JCOVDEN Suspension for injection Ref.[11085] Active ingredients: SARS-CoV-2 Spike glycoprotein (Ad26.COV2-S)

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

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.

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 an acute severe febrile illness or acute infection. However, the presence of a minor infection and/or low-grade fever should not delay vaccination.

Coagulation disorders

Thrombosis with thrombocytopenia syndrome: A combination of thrombosis and thrombocytopenia, in some cases accompanied by bleeding, has been observed very rarely following vaccination with JCOVDEN. This includes severe cases of venous thrombosis at unusual sites such as cerebral venous sinus thrombosis (CVST), splanchnic vein thrombosis as well as arterial thrombosis concomitant with thrombocytopenia. Fatal outcome has been reported. These cases occurred within the first three weeks following vaccination, and mostly in women under 60 years of age.

Thrombosis in combination with thrombocytopenia requires specialised clinical management. Healthcare professionals should consult applicable guidance and/or consult specialists (e.g., haematologists, specialists in coagulation) to diagnose and treat this condition.

Individuals who have experienced thrombosis with thrombocytopenia syndrome following vaccination with any COVID-19 vaccine should not receive JCOVDEN (See also section 4.3).

Venous thromboembolism: Venous thromboembolism (VTE) has been observed rarely following vaccination with JCOVDEN (see section 4.8). This should be considered for individuals at increased risk for VTE.

Immune thrombocytopenia: Cases of immune thrombocytopenia with very low platelet levels (<20000 per μL) have been reported very rarely after vaccination with JCOVDEN, usually within the first four weeks after receiving JCOVDEN. This included cases with bleeding and cases with fatal outcome. Some of these cases occurred in individuals with a history of immune thrombocytopenia (ITP). If an individual has a history of ITP, the risks of developing low platelet levels should be considered before vaccination, and platelet monitoring is recommended after vaccination.

Healthcare professionals should be alert to the signs and symptoms of thromboembolism and/or thrombocytopenia. Those vaccinated should be instructed to seek immediate medical attention if they develop symptoms such as shortness of breath, chest pain, leg pain, leg swelling, or persistent abdominal pain following vaccination. Additionally, anyone with neurological symptoms including severe or persistent headaches, seizures, mental status changes or blurred vision after vaccination, or who experiences spontaneous bleeding, skin bruising (petechia) beyond the site of vaccination after a few days, should seek prompt medical attention.

Individuals diagnosed with thrombocytopenia within 3 weeks after vaccination with JCOVDEN should be actively investigated for signs of thrombosis. Similarly, individuals who present with thrombosis within 3 weeks of vaccination should be evaluated for thrombocytopenia.

Risk of bleeding with intramuscular administration

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

Very rare cases of capillary leak syndrome (CLS) have been reported in the first days after vaccination with JCOVDEN, in some cases with a fatal outcome. A history of CLS has been reported. CLS is a rare disorder characterised by acute episodes of oedema mainly affecting the limbs, hypotension, haemoconcentration and hypoalbuminaemia. Patients with an acute episode of CLS following vaccination require prompt recognition and treatment. Intensive supportive therapy is usually warranted. Individuals with a known history of CLS should not be vaccinated with this vaccine. See also section 4.3.

Guillain-Barré syndrome and transverse myelitis

Guillain-Barré syndrome (GBS) and transverse myelitis ™ have been reported very rarely following vaccination with JCOVDEN. Healthcare professionals should be alert to GBS and TM signs and symptoms to ensure correct diagnosis, in order to initiate adequate supportive care and treatment and to rule out other causes.

Risk of very rare events after a booster dose

The risk of very rare events (such as coagulation disorders including thrombosis with thrombocytopenia syndrome, CLS and GBS) after a booster dose of JCOVDEN has not yet been characterised.

Immunocompromised individuals

The efficacy, safety and immunogenicity of the vaccine have not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of JCOVDEN 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

Protection starts around 14 days after vaccination. As with all vaccines, vaccination with JCOVDEN may not protect all vaccine recipients (see section 5.1).

