Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Novavax CZ a.s., Bohumil 138, Jevany, 28163, Czechia
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Events of anaphylaxis have been reported with COVID-19 vaccines. 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 Nuvaxovid.
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.
Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination.
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.
The efficacy, safety, and immunogenicity of the vaccine has been assessed in a limited number of immunocompromised individuals. The efficacy of Nuvaxovid may be lower in immunosuppressed individuals.
The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials.
Individuals may not be fully protected until 7 days after their second dose. As with all vaccines, vaccination with Nuvaxovid may not protect all vaccine recipients.
This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumfree’.
This vaccine contains potassium, less than 1 mmol (39 mg) per 0.5 mL, that is to say, essentially ‘potassium-free’.
Co-administration of Nuvaxovid with inactivated influenza vaccines has been evaluated in a limited number of participants in an exploratory clinical trial sub-study, see section 4.8 and section 5.1.
The binding antibody response to SARS-CoV-2 was lower when Nuvaxovid was given concomitantly with inactivated influenza vaccine. The clinical significance of this is unknown.
Concomitant administration of Nuvaxovid with other vaccines has not been studied.
There is limited experience with use of Nuvaxovid 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, see section 5.3.
Administration of Nuvaxovid in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.
It is unknown whether Nuvaxovid is excreted in human milk.
No effects on the breast-fed newborn/infant are anticipated since the systemic exposure of the breastfeeding woman to Nuvaxovid is negligible.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, see section 5.3.
Nuvaxovid has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under section 4.8 may temporarily affect the ability to drive or use machines.
The safety of Nuvaxovid was evaluated from an interim analysis of pooled data from 5 ongoing clinical trials conducted in Australia, South Africa, the United Kingdom, the United States and Mexico. At the time of the analysis, a total of 49,950 participants age 18 years and older received at least one dose of Nuvaxovid (n=30,058) or placebo (n=19,892). At the time of vaccination, the median age was 48 years (range 18 to 95 years). The median duration of follow-up was 70 days post-Dose 2, with 32,993 (66%) participants completing more than 2 months follow-up post-Dose 2.
Of the pooled reactogenicity data, which includes participants age 18 years and older enrolled in the two phase 3 studies who received at least one dose of Nuvaxovid (n=19,898) or placebo (n=10,454), the most frequent adverse reactions were injection site tenderness (75%), injection site pain (62%), fatigue (53%), myalgia (51%), headache (50%), malaise (41%), arthralgia (24%), and nausea or vomiting (15%). Adverse reactions were usually mild to moderate in severity with a median duration of less than or equal to 2 days for local events and less than or equal to 1 day for systemic events following vaccination.
Overall, there was a higher incidence of adverse reactions in younger age groups: the incidence of injection site tenderness, injection site pain, fatigue, myalgia, headache, malaise, arthralgia, and nausea or vomiting was higher in adults aged 18 to less than 65 years than in those aged 65 years and above.
Local and systemic adverse reactions were more frequently reported after Dose 2 than after Dose 1.
Licensed inactivated seasonal influenza vaccines were co-administered to participants on the same day as Dose 1 of Nuvaxovid (n=217) or placebo (n=214) in the opposite deltoid muscle of the arm in 431 participants enrolled in an exploratory Phase 3 (2019nCoV-302) sub-study. The frequency of local and systemic adverse reactions in the influenza sub-study population was higher than in the main study population following Dose 1 in both Nuvaxovid and placebo recipients.
Adverse reactions observed during clinical studies are listed below according to the following frequency categories: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data).
Table 1. Adverse reactions from Nuvaxovid clinical trials:
| System Organ Class | Very common (≥1/10) | Common (≥1/100 to <1/10) | Uncommon (≥1/1,000 to <1/100) | Rare (≥1/10,000 to <1/1,000) | Very rare (<1/10,000) | Not known (cannot be estimated from the available data) |
|---|---|---|---|---|---|---|
| Blood and lymphatic system disorders | Lymphadenopathy | |||||
| Nervous system disorders | Headache | |||||
| Vascular disorders | Hypertension | |||||
| Gastrointestinal disorders | Nausea or vomitinga | |||||
| Skin and subcutaneous tissue disorders | Rash Erythema Pruritus Urticaria | |||||
| Musculoskeletal and connective tissue disorders | Myalgiaa Arthralgiaa | |||||
| General disorders and administration site conditions | Injection site tendernessa Injection site paina Fatiguea Malaisea,b | Injection site rednessa,c Injection site swellinga Pyrexiaa Chills Pain in extremity | Injection site pruritus |
a Higher frequencies of these events were observed after the second dose.
b This term also included events reported as influenza-like illness
c This term includes both injection site redness and injection site erythema (common).
Throughout the clinical trials, an increased incidence of hypertension following vaccination with Nuvaxovid (n=46, 1.0%) as compared to placebo (n=22, 0.6%) was observed in older adults during the 3 days following vaccination.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V and include batch/Lot number if available.
This medicinal product must not be mixed with other medicinal products or diluted.
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