HEALTH CARE BRIEFING: FDA Vaccine Rules Challenged as Weak

U.S. vaccine advisers questioned whether safety and efficacy standards set by Food and Drug Administration officials were high enough to warrant emergency authorization of a shot.

About two dozen outside advisers to the FDA with expertise in infectious diseases met yesterday to weigh in on agency standards that require a vaccine to work in at least 50% of people and for drugmakers to collect two months of safety data on at least half of clinical trial volunteers.

“They haven’t gone far enough” in terms of safety, said Hayley Altman-Gans, a panel member and pediatrics professor at Stanford University Medical Center.

Many panel members and outside researchers who commented during the hearing worried that if a vaccine is rushed out that later turns out to have safety problems or to be less effective than promised, it could backfire in a big way, undermining public confidence in Covid-19 vaccines for years to come.

Several panel members expressed concern that the two-month safety follow-up the FDA is calling for before a vaccine gets an emergency authorization is simply not enough. In addition to safety, it means that doctors won’t know whether a vaccine’s efficacy could fade after just a few months.

Diana Zuckerman of the National Center for Health Research told the committee the vaccine trials “have serious design flaws.”

The trials are too geared to preventing mild infections, and may not show whether they prevent severe infections and hospitalizations, she said. Longer follow up may be especially important because some of the first vaccines, including messenger RNA vaccines from Pfizer and Moderna, are based on new technologies that have never been used in an approved product. Read more from Anna Edney and Robert Langreth.

The Coronavirus Pandemic

Trump, Biden Debate Health, Virus Issues: President Donald Trump and Democratic presidential candidate Joe Biden’s final debate last night touched on Trump’s vaccine timing claims and response to the coronavirus. Read a fact check here.

Pelosi-Mnuchin Talks Drag, Likely Pushing Stimulus Past Election: Prospects for a U.S. stimulus package passing Congress before the Nov. 3 election are fading fast as Speaker Nancy Pelosi (D-Calif.) and Treasury Secretary Steven Mnuchin dicker over the details of a nearly $2 trillion aid package. With the pace of talks dragging, resistance from Senate Republicans is building and President Donald Trump’s ability to twist arms into supporting a deal appears to be waning. Now some House Democrats are telling Pelosi that they don’t want to vote on legislation before the election if the Senate won’t do so, according to a party official. Read more from Billy House and Erik Wasson.

Clyburn Threatens HHS Subpoena Over CDC Info: House Select Subcommittee on the Coronavirus Crisis Chairman James Clyburn (D-S.C.) is threatening to subpoena the Health and Human Services Department if it doesn’t turn over records and witnesses sought in a probe of alleged political meddling at the U.S. Centers for Disease Control and Prevention during the Covid pandemic. “If you refuse to comply voluntarily, you will force the Select Subcommittee to consider issuing subpoenas,” he wrote in a letter to Secretary Alex Azar. HHS has offered “zero documents and zero witnesses,” Clyburn says. Read more from Max Reyes.

Meanwhile, the CDC will update school opening guidance to reflect rise of Covid-19 cases, House Democrats said, Alex Ruoff reports.

Michael Beach, the CDC’s deputy incident manager for the Covid-19 response, told staff for the House coronavirus panel that the agency’s school reopening guidance is “outdated and will be updated to reflect the current science on risks to children,” according to a readout of a meeting between Beach and the panel provided to reporters.

“With coronavirus cases rising around the country yet again, CDC must act swiftly to provide objective, science-based information—without political meddling from the Trump Administration—so schools and parents can make decisions based on unbiased advice from the agency’s public health experts,” Clyburn said.

Beach also said that college students return to campuses this fall contributed to the rising number of Covid-19 cases in the U.S., according to the readout.

Remdesivir Is First Covid Drug to Get FDA OK: The Food and Drug Administration approved Gilead Sciences’ antiviral therapy drug remdesivir yesterday, making it the first medication to obtain formal clearance for treating Covid-19. U.S. regulators had granted an Emergency Use Authorization for remdesivir earlier this year, and since then the drug has become a widely used therapy in hospitalized coronavirus patients. It was given to Trump this month when he was diagnosed with the virus.

