UK Authorizes Pfizer COVID-19 Vaccine for 12 to 15-Year-Olds, but They May Not Be Offered It
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The UK Medicines and Healthcare Regulatory Agency (MHRA) has authorized an extension to the UK approval of the Pfizer/BioNTech COVID-19 vaccine (BNT162b2), permitting its use in children aged 12–15.
The UK's vaccination schedule
Pfizer/BioNTech's Phase III clinical trial of BNT162b2 in 12–15-year-olds demonstrated the vaccine was safe and had an efficacy rate of 100%. In May 2021, the US Food and Drug Administration (FDA) announced it was expanding the emergency use authorization (EUA) of the mRNA vaccine for this age group. Now, the UK's MHRA has shared that it will do the same: “We have carefully reviewed clinical trial data in children aged 12–15 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," Dr June Raine, chief executive at the MHRA said.
In the UK, BNT162b2 has been approved for use in individuals aged 16 and over since December 2020. The UK's vaccine delivery plan divided the population into a number of priority groups and placed focus on ensuring the elderly and most clinically vulnerable individuals were the first to be immunized. As of June 5, more than 27.5 million people (52.5%) have received two doses of a COVID-19 vaccine, be it BNT162b2, AstraZeneca/Oxford's Vaxzevria or Moderna's mRNA-1273.
Vaccinating children: A difficult decision
While the Pfizer vaccine is now approved for use in 12–15-year-olds, it does not necessarily mean that they will be offered it. This decision will fall to the Joint Committee on Vaccination and Immunisation (JCVI) which advises the UK's health department on immunization.
There are a number of factors that the JCVI will have to consider here. Dominic Wilkinson, professor of medical ethics at the University of Oxford, stated that 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 interests if the benefit outweighs any side effects," he said.
We know that children are much less likely to suffer from severe illness if they become infected with SARS-CoV-2. "This is good news of course, but it means that the balance between benefit and risk from vaccines is difficult to assess," Wilkinson commented.
He emphasized that the currently available clinical trial data sets assessing COVID-19 vaccines in young people are not large enough to identify rare events. "For example, we do not know whether there is a risk of serious blood clots in young people who have COVID vaccines. If there is a risk, we simply cannot say yet whether that risk is higher or lower than the risk that young people face from COVID-19," he added.
The risk-benefit debate will also have to conclude the appropriate action for ensuring young people with comorbidities are protected. While younger people are generally less at risk from COVID-19 than adults, certain health conditions can mean the disease can pose a greater threat to children and adolescents. "There is an urgent need to define more clearly which of the many children with comorbidities who have been shielding these many months are really at enhanced risk of serious illness when they get 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 COVID-19 vaccine supply and demand. In April the UK government Vaccines Taskforce confirmed that it had secured an extra 60 million doses of BNT162b2 to help support a booster program that is planned to commence in the autumn. However, in poorer countries around the world, the vaccine landscape picture is quite different. "There are current surges in COVID cases in a number of poorer countries where only a very small proportion of the population has been vaccinated. To put it simply, 99% of COVID deaths occur in adults over the age of 55 and those people with other underlying illness. There are millions of people at high risk of dying from COVID-19 who do not currently have access to effective vaccines," said Wilkinson.
At a time when demand significantly outweighs supply, Wilkinson stated that it would be "unethical" to extend the UK's COVID vaccination programs to include children.