- Date 1 Sep 2020
AstraZeneca is today issuing a commitment to the highest safety standards and to broad and equitable access around the world for its COVID-19 vaccine AZD1222.
At the heart of AstraZeneca’s core values is to “follow the science” and adhere to the highest scientific and clinical standards, making the safety and efficacy of the vaccine of paramount importance. The Company’s submissions for market authorisation will meet the stringent requirements established by regulators everywhere around the world.
To this end, AstraZeneca is implementing a clinical development program that will enrol in excess of 50,000 volunteers, including 30,000 in the US, in Latin America, Asia, Europe, Russia and Africa that will provide data for ethnically diverse populations.
The Company also has a core value to “put patients first” and will continue to work with governments and other organisations towards broad and equitable global access to the vaccine, scaling up manufacturing with independent parallel supply chains around the world to produce billions of doses to a consistent and high standard of safety and efficacy.
Pascal Soriot, Chief Executive Officer, said: “In recent weeks we have seen an increasing number of questions around the safety and availability of vaccines to fight this terrible COVID-19 pandemic and I want to reiterate my commitment that we are putting science and the interest of society at the heart of our work. We are moving quickly but without cutting corners, and regulators have clear and stringent efficacy and safety standards for the approval of any new medicine, and that includes this potential COVD-19 vaccine. We will remain true to our values as we continue our efforts to bring this vaccine broadly and equitably to billions of people around world.”
In July 2020, interim results from the ongoing Phase I/II COV001 trial were published in The Lancet and showed AZD1222 was tolerated and generated robust immune responses against the SARS-CoV-2 virus in all evaluated participants.
AstraZeneca continues to engage with governments, multilateral organisations and partners around the world to ensure broad and equitable access to the vaccine, should clinical trials prove successful. Recent supply announcements with Russia, South Korea, Japan, China, Latin America and Brazil take the global supply capacity towards three billion doses of the vaccine.
AZD1222 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.