VAQTA ADULT Suspension for injection Ref.[8207] Active ingredients: Hepatitis A, inactivated vaccine

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.

Individuals who develop symptoms suggestive of hypersensitivity after an injection of VAQTA Adult should not receive further injections of the vaccine. This vaccine may contain traces of neomycin and formaldehyde which are used during the manufacturing process (see sections 2 and 4.3).

VAQTA Adult must not be administered into a blood vessel.

Use caution when vaccinating latex-sensitive individuals since the syringe plunger stopper and tip cap contain dry natural latex rubber that may cause allergic reactions.

Qualitative testing for antibodies to hepatitis A prior to immunisation should be considered based on the probability of previous hepatitis A virus infection in patients who grew up in areas of high endemicity, and/or with a history of jaundice.

VAQTA Adult does not cause immediate protection against hepatitis A, and there may be a period of 2 to 4 weeks before antibody becomes detectable.

VAQTA Adult will not prevent hepatitis caused by infectious agents other than hepatitis A virus. Because of the long incubation period (approximately 20 to 50 days) for hepatitis A, it is possible for unrecognised hepatitis A infection to be present at the time the vaccine is given. The vaccine may not prevent hepatitis A in such individuals.

As with any vaccine, adequate treatment provisions, including epinephrine (adrenaline), should be available for immediate use should an anaphylactic or anaphylactoid reaction occur.

VAQTA Adult may be administered subcutaneously when clinically appropriate (e.g. for people with bleeding disorders who are at risk of haemorrhage), although the kinetics of seroconversion are slower for the first subcutaneous dose of VAQTA Adult compared with historical data for intramuscular administration.

As with any vaccine, vaccination with VAQTA Adult may not result in a protective response in all susceptible vaccinees.

Excipient(s) with known effect: This medicinal product contains less than 1 mmol (23 mg) sodium per dose and is considered to be essentially sodium free.

If VAQTA Adult is used in individuals with malignancies or those receiving immunosuppressive therapy or who are otherwise immunocompromised, the expected immune response may not be obtained.

Known or presumed exposure to HAV/Travel to endemic areas

Use with immune globulin

For individuals requiring either post-exposure prophylaxis or combined immediate and longer term protection (e.g., travellers departing on short notice to endemic areas), in countries where IG is available VAQTA Adult may be administered concomitantly with IG using separate sites and syringes. Although the antibody titre obtained is likely to be lower than when the vaccine is given alone. The clinical relevance of this observation has not been established.

Use with other vaccines

VAQTA Adult may be given concomitantly at separate injection sites with yellow fever and polysaccharide typhoid vaccines (see section 5.1). Though data in subjects 18 years of age and older are not available, studies in children 12 through 23 months of age have shown that VAQTA may be administered concomitantly with measles, mumps, rubella, varicella, pneumococcal 7-valent conjugate and inactivated polio vaccines. Immunogenicity data are insufficient to support concomitant administration of VAQTA with DTaP (Diphtheria, Tetanus and acellular Pertussis) vaccine.

Interaction studies other than with yellow fever and polysaccharide typhoid vaccines are not yet available; however, interactions with other vaccines are not anticipated when vaccines are administered at different injection sites. When concurrent administration is necessary, VAQTA Adult must not be mixed with other vaccines in the same syringe, and other vaccines should be administered at different sites.

Pregnancy

It is not known whether VAQTA Adult can cause foetal harm when administered to a pregnant woman, or can affect reproduction capacity. VAQTA Adult is not recommended in pregnancy unless there is a high risk of hepatitis A infection, and the attending physician judges that the possible benefits of vaccination outweigh the risks to the foetus.

Breast-feeding

It is not known whether VAQTA Adult is excreted in human milk, and the effect on breastfed infants following administration of VAQTA Adult to mothers has not been studied. Hence, VAQTA Adult should be used with caution in women who are breastfeeding.

Fertility

VAQTA Adult has not been evaluated in fertility studies.

Animal reproduction studies have not been conducted with VAQTA Adult.

No studies on the effects on the ability to drive and use machines have been performed. However, VAQTA Adult is expected to have no or negligible influence on the ability to drive and use machines.

Summary of the safety profile

In clinical trials with 1,529 healthy adults who received one or more doses of hepatitis A vaccine, subjects were followed for elevated temperature and local reactions during a 5-day period postvaccination and systemic adverse events including fever during a 14-day period postvaccination. Injection-site reactions, generally mild and transient, were the most frequently reported adverse events.

Post-marketing safety study

In a post-marketing safety study, a total of 29,587 individuals ≥18 years of age received 1 or 2 doses of VAQTA Adult. There was no serious, vaccine-related, adverse event identified. There was no nonserious, vaccine-related, adverse event resulting in outpatient visits, with the exception of diarrhoea/gastroenteritis in adults at a rate of 0.5%.

Tabulated summary of adverse reactions

The table presents adverse reactions reported as vaccine related observed in clinical trials, and in a post-authorisation safety study and adverse reactions spontaneously reported after use of the marketed vaccine.

Adverse reactions are ranked under headings of frequency using the following convention: [Very Common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1000 to <1/100); Rare (≥1/10,000 to <1/1000); Very Rare (<1/10,000); Not Known (cannot be estimated from the available data)].

¹ Post-authorisation safety study
² Spontaneous reporting after use of marketed vaccine

Description of selected adverse reactions

As with all vaccines, allergic reactions, in rare cases leading to shock, may occur (see section 4.4).

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.