Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Hepatitis a vaccine, inactivated, adsorbed may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for.
Vaqta Adult is one of a general group of medicines called vaccines. Vaccines are used to protect against infectious diseases. They work by causing the body to produce its own protection against the targeted disease. This vaccine helps to protect against hepatitis A infection. Hepatitis A is a virus that attacks the liver, which can be caught from food or drink that contains the virus. Symptoms of hepatitis A include a yellowing of the skin and eyes (jaundice) and feeling generally unwell. When an injection of this vaccine is given, the body's natural defences will produce protection (antibodies) against the hepatitis A infection. However, it usually takes 2 to 4 weeks after receiving the injection before you will be protected. This vaccine will not protect you against other viruses that infect the liver (such as hepatitis B, hepatitis C or hepatitis E). This vaccine protects against hepatitis A but cannot cause hepatitis A infection.
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The vaccination may not work properly if the person to be vaccinated is already infected with the hepatitis A virus. Vaqta Adult is for adults aged 18 years and over. This vaccine is not suitable for anyone younger than 18 years of age.
2.
What you need to know before VAQTA Adult is given
Do not use Vaqta Adult:
•
if you are allergic to the active substance or any of the other ingredients of Vaqta Adult (listed in section 6) or to neomycin or formaldehyde (see section "Warnings and precautions").
•
if you are ill with a high temperature. The vaccination should be delayed until you have recovered.
Warnings and precautions Talk to your doctor, pharmacist or nurse before Vaqta Adult is given:
•
if you have ever had an allergic reaction to a previous dose of Vaqta Adult. This vaccine may contain traces of an antibiotic called neomycin and a substance called formaldehyde, both of which are used during vaccine production and may be present in the vaccine in trace amounts.
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if you have a poor or reduced immune system, due to:
•
−
corticosteroids, cytotoxic drugs or radiotherapy. Your doctor or nurse may wait until the treatment has finished.
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HIV (human immunodeficiency virus infection) or any disease that affects the immune system. The vaccine may not protect as well as it protects people whose immune system is healthy.
if you have any problems with the blood that causes easy bruising or bleeding for a long time after minor cuts. Your doctor or nurse may still advise that you should have Vaqta Adult but extra care is needed because of the risk of bleeding at the injection site. Your doctor or nurse may give Vaqta Adult as an injection under the skin instead of into muscle (see section 3) to try to reduce the risk of deep bleeding.
The vial stopper on the single dose vial contains latex rubber. May cause severe allergic reactions. As with other vaccines, Vaqta Adult may not completely protect all persons who are vaccinated. Please tell your doctor if you have a history of jaundice or have lived in an area where hepatitis A is common. Your doctor will determine whether you should be tested for hepatitis A antibodies prior to vaccination.
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Other medicines and VAQTA Adult Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines (or other vaccines). This vaccine can be given at the same time as any of the following provided that they are given in different parts of the body (for example another arm) and are not mixed in the same syringe.
• • •
Vi polysaccharide typhoid vaccine, Yellow fever vaccine, Immunoglobulins (antibodies obtained from blood donors)
Studies with a paediatric formulation have shown that the vaccine may be given at the same time as measles, mumps, rubella, varicella, pneumococcal 7-valent conjugate, inactivated polio, diphtheria toxoid, tetanus toxoid, acellular pertussis or Haemophilus influenzae type b vaccines.
Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice whether you should receive the vaccine. Driving or using machines There are no data to suggest that Vaqta Adult affects the ability to drive or operate machinery. VAQTA Adult contains sodium This medicine contains less than 1mmol (23mg) per dose, that is to say, essentially 'sodium-free'.
3.
The vaccine will be injected by a doctor or nurse who has been trained in the use of vaccines and who is equipped to deal with any rare severe allergic reaction to the injection. Short term protection against hepatitis A is achieved within 2 to 4 weeks after receiving this vaccination. This may take a little longer if the injection is given under the skin, rather than into the muscle. Long-term protection against hepatitis A requires a second dose (booster injection) of an inactivated hepatitis A vaccine. This is usually given between 6 and 18 months after the first dose. This booster will protect you against hepatitis A for at least 6 years. It is predicted that hepatitis A antibodies will remain at least 25 years after vaccination. If necessary, Vaqta Adult can be given as a booster injection 6 to 12 months after you received a first dose of another inactivated hepatitis A vaccine.
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Method of administration The doctor or nurse will shake the syringe immediately before use and check that the liquid is white and cloudy and that there are no large particles. The vaccine is given as an injection into a muscle in the upper outer part of the arm. Your doctor or nurse will avoid giving you the injection either into the skin or into a blood vessel. People who are at risk of bleeding a lot after an injection (see section 2) may sometimes be given Vaqta Adult as an injection under the skin but not into muscle to try to reduce the risk of bleeding.
