Under the agreement, BARDA will spend $1.2 billion on to support development and manufacturing of the vaccine, first conceived at the University of Oxford.
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.
Real-World Study Reveals Key Insights into DLBCL Treatment Patterns, Outcomes
April 18th 2024A recent study offers valuable insights into the characteristics, treatment patterns, and outcomes of diffuse large B-cell lymphoma (DLBCL) in patients across different lines of therapy, providing a look into the landscape of DLBCL management.
Read More
Overcoming Employment Barriers for Lasting Social Impact: Freedom House 2.0 and Pathways to Work
April 16th 2024To help celebrate and recognize National Minority Health Month, we are bringing you a special month-long podcast series with our Strategic Alliance Partner, UPMC Health Plan. Welcome to our second episode, in which we learn all about Freedom House 2.0 and the Pathways to Work program.
Listen
Gene, Light Therapy Combo Shows Promise Against Prostate Cancer Cells in Proof-of-Concept Study
April 18th 2024In their preclinical model, the researchers found efficacy both in vitro and in vivo by using CRISPR-Cas9 to mimic porphyria and combining the technology with light therapy.
Read More
Making Giant Strides in Maternity Health Through Baby Steps
April 9th 2024To help celebrate and recognize National Minority Health Month, we are kicking off a special month-long podcast series with our strategic alliance partner, UPMC Health Plan. Welcome to our first episode, which is all about the Baby Steps Maternity Program and its mission to support women throughout every step of their pregnancy journey.
Listen
Collecting SDOH Data Can Assess Risk of Medical Nonadherence, Improve HEI and Star Ratings
April 18th 2024At the Academy of Managed Care Pharmacy (AMCP) 2024 annual meeting, a panel of presenters explored changes coming to Medicare that incorporate social determinants of health (SDOH) data to improve patient and health system outcomes.
Read More