Recommendations of the European Medicines Agency on additional doses and booster doses
The Committee for Medicines in Human Medicine (CHMP) to Emma came to the conclusion that an additional dose of vaccines against the Covid-19 Comirnaty (Biontech / Pfizer) and Spikevax (Moderna) can be applied to people with a highly weakened immune system at least 28 days after the second dose is placed.
This recommendation comes as a result of studies that have shown that the additional dose of these vaccines increases the ability to form antibodies against the virus that causes CIVID-19 in patients with an organ transplant with a weakened immune system.
Although there is no direct evidence that the ability to form antibodies in these patients has created protection against COVID-19 is expected that the additional dose will increase protection at least in some patients. Emma will continue to track all the data emerged in connection with its effectiveness.
The product information of the two vaccines will be updated to include this recommendation.
Booster doses
It is important to make a difference between an additional dose in people with a weakened immune system and a booster dose in people with a normal immune system.
With regard to the latter, the CHMP has performed an assessment of data for Comirnaty, which show an increase in antibody levels when using a booster dose of about 6 months after the second dose in people aged 18 to 55. Based on these data, the CHMP concludes that the application of booster doses may consider at least 6 months after the second dose in humans at 18 years and older.
Implementation of booster doses will follow official recommendations at national level given by public health authorities, given the latest data on efficiency and all safety considerations. The risk of inflammatory heart disease or other very rare adverse reactions after a booster dose is not known and carefully monitored. As with all medicines, Emma will continue to review all vaccine performance and efficiency data.
For Comirnaty, more information on the recommendations for booster doses will be available in updated product information.
For SPIKEVAX, the CHMP currently evaluates data to support the application of a booster dose. Upon completion of the EMA evaluation will communicate the result
National vaccination campaigns
The conduct of vaccination campaigns in the EU remains the prerogative of the national technical advisory groups on immunization issues that manage vaccination campaigns in each EU Member State. These bodies are in the best position to take into account local conditions, including the spread of the virus (especially variants of the greatest importance), the availability of vaccines and the capacity of national health systems.
EMA will continue to work closely with the National Authorities and the European Disease Prevention and Control (ECDC) to assess available data and giving recommendations for the protection of society during the ongoing pandemic.
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Source: Министерство на здравеопазването на Република България 
