Oxford University/AstraZeneca COVID-19 vaccine Safety data

by Global Pharmacovigilance Team
December 31, 2020
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Oxford University/AstraZeneca COVID-19 vaccine Safety data: On 30 December 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) approved the COVID-19 vaccine developed by Oxford University/AstraZeneca for emergency supply in the United Kingdom.

AstraZeneca COVID-19 Vaccine is a monovalent vaccine composed of a single recombinant, replication-deficient chimpanzee adenovirus (ChAdOx1) vector encoding the S glycoprotein of SARS-CoV-2.

After administration, SRAS-CoV-2 glycoprotein S is expressed by locally stimulating neutralizing antibodies and cell immune responses.

AstraZeneca Vaccine is indicated for active immunisation of individuals 18 years or older for the prevention of coronavirus disease 2019 (COVID-19).

The AstraZeneca Vaccine consists of two separate doses of 0.5 ml each. The second dose should be given within 4 to 12 weeks of the first dose.

Oxford University/AstraZeneca Vaccine is for intramuscular (IM) injection only, preferably in the deltoid muscle.

The transport and storage requirements for this vaccine mean that it must be stored at temperatures between 2 C and 8 C.

MHRA confirmed that AstraZeneca COVID-19 Vaccine does not contain any components of animal origin.

Table of Contents

Oxford University/AstraZeneca COVID-19 vaccine Clinical data

AstraZeneca evaluated efficacy data based on an interim analysis of pooled data from four on-going randomized, blinded, controlled trials.

Study Name	Country	Study description	Study Start date	Status
COV001	UK	A Phase I/II Study to Determine Efficacy, Safety and Immunogenicity of the Candidate Coronavirus Disease (COVID-19) Vaccine ChAdOx1 nCoV-19 in UK Healthy Adult Volunteers	23 April 2020	Ongoing
COV002	UK	A Phase II/III Study, COV002, in adults ≥18 years of age (including the elderly) in the UK	28 May 2020	Ongoing
COV003	Brazil	A Phase III Study, COV003, in adults ≥18 years of age (including the elderly) in Brazil	23 June 2020	Ongoing
COV005	South Africa	A Phase I/II study, COV005, in adults aged 18 to 65 years of age in South Africa	28 June 2020	Ongoing

The primary efficacy endpoint based on a pooled analysis showed that the vaccine was 70.4% effective at preventing symptomatic COVID-19 occurring more than 14 days after receiving two doses of the vaccine.

A secondary efficacy endpoint of prevention of severe disease demonstrated no cases of severe infections or hospitalisations in the vaccine group.

Oxford University/AstraZeneca COVID-19 vaccine Safety data

Summary of AstraZeneca COVID-19 Vaccine Safety Profile

The overall safety of AstraZeneca Vaccine is based on an interim analysis of pooled data from four clinical studies conducted in the United Kingdom, Brazil, and South Africa.

At the time of analysis, 23,745 participants 18 years or older had been randomised and received either COVID-19 Vaccine AstraZeneca or placebo.

Of this number, 12,021 were vaccinated with at least one dose of the AstraZeneca COVID-19 vaccine.

The median duration of follow-up for the AstraZeneca COVID-19 vaccine was 105 days after dosage 1 and 62 days after dosage 2.

The possible Adverse drug reactions are as follows by category

Unsolicited uncommon Adverse drug reactions are

Lymphadenopathy
Decreased appetite
Dizziness
Abdominal pain
Hyperhidrosis
Pruritus
Rash
Injection site bruising includes injection site haematoma

Unsolicited common Adverse drug reactions are

Influenza-like illness

Very common Adverse drug reactions are

Headache
Nausea
Myalgia
Arthralgia
Injection site tenderness
Injection site pain
Injection site warmth
Injection site erythema
Injection site pruritus
Injection site swelling
Fatigue
Malaise
Pyrexia
Chills

Common Adverse drug reactions are

Vomiting
Injection site induration

Notes:

Very Common Adverse drug reactions means may affect more than 1 in 10 people
Common Adverse drug reactions means may affect up to 1 in 10 people
Uncommon Adverse drug reactions may affect up to 1 in 100 people

In clinical studies, there were very rare reports of events associated with inflammation of the nervous system, which may cause numbness, pins, and needles, and/or loss of feeling. However, it is not confirmed whether these events were due to the vaccine.

Reporting suspected adverse reactions If you are concerned about an adverse event, it must be reported to a Yellow Card.

Reporting forms and information can be found at https://coronavirus-yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store and include the vaccine brand and batch/Lot number if available.

To compare vaccines Oxford University/AstraZeneca COVID-19 vaccine Safety data with other vaccines, click here

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