Drugmakers seeking an emergency authorization for a coronavirus vaccine will have to meet a higher standard of efficacy than normally would be required for such clearance, the head of the Food and Drug Administration’s office handling vaccines said yesterday.
Typically, an emergency use authorization, or EUA, would require a company to show their product may be effective. Peter Marks, director of the FDA’s biologics office, said the FDA will require more robust data about how well a coronavirus vaccine works before granting an emergency waiver, which he called “EUA plus.”
Marks said the data requirement will more closely mimic standards that apply for an application for a regular approval. The emergency pathway will be used mostly to help shed some paperwork and technical requirements to help push out a vaccine to Americans more quickly, he said.
The efficacy and safety data that’s required are expected to “indicate to us that we have a product that’s going to do what it’s intended to do,” Marks said at a Research! America event. He said that once a vaccine reaches the market there will be additional safety monitoring.
The medical community has raised fears about letting a vaccine hit the market under emergency authorizations, instead of the regular FDA approval process, particularly given President Donald Trump’s push to have a candidate available by the Nov. 3 election. Read more from Anna Edney.
- Also in the vaccine race, AstraZeneca CEO Pascal Soriot said the coronavirus vaccine that his company is developing with Oxford University could still be ready before the end of the year after pausing its trials due to a potentially serious neurological problem in one participant. Soriot sought to reassure investors after the drugmaker confirmed it temporarily halted giving people the candidate. Suzi Ring and James Paton have more.
- Meanwhile, the chairman of the Senate Appropriations subcommittee on health, Roy Blunt (R-Mo.), wrote a letter to Centers for Disease Control and Prevention Director Robert Redfield for answers about CDC’s “development of a fair, efficient plan” for distributing an eventual vaccine. Blunt also announced plans to hold a hearing later this month on vaccine development and distribution. Read the letter here.
The Coronavirus Pandemic
Stimulus Hopes Fade With GOP Bill Blocked: Odds of another round of fiscal stimulus for the U.S. economy fell yesterday as senators departed Washington for the weekend following a partisan split over a scaled-down package offered by Senate Republicans. The Senate voted 52 to 47 to advance a bill introduced by Majority Leader Mitch McConnell (R-Ky.), shy of the 60 needed to bring it up. Democrats were united in blocking the legislation.
Estimated at roughly $500 billion to $700 billion, the bill was intended to target the most pressing areas for assistance—revived supplemental unemployment insurance benefits and extended aid for small businesses, in particular. It was a fraction of the $2.2 trillion backed by Democrats and even below Republicans’ previous $1 trillion.
- The pared-back proposal provided a $300-per-week unemployment benefit enhancement, $105 billion for schools, a $10 billion grant to the U.S. Postal Service, $258 billion for small business loans, $47 billion for Covid vaccines and testing needs, and liability protections for employers.
- Among the bigger items excluded from the bill were large-scale assistance to state and local authorities, which have seen their revenues walloped by the Covid-19 crisis. That has been a key area of dispute in the negotiations, with Trump casting the near $1 trillion offered by House Democrats as a subsidy for poorly run blue states.
Democratic leaders and the White House broke off talks on a compromise over a month ago, and with nothing further scheduled, chances are rising that there will be no further aid before the November election. A number of GOP senators offered pessimistic outlooks after yesterday’s vote about the hopes of a revival of talks ahead of the election, Laura Litvan, Erik Wasson, and Billy House report.
Energy Research & Virus: The House Science, Space and Technology Subcommittee on Energy scheduled a hearing today on Energy Department biological research and responding to Covid-19.
NIH Targets Clots Tied to Covid: U.S. researchers have begun two clinical trials examining the use of blood thinners to help coronavirus patients avoid clotting that’s led to strokes, heart attacks, and organ failure. In one study, the National Institutes of Health will look at patients who are hospitalized, NIH chief Francis Collins said on a call with reporters. The second study will focus on people who haven’t been hospitalized. Read more from Anna Edney.
Funding Flaw Undercuts Hospitals in Black Areas: The federal government is doling out pandemic aid funding to hospitals using a formula that discriminates against predominantly Black communities because, generally, less cash is spent on their health care even when their need is greater. The methodology used by the Health and Human Services Department to help care providers hammered by Covid-19 is based upon past revenue at those institutions. This shortchanges counties that have more Black residents, according to a report published in JAMA. Read more from Dina Bass and John Tozzi.
- Europe Surpasses U.S. in New Virus Cases, Returning as Hot Spot
- U.S. Ends Airport Screening for Covid-19 in International Arrivals
- New Yorkers Face Fines for Not Wearing Masks on Mass Transit
- Houston Region’s Daily Covid Tally Inflated by Months-Old Cases
- Corvus Virus Immunotherapy Group Yields Antibody Production
- India Vaccine Maker Reverses Course, Stops Testing Astra Shots
- Minnesota Legislators to Consider Renewing Emergency Virus Order
- Flu Season Could Batter Testing Network Strained by Covid-19
What Else to Know
Democrats Want $6 Million Payment From Verma: Congressional Democrats, alleging the Trump administration’s Medicare chief created a publicly funded $6 million “shadow operation” and self-promotion effort, want reimbursement and a probe by a government watchdog agency. Centers for Medicare and Medicaid Services Administrator Seema Verma paid private communications consultants with ties to GOP circles up to $380 per hour to arrange media appearances and secure profile pieces, as well as book private meetings and lunches, Democratic leaders said in a report. Read more from Alex Ruoff.
New Coverage Plans Could Expand ACA: Growing business interest in a new type of health-care arrangement could bolster enrollment in Obamacare, lower costs, and ensure that some employees stay covered through the public health crisis, state exchange officials claim. Individual coverage health reimbursement arrangements (ICHRAs) allow employers to reimburse their workers tax-free for individual health insurance that they purchase on the exchange. Read more from Sara Hansard.
- Meanwhile, multiple states told a federal court in New York that the Health and Human Services Department’s rewrite of a rule implementing the anti-discrimination section of the ACA must be vacated because HHS had acted arbitrarily and outside the scope of its statutory authority. Read more from Mary Anne Pazanowski.
FDA Says Abortion Pill Dispensing Rule Valid: An in-person dispensing rule for a drug used in medication abortions is consistent with legal precedent and does not pose a substantial obstacle to abortion access amid the Covid-19 pandemic, the Food and Drug Administration told the U.S. Supreme Court. The nation’s top court should lift a lower court verdict barring the FDA from insisting that women go to doctor’s offices, clinics or hospitals to pick up the drug mifepristone during the pandemic, the FDA said. Read more from Mary Anne Pazanowski.
- Walmart, CVS Get Complaint Over Alleged Cosmetic Knockoffs
- Medicare Private Plans Got $2.6 Billion in Suspect Payments
- Medicare Agency Loses Over Payments to Bankrupt Provider
- Eisai, CVS Say Belviq Class Lawsuit Plaintiffs Weren’t Harmed
- Cigna, Other Insurers to Reach More Obamacare Markets in 2021
To contact the reporter on this story: Brandon Lee in Washington at email@example.com