Excipients

Sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per 0.5 mL dose, that is to say essentially ‘sodium-free’.

Ethanol

This medicinal product contains 2 mg of alcohol (ethanol) per 0.5 mL dose. The small amount of alcohol in this medicinal product will not have any noticeable effects.

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

Pregnancy

There is limited experience with the use of JCOVDEN in pregnant women. Animal studies with JCOVDEN do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or postnatal development (see section 5.3).

Administration of JCOVDEN in pregnancy should only be considered when the potential benefits outweigh any potential risks to the mother and foetus.

Breast-feeding

It is unknown whether JCOVDEN is excreted in human milk.

Fertility

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).

JCOVDEN has no or negligible influence on the ability to drive and use machines. However, some of the adverse reactions mentioned under section 4.8 may temporarily affect the ability to drive or use machines.

Summary of safety profile

Primary vaccination (primary analysis)

The safety of JCOVDEN was evaluated in an ongoing phase 3 study (COV3001). A total of 21 895 adults aged 18 years and older received JCOVDEN. The median age of individuals was 52 years (range 18-100 years). The safety analysis was performed once the median follow-up duration of 2 months after vaccination was reached. Longer safety follow-up of >2 months is available for 11 948 adults who received JCOVDEN.

In study COV3001, the most common local adverse reactions reported was injection site pain (48.6%). The most common systemic adverse reactions were headache (38.9%), fatigue (38.2%), myalgia (33.2%) and nausea (14.2%). Pyrexia (defined as body temperature ≥38.0°C) was observed in 9% of participants. Most adverse reactions occurred within 1–2 days following vaccination and were mild to moderate in severity and of short duration (1–2 days).

Reactogenicity was generally milder and reported less frequently in older adults (763 adults ≥65 years old).

The safety profile was generally consistent across participants with or without prior evidence of SARS-CoV-2 infection at baseline; a total of 2.151 adults seropositive at baseline received JCOVDEN (9.8%).

Booster dose (second dose) following primary vaccination with JCOVDEN

The safety of a booster dose (second dose) with JCOVDEN administered approximately 2 months after the primary vaccination was evaluated in an ongoing randomised, double-blind, placebo-controlled Phase 3 Study (COV3009). In the FAS (full analysis set), from the 15708 adults aged 18 years and older who received 1 dose of JCOVDEN, a total of 8646 individuals received a second dose during the double-blind phase. In the reactogenicity subset, from the 3016 individuals who received 1 dose of JCOVDEN, 1559 individuals received a second dose during the double-blind phase. The median age of individuals was 53.0 years (range: 18-99 years). At the data-cut off (25 June 2021), the median follow-up duration after the booster dose with JCOVDEN was 38 days. The solicited adverse reaction profile for the booster dose was similar to that after the first dose. There were no new safety signals identified.

Booster dose following primary vaccination with an approved mRNA COVID-19 vaccine

The safety of a booster dose with JCOVDEN administered at least 12 weeks after the primary vaccination with an approved mRNA COVID-19 vaccine regimen was assessed after 2 doses of Spikevax (49 individuals) or Comirnaty (51 individuals), or 1 dose of JCOVDEN (50 individuals). The median age of individuals was 55.0 years (range: 20-77 years). At the data-cut off (24 September 2021), 98.7% of the subjects had completed the Day 29 visit after booster vaccination (none has reached Day 91). Following the JCOVDEN heterologous booster, the solicited adverse reaction profile was similar to that following a JCOVDEN primary vaccination or homologous booster dose.

Tabulated list of adverse reactions

Adverse drug reactions observed during study COV3001 are organised by MedDRA System Organ Class (SOC). Frequency categories are defined as follows: 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).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Table 1. Adverse reactions reported following vaccination with JCOVDEN:

^a Hypersensitivity refers to allergic reactions of the skin and subcutaneous tissue.
^b Cases received from an ongoing open-label study in South Africa.

Reporting of suspected adverse reactions

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.