Johnson & Johnson launches huge human trial of COVID-19 vaccine

Written by Tom Howell Jr. on September 29, 2020. Posted in Current News

Pharmaceutical giant Johnson & Johnson started a massive human trial of its coronavirus vaccine Wednesday, lining up another option as federal officials told Congress they will resist political pressure ahead of an unprecedented push to inoculate the country.

The Janssen Pharmaceutical Companies of J&J said it plans to enroll up to 60,000 adults at nearly 215 clinical research sites in the U.S. and abroad. The company said its vaccine candidate offers twin advantages over some of its competitors — it can be delivered in a single dose and doesn’t require unusually cold storage temperatures.

The Trump administration, through “Operation Warp Speed,” is supporting private drugmakers as it tries to lock down a successful vaccine before the end of the year.

Three companies — AstraZeneca, Pfizer and Moderna — began their phase 3 trials weeks ago and expect to receive data on whether their candidates are effective as soon as late October.

President Trump said he’s encouraged by the record pace of development.

Mr. Trump also said he’s distributed $200 million in CARES Act so that states can distribute an eventual vaccine immediately.

“We want to do that the instant it is approved,” Mr. Trump said.

Many view a vaccine as the most critical tool in getting life back to normal. The coronavirus pandemic that began in Wuhan, China, in December, has devastated economies and killed nearly 1 million worldwide, including more than 200,000 in the U.S.

Critics of the Trump administration fear the president will force the Food and Drug Administration to approve a vaccine for emergency use before Election Day, before it is fully vetted.

FDA Commissioner Stephen Hahn rejected those claims in Senate testimony Wednesday.

“In the end, FDA will not authorize or approve a vaccine that we would not feel comfortable giving to our families,” he told the Senate Health, Education, Labor and Pensions Committee.

He said science will guide the agency’s decisions and the “FDA will not permit any pressure from anyone to change that.”

Later Wednesday, the president chafed at reports the FDA might beef up its standard for approving a vaccine for emergency authorization use, or EUA, to make sure the public has confidence in its review.

“That sounds like a political move,” Mr. Trump said. “I’m saying why would they have to be adding great length to the process?”

The president said he trusts companies to do rigorous testing in conjunction with government support.

“I don’t see any reason why it should be delayed further,” Mr. Trump said.

Read more at www.washingtontimes.com

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