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Statement no. 8: On 21 December 2020, the European Medicines Agency (EMA) announced its evaluation of the vaccine from Pfizer and BioNTech called Comirnaty as safe for humans and effective in preventing COVID-19

The vaccine was created based on the mRNA technology developed by the German company BioNTech, which it had already began working on in January 2020, immediately after the publication of the genetic sequence of the SARS-CoV-2 virus.

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Preclinical studies and animal tests allowed the first preparations to be developed within a short time. Soon after BioNTech began working with Pfizer in March, phase one and phase two clinical trials began. This means that the first several hundred people received the preparation as long as 8 months ago. Then, in July, the third phase of the study was launched, with over 43,000 people participating. Half of them received the vaccine, the other half a placebo. The study showed that the vaccine is 95% effective against COVID-19. The protective effect was observed regardless of gender, race, age, or comorbidities. The full effectiveness of the vaccine is achieved after it is administered intramuscularly in two doses, 3 weeks apart. However, the body starts acquiring immunity after the administration of the first dose. It is estimated that maximum protection is attained approximately one week after receiving the second dose.

In the case of the Comirnaty vaccine, no side effects have been observed that could have lasting consequences for people’s health or life. The most severe symptoms that have been associated with the administration of the vaccine were one case of a shoulder injury around the injection site and one case of lymph node swelling in the groin, on the opposite side of the body to the injection site. However, it should be borne in mind that the administration of the vaccine may be associated in some people with local symptoms and flu-like symptoms – fever, muscle pain and general malaise – which improve spontaneously within a few days.

Because isolated cases of anaphylactic reaction have been reported, as with other drugs and intramuscular preparations, each patient should remain under observation for at least 15 minutes after vaccination. Cooccurrence of flu-like diseases or respiratory diseases is not a contraindication to vaccination. The results of the phase-three clinical trial indicate that there is likewise no reason to delay vaccination in individuals who have recovered. Care should be taken with patients with blood clotting disorders, who may experience bruising and bleeding associated with the puncture itself. Comirnaty should not be administered to children under 16 years of age or to pregnant women, as studies have not yet been carried out with these groups of patients. In people with impaired immunity, the vaccine may have a reduced effect, but is not contraindicated.

Based on the presented data, it can be concluded that we now have the first highly effective vaccine, which we can and should use to get vaccinated.

About the team

The Interdisciplinary COVID-19 Advisory Team to the President of the Polish Academy of Sciences was set up on 30 June 2020. The team is chaired by Prof. Jerzy Duszyński, President of PAS, with Prof. Krzysztof Pyrć (Jagiellonian University) as deputy chair and Dr. Anna Plater-Zyberk (Polish Academy of Sciences) as its secretary.

Other members of the team are:
Dr. Aneta Afelt (University of Warsaw)
Prof. Małgorzata Kossowska (Jagiellonian University)
Prof. Radosław Owczuk, MD (Medical University of Gdańsk)
Dr. Anna Ochab-Marcinek (PAS Institute of Physical Chemistry)
Dr. Wojciech Paczos (PAS Institute of Economics, Cardiff University)
Dr. Magdalena Rosińska, MD (National Institute for Public Health – National Hygiene Institute, Warsaw)
Prof. Andrzej Rychard (PAS Institute of Philosophy and Sociology)
Dr. Tomasz Smiatacz, MD (Medical University of Gdańsk)