vaccine

Siding with Big Pharma, Trump overrules FDA on stricter COVID-19 vaccine standards

Taking the advice of profit-driven pharmaceutical corporations over that of his own public health agencies and experts, President Donald Trump is blocking the Food and Drug Administration from imposing tougher safety requirements on the authorization of a coronavirus vaccine after drug company executives privately voiced disapproval with the push for stricter federal standards.

Politico reported late Monday that the White House’s “decision to halt release of new standards for emergency authorization of a Covid-19 vaccine came after officials close to [Trump] told the FDA that the pharmaceutical industry had objected to the tougher requirements.”

“The White House cited the private-sector opposition as a chief reason for blocking the guidelines, which aim to hold companies’ vaccines to a higher bar for safety and effectiveness and would likely push any authorization beyond Election Day,” according to Politico. “The fact that the president was siding with drug makers over his own regulators in shelving the guidance… adds a new dimension to concerns about White House interference in the FDA.”

Trump’s stonewalling of more stringent federal standards comes amid widespread concerns that the president’s politically motivated push for approval of a coronavirus vaccine before November 3 could result in a product that is insufficiently tested and unsafe. Late Monday, shortly after his release from Walter Reed National Military Medical Center, the president declared that “vaccines are coming momentarily”—a timeline scientists have rejected.

During the presidential debate last week with Democratic nominee Joe Biden, Trump dismissed more cautious vaccine timelines suggested by experts in his own administration as “very political” and said pharmaceutical executives have personally told him that “they can go faster than that by a lot.”

“I’ve spoken to Pfizer, I’ve spoken to all of the people that you have to speak to, Moderna, Johnson & Johnson, and others,” the president said.

When

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Exclusive: Moderna vaccine trial contractors fail to enroll enough minorities, prompting slowdown – sources

CHICAGO (Reuters) – Private contractors hired by Moderna Inc to recruit volunteers for its coronavirus vaccine trial failed to enroll enough Black, Latino and Native American participants to determine how well the vaccine works in these populations, company executives and vaccine researchers told Reuters.

FILE PHOTO: A sign marks the headquarters of Moderna Therapeutics, which is developing a vaccine against the coronavirus disease (COVID-19), in Cambridge, Massachusetts, U.S., May 18, 2020. REUTERS/Brian Snyder/File Photo

To make up for the shortfall, Moderna slowed enrollment of its late-stage trial and instructed research centers to focus on increasing participation among minority volunteers, the company said. The effort is being bolstered by academic researchers who have longstanding relationships with organizations in Black and other minority communities.

Five investigators working on the Moderna trial said in interviews that commercial site investigators quickly filled a large portion of the 30,000-person study with mostly white volunteers.

But COVID-19 infects Blacks in the United States at nearly three times the rate of white Americans, and they are twice as likely to die from the virus, according to a report by the National Urban League and other studies.

And communities of color count prominently among healthcare workers and populations at high risk of COVID-19 complications, making them among the first likely to be eligible for a new vaccine, experts said.

Dr. Paul Evans, chief executive of Velocity Clinical Research in Durham, North Carolina, whose company was hired to test the Moderna vaccine at five sites, said efforts to enroll volunteers from diverse backgrounds to provide proper population balance is “notoriously difficult” in any clinical trial.

“If there’s a problem with recruiting minorities, and there is, you can’t fix that overnight,” he said.

Black Americans made up only about 7% of the trial as of Sept. 17. That should be

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Trump’s coronavirus vaccine czar is siding with the FDA on safety standards that make a vaccine approval unlikely if not impossible before the election



a man wearing a suit and tie: Dr Moncef Slaoui speaks at a White House press conference on May 15, 2020, announcing a program to rapidly develop a coronavirus vaccine. AP Photo/Alex Brandon


© AP Photo/Alex Brandon
Dr Moncef Slaoui speaks at a White House press conference on May 15, 2020, announcing a program to rapidly develop a coronavirus vaccine. AP Photo/Alex Brandon

  • The man in charge of the Trump administration’s efforts to aid the development of coronavirus vaccines told Business Insider he supports a decision to require two months of safety data before approving any COVID-19 vaccine.
  • “I do think it is appropriate to set the threshold of safety follow-up,” Moncef Slaoui, the scientific head of Operation Warp Speed, said in a Tuesday morning phone interview. “It’s very important.”
  • That requirement will almost certainly prevent a vaccine from gaining emergency approval before the presidential election on November 3.
  • The agency spelled out its requirements Tuesday by releasing guidance for industry. Top White House officials reportedly opposed that guidance.
  • For more stories like this, sign up here for our daily healthcare newsletter.

