The European Medicines Agency’s (EMA) human medicines committee has recommended extending the use of Comirnaty and Spikevax targeting the original strain of SARS-CoV-2, to include the use in children aged six months to four years for Comirnaty and use in children aged six months to five years for Spikevax, the EMA said.
Comirnaty and Spikevax are already approved in both adults and children aged from five and six years, respectively.
Compared to the doses for already authorised age groups, the doses of both vaccines in these new younger age groups will be lower.
In children from six months to four years of age, Comirnaty can be given as primary vaccination consisting of three doses (of three micrograms each); the first two doses are given three weeks apart, followed by a third dose given at least eight weeks after the second dose.
In children from six months to five years of age, Spikevax can be given as primary vaccination consisting of two doses (of 25 micrograms each), four weeks apart.
For children within these age groups, both vaccines are given as injections in the muscles of the upper arm or the thigh.
For Comirnaty, a main study in children from six months to four years of age showed that the immune response to the lower dose of Comirnaty (three micrograms) was comparable to that seen with the higher dose (30 micrograms) in 16- to 25-year-olds.
For Spikevax, a main study in children from six months to five years of age showed that the immune response to the lower dose of Spikevax (25 micrograms) was comparable to that seen with the higher dose (100 micrograms) in 18- to 25-year-olds.
Both studies evaluated the immune response triggered by the vaccines by measuring the level of antibodies against SARS-CoV-2.
The EMA said that the most common side effects for both vaccines, in children aged from six months to four or five years, were comparable to those seen in older age groups.
Irritability, sleepiness, loss of appetite, rash and tenderness at the injection site were also common side effects in children aged six to 23 months with Comirnaty, while irritability, crying, loss of appetite and sleepiness were common side effects in children aged six to 36 months with Spikevax, the EMA said.
For both vaccines, these effects were usually mild or moderate and improved within a few days of vaccination, the agency said.
The EMA human medicines committee concluded that the benefits of Comirnaty and Spikevax in children aged from six months to four and five years, respectively, outweigh the risks.
The safety and efficacy of both vaccines, in children and adults, will continue to be monitored closely as they are used in vaccination campaigns in EU countries through the EU pharmacovigilance system and ongoing and additional studies conducted by the company and coordinated by European authorities, the EMA said.
The originally authorised vaccines, Comirnaty and Spikevax, are both effective at preventing severe disease, hospitalisation and death associated with Covid-19 and continue to be used within vaccination campaigns in the EU, in particular for primary vaccinations, the agency said.
National authorities in EU member states will determine who is recommended to be vaccinated and when, taking into account factors such as infection and hospitalisation rates, the risk to vulnerable populations, vaccination coverage and vaccine availability.
The EMA said in its October 19 statement that its recommendations would now be sent to the European Commission, which will issue final decisions applicable in all EU member states.
(Photo: EC Audiovisual Service)
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