The European Union’s drug regulator launched a review to evaluate whether the Pfizer/BioNTech COVID-19 vaccine can be used as a booster shot in adolescents aged 12 to 15, even after several countries have already started such a campaign.
In its statement on Tuesday, the European Medicines Agency said that a review of booster shots given to 16- and 17-year-olds was ongoing.
Germany’s vaccine committee last month recommended that all children between the ages of 12 and 17 receive a booster, following the initial two-shot course, as infection rates continue to soar among youngsters in particular.
Other states in the bloc followed suit.
EMA said on Tuesday that “advice on how vaccinations should be given remains the prerogative” of member states’ advisory groups.
The European Centre for Disease Prevention and Control (ECDC) said in a separate report that findings so far suggest an increase of vaccine effectiveness against infection in adolescents who received a booster compared to adolescents who have recently completed the primary vaccination course.
It added, however, that no data was yet available on the duration of protection from a booster dose and the additional effectiveness against severe disease.
The ECDC said 10 countries in the European Economic Area, which comprises the 27 EU member states plus Liechtenstein, Iceland and Norway, had already recommended a booster dose for those under 18.
A booster dose of Comirnaty can currently be administered to vaccinated individuals 18 and older, restoring protection after it has waned.
The EMA’s human medicines committee (CHMP) will carry out an accelerated assessment of data submitted by the company that markets Comirnaty, including results from real-world evidence from Israel.
National public health bodies can issue official recommendations on the use of booster doses and associated travel certification requirements, taking into account emerging effectiveness data and limited safety data.
The EMA said that Comirnaty contains a molecule called messenger RNA (mRNA) with instructions for producing a protein, known as the spike protein, naturally present in SARS-CoV-2, the virus that causes COVID-19.
The vaccine works by preparing the body to defend itself against SARS-CoV-2.