In the race to develop a coronavirus vaccine, US regulators just laid down guidelines that make it difficult, if not impossible, for any COVID-19 shot to win emergency approval before Election Day.

The US Food and Drug Administration is asking vaccine developers to submit at least two months of safety data as part of an emergency-approval application, according to documents released Tuesday. The White House reportedly opposed that measure, with President Donald Trump saying on September 23 it “sounds like a political move.”

Despite pushback from the administration, the FDA publicly released those guidelines on Tuesday. And the man leading the US government’s efforts to help develop a vaccine said he supports the FDA.

“I do think it is appropriate to set the threshold of safety follow-up,” Moncef Slaoui, the chief advisor to Operation Warp Speed, told Business Insider in a Tuesday phone interview. “It’s very important.” Business Insider asked

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Moderna vaccine trial contractors fail to enroll enough people of color, prompting slowdown

CHICAGO – Private contractors hired by Moderna Inc. to recruit volunteers for its coronavirus vaccine trial failed to enroll enough Black, Latino and Native American participants to determine how well the vaccine works in these populations, company executives and vaccine researchers told Reuters.

To make up for the shortfall, Moderna slowed enrollment of its late-stage trial and instructed research centers to focus on increasing participation among minority volunteers, the company said. The effort is being bolstered by academic researchers who have longstanding relationships with organizations in Black and other minority communities.

Five investigators working on the Moderna trial said in interviews that commercial site investigators quickly filled a large portion of the 30,000-person study with mostly white volunteers.

But COVID-19 infects Blacks in the United States at nearly three times the rate of white Americans, and they are twice as likely to die from the virus, according to a report by the National Urban League and other studies.

And communities of color count prominently among healthcare workers and populations at high risk of COVID-19 complications, making them among the first likely to be eligible for a new vaccine, experts said.

Dr. Paul Evans, chief executive of Velocity Clinical Research in Durham, North Carolina, whose company was hired to test the Moderna vaccine at five sites, said efforts to enroll volunteers from diverse backgrounds to provide proper population balance is “notoriously difficult” in any clinical trial.

“If there’s a problem with recruiting minorities, and there is, you can’t fix that overnight,” he said.

Black Americans made up only about 7 percent of the trial as of Sept. 17. That should be closer to 13 percent to reflect the actual U.S. population.

During the last two weeks of September, Moderna said it increased the proportion of Black enrollment, but declined to provide

Continue Reading

Moderna vaccine trial contractors fail to enroll enough minorities

Private contractors hired by Moderna Inc to recruit volunteers for its coronavirus vaccine trial failed to enroll enough Black, Latino and Native American participants to determine how well the vaccine works in these populations, company executives and vaccine researchers told Reuters.

To make up for the shortfall, Moderna slowed enrollment of its late-stage trial and instructed research centers to focus on increasing participation among minority volunteers, the company said. The effort is being bolstered by academic researchers who have longstanding relationships with organizations in Black and other minority communities.

Five investigators working on the Moderna trial said in interviews that commercial site investigators quickly filled a large portion of the 30,000-person study with mostly white volunteers.

But COVID-19 infects Blacks in the United States at nearly three times the rate of white Americans, and they are twice as likely to die from the virus, according to a report by the National Urban League and other studies.

And communities of color count prominently among healthcare workers and populations at high risk of COVID-19 complications, making them among the first likely to be eligible for a new vaccine, experts said.

Dr. Paul Evans, chief executive of Velocity Clinical Research in Durham, North Carolina, whose company was hired to test the Moderna vaccine at five sites, said efforts to enroll volunteers from diverse backgrounds to provide proper population balance is “notoriously difficult” in any clinical trial.

“If there’s a problem with recruiting minorities, and there is, you can’t fix that overnight,” he said.

Black Americans made up only about 7% of the trial as of Sept. 17. That should be closer to 13% to reflect the actual U.S. population.

During the last two weeks of September, Moderna said it increased the proportion of Black enrollment,

Continue Reading