vaxzevria-previously-covid-19-vaccine-astrazeneca-epar-product-information_en-1.pdf

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ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
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This medicinal product is subject to additional monitoring. This will allow quick identification of
new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Vaxzevria suspension for injection
COVID-19 Vaccine (ChAdOx1-S [recombinant])
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
These are multidose vials which contain 8 doses or 10 doses of 0.5 ml per vial (see section 6.5).
One dose (0.5 ml) contains:
Chimpanzee Adenovirus encoding the SARS-CoV-2 Spike glycoprotein (ChAdOx1-S)
*
, not less than
2.5 × 10
8
infectious units (Inf.U)
*
Produced in genetically modified human embryonic kidney (HEK) 293 cells and by recombinant
DNA technology.
This product contains genetically modified organisms (GMOs).
Excipient with known effect
Each dose (0.5 ml) contains approximately 2 mg of ethanol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection (injection).
The suspension is colourless to slightly brown, clear to slightly opaque with a pH of 6.6.
4.
4.1
CLINICAL PARTICULARS
Therapeutic indications
Vaxzevria is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in
individuals 18 years of age and older.
The use of this vaccine should be in accordance with official recommendations.
4.2
Posology and method of administration
Posology
Individuals 18 years of age and older
The Vaxzevria vaccination course consists of two separate doses of 0.5 ml each. The second dose
should be administered between 4 and 12 weeks (28 to 84 days) after the first dose (see section 5.1).
There are no data available on the interchangeability of Vaxzevria with other COVID-19 vaccines to
complete the vaccination course. Individuals who have received the first dose of Vaxzevria should
receive the second dose of Vaxzevria to complete the vaccination course.
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Paediatric population
The safety and efficacy of Vaxzevria in children and adolescents (less than 18 years of age) have not
yet been established. No data are available.
Elderly population
No dose adjustment is required. See also sections 4.4 and 5.1.
Method of administration
Vaxzevria is for intramuscular injection only, preferably in the deltoid muscle of the upper arm.
Do not inject the vaccine intravascularly, subcutaneously or intradermally.
The vaccine should not be mixed in the same syringe with any other vaccines or medicinal products.
For precautions to be taken before administering the vaccine, see section 4.4.
For instructions on handling and disposal, see section 6.6.
4.3
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4
Special warnings and precautions for use
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 event 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
Vaxzevria.
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.
Thrombocytopenia and coagulation disorders
A combination of thrombosis and thrombocytopenia, in some cases accompanied by bleeding, has
been observed very rarely following vaccination with Vaxzevria. This includes severe cases presenting
as venous thrombosis, including unusual sites such as cerebral venous sinus thrombosis, splanchnic
vein thrombosis, as well as arterial thrombosis, concomitant with thrombocytopenia. Some cases had a
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fatal outcome. The majority of these cases occurred within the first fourteen days following
vaccination and occurred mostly in women under 60 years of age.
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 swelling, persistent abdominal pain
following vaccination. Additionally, anyone with neurological symptoms including severe or
persistent headaches or blurred vision after vaccination, or who experiences skin bruising (petechia)
beyond the site of vaccination after a few days, should seek prompt medical attention.
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.
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 Vaxzevria 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 from approximately 3 weeks after the first dose of Vaxzevria. Individuals may not be
fully protected until 15 days after the second dose is administered. As with all vaccines, vaccination
with Vaxzevria may not protect all vaccine recipients (see section 5.1).
Currently available clinical trial data do not allow an estimate of vaccine efficacy in subjects over
55 years of age.
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.
4.5
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Concomitant administration of Vaxzevria with other vaccines has not been studied.
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4.6
Fertility, pregnancy and lactation
Pregnancy
There is limited experience with use of Vaxzevria in pregnant women.
Animal reproductive toxicity studies have not been completed. Based upon results from the
preliminary study, no effects are expected on development of the fetus (see section 5.3).
Administration of Vaxzevria during pregnancy should only be considered when the potential benefits
outweigh any potential risks for the mother and fetus.
Breastfeeding
It is unknown whether Vaxzevria 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).
4.7
Effects on ability to drive and use machines
Vaxzevria 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.
4.8
Undesirable effects
Summary of the safety profile
The overall safety of Vaxzevria is based on an interim analysis of pooled data from four clinical trials
conducted in the United Kingdom, Brazil, and South Africa. At the time of analysis,
23,745 participants ≥18 years old had been randomised and received either Vaxzevria or control. Out
of these, 12,021 received at least one dose of Vaxzevria and 8,266 received two doses. The median
duration of follow-up was 62 days post-dose 2.
The most frequently reported adverse reactions were injection site tenderness (63.7%), injection site
pain (54.2%), headache (52.6%), fatigue (53.1%), myalgia (44.0%), malaise (44.2%), pyrexia
(includes feverishness (33.6%) and fever >38°C (7.9%)), chills (31.9%), arthralgia (26.4%) and nausea
(21.9%). The majority of adverse reactions were mild to moderate in severity and usually resolved
within a few days of vaccination. When compared with the first dose, adverse reactions reported after
the second dose were milder and reported less frequently.
Reactogenicity was generally milder and reported less frequently in older adults (≥65 years old).
The safety profile was consistent across participants with or without prior evidence of SARS-CoV-2
infection at baseline; the number of seropositive participants at baseline was 718 (3.0%).
Tabulated list of adverse reactions
Adverse drug reactions (ADRs) are organised by MedDRA System Organ Class (SOC). Frequencies
of occurrence of adverse reactions are defined as: very common (≥1/10); common (≥1/100 to <1/10);
uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000) and not known
(cannot be estimated from available data); within each SOC, preferred terms are arranged by
decreasing frequency and then by decreasing seriousness.
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