“The proposal is based on a dose three times lower than the approved dose for adults. The proposed schedule for this administration is to keep the two doses separate for at least three weeks. Our recommendation is expected within two months, but additional information or analysis may be necessary”, said Marco Cavaleri, responsible for the Biological Threats Strategy for Health and Vaccines at the institution.
The deadline for the announcement of a recommendation for this vaccine (Comirnaty) came at a press conference held in Amsterdam, the Netherlands, just days after the EMA unveiled the start of the evaluation process for the administration of the vaccine in this age group. Until now, the use of the Pfizer/BioNTech vaccine is only authorized for persons at least 12 years of age.
At the same time, Marco Cavaleri also said that data on vaccination against covid-19 in children between 5 and 11 years old are being generated for the Spikevax (Modern) vaccine and that the EMA “is discussing the potential 'timing' of candidacy for management in the future”, anticipating more information on this topic in the coming weeks.
The issue of booster doses was also under analysis, with the European institution scheduling the announcement of a conclusion on the authorization of administration of the Moderna vaccine in people over 12, six months after the second dose, for “the 25th of October”. According to the EMA, the pharmaceutical company proposes "a booster dose of 50 micrograms, which is half the dose used in the first series."
Also on this matter, Janssen must also send in the coming weeks data on the administration of a booster dose with an interval of at least six months after the single dose of administration, according to the EMA.
Regarding the combination of different vaccines against covid-19 in this immunization booster process, Marco Cavaleri noted that the agency continues to collect information “on the efficacy and safety” of the process, but highlighted the “promising results” of some studies, which “confirm that this approach triggers a strong immune response” to the administration of the same vaccine.
“It's premature to say, but messenger RNA vaccines seem to be working well as a booster. However, all reinforcement combinations will continue to be valuable”, he stressed.