fail to act and the human costs are inconceivable.’