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AstraZeneca Proceeding with At-Risk Vaccine Development

AstraZeneca Proceeding with At-Risk Vaccine Development

  • Posted by ISPE Boston
  • On June 4, 2020

AstraZeneca is advancing its ongoing response to address the unprecedented challenges of COVID-19, collaborating with a number of countries and multilateral organizations to make the University of Oxford’s COVID-19 vaccine, formerly called ChAdOx1 and now known as AZD1222, widely accessible around the world in an equitable manner. The company has concluded the first agreements for at least 400 million doses and has secured total manufacturing capacity for one billion doses so far and will begin first deliveries in September 2020. AstraZeneca aims to conclude further agreements supported by several parallel supply chains, which will expand capacity further over the next months to ensure the delivery of a globally accessible vaccine.

AstraZeneca has received support of more than $1billion from the US Biomedical Advanced Research and Development Authority (BARDA) for the development, production and delivery of the vaccine, starting in the fall. The development program includes a Phase III clinical trial with 30,000 participants and a pediatric trial.

A Phase I/II clinical trial of AZD1222 began last month to assess safety, immunogenicity and efficacy in over 1,000 healthy volunteers aged 18 to 55 years across several trial centers in southern England. Data from the trial is expected shortly which, if positive, would lead to late-stage trials in a number of countries. AstraZeneca recognizes that the vaccine may not work but is committed to progressing the clinical program with speed and scaling up manufacturing at risk.

AZD1222 was developed by Oxford University’s Jenner Institute, working with the Oxford Vaccine Group. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold (adenovirus) virus that causes infections in chimpanzees and contains the genetic material of SARS-CoV-2 spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack COVID-19 if it later infects the body.

The recombinant adenovirus vector (ChAdOx1) was chosen to generate a strong immune response from a single dose and it is not replicating, so cannot cause an ongoing infection in the vaccinated individual. Vaccines made from the ChAdOx1 virus have been given to more than 320 people to date and have been shown to be safe and well tolerated

The company’s comprehensive pandemic response also includes rapid mobilization of AstraZeneca’s global research efforts to discover novel coronavirus-neutralizing antibodies to prevent and treat progression of the COVID-19 disease, with the aim of reaching clinical trials in the next three to five months. Additionally, the Company has quickly moved into testing of new and existing medicines to treat the infection. (Source: AstraZeneca Website, 21 May, 2020)

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