Special Warning : אזהרת שימוש

4.4. Special warnings and precautions for use

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Hypersensitivity and anaphylaxis

Anaphylaxis has been reported in individuals who have received Spikevax. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following administration of the vaccine.
Close observation for at least 15 minutes is recommended following vaccination.
Subsequent doses of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of Spikevax. In cases of hypersensitivity reactions (excluding 
anaphylaxis) following first dose of the vaccine, a consultation with allergy expert should be considered and close observation is recommended following vaccination as follows: 30 minutes:
• People with a history of an immediate allergic reaction of any severity to another vaccine or injectable therapy.
• People with a history of anaphylaxis due to any cause.
15 minutes:
• All other persons.

Myocarditis and pericarditis

There is an increased risk for myocarditis and pericarditis following vaccination with Spikevax.

These conditions can develop within just a few days after vaccination, and have primarily occurred within 14 days. They have been observed more often in younger males, and more often after the second dose compared to the first dose (see section 4.8).

Available data indicate that most cases recover. Some cases required intensive care support and fatal cases have been observed.

Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Vaccinees should be instructed to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis such as (acute and persisting) chest pain, shortness of breath, or palpitations following vaccination.

Healthcare professionals should consult guidance and/or specialists to diagnose and treat this condition.

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.


Capillary leak syndrome flare-ups
A few cases of capillary leak syndrome (CLS) flare-ups have been reported in the first days after vaccination with Spikevax. Healthcare professionals should be aware of signs and symptoms of CLS to promptly recognise and treat the condition. In individuals with a medical history of CLS, planning of vaccination should be made in collaboration with appropriate medical experts.


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

Limitations of vaccine effectiveness

Individuals may not be fully protected until 14 days after their second dose. As with all vaccines, vaccination with Spikevax may not protect all vaccine recipients.

Excipients with known effect

Sodium
This medical product contains less than 1 mmol sodium (23 mg) per dose, that is to say, essentially ‘sodium-free’.

Effects on Driving