First Doses Due in October
— By Mary Caffrey, May 21, 2020, AJMC
UPDATE: The U.S. ordered 300 million doses of a potential coronavirus vaccine from British drugmaker AstraZeneca, officials said May 21, 2020. The company will get up to $1.2 billion from the US Department of Health and Human Services to speed the development and production of the vaccine with the goal of delivering the first doses as early as October.
The Trump Administration announced early today that HHS and AstraZeneca will collaborate on a coronavirus disease vaccine called AZD1222. A statement released from HHS said the partnership will make “at least 300 million doses” of the vaccine available, “with the first doses delivered as early as October 2020.”
The vaccine is one originally developed at the University of Oxford; the university and AstraZeneca announced a global development agreement for the vaccine on April 30. In its own statement early today, AstraZeneca said a phase 1/2 clinical trial of the vaccine began last month to assess its safety immunogenicity and efficacy in over 1000 healthy volunteers, who are 18 to 55 years of age. These volunteers are all in the United Kingdom. Late-stage trials would begin in several countries based on these results, the statement said.
According to HHS, the agreement between AstraZeneca and the Biomedical Advanced Research and Development Authority (BARDA), an agency within HHS, would essentially kick start manufacturing of the doses while phase 3 clinical studies are under way this summer, involving 30,000 volunteers in the United States. BARDA will spend up to $1.2 billion for research, technology transfer, and scaled-up manufacturing,
Emergency use authorization or licensure from FDA would be needed for the vaccine to reach the public, the statement said. As for the timeline, “Early milestones enable BARDA and AstraZeneca to determine how the program progresses forward.”
“This contract with AstraZeneca is a major milestone in Operation Warp Speed’s work toward a safe, effective, widely available vaccine by 2021,” said HHS Secretary Alex Azar. “Getting a vaccine to the American public as soon as possible is one part of President Trump’s multi-faceted strategy for safely reopening our country and bringing life back to normal, which is essential to Americans’ physical and mental well-being in so many ways.”
“The Trump Administration is making multiple major investments in developing and manufacturing promising vaccines long before they’re approved so that a successful vaccine will reach the American people without a day wasted,” Azar said.
Besides the BARDA agreement, AstraZeneca said it has reached deals with the Coalition for Epidemic Preparedness Innovations (CEPI), the Vaccine Alliance and the World Health Organisation (WHO), to ensure the fair allocation and distribution of the vaccine around the world. AstraZeneca is also in discussions the Serum Institute of India and other potential partners to boost production and distribution.
AstraZeneca also holds a major stake in Moderna Therapeutics, which announced earlier this week its experimental vaccine had produced antibodies in small group of healthy volunteers.