The approval of remdesivir, sold under the brand name Veklury, will allow Gilead to market the drug and talk about its benefits to doctors, nurses, and patients. That could help solidify its position as a go-to medicine for Covid patients, even as other drugs for the disease start entering the market. The company said in June that it will charge U.S. hospitals about $3,120 for most patients who need remdesivir. Read more from Robert Langreth.

Moderna Completes Enrollment for Final Trials: Meanwhile, Moderna said it’s completed enrollment of 30,000 volunteers for its Phase 3 study of mRNA-1273, its vaccine candidate. More than 25,650 participants have received a second vaccination, the company said. Moderna said it will decide whether to submit a dossier to the Food and Drug Administration seeking an Emergency Use Authorization based on an assessment of whether the potential benefit of the shot outweighs the potential risks once the two months of safety follow-ups are done. Erin McClaim has more.

Mental Health Professionals Eligible for Federal Aid: Behavioral health professionals, such as psychiatrists, and other health-care providers who don’t accept Medicare or Medicaid are now eligible for pandemic assistance under the Provider Relief Fund, the Health and Human Services Department announced yesterday. Dentists, eye doctors, chiropractors, laboratories, osteopathic physicians, and hospice providers are among medical professions newly eligible. Read more from Shira Stein.

Warren, Khanna Lead Pandemic Push: Over 140 lawmakers led by Sen. Elizabeth Warren (D-Mass.) and Rep. Ro Khanna (D-Calif.) signed a letter to House and Senate leadership asking them to prioritize developing plans to prevent future pandemics, as well as mitigate the current one with more relief to Americans. Read the letter here.

More Headlines:

What Else to Know

HHS Sued for Drug Discount Dispute Process: Health-care centers have no remedy against pharmaceutical companies that they say are overcharging them for certain drugs because the government isn’t doing its regulatory duties, a community health-care association alleged in a lawsuit against the HHS. The National Association of Community Health Centers called on the government to finalize a dispute resolution policy so facilities have a clearer way to push back against drug companies, according to a complaint filed in federal court in Washington. Read more from Jacquie Lee.

Anti-Opioid Rules Stymie Access for Black Patients: Federal prescription drug laws and a lack of trained physicians are hindering access in Black communities to a take-at-home treatment for opioid use disorder, health-care advocates say. Buprenorphine has emerged as an effective tool in helping people beat substance use disorder. But not many doctors have completed the requisite extra training that would allow them to prescribe it. And a federal cap on the number of patients each health-care provider is allowed to treat with buprenorphine further restricts access to the medication. That creates a particular challenge for ensuring access to the treatment for patients in Black communities, which face shortages of primary care physicians and die of opioid overdose at a disproportionately high rate. Read more from Christopher Brown.

Walmart Sues U.S. to Fend Off Claims It Mishandled Opioids: Walmart sued the federal government in an effort to preempt regulators’ claims that the retailer added fuel to the U.S.’s opioid crisis by filling suspicious painkiller prescriptions in its pharmacies. The world’s largest retailer argues in the suit that the U.S. Justice Department and Drug Enforcement Administration is scapegoating the chain to divert attention from the agencies’ failures to effectively address the public-health crisis over opioids. Read more from Jef Feeley.

Barrett Advances to Senate Floor Amid Boycott: The Senate Judiciary Committee advanced the Supreme Court nomination of Judge Amy Coney Barrett, setting up a final vote to confirm Trump’s choice a week before the election. All 12 GOP senators on the panel voted in favor of Barrett’s nomination. Democrats boycotted the vote. The committee’s action means that the conservative judge’s confirmation is cruising toward a rapid finish Monday, eight days before Election Day. Read more from Laura Litvan.

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With assistance from Alex Ruoff

To contact the reporter on this story: Brandon Lee in Washington at blee@bgov.com

To contact the editors responsible for this story: Zachary Sherwood at zsherwood@bgov.com; Giuseppe Macri at gmacri@bgov.com; Michaela Ross at mross@bgov.com

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