- The Washington Times - Wednesday, June 10, 2020

Pharmaceutical giant Johnson & Johnson said Wednesday it will accelerate the development of its COVID-19 vaccine by launching human trials in late July instead of September, making it the latest company to up the ante in a pandemic race that is contending with the rigorous demands of science and public fears that drugmakers will cut corners.

The J&J trial will vet the investigational vaccine’s safety and its ability to produce an immune response in over 1,000 adults in the U.S. and Belgium, the company said.

J&J’s chief scientific officer, Paul Stoffels, said its Janssen division sped up the timeline based on “the strength of the preclinical data we have seen so far and interactions with the regulatory authorities.”

The acceleration is the latest twist in the unprecedented race to develop a vaccine to a virus that has infected over 7 million people worldwide and killed over 400,000. About a quarter of the officially acknowledged deaths have been recorded in the U.S.

The lack of a vaccine is impeding efforts to get back to normal after a series of stay-at-home orders that shut down businesses and hobbled the economy.

More than 130 vaccines for COVID-19 are in development. Clinical trials are underway for 10 of them.

A vaccine typically takes years to develop, but President Trump, demanding a vaccine by the end of the year, launched Operation Warp Speed to support companies that show promise.

“President Trump looked at the timelines that all of these players in the pharmaceutical industry and elsewhere said would be needed to bring all of these products to market, and he said, ‘That’s not acceptable,’” Health and Human Services Secretary Alex Azar said in a video update Wednesday.

But the push to get a vaccine on the market by early next year is making some Americans leery.

A survey by The Associated Press-NORC Center for Public Affairs Research in May found that almost half of Americans would accept a coronavirus vaccine if it becomes available, but 20% said they would not. Thirty-one percent replied they were not sure.

Concerns about side effects was the top reason why respondents said they would not accept a vaccine.

In a separate ABC News/Washington Post poll, 27% of adults said they “definitely” or “probably” would not get the vaccine. Among them, half said they don’t trust vaccines in general and 23% said they don’t think it’s necessary.

Some experts say the administration and drug companies have made the effort difficult for themselves by promising a vaccine by the end of the year before they know whether it is possible. They also have issued press releases that seem to jolt stock prices but offer little in terms of tangible data.

The White House invited scrutiny by tapping a longtime pharmaceutical executive, Moncef Slaoui, to be its vaccine czar. Mr. Slaoui is divesting parts of his stock portfolio to address perceived conflicts of interest with companies involved in the vaccine effort.

Peter Hotez, dean of the National School of Tropical Medicine at the Baylor College of Medicine, said the anti-vaccine movement tends to believe that vaccines are rushed and that there is a “conspiratorial relationship” between Big Pharma and government, so the current environment will feed into their assertions.

“I don’t believe safety is being jeopardized,” he said. “But the messaging from the biotechs, pharma companies and White House is just awful and now enabling the anti-vaccine movement in the U.S., so that studies show many Americans now won’t accept vaccines.”

Some public health experts are trying to reassure wary Americans.

“The public shouldn’t worry. The vaccine approval process will still be in place at the [Food and Drug Administration] as they go through the emergency-use authorization process, and data on safety and efficacy will be reviewed by the FDA to ensure that we have a safe and effective vaccine,” said Litjen Tan, chief strategy officer of the Immunization Action Coalition.

Even after emergency use is granted, he added, regulators will monitor ongoing trials to compile data on long-term safety and how long immunity lasts.

“The U.S. has the best vaccine safety surveillance systems in the world,” he said.

William Schaffner, an infectious disease specialist at Vanderbilt University, said the U.S. also got a head start on a coronavirus vaccine by working on candidate vaccines for severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), both of which are caused by related viruses.

The general public might think corners are being cut since vaccine development is moving more quickly, but that’s not the case, he said. Many procedures are being done at once, instead of in-sequence, to speed up the process.

The administration is aiming to have 100 million doses of one vaccine candidate by the end of the year, said Dr. Anthony Fauci, the government’s top infectious diseases scientist. That means the manufacturing process will begin before scientists know whether the vaccine works or not so it can be distributed quickly if it does.

Another top official, drawing a comparison to the flu vaccine, said any coronavirus vaccine would have to be about 60% effective to be considered viable.

“Flu is not an ideal vaccine because, as we all know, we have to get it every year and change it often. So it’s sometimes 50 or 60% effective, and we have to get it every year. And yet we use it and it saves tens of thousands of lives every year,” John Mascola, director of the Dale and Betty Bumpers Vaccine Research Center at the National Institute of Allergy and Infectious Diseases, said during a SciLine media briefing. “So I think it would be similar with the coronavirus vaccine. If we could get up to 60% … given that range, you have a pretty good vaccine.”

The administration is eyeing five COVID-19 vaccine candidates. Besides J&J, research is being conducted by Moderna Inc.; Oxford University in partnership with AstraZeneca; Pfizer; and Merck, according to The New York Times.

The Department of Health and Human Services declined to comment Wednesday on which projects appear to be the most promising.

The vaccine candidate produced by Moderna and Dr. Fauci’s agency is anticipated to go into the final, third phase of the clinical trials by the first week of July. The phase three trial will include 30,000 people ages 18 to 55, the elderly and people with underlying health conditions.

J&J, meanwhile, said Wednesday that it wants to provide 1 billion doses globally through the course of next year, provided the vaccine is safe and effective.

Pfizer said it has the potential to supply millions of doses of vaccine by the end of this year, subject to the “success of the development program and regulatory approval,” and that people should feel comfortable with a final product.

“Vaccines undergo extensive testing to make sure they are safe and effective,” Pfizer spokesman Steven Danehy said. “Once a vaccine is licensed, regulatory authorities routinely monitor its use and investigate any potential safety concerns.”

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