HEALTH CARE BRIEFING: White House Says J&J Will Meet Targets

President Joe Biden’s administration is “assured” that Johnson & Johnson will meet its U.S. vaccine delivery targets despite a setback at a Baltimore site, White House Press Secretary Jen Psaki said.

Psaki spoke