UK clears Pfizer COVID-19 vaccine for 12-15 year olds, but may not be offered
the UK Medicines and Healthcare Regulatory Agency (MHRA) possesses authorized an extension of the UK approval of the Pfizer / BioNTech COVID-19 vaccine (BNT162b2), allowing its use in children aged 12 years–15.
The UK vaccination schedule
Pfizer / BioNTech Phase III Clinical Trial of BNT162b2 in Children 12 to 15 Years of Age demonstrated that the vaccine was safe and had a 100% effectiveness rate. In May 2021, the United States Food and Drug Administration (FDA) ad it extended the Emergency Use Authorization (EUA) of the mRNA vaccine for this age group. Now the UK’s MHRA has announced it will do the same: “We have carefully reviewed clinical trial data in children aged 12 to 15 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 ”, Dr June Raine, Executive Director of MHRA mentionned.
In the UK, BNT162b2 has been approved for use in people aged 16 and over since December 2020. vaccine delivery plan divided the population into a number of priority groups and emphasized that the elderly and the most clinically vulnerable are the first to be immunized. As of June 5, more than 27.5 million people (52.5%) received two doses of a COVID-19 vaccine, whether BNT162b2, Vaxzevria from AstraZeneca / Oxford or mRNA-1273 from Moderna.
Vaccinate children: a difficult decision
While the Pfizer vaccine is now approved for use in 12-15 year olds, that doesn’t necessarily mean they will be offered. This decision will be up to Joint Committee on Vaccination and Immunization (JCVI) who advises the UK Department of Health on immunization.
There are a number of factors the JCVI will need to consider here. Dominique wilkinson, professor of medical ethics at the University of Oxford, said it is not yet clear whether COVID vaccines are in the best interests of children and young people. “A vaccine can be in someone’s best interest if the benefits outweigh the side effects,” he said.
We know that children are much less likely to have a serious illness if they are infected with SARS-CoV-2. “This is good news of course, but it means that the balance between the benefits and risks of vaccines is difficult to assess,” Wilkinson commented.
He stressed that the currently available clinical trial data sets evaluating COVID-19 vaccines in young people are not large enough to identify rare events. “For example, we don’t know if there is a risk of serious blood clots in young people who have received COVID vaccines. If there is a risk, we just cannot yet say whether that risk is greater or less than the risk that young people face. COVID-19, “he added.
The risk-benefit debate should also conclude on the appropriate action to ensure the protection of young people with co-morbidities. While young people are generally less exposed to COVID-19 than adults, certain health issues may mean that the disease may pose a greater threat to children and adolescents. “There is an urgent need to define more clearly which of the many children with co-morbidities who have been protected over the many months are truly at increased risk of serious illness when they contract this infection so that they can be offered vaccination without delay and that work is in progress, “said Professor Adam Finn from the University of Bristol.
Supply and demand issues
Finally, there is the issue of supply and demand for COVID-19 vaccines. In April, the UK government’s vaccine task force confirmed that he had obtained an additional 60 million doses of BNT162b2 to help support a booster program scheduled to begin in the fall. However, in the poorest countries of the world, the vaccine landscape is quite different. “There is currently an increase in COVID cases in a number of poorer countries where only a very small proportion of the population has been vaccinated. Simply put, 99% of COVID deaths occur in adults over 55 and people with other underlying illnesses. There are millions of people at high risk of dying from COVID-19 who currently do not have access to effective vaccines, ”Wilkinson said.
At a time when demand greatly exceeds supply, Wilkinson said it would be “unethical” to expand COVID vaccination programs in the UK to include children.