Smallpox, live attenuated interacts in the following cases:
The concomitant administration of the vaccine with any immunoglobulin including Vaccinia Immune Globulin (VIG) has not been studied and should be avoided.
No interaction studies with other vaccines or medicinal products have been performed. Therefore, concomitant administration of smallpox vaccine with other vaccines should be avoided.
There are limited data (less than 300 pregnancy outcomes) from the use of smallpox, live attenuated vaccine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure the use of smallpox, live attenuated vaccine should be avoided during pregnancy unless it is considered that the possible benefit in terms of preventing smallpox would outweigh the potential risk.
It is not known whether smallpox, live attenuated vaccine is excreted in human milk. Smallpox, live attenuated vaccine should be avoided during breastfeeding unless it is considered that the possible benefit in terms of preventing smallpox would outweigh the potential risk.
Animal studies did not reveal any evidence of impaired female and male fertility.
Some of the undesirable effects may affect the ability to drive or use machines (e.g. dizziness).
The safety of smallpox, live attenuated vaccine has been assessed in 20 clinical trials in which 5,261 Vaccinia-naïve individuals received two doses of no less than 5 × 107 Inf.U four weeks apart while 534 Vaccinia- and Smallpox, live attenuated vaccine-experienced individuals received a single booster dose.
The most common adverse reactions observed in clinical trials were injection site reactions and common systemic reactions typical for vaccines which were mild to moderate in intensity and resolved without intervention within seven days following vaccination.
Adverse reaction rates reported after either vaccination dose (1st, 2nd or booster) were similar.
Adverse reactions from all clinical trials are listed according to the following frequency: 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).
Adverse Reactions Reported in Completed Clinical Trials with Smallpox, live attenuated vaccine (N=7,082 subjects):
| MedDRA 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) |
|---|---|---|---|---|
| Infections and infestations | - | - | Nasopharyngitis, Upper respiratory tract infection | Sinusitis, Influenza, Conjunctivitis |
| Blood and lymphatic system disorders | - | - | Lymphadenopathy | - |
| Metabolism and nutrition disorders | - | Appetite disorder | - | - |
| Psychiatric disorders | - | - | Sleep disorder | - |
| Nervous system disorders | Headache | - | Dizziness, Paresthesia | Migraine, Peripheral sensory neuropathy, Somnolence |
| Ear and labyrinth disorders | - | - | - | Vertigo |
| Cardiac disorders | - | - | - | Tachycardia |
| Respiratory, thoracic and mediastinal disorders | - | - | Pharyngolaryngeal pain, Rhinitis, Cough | Oropharyngeal pain |
| Gastrointestinal disorders | Nausea | - | Diarrhoea, Vomiting | Dry mouth, Abdominal Pain |
| Skin and subcutaneous tissue disorders | - | - | Rash, Pruritus, Dermatitis | Urticaria, Skin discolouration, Hyperhidrosis, Ecchymosis, Night sweats, Subcutaneous nodule, Angioedema |
| Musculoskeletal and connective tissue disorders | Myalgia | Pain in extremity, Arthralgia | Musculoskeletal stiffness | Back pain, Neck pain, Muscle spasms, Musculoskeletal pain, Muscular weakness |
| General disorders and administration site conditions | Injection site pain, Injection site erythema, Injection site swelling, Injection site induration, Injection site pruritus, Fatigue | Rigor/Chills, Injection site nodule, Injection site discolouration, Injection site haematoma, Injection site warmth | Underarm swelling, Malaise, Injection site haemorrhage, Injection site irritation, Flushing, Chest pain | Axillary pain, Injection site exfoliation, Injection site inflammation, Injection site paraesthesia, Injection site reaction, Injection site rash, Oedema peripheral, Asthenia, Injection site anesthesia, Injection site dryness, Injection site movement impairment, Influenza like illness, Injection site vesicles |
| Investigations | - | Body temperature increased, Pyrexia | Troponin I increased, Hepatic enzyme increased, White blood cell count decreased, Mean platelet volume decreased | White blood cell count increased |
| Injury, poisoning and procedural complications | - | - | - | Contusion |
In a non-placebo controlled clinical trial that compared the safety of smallpox, live attenuated vaccine in individuals with AD to healthy individuals, individuals with AD reported erythema (61.2%) and swelling (52.2%) at the injection site with a higher frequency than healthy individuals (49.3% and 40.8%, respectively). The following general symptoms were reported more frequently in individuals with AD compared to healthy individuals: headache (33.1% vs. 24.8%), myalgia (31.8% vs. 22.3%), chills (10.7% vs. 3.8%), nausea (11.9% vs. 6.8%), and fatigue (21.4% vs. 14.4%).
7% of the individuals with AD in clinical trials with smallpox, live attenuated vaccine experienced a flare-up or worsening of their skin condition during the course of the trial.
Smallpox, live attenuated vaccine may trigger local rashes or more widespread eruptions. Events of rash after vaccination (related cases observed in 0.4% of subjects) with smallpox, live attenuated vaccine tend to occur within the first days after vaccination, are mild to moderate in intensity and usually resolve without sequelae.
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