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British vaccine provokes immune response in first human studies - POLITICO

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Two front-runners in the race to develop a Covid-19 vaccine reported encouraging results from clinical trials on Monday, including one candidate that’s received more than $1 billion from the U.S. government.

Two experimental coronavirus vaccines — one developed by the University of Oxford and AstraZeneca and another by a Chinese company — both created strong immune responses in early trials, researchers reported in The Lancet medical journal.

AstraZeneca in May struck a $1.2 billion deal to provide the U.S. with 300 million initial doses of the shot this fall. The company also promised the U.K. 100 million initial doses.

Background: The AstraZeneca vaccine, which went into human trials in April, produced a promising immune response that lasted for nearly two months in an early study involving more than 1,000 healthy adults, researchers reported. The response was even stronger in 10 participants who received a second dose, the scientists said.

The Oxford study combines the initial Phase I safety trials with Phase II trials that examine both safety and the strength of any immune response. The results show that the vaccine induced not only a strong antibody response but also the production of immune cells called T cells. Scientists say both can be vital to a durable vaccine.

FDA Commissioner Stephen Hahn called the results "important" during an interview on Fox News, though he said more study is needed in larger trials.

“There is still much work to be done before we can confirm if our vaccine will help manage the COVID-19 pandemic, but these early results hold promise,” said Sarah Gilbert, one of Oxford’s lead researchers on the study, in a statement.

Meanwhile, a vaccine candidate developed by a Chinese company, CanSino Biologics, was generally safe and well-tolerated, researchers found in a separate 500-person Phase II trial that tested two different dose strengths. However, older participants showed significantly weaker immune responses than did younger participants, suggesting that older people might need two doses to the vaccine if it's ultimately approved.

What's next: The AstraZeneca vaccine has already moved into combined Phase II and III trials in several countries. Phase III trials are normally the final step to determine if a vaccine is effective.

Oxford researchers have also said they are open to intentionally infecting people with the virus in future trials to see if the vaccine definitely works, an approach known as human challenge studies.

“If our vaccine is effective, it is a promising option as these types of vaccine can be manufactured at large scale,” Gilbert said.

Phase III trials of the CanSino candidate are underway, and the company said it plans to include 40,000 participants at potential sites in Russia, Brazil, Chile and Saudi Arabia.

The company also signed an agreement in May with Canada's National Research Council to scale up production at a government facility in Montreal. CanSino hopes to conduct clinical trials in Canada over the next year.

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