Document in Bulgarian Shows Possible Side Effects of First COVID Vaccine – Bulgaria

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The Ministry of Health and the Executive Agency for Medicines have published the leaflet and summary of the first vaccine against COVID-19 approved for use in the European Union. It is called “Comirnaty” and belongs to the American corporation “Pfizer” and its German partner “BioNTech”. Strict compliance with the so-called refrigeration chain is required for storage, and the package insert and short description contain information (in Bulgarian) to whom it can be applied and what the possible side effects are. His placement in Bulgaria for the first time in the healthcare system is expected to start on December 27.

Do not apply “Komirnati” …

With the explicit clarification that before administering the vaccine to anyone, it must be consulted and carried out by a doctor, the “Komirnati” vaccine leaflet states that it should not be used if a person is allergic to the active ingredient or to any of the others. components of the vaccine. The following are:

The package insert states that a person can be vaccinated against COVID-19 if they have a “mild fever or a mild upper respiratory infection, such as a cold.” Part of the content of the leaflet is that “Comirnaty is not recommended for children under the age of 16”. As an argument, the summary of product characteristics states that the safety and efficacy of the vaccine for humans in this group has not yet been established and that the data available is limited.

How much it protects

One of the most frequently asked questions, not only in Bulgaria but also around the world, since the beginning of the pandemic is what immunity a person has who has had coronavirus and how long the protection against the vaccine will last, if any. These questions are definitely not answered in the Pfizer product brochure https://news.google.com/ BioNTech. It is briefly written that:

Possible side effects

As is known from drugs, possible adverse reactions are listed for the first approved COVID-19 vaccine based on their frequency. Dnevnik cited them one by one, according to the Health Ministry:

Very common side effects: may affect more than 1 in 10 people.
– at the injection site: pain, swelling;
– fatigue
– headache
– Muscle pain
– joint pain
– shaking chills
– fever

Common side effects: may affect up to 1 in 10 people.
– redness at the injection site
– nausea

Uncommon side effects: may affect up to 1 in 100 people.
– enlarged lymph nodes
– discomfort
– pain in the extremities
– insomnia
– itching at the injection site

Rare side effects: may affect up to 1 in 1,000 people.
– temporary unilateral sagging of the face

Not known (cannot be estimated from the available data)
– severe allergic reaction

People should contact their doctor, pharmacist or nurse to report an adverse reaction and contact the Executive Agency for Medicines.

After defrosting

Komirnati vaccine should be stored between -90 ° C and -60 ° C (in special refrigerators), protected from light. Once thawed, it can stand for up to five days at 2-8 ° C (in a regular refrigerator). Once removed from the ordinary refrigerator, the vaccine can stay for up to two hours at temperatures up to 30 ° C. This creates additional organizational challenges for dispensing clinicians, as there are five doses in a vial (which must be diluted). In other words, five people are vaccinated with one vial. The second dose of the vaccine is given after at least 21 days. The injection is given into a muscle in the upper arm.

The full text of the leaflet and the brief description of the product can be read here.