AstraZeneca has begun the final stage of trials in the US of a potential coronavirus vaccine developed by University of Oxford researchers.
The British drug company has begun recruiting up to 30,000 people to take part in the Phase III trials, with volunteers in Peru and Chile also participating.
The firm has also expanded an agreement to mass-produce its the vaccine candidate as it seeks to scale-up supply ahead of possible fast-tracked approval in the US.
The Cambrige-based company is to pay cell therapy firm Oxford Biomedica £15m upfront to reserve capacity in its plant, which will manufacture millions of doses of the vaccine. The deal, worth £50m in total, will see the Oxford company produce “multiple large-scale batches” of the vaccine over the next 18 months and could be extended until the end of 2023.
AstraZeneca announced on Monday night that the AZD1222 vaccine had entered late-stage trials in the US.
The American government has agreed to fast-track approval of the vaccine, subject to trial results, with a view to the first doses being delivered next month. The Trump administration has said it wants at least 300 million doses of the vaccine to be widely available by 2021.
Participants in the US trial will receive two doses of AZD1222 four weeks apart. AstraZeneca said it anticipated results “later this year, depending on the rate of infection within the clinical trial communities”.
Preliminary results of earlier trials showed the vaccine candidate induces a strong immune response and appears to be safe. Late-stage testing is also underway in the UK, Brazil, South Africa, and India, and is due to begin in Japan and Russia, with 50,000 participants expected in total.
AstraZeneca has also signed manufacturing deals in Russia, South Korea, Japan, China, Latin America and Brazil to take the global supply capacity to almost three billion doses of the vaccine.
Mene Pangalos, the firm’s executive vice-president of biopharmaceuticals research and development, said: “Should clinical trials demonstrate the vaccine protects against COVID-19 disease and is approved for use, we will work hard to make it globally available in a fair and equitable manner as rapidly as possible.”
AZD1222 is seen as one of the leading hopes among dozens of coronavirus vaccine candidates in development around the world.
Vaccines can typically take years to be developed, tested and approved, but research has been accelerated during the pandemic.
“We’ve been able to find ways to save time when going through all the normal processes,” Sarah Gilbert, professor of vaccinology at the University of Oxford, told The Independent this week.
She added: “We’ve worked with the regulators and ethical committee to minimise the time it takes to get to approval, but the approval is still the full approval – it’s not missing anything.”
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