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NIH promises Congress the U.S. won't skip safety steps in coronavirus vaccine approval

The head of the National Institutes of Health told Congress on Wednesday that U.S. health officials will not skip or abbreviate any safety assessments in the development of a coronavirus vaccine.

NIH Director Dr. Francis Collins said studying the safety and effectiveness of Covid-19 vaccine candidates is now the agency’s “top priority” as ModernaPfizer and AstraZeneca race to complete late-stage testing and submit approval applications to the Food and Drug Administration by the end of the year.

On Tuesday, AstraZeneca announced that it was pausing its late-stage trial after a suspected serious adverse reaction in one participant in the United Kingdom.

“The critical final steps in clinical trials will be well coordinated and done in parallel with manufacturing, but with NIH and industry providing the FDA with all of the critical safety and efficacy data necessary for sound scientific decision-making,” he told the Senate Committee on Health, Education, Labor and Pensions in prepared remarks submitted ahead of a hearing on coronavirus vaccines.

An independent data and safety monitoring board is reviewing the integrity of the trials and continues to monitor ongoing results to ensure participants are safe, Collins told the lawmakers. The protocols for the trials are being overseen by the U.S. government, in contrast to traditional trials in which pharmaceutical companies are solely responsible for design and implementation, he added.

“Efforts to shorten the timeline from bench to bedside, but still achieve a safe and effective vaccine, have been accomplished by eliminating down times and assuming the costs of at-risk manufacturing,” he said. 

The comments come as infectious disease experts and scientists have said they worry the vaccine approval process in the U.S. could be polluted by politics.

President Donald Trump, who is seeking reelection, has suggested a vaccine could be approved before Election Day on Nov. 3. 

The Centers for Disease Control and Prevention is asking governors and health departments to prepare to distribute a vaccine as soon as Nov. 1. Dr. Stephen Hahn, commissioner of the FDA, has also said the agency is prepared to bypass the full federal approval process in order to make a vaccine available as soon as possible. 

In recent days, U.S. health officials and drugmakers have attempted to alleviate concerns about the regulatory process and possible timeline for a vaccine approval. 

On Tuesday, nine drugmakers released a public letter pledging to “uphold the integrity of the scientific process” as they work toward potential global regulatory filings and approvals of the first Covid-19 vaccines.

“We saw it critical to come out and reiterate our commitment,” Pfizer CEO Albert Bourla told NBC’s “TODAY” on Tuesday. “We will develop our product, develop our vaccine using the highest ethical standards.”  

The same day, Dr. Anthony Fauci, the nation’s leading infectious disease expert, said it’s “unlikely” the U.S. will have a safe and effective vaccine before the election, throwing cold water of Trump’s estimation.

Dr. Moncef Slaoui, who is leading the Trump administration’s Operation War Speed initiative, told National Public Radio that it was “possible but very unlikely” a vaccine will be ready to distribute by the end of October or early November.

And on Thursday, Health and Human Services Secretary Alex Azar insisted the government’s Nov. 1 deadline for states is not linked to the presidential election at all. 

Collins, who was appearing Wednesday with U.S. Surgeon General Dr. Jerome Adams, will likely be grilled by lawmakers on the vaccine approval process. 

He is also expected to make a push for Americans to get vaccinated for the flu as influenza is expected to make the coronavirus pandemic much more complicated in the fall and winter. 

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