EMA: special warnings and precautions for use of Comirnaty, an anti-COVID-19 vaccine


EMA ( European Medicines Agency ) has granted conditional marketing authorisation for the vaccine Comirnaty, developed by BioNTech and Pfizer, to prevent coronavirus disease 2019 ( COVID-19 ) in people from 16 years of age.

Hypersensitivity and anaphylaxis

Events of anaphylaxis have been reported. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine. Close observation for at least 15 minutes is recommended following vaccination. A second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of Comirnaty.

Anxiety-related reactions

Anxiety-related reactions, including vasovagal reactions ( syncope ), hyperventilation or stress‐related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting.

Concurrent illness

Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination.

Thrombocytopenia and coagulation disorders

As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder ( such as haemophilia ) because bleeding or bruising may occur following an intramuscular administration in these individuals.

Immunocompromised individuals

The efficacy, safety and immunogenicity of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of Comirnaty may be lower in immunosuppressed individuals.

Duration of protection

The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials.

Limitations of vaccine effectiveness

As with any vaccine, vaccination with Comirnaty may not protect all vaccine recipients. Individuals may not be fully protected until 7 days after their second dose of vaccine.

Excipients

The vaccine Comirnaty contains less than 1 mmol potassium ( 39 mg ) per dose, that is to say essentially potassium-free. The vaccine contains less than 1 mmol sodium ( 23 mg ) per dose, that is to say essentially sodium-free.

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.
Concomitant administration of Comirnaty with other vaccines has not been studied.

Fertility, pregnancy and lactation

Pregnancy - There is limited experience with use of Comirnaty in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo / foetal development, parturition or post-natal development. Administration of Comirnaty in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.

Breast-feeding - It is unknown whether Comirnaty is excreted in human milk.

Fertility - Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.

Effects on ability to drive and use machines

Comirnaty has no or negligible influence on the ability to drive and use machines. However, some of effects can temporarily affect the ability to drive or use machines. ( Xagena )

Source: EMA, 2020

XagenaMedicine_2020



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