Will Spain vaccinate children aged 5-11 after EMA green light?

by Lorraine Williamson
EMA gives green light

The European Medicines Agency (EMA) gave the green light on Thursday for EU countries to vaccinate children between the ages of 5 and 11 against Covid. EMA believes the benefits outweigh the risks, especially in children with health problems that increase the risk of serious consequences.  

For the time being it concerns Pfizer’s vaccine, whose application has now been approved. But ultimately the decision may depend on the country. Furthermore, Moderna’s application, which was submitted later, is still being assessed. 

Children receive lower dose 

The EMA announced the decision via social media. The dose used for this age group is lower than that of people aged 12 and above. The children will receive one third of the dose currently administered to vaccinated persons. What will not be changed is the three-week period between the first and second dose. The place of injection, in the muscles of the upper arm, will also remain the same.  

Actual effectiveness between 67 and 98% 

According to the EMA, a study in children aged 5 to 11 years showed that their immune response with a three times lower dose from Pfizer was “comparable” to that with a full dose in people aged 16 to 25 years. 

The efficacy of Cominarty, Pfizer’s vaccine, was tested in nearly 2,000 children aged 5 to 11 who had not previously been infected with Covid. Of these, 1,305 received the vaccine, three became infected with Covid. Of the 663 children who received the placebo, 16 became infected. 

According to EMA, this shows that the vaccine in this study was 90.7% effective in preventing Covid with symptoms. EMA estimates ‘the true rate’ of effectiveness in preventing infection to be between 67.7 and 98.3%. 

Side effects 

Regarding side effects of the vaccine in children aged 5-11 years, the ‘most common’ side effects were ‘similar’ to those in the older population. These were mainly pain or irritation at the puncture site, fatigue, headache or muscle pain. However, these risks do not outweigh the benefits, especially in children with conditions that increase the risk of serious Covid. 

What will Spain do? 

Formally, the EMA will now forward its recommendation to the European Commission, which is responsible for authorising vaccination in the EU, in this case for children aged 5 and 11. Once this process is complete, the final decision will be passed on to the EU countries. Furthermore, it is the national health authorities that have the final say. 

In Spain, the process will begin with the Vaccines Department of the Ministry, which will prepare a proposal – for example, on whether or not to vaccinate – for the communities, which will then be decided in the Public Health Commission. 

Will it be a positive decision? 

Health Minister Carolina Darias on Wednesday insisted on this procedure not to confirm for the time being whether Spain will vaccinate children aged 5 to 11 against the coronavirus after the green light from EMA. She did, however, refer to the preparation and the vaccines already purchased. This could anticipate a positive decision to vaccinate children.   

Spanish health system is prepared 

‘We are waiting for approval, for the children vaccination from 5 to 11 years with Pfizer, and from there the Vaccine Committee will review it and ask the Public Health Commission to approve it,’ Darias said, hinting at a veiled confirmation. ‘Spain will have to wait and see when the vaccines for children arrive, because they are not the same vials as those for children over 12,’ Darias said. She also assured that ‘the government has done its homework and has already purchased the vaccines. The national health system is ready to start when needed’.  

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