Use in children and adolescents Vaqta Adult is not recommended for individuals less than 18 years of age.
4.
Possible side effects
Like all medicines and vaccines, this vaccine can cause side effects, although not everybody gets them. As with all vaccines, allergic reactions, in rare cases leading to shock, may occur. These reactions may include:
Frequency of side effects Very common: may affect more than 1 in 10 people Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Side effects injection-site tenderness, pain, warmth, swelling, redness
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headache arm pain (in the injected arm) weakness/tiredness, fever (38.3 C or over), bleeding under the skin at the injection site (ecchymosis), pain and soreness sore throat, upper respiratory infections swelling of the lymph nodes dizziness, abnormal skin sensations such as tingling ear ache hot flushes
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Rare: may affect up to 1 in 1,000 people
Not known: frequency cannot be estimated from the available data
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runny or blocked nose and airways, cough feeling sick (nausea), diarrhoea, excessive gas in the stomach and intestines, vomiting hives, itching, redness muscle pain, stiffness, shoulder pain, musculoskeletal pain (pain that affects the muscles, ligaments and tendons, along with the bones) back pain, joint pain, leg pain, neck pain, muscle weakness itching at the injection-site, stiffness/tightness, pain, bruising at the injection-site, chills, stomach ache, feeling generally unwell, hardness (induration) and numbness at the injection-site, cold sensation, flu-like illness bronchitis, inflammation of the stomach and intestines (gastroenteritis) loss of appetite lacking energy, trouble sleeping sleepiness, migraine, tremor itching eyes, sensitivity to light, increased flow of tears vertigo swelling of the throat, problems with the sinuses dryness of the mouth, mouth ulcers night sweats, rash, skin disorders muscle cramp, elbow pain, hip pain, jaw pain, spasm problems with periods injection-site burning, lump (≤2.5 centimetres), muscle twitching, rash, swelling of the stomach, chest pain, pain in the side; irritability Guillain-Barré syndrome (muscle weakness, abnormal sensations, tingling in the arms, legs and upper body) thrombocytopenia (reduction in blood platelets which increases risks of bleeding and bruising)
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report
directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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VAQTA Adult
5.
Keep this vaccine out of the sight and reach of children. The vaccine should not be used after the expiry date (Exp) which is stated on the carton and syringe or vial label. The vaccine must be stored in a refrigerator between 2°C and 8°C (making sure that it does not freeze) so that the vaccine keeps its effectiveness. Do not use this vaccine if you notice that it has an unusual appearance (see section 6) or contains particulate matter. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6.
What Vaqta Adult contains The active ingredient is: Inactivated hepatitis A virus (produced on MRC-5 human diploid cells, adsorbed on amorphous aluminium hydroxyphosphate sulfate). One dose (1 mL) contains 50U hepatitis A virus (inactivated) adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.45 milligram as aluminium). The other ingredients are:
• • •
sodium borate sodium chloride water for injections
What Vaqta Adult looks like and contents of the pack A pre-filled syringe or vial containing 1 millilitre (one dose) of the vaccine. The vaccine is available in single packs of the vial or pre-filled syringe with or without a needle. Not all presentations may be marketed. After thorough agitation Vaqta Adult is an opaque white suspension.
Marketing Authorisation Holder The Marketing Authorisation Holder in the UK is: Merck Sharp & Dohme (UK) Limited 120 Moorgate London EC2M 6UR UK
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Manufacturer The manufacturer responsible for batch release at the following manufacturing sites is: Merck Sharp and Dohme B.V., Waarderweg 39, PO Box 581, 2003 PC Haarlem, Netherlands This leaflet was last revised in November 2025. © 2025 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved. IB-045G ———————————————————————————————————-The following information is intended for healthcare professionals only: Incompatibilities In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. Instructions for use and handling The vaccine should be used as supplied. The vaccine should be inspected visually prior to administration for any foreign particulate matter and/or abnormal physical appearance. Discard the product if particulates are present or if it appears discoloured. The syringe should be well shaken until a slightly opaque white suspension is obtained. Thorough agitation is necessary to maintain suspension of the vaccine. For syringe without attached needle, hold the syringe barrel and attach the needle by twisting in clockwise direction until the needle fits securely on the syringe and give the vaccine immediately. © 2025 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved. IB-045G
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VAQTA Adult, suspension for injection comes as oral solution. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in VAQTA Adult, suspension for injection is hepatitis a vaccine, inactivated, adsorbed.
Medicines with the same active substance, strength and form include: AVAXIM Junior, suspension for injection in pre-filled syringe, AVAXIM suspension for injection in a pre-filled syringe, VAQTA Paediatric, suspension for injection. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for VAQTA Adult, suspension for injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
VAQTA Adult is indicated for active pre-exposure prophylaxis against disease caused by hepatitis A virus. VAQTA Adult is recommended for healthy adults 18 years of age and older who are at risk of contracting or spreading infection or who are at risk of life-threatening disease if infected (e.g. those with Human Immunodeficiency Virus [HIV] or hepatitis C with diagnosed liver disease).
The use of VAQTA Adult should be based on official recommendations.
For optimal antibody response, primary immunisation should be given at least 2, preferably 4 weeks prior to expected exposure to hepatitis A virus.
VAQTA Adult will not prevent hepatitis caused by infectious agents other than hepatitis A virus.
Posology
The vaccination series consists of one primary dose and one booster dose given according to the following schedule:
Primary dose:
Adults 18 years of age and older should receive a single 1.0 mL (50 U) dose of vaccine at an elected date.
Booster dose:
Adults 18 years of age and older who received a primary dose should receive a booster dose of 1.0 mL (50 U) 6 to 18 months after the first dose.
Hepatitis A virus (HAV) antibodies persist for at least 6 years after the second dose (i.e. booster). Based on mathematic modeling duration of antibody persistence is predicted for at least 25 years (see section 5.1).
Interchangeability of the booster dose
A booster dose of VAQTA may be given at 6 to 12 months following the initial dose of other inactivated hepatitis A vaccines. (See section 5.1.)
Adults with HIV
HIV-infected adults should receive a single dose of 1.0 mL (50 U) of VAQTA Adult at an elected date followed by a booster dose of 1.0 mL (50 U) 6 months later.
Paediatric population
There is a paediatric formulation available for children and adolescents. For details please refer to the Summary of Product Characteristics for VAQTA Paediatric.
Method of Administration
VAQTA Adult should be injected INTRAMUSCULARLY in the deltoid region. The vaccine should not be administered intradermally since administration by this route may result in a less than optimal response.
For individuals with bleeding disorders who are at risk of haemorrhage following intramuscular injection (e.g. haemophiliacs), this vaccine may be administered subcutaneously (see section 5.1).
Precautions to be taken before handling or administering the medicinal product
For instructions on preparation of the medicinal product before administration, see section 6.6.
History of hypersensitivity to the active substances, to any of the excipients listed in section 6.1, to neomycin or to formaldehyde (which may be present as trace residues, see sections 2 and 4.4).
Vaccination should be delayed in subjects with current severe febrile infections.
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 using the single dose vial since the vial stopper contains 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)].
System Organ Class
Frequency
Adverse reactions
Infections and infestations
Uncommon
Pharyngitis, Upper respiratory infection
Rare
Bronchitis, Infectious gastroenteritis
Blood and lymphatic system disorders
Uncommon
Lymphadenopathy
Not Known
Thrombocytopenia1
Metabolism and nutrition disorders
Rare
Anorexia
Psychiatric disorders
Rare
Apathy, Insomnia
Nervous system disorders
Common
Headache
Uncommon
Dizziness, Paresthesia
Rare
Somnolence, Migraine, Tremor
Not Known
Guillain-Barré syndrome1
Eye disorders
Rare
Itching eye, Photophobia, Tearing
Ear and labyrinth disorders
Uncommon
Ear pain
Rare
Vertigo
Vascular disorders
Uncommon
Hot flashes
Respiratory, thoracic and mediastinal disorders
Uncommon
Respiratory congestion, Nasal congestion, Cough
Rare
Pharyngeal edema, Sinus disorder
Gastrointestinal disorders
Uncommon
Nausea, Diarrhoea/ Gastroenteritis2, Flatulence, Vomiting
Rare
Dry mouth, Mouth ulcer
Skin and subcutaneous tissue disorders
Uncommon
Pruritus, Urticaria, Erythema
Rare
Night sweats, Rash, Skin disorder
Musculoskeletal and connective tissue disorders
Common
Arm pain (in the injected arm)
Uncommon
Myalgia, Stiffness, Shoulder pain, Musculoskeletal pain, Back pain, Arthralgia, Leg pain, Neck pain, Muscle weakness
Rare
Muscle cramp, Elbow pain, Hip pain, Jaw pain, Spasm
Reproductive system and breast disorders
Rare
Menstruation disorder
General disorders and administrative site conditions
Very Common
Injection-site tenderness, Pain, Warmth, Swelling, Erythema
Common
Asthenia/Fatigue, Fever (≥38.3°C, Oral) Injection-site ecchymosis, Pain/Soreness
Uncommon
Injection-site pruritus, Stiffness/Tightness, Pain, Injection-site hematoma, Chills, Abdominal pain, Malaise, Injection-site induration and numbness, Cold sensation, Flu-like illness
Rare
Injection-site burning, Induration (≤2.5 centimeters), Muscle twitching, Rash, Abdominal distention, Chest pain, Flank pain, Irritability
1 Spontaneous reporting after use of marketed vaccine
2 Post-authorisation safety study
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
There are no data with regard to overdose.
Ask anything about VAQTA Adult, suspension for injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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