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2 U.S. vaccine trials to resume after pauses

By Jean Lotus
2 U.S. vaccine trials to resume after pauses
Vaccine trials by AstraZeneca and Johnson & Johnson were approved by the Food and Drug Administration to resume trials that were temporarily halted after participants fell ill.  File Photo by Drago Prvulovic/EPA

Oct. 24 (UPI) -- Vaccine trials will resume in the United States for two late-stage COVID-19 medications in production by drugmakers AstraZeneca and Johnson & Johnson, both of which were halted after participants became ill.

AstraZeneca announced Saturday that the Food and Drug Administration had authorized the company to resume trials that stopped in September, after a neurological problem sickened a participant.

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"The restart of clinical trials across the world is great news as it allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic," Pascal Soriot, AstraZaneca's CEO said in a statement. "We should be reassured by the care taken by independent regulators to protect the public and ensure the vaccine is safe before it is approved for use."

The AstraZeneca trial is being co-developed at Britain's Oxford University, and overseas drug trials have continued.

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A trial by drugmaker Johnson & Johnson has started up again after it was halted earlier this month when a volunteer participant suffered a stroke, the Washington Post reported Saturday.

An independent board investigates when a participant becomes ill during a vaccine trial. The board gave the OK for Johnson & Johnson to continue, the company said.

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"With the information which we gathered to date and the information from external experts, the company found no evidence the vaccine candidate caused it," Paul Stoffels, chief scientific officer told the Washington Post.

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Two other companies, Moderna and Pfizer, are also working on stage-three vaccine trials in the United States.

About 30,000 volunteer participants are being tested in FDA-approved trials for each vaccine. It is not unusual that in such large-scale trials, some participants will become ill, but companies are rushing forward with vaccine trials because the coronavirus has affected so many people, with more than 42.6 million infections worldwide.

Medical experts predict that more than one vaccine will be needed to distribute quickly to people in the United States and around the world.

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"The demand for safe and effective COVID-19 vaccines exceeds any single manufacturer's production capacity," Luciana Borio, a former acting chief scientist at the Food and Drug Administration told the New York Times. "We really need several in the field."

The speed of the vaccine development has become a political issue in the 2020 presidential race, with President Donald Trump promising the vaccine "within weeks" at the presidential debate against former vice president Joe Biden in Nashville Thursday.

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Vice presidential candidate Kamala Harris said on the campaign trail that she would not trust the vaccine if it was approved by Trump, but she would accept it if it was approved by "public health professionals."

Federal epidemiologists, such as the National Institute of Health's Anthony Fauci, have predicted that the vaccine will be available in spring of 2021 at the earliest.

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