Johnson & Johnson said Wednesday (Sept. 23) that it has launched the final phase of a trial of its one-shot new coronavirus vaccine, which the company hopes will determine whether the vaccine is safe and effective late this year or early next year.
Johnson & Johnson says 60,000 volunteers are currently participating in trials in the United States, Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa.
Several new coronavirus vaccines are in the final stages of testing in the U.S. and other countries, including vaccines developed separately by Moderna Inc. and Pfizer Inc.
Many vaccine experts question whether the U.S. Food and Drug Administration (FDA) will take the easy way out to get President Trump’s final approval. President Trump has been giving a shorter trial timeline than experts believe is needed to fully test candidate vaccines.
President Trump, who predicted the vaccine would be available before the Nov. 3 presidential election, again urged on Wednesday that approval be expedited. He tweeted that the FDA “must act quickly.
But Dr. Francis Collins, director of the National Institutes of Health (NIH), told reporters this week, “We want to do everything we can without sacrificing safety and efficacy.”
In an effort to promote transparency, the Washington Post reported Wednesday that the FDA will disclose details of stricter approval criteria for emergency approval of vaccines, which reduces the likelihood that a vaccine will be approved before Election Day.
Even if the FDA gives emergency approval for a vaccine before the end of the year, because supplies are limited, the vaccine must first be used in high-risk groups such as health care workers.
Other new coronavirus vaccines that are in late-stage trials in the U.S. require two injections, but the Johnson & Johnson vaccine requires only one injection. If approved, the one-shot vaccine would relatively simplify the distribution of millions of doses of vaccine compared to the major competing vaccines.
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