BioPharma, Policy

AstraZeneca gets $1B in BARDA funding to advance Covid-19 vaccine

The drugmaker licensed the vaccine last month from the University of Oxford, which is developing it in a Phase I/II clinical trial in southern England. The company also plans a Phase III study.

A British drugmaker is getting a helping hand from the U.S. federal agency tasked with assisting the development of vaccines for Covid-19.

London-based AstraZeneca said Thursday that it had received more than $1 billion from the Biomedical Advanced Research and Development Authority for development, production and delivery of a vaccine against the SARS-CoV-2 virus that it licensed from Oxford university, currently known as AZD1222 and previously known as ChAdOx1 nCoV-19. Those efforts will start in the fall, and the company plans a Phase III clinical trial with 30,000 participants as well as a trial in children.

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A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

Shares of AstraZeneca were up about 4.5% on the London Stock Exchange in afternoon trading Thursday, and were up 6% on the New York Stock Exchange when U.S. markets opened in the morning.

Overall, the drugmaker said it had concluded initial agreements for at least 400 million doses and has the capacity to manufacture 1 billion, with the first deliveries planned for September. AstraZeneca started a Phase I/II trial of AZD1222 in 1,000 healthy volunteers at centers in southern England last month and expects to have data from that study shortly. According to ClinicalTrials.gov, the University of Oxford-sponsored study began on April 23 and is now listed as active, but not recruiting, suggesting it has completed enrollment. The university and AstraZeneca signed a development, manufacturing and distribution agreement on April 30.

“This pandemic is a global tragedy, and it is a challenge for all of humanity,” AstraZeneca CEO Pascal Soriot said in a statement. “We need to defeat the virus together or it will continue to inflict huge personal suffering and leave long-lasting economic and social scars in every country around the world.”

AstraZeneca now joins the ranks of a growing number of companies with vaccines against SARS-CoV-2 entering advanced clinical development.

Earlier this week, Cambridge, Massachusetts-based Moderna announced the first clinical data for a SARS-CoV-2 vaccine, disclosing preliminary figures from the National Institute of Allergy and Infectious Diseases-sponsored Phase I trial of mRNA-1273. Although the announcement sent the company’s stock skyrocketing, it has since come back down to earth, as experts have cautioned about the significant limitations in interpreting the data. Moderna plans to open a Phase II study soon and a Phase III study over the summer.

Meanwhile, Tianjin, China-based CanSino Biologics has its vaccine in Phase II development and has recently announced plans to develop it in Canada. Pfizer and BioNTech are also developing a candidate that, like Moderna’s vaccine, uses messenger RNA.

Photo: Kaikoro, Getty Images