AstraZeneca receives $1B to advance COVID-19 vaccine
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WILMINGTON – Pharmaceutical giant AstraZeneca announced May 21 that it will receive upward of $1.2 billion from the federal government to advance work on its COVID-19 vaccine.
The Cambridge-based company, which has its U.S. headquarters in north Wilmington, reached a public-private partnership with the Biomedical Advanced Research and Development Authority (BARDA), the U.S Department of Health and Human Services office responsible for supporting drug development in the fight against the COVID-19 virus.
The funding will expedite development and manufacturing of an investigational vaccine known as AZ1222 to begin Phase 3 clinical studies this summer with approximately 30,000 U.S. patients, as well as a pediatric trial. None of the development will be done in Delaware.
It is the fourth vaccine candidate backed by BARDA, which has also invested in drugs from Moderna, Sanofi and Johnson & Johnson.
A Phase I/II clinical trial of AZD1222 involving 1,000 patients in southern England began in April. Results are expected soon from that trial, but the company noted that 320 people had already received the vaccine, saying it has “been shown to be safe and well tolerated.”
AstraZeneca licensed AZ122 from Oxford University in the U.K., where researchers had been developing it, for an undisclosed sum. The company reported that it had also agreed to support the establishment of a joint research center at Oxford for pandemic preparedness research.
In a statement announcing the BARDA deal, AstraZeneca CEO Pascal Soriot called the pandemic “a global tragedy” that is “a challenge for all of humanity.”
“We will do everything in our power to make this vaccine quickly and widely available,” he said, thanking the American and British governments for their investments in the work.
“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 in a statement, referring to the initiative by President Donald Trump to develop 300 million doses of SARS-CoV-2 vaccine by January 2021. “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.”
The BARDA funding backs at least 300 million doses of the drug for the U.S. should it be approved by the U.S. Food and Drug Administration, with deliveries as early as October. AstraZeneca reported that it had secured manufacturing capacity for 1 billion doses so far, with first deliveries scheduled for as early as September in the U.K., which has backed the manufacturing of 100 million doses. Those 400 million doses would be enough to vaccinate the entire populations of both nations.
“This is a bet, but if you look at it the investment is absolutely worth it,” Soriot said in a May 21 CNN Business interview. “It is, of course, not a guarantee that it will work, but we have very good hope and we’re confident that there’s good reason for it to work.”
Soriot said that about 30% of the vaccine’s deliveries would occur in September and October, with the remainder arriving by January. The company can expedite its research and potential manufacturing of the vaccine because it is working closely with regulators, he added, noting they are exchanging trial results daily.
In a May 24 BBC interview, Soriot revealed that the company has established supply chains in the U.S., U.K., Europe, India and China, which would help it disseminate the drug quickly around the world. AstraZeneca is reportedly talking with international organizations, such as the Coalition for Epidemic Preparedness Innovations, Gavi the Vaccine Alliance and the World Health Organization regarding the “fair allocation and distribution of the vaccine around the world.”
AstraZeneca is not making a profit off the government-backed work, only offsetting costs. Nonetheless, news of BARDA’s investment caused a spike in AstraZeneca’s stock of more than $3 a share. As enthusiasm over vaccine trials wanes, however, investors dumped the company’s stock over the holiday weekend, opening Tuesday at nearly $2 less per share than before BARDA’s funding.
By Jacob Owens
jowens@delwarebusinesstimes.com