EMA panel backs use of original Moderna, Pfizer COVID vaccines in infants
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A committee of the European Medicines Agency (EMA) recommended the expanded use of Moderna's (NASDAQ:MRNA) Spikevax and Pfizer (NYSE:PFE) and BioNTech's (NASDAQ:BNTX) Comirnaty vaccines targeting the original strain of the coronavirus, for use in infants
The EMA's Committee for Medicinal Products for Human Use (CHMP) on Wednesday said that it recommended Comirnaty's use in children aged 6 months to 4 years, and Spikevax's use in children 6 months to 5 years of age.
Comirnaty and Spikevax are already approved in both adults and children aged from five and six years, respectively, the CHMP noted.
The doses of both vaccines for these new younger age groups will be lower.
The CHMP added that Comirnaty can be given as primary vaccine consisting of three doses (of 3 micrograms each) âfirst two doses given three weeks apart, then third dose at least eight weeks after the second dose.
Spikevax can be given as primary vaccination consisting of two doses (25 micrograms each), four weeks apart, the panel noted.
The CHMP said that a study in children aged six months to four years of age showed that the immune response to lower dose of Comirnaty (3 micrograms) was comparable to that seen with the higher dose (30 micrograms) in people aged 16 years to 25 years.
Similarly, data for Spikevax (25 micrograms) was comparable to that seen with the higher dose (100 micrograms) in people aged 18 years to 25 years.
The European Commission, which generally follows the opinion of the CHMP, will issue final decisions on the two vaccines.
According to the World Health Organization COVID-19 still remains a global health emergency.