General information
The vaccine COMIRNATY / COMIRNATY™ (hereinafter – the COMIRNATY vaccine), manufactured by Pfizer Manufacturing Belgium NV, Belgium, BioNTech Manufacturing GmbH, Germany, is an mRNA vaccine intended for active immunization for the prevention of COVID-19 infections caused by the SARS-CoV-2 virus. Intended for persons aged 16 years and older.
Vaccination with the COMIRNATY vaccine induces the formation of neutralizing antibodies and a cellular immune response to the antigen – the surface spike protein (S protein) of the virus, which may contribute to protection against COVID-19. If, after vaccination with the COMIRNATY vaccine, a person comes into contact with the SARS-CoV-2 virus, their immune system recognizes it and protects the body. Since the COMIRNATY vaccine does not contain the SARS-CoV-2 virus, it is not possible to become infected with COVID-19 from vaccination.
The COMIRNATY vaccine was developed by the German company BioNTech Manufacturing GmbH, Germany, jointly with the American pharmaceutical corporation Pfizer. A special feature of the COMIRNATY vaccine is the conditions for its transportation and storage at low temperatures from -80 to -60 °C. It should be noted that in February 2021, based on updated vaccine stability data, the FDA and EMA allowed the vaccine to be transported and stored at temperatures from -25 to -15°C for two weeks before use.
The COMIRNATY vaccine is used in the USA, the United Kingdom, Canada and EU countries. It has passed the approval procedure of the World Health Organization and is included in the list of vaccines that may be used for emergency use under the COVAX program.
In accordance with Resolution of the Cabinet of Ministers of Ukraine No. 95 of 08.02.2021, which provides for the registration of vaccines for the prevention of COVID-19 under obligation for emergency medical use, the vaccine COMIRNATY / COMIRNATY™ (hereinafter – the COMIRNATY vaccine), manufactured by Pfizer Manufacturing Belgium NV, Belgium, and BioNTech Manufacturing GmbH, Germany, is authorized for emergency use in Ukraine (registration certificate No. UA/18592/01/01. MoH of Ukraine order of 22.02.2021 No. 308).
How is Comirnaty administered?
The COMIRNATY vaccine is administered intramuscularly into the deltoid muscle of the upper arm. The patient receives 2 injections. It is recommended to receive the second dose of the same vaccine 21 days after the first one in order to complete the vaccination course.
What efficacy did Comirnaty demonstrate in clinical trials?
Phase 1-3 clinical trials included a total of 43 448 participants who received at least one dose of the vaccine (N = 21 720) or placebo (N = 21 728), regardless of the duration of follow-up.
The overall efficacy of the vaccine against symptomatic COVID-19 was assessed 7 days after dose 2 and was 95,0% in subjects aged ≥16 years without prior evidence of SARS-CoV-2 infection and 94,6% in all subjects, regardless of prior evidence of SARS-CoV-2 infection. Vaccine efficacy after dose 1 up to dose 2 was 52,4%. Vaccine efficacy from 10 days after dose 1 up to dose 2 was 86,7%.
How long does the protection provided by Comirnaty last?
There is currently insufficient data on the duration of protection after vaccination with COMIRNATY. For additional information, follow-up of persons vaccinated during the clinical trial will continue for 2 years.
Can the second dose of the vaccine be given after a period longer than 21 day?
To date, there are insufficient data on the safety, immunogenicity, and efficacy of the vaccine if more than 21 day has passed since the first dose. Analysis of data obtained during Phase III clinical trials of the vaccine showed that the second dose can be administered between 19 and 42 days. If you have missed 21 day, we recommend receiving the second dose at the first opportunity. There is no need to repeat the series.
Can persons who have had COVID-19 be vaccinated with Comirnaty?
The clinical studies did not provide enough data to conclude how well the Comirnaty vaccine "works" in people who have already had COVID-19.
Safety of the Comirnaty vaccine
The safety of the Comirnaty vaccine was assessed in people aged 16 years and older in two clinical studies, which included 21 744 participants (who received at least one dose of Comirnaty). The most common adverse events following immunization (hereinafter – AEFI) were injection site pain, increased fatigue, headache, myalgia and chills. In general, all AEFI were mild or moderate in intensity and resolved within a few days after vaccination.
For detailed information on the specifics of using this medicinal product and possible AEFI, please refer to the instructions.
