Summary of the Public Assessment Report (PAR) for Vaxzevria - last updated 03/23
Updated 22 November 2023
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This publication is available at https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca/summary-of-the-public-assessment-report-par-for-vaxzevria
The Public Assessment Report summarises the initial assessment at the time of approval in December 2020. The text in the original report remains unchanged.
Our advice is regularly updated on the basis of significant new data and our latest advice can be found in the Summary of Product Characteristics and the Summary of Coronavirus Yellow Card reporting.
Lay summary, Vaxzevria (previously COVID‑19 Vaccine AstraZeneca, suspension for injection) COVID-19 Vaccine (ChAdOx1‑S [recombinant])
This is a summary of the Public Assessment Report (PAR) for Vaxzevria (previously COVID‑19 Vaccine AstraZeneca, suspension for injection). It explains how this product was assessed and its authorisation recommended, as well as its conditions of use. It is not intended to provide practical advice on how to use this product.
This product was approved with a national Conditional Marketing Authorisation (CMA) which is used for medicinal products that fulfil an unmet medical need.
This product will be referred to as Vaxzevria in this lay summary for ease of reading and by its previous name, COVID 19 Vaccine AstraZeneca, suspension for injection, elsewhere in this PAR.
For practical information about using Vaxzevria, patients should read the Patient Information Leaflet (PIL) or contact their doctor or pharmacist.
What is Vaxzevria and what is it used for?
Vaxzevria is a vaccine indicated for active immunisation of individuals 18 years of age and older for the prevention of coronavirus disease 2019 (COVID‑19).
How does Vaxzevria work?
Vaxzevria stimulates the body’s natural defences (immune system) and causes the body to produce its own protection (antibodies) against the virus. None of the ingredients in this vaccine can cause COVID‑19.
How is Vaxzevria used?
The pharmaceutical form of this medicine is a suspension for injection and the route of administration is intramuscular injection. Vaxzevria will be given to you by an authorised practitioner as an intramuscular injection into the muscle at the top of the upper arm (deltoid muscle).
You will receive 2 injections of Vaxzevria, each of 0.5ml. You will be told when you need to return for your second injection of Vaxzevria. The second injection can be given between 4 and 12 weeks after the first injection.
You may receive a third (booster) injection of Vaxzevria. The booster injection may be given at least 6 months after the second injection.
For further information on how Vaxzevria is used, refer to the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) available on the Medicines and Healthcare products Regulatory Agency (MHRA) website.
This vaccine can only be obtained with a prescription.
If a person has any questions concerning the vaccine, they should ask the administering healthcare practitioner.
What benefits of Vaxzevria have been shown in studies?
Vaxzevria has been given to approximately 24,000 individuals aged 18 years or older in four ongoing clinical trials in the UK, Brazil and South-Africa. Most were equally allocated to COVID 19 Vaccine AstraZeneca or a control (another vaccine not targeting SARS-CoV-2 or a placebo).
In a pre-specified preliminary analysis, those who received the vaccine had a reduction in the rate of COVID-19 illness compared to those who received the control (30 cases of COVID-19 illness in the vaccinated group compared to 101 cases in the control group). These results were observed two weeks or more after the second dose in study participants with no evidence of prior SARS-CoV-2 infection. In an updated analysis, COVID-19 illness was reported in 84 cases in the vaccinated group compared to 248 cases in the control group.
A similar benefit was observed in participants who had one or more other medical conditions that increase the risk of severe COVID-19 disease, such as obesity, cardiovascular disorder, respiratory disease or diabetes.
Booster
In a small sub-study, a third dose booster of Vaxzevria given 28 to 38 weeks after the second dose was shown to induce higher levels of antibodies, including against the Beta and Delta variants, compared to those achieved after the second dose. The booster was also responsible for maintaining Spike-specific T-cell responses
What are the possible side effects of Vaxzevria?
The most common side effects with Vaxzevria (which may affect more than 1 in 10 people) were tenderness, pain, warmth, itching, or bruising where the injection is given, generally feeling unwell, feeling tired (fatigue), chills or feeling feverish, headache, feeling sick (nausea), joint pain or muscle ache. In clinical studies, most side effects were mild to moderate in nature and resolved within a few days with some still present a week after vaccination.
For the full list of all side effects reported with this medicine, see Section 4 of the Patient Information Leaflet (PIL) or Section 4.8 of the Summary of Product Characteristics (SmPC) available on the MHRA website.
Why was Vaxzevria approved?
It was concluded that Vaxzevria has been shown to be effective in the prevention of COVID-19. Furthermore, the side effects generally observed with use of this product are considered to be similar to those seen for other vaccines. Therefore, the MHRA concluded that the benefits are greater than the risks and recommended that this medicine can be authorised for use. Vaxzevria has been authorised with a Conditional Marketing Authorisation (CMA). CMAs are intended for medicinal products that address an unmet medical need, such as a lack of alternative therapy for a serious and life-threatening disease. CMAs may be granted where comprehensive clinical data are not yet complete, but it is judged that such data will become available soon.
What measures are being taken to ensure the safe and effective use of Vaxzevria?
All new medicines approved require a Risk Management Plan (RMP) to ensure they are used as safely as possible. An RMP has been agreed for the use of Vaxzevria in the UK. Based on this plan, safety information has been included in the Summary of Product Characteristics (SmPC) and the Patient Information Leaflet (PIL), including the appropriate precautions to be followed by healthcare professionals and patients.
All side effects reported by patients/healthcare professionals are continuously monitored. Any new safety signals identified will be reviewed and, if necessary, appropriate regulatory action will be taken. The MHRA has also put in place an additional proactive safety monitoring plan for all COVID-19 vaccines to enable rapid analysis of safety information which is important during a pandemic.
Other information about Vaxzevria
A Conditional Marketing Authorisation was granted in Great Britain on 24 June 2021.
The full public assessment report for Vaxzevria (previously COVID‑19 Vaccine AstraZeneca) is available in the downloadable PDF.
This summary was last updated in March 2023.