AstraZeneca inked a $1 billion deal with the U.S. government for COVID-19 vaccine development and production. (AstraZeneca)
Published: May 21, 2020 From FiercePharma
Only days after Moderna reported positive early results for its potential COVID-19 vaccine, AstraZeneca has stolen the spotlight back. On Thursday, the U.K. drug giant scored a $1.2 billion contribution from the United States for development, production and delivery of its potential shot starting this fall.
The vaccine, developed by the University of Oxford’s Jenner Institute, contains the genetic material of SARS-CoV-2 spike protein. It isn’t replicating, so it can’t cause an ongoing infection in recipients, AZ says. The company hopes the vaccine can deliver a strong immune response from one dose by triggering the body to produce the spike protein and attack the novel coronavirus upon infection.
AstraZeneca has signed up to deliver 400 million doses through its initial supply agreements. The United States deal—through the HHS’ BARDA agency—follows a U.K. pact unveiled Sunday for 100 million total doses. That gives the U.S. delivery of about 300 million vaccine doses starting this fall.
BARDA, the Biomedical Advanced Research and Development Authority, says the money is “intended to help enable the Operation Warp Speed goal of making doses available by the end of 2020 and additional doses by the end” of the first quarter of 2021. President Donald Trump unveiled the “Warp Speed” program at a Rose Garden event late last week.
AstraZeneca says it can produce about 1 billion doses of its vaccine into next year, but it’s also planning to keep building out capacity and scouting for partners to broaden the potential rollout. There’s always the risk the vaccine won’t work, but AZ is pressing ahead with manufacturing preparations to deliver the vaccine as quickly as possible should it succeed in testing.
Aside from the production deals with the U.K. and U.S., AstraZeneca is in talks with other governments. It’s further engaged with international vaccine and health groups for potential global distribution, and it’s discussing options with the Serum Institute of India, the world’s largest vaccine distributor.
On the R&D side, the BARDA funding calls for a phase 3 trial in 30,000 participants, plus a pediatric trial, AZ says.
The team began human trials last month in a phase 1/2 study set to test the vaccine in 1,000 healthy volunteers ages 18 to 55 in England. If the results are positive, AZ plans to start late-stage trials in several countries.
And last week, the Oxford vaccine posted positive data in a preclinical challenge study. A single dose induced a humoral and cellular immune response in rhesus macaques, researchers said, and no pneumonia was observed in the macaques that received the vaccine.
On Sunday, U.K. Secretary of State for Business, Energy and Industrial Strategy Alok Sharma said the drugmaker agreed to distribute 30 million doses to the U.K. in September, and 100 million total. The U.K. “will be first to get access” if the vaccine is successful, Sharma said at a briefing.
Aside from AstraZeneca, other global drug giants and biotechs are advancing vaccines, with Moderna generating considerable buzz this week with its initial human data. Still, experts warn there is a way to go for any promising program.
Link : https://www.fiercepharma.com/pharma/astrazeneca-scores-1b-from-u-s-signs-up-to-deliver-hundreds-millions-covid-19-vaccines