AstraZeneca’s COVID-19 vaccine has received interim recommendations from the World Health Organization’s (WHO) Strategic Advisory Group of Experts on Immunization (SAGE), for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.
The WHO’s SAGE has recommended two doses of COVID-19 Vaccine AstraZeneca, in individuals aged 18 years and above, including individuals aged 65 and over. The WHO noted that the labelled dosing interval is four to 12 weeks and recommended an interval of eight to 12 weeks between doses. This dosing regimen was shown in clinical trials to be safe and effective in preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose. In addition, the WHO SAGE recommended COVID-19 Vaccine AstraZeneca in countries where new variants, including the South African variant, are prevalent.
This interim policy recommendation is a key milestone ahead of an Emergency Use Listing (EUL) by the WHO which, should it be granted, would provide global access to the vaccine during the pandemic. It also means that AstraZeneca is one step closer to starting global supply of the vaccine through the COVAX Facility, which aims to deliver effective vaccines around the world, regardless of income level.
AstraZeneca was the first global pharmaceutical company to join COVAX in June 2020 due to the Company’s shared commitment to global, equitable access to vaccines. In the first half of 2021, over 300 million doses of the vaccine are targeted to be made available to 145 countries through COVAX from AstraZeneca and sub-license partner, Serum Institute of India, pending regulatory approvals and supply constraints. These doses will be equitably allocated based on the COVAX Allocation Framework.
Pascal Soriot, Chief Executive Officer, said: “This recommendation is a critical step to make our vaccine available across the world and will help protect millions of people, even where there are different variants of the SARS-CoV-2 virus in circulation. From the beginning, we made a commitment with Oxford University to ensure broad and equitable access, at no profit during the pandemic. We hope that very soon we will be able to realise this vision.”
Andrew Pollard, Professor of Paediatric Infection and Immunity, and Chief Investigator on the Oxford vaccine trial, said: “The new guidance from WHO is an important milestone in extending access to the Oxford-AZ vaccine to all corners of the world and providing further endorsement that after rigorous scrutiny by the WHO Strategic Advisory Group of Experts the vaccine can be used to help protect populations from the coronavirus pandemic.”
AstraZeneca continues to work with regulatory authorities around the world to support their ongoing rolling reviews for emergency supply or conditional approval during the health crisis.
The vaccine can be stored, transported and handled at normal refrigerated conditions (two-eight degrees Celsius/36-46 degrees Fahrenheit) for at least six months and administered within existing healthcare settings.
COVID-19 Vaccine AstraZeneca, formerly AZD1222
COVID-19 Vaccine AstraZeneca was co-invented by the University of Oxford and its spin-out company, Vaccitech. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.
WHO SAGE’s interim recommendation was based on an analysis of 23,745 participants aged 18 years and older, accruing 232 symptomatic COVID-19 infections from the UK and Brazil Phase III trials conducted by Oxford University.
The safety data published so far is from over 20,000 participants enrolled across four clinical trials in the UK, Brazil and South Africa. The publication in The Lancet confirmed that COVID-19 Vaccine AstraZeneca was well tolerated and that there were no serious safety events confirmed related to the vaccine. The participants were from diverse ethnic and geographic groups who were healthy or had stable underlying medical conditions.
In addition to the programme led by Oxford University, AstraZeneca is conducting a large trial in the US and globally. In total, Oxford University and AstraZeneca expect to enrol up to 60,000 participants globally.
The AstraZeneca COVID-19 vaccine has already been granted a conditional marketing authorisation or emergency use in more than 50 countries, spanning four continents including the European Union, a number of Latin American countries, India, Morocco and the UK.
Veeva ID: Z4-30775
Date of Preparation: February 2021