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National information platform on anti-COVID vaccination: BioNTech-Pfizer vaccine to be used after careful scientific evaluation

The national information platform on vaccination against COVID-19 informed on Thursday that the BioNTech-Pfizer vaccine will be used in the European Union only after a careful scientific evaluation attesting that it meets all the conditions provided for in the existing rules.

These details came after two anaphylactic-type adverse reactions that required medical monitoring were reported as part of the vaccination campaign of the UK population with the new BioNTech-Pfizer vaccine against SARS-CoV-2, an event that "caused a wave of concern about the possibility of allergic reactions."

"The start of the UK vaccination campaign with the new BioNTech-Pfizer vaccine against SARS-CoV-2 was marked by the reporting of two anaphylactic-type adverse reactions that required medical monitoring. This event caused a wave of concern with on the possibility of allergic reactions, but some clarification is needed. The Food and Drug Administration (FDA) has made recommendations for the administration of the vaccine against COVID-19. Experts believe that the vaccine can be safely administered even to patients with a history of allergies, but should be avoided in the case of those with a history of severe allergic reactions to the components of the vaccine.


However, the Medicines and Healthcare products Regulatory Agency (MHRA) has recommended that people with a history of allergies (whether food or medicine) avoid vaccination," reads a press release sent by the national information platform on vaccination against COVID-19.

According to the quoted source, anaphylactic reactions occur in the context of a pre-existing personal terrain and are adverse reactions that, although known to all vaccines, are rare and do not represent an adverse effect that most people who are vaccinated face. Only two out of tens of thousands who were given the Pfizer-BioNTech vaccine in the UK had such an allergic reaction, the release said.

"Any medicine can have side effects, but most of them are not serious. The Romanian Society of Allergology and Clinical Immunology also points out that any vaccine comes with the risk of possible allergic reactions. The frequency of their occurrence is specified in the package leaflet of each product and derives from the data obtained from clinical trials. For the Pfizer-BioNTech vaccine against COVID-19, the trials of phase 3 which included 44,000 participants, showed that the risk of developing allergic reactions was 0.63% in the group of people vaccinated versus 0.50% in the placebo group. This vaccine is currently being evaluated for approval by the European Medicines Agency, so the vaccine will only be used in the European Union after careful scientific evaluation attesting the fact that it fulfills all the conditions provided in the existing norms," reads the release.