European Medicines Agency permits use of Pfizer/BioNTech vaccine on 5-11 year old children

On Thursday, 25 November, the European Medicines Agency (EMA) approved the use of Pfizer/BioNTech Covid-19 vaccine Comirnaty for children under the age of 11 years.
Following the decision from EMA this will be the first Covid-19 immunization opportunity for children in Europe.
EMA’s decision will be sent to the European Commission, which will make the final decision in regards to registration options in all EU member states.
Until now Comirnaty vaccine was approved for use for children aged 12 years and older and adults.
Vaccination children younger than 11 years will commence once the National Immunisation Council (IVP) has provided recommendations and information to healthcare institutions and general practitioners with respect to information from the National Health Service’s Vaccination Project Office, as reported by the State Agency for Medicines representatives Dita Okmane.
The manufacturer of the vaccine has informed EU members states that the expected dose of the vaccine for children will become known around mid-December.
According to information from NVD, it is planned that Covid-19 vaccination of children will be performed by general practitioners and healthcare institutions.
The dose of Comirnaty vaccine for children will be lower than the one used for residents aged 12 years and older (10 µg as opposed to 30 µg). The injection is administered in the shoulder muscle wit at least a three-week interval between shots.
The efficacy of Comirnaty was calculated based on nearly 2 000 children aged 5 to 11 years who showed no previous signs of infection.
These children were administered either the vaccine or a placebo (imitated injection). Of the 1 305 children who received the vaccine, three developed Covid-19 as compared to 16 out of 663 who received a placebo. This means the vaccine’s efficacy for prevention of symptomatic Covid-19 infection was 90.7% (which can be considered a level of efficacy between 67.7% to 98.3%).
The most commonly observed side effects from vaccination observed among children 5 to 11 years were similar to those experienced by people aged 12 years or older. These include pain in the place of injection, exhaustion, headaches, redness and swelling around the injection location, muscle pains and shivering. These side-effects are generally of light to moderate severity and pass after a couple of days after vaccination, explains Okmane.
The Medicines Committee of the European Medicines Agency concluded the benefits from Comirnaty vaccine for children aged 5 to 11 years outweigh the risks.
Because Comirnaty vaccine is used to promote vaccination in all EU member states, the safety and efficacy of this vaccine will bee supervised by the EU Pharmacovigilance System, as well as surveys and additional research by EU institutions.