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May 22, 2020

AstraZeneca, HHS strike $1.2B deal for 300M doses of experimental coronavirus vaccine

Daily Briefing

    HHS on Thursday announced that it has entered an agreement to pay British drugmaker AstraZeneca up to $1.2 billion to support the accelerated development of a potential vaccine against the new coronavirus and acquire at least 300 million doses of the inoculum.

    Will we really have a coronavirus vaccine in 12 to 18 months?

    US Covid-19 cases near 1.6M, death toll tops 94K

    The announcement come as U.S. officials as of Friday morning had reported 1,584,800 cases of Covid-19, the disease caused by the new coronavirus—up from 1,559,300 cases as of Thursday morning.

    As of Friday morning, officials also had reported a total of 94,722 U.S. deaths linked to the new coronavirus—up from 93,408 deaths reported as of Thursday morning.

    Recent data indicates the new coronavirus is now spreading widely in America's rural counties and small towns, with spikes in the numbers of Covid-19 cases being reported in Midwestern and Southern states—which are now becoming epicenters of the country's Covid-19 epidemic.

    For example, data shows Tampa and St. Petersburg, Florida, are recording dozens of newly reported Covid-19 cases daily—and experts are seeing similar trends in Collin County, Texas; Columbus, Ohio; Minneapolis; Milwaukee; Wake County, North Carolina; and Yell County, Arkansas, The Hill reports.

    A model by PolicyLab researchers at the Children's Hospital of Philadelphia on Wednesday projected Southern communities that have moved quickly to reopen nonessential businesses and ease social distancing measures could see a second wave of rising Covid-19 cases over the next four weeks. The researchers, who use cellphone data to predict the epidemic's course and monitor social mobility, said most American communities should not experience a second wave of rising Covid-19 cases if they continue to maintain social distancing as nonessential businesses reopen and other restrictions intended to curb the new coronavirus' spread are lifted.

    HHS to pay AstraZeneca up to $1.2B to speed vaccine development

    As the numbers of reported Covid-19 cases and related deaths continue to rise throughout the United States, HHS on Thursday announced that the Biomedical Advanced Research and Development Authority (BARDA) has entered into a contract with AstraZeneca to help speed up the development and manufacturing of the company's new coronavirus vaccine candidate, called AZD 1222. The vaccine, which the University of Oxford's Jenner Institute developed and licensed to AstraZeneca, is one of the few vaccine candidates for the new coronavirus that are currently being tested in humans.  

    Under the agreement, which BARDA reached with AstraZeneca under the Trump administration's "Operation Warp Speed" initiative, BARDA will pay AstraZeneca up to $1.2 billion to support advanced clinical trials, process development, ramped-up manufacturing, the transfer of vaccine manufacturing technology, and other activities related to the potential vaccine's development and manufacturing. According to HHS, AstraZeneca will accelerate the vaccine's development and manufacturing by ramping up production of the vaccine at BARDA's Centers for Innovation and Advanced Development in Manufacturing at the same time the company begins late-stage clinical trials on the inoculum.

    HHS said AstraZeneca under the agreement will launch late-stage clinical trials this summer to test the vaccine's safety and effectiveness among approximately 30,000 trial participants in the United States.

    In addition, AstraZeneca under the agreement would collaborate with BARDA to produce at least 300 million doses of the vaccine for the United States. HHS said AstraZeneca could deliver the first doses of the potential vaccine as soon as October 2020 if FDA approves it or issues an emergency use authorization for the immunization.

    The Trump administration has entered similar agreements with other drugmakers. For example, Johnson & Johnson received $456 million from the federal government to scale up production of its vaccine candidate to 300 million doses, with the first doses of the vaccine expected by early 2021 if FDA signs off. In addition, Moderna received $483 million from the federal government to ramp up production of its vaccine candidate if FDA signs off, and Sanofi received $30 million to support vaccine development research.

    HHS Secretary Alex Azar said, "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."

    However, health experts caution that the agreements do not mean the United States will have an effective vaccine against the new coronavirus in the coming months, because many promising vaccines fail in late-stage trials. Experts have noted that the record for developing a new vaccine is at least four years—and that many vaccines have taken 10 years or more to develop and get the federal government's approval (Wilson, The Hill, 5/21; Achenbach et al., Washington Post, 5/20; Roland, Wall Street Journal, 5/21; Wilkerson, Inside Health Policy, 5/21 [subscription required]; Silverman, "Pharmalot," STAT News, 5/21; B et al., Reuters, 5/21; HHS release, 5/21; New York Times, 5/22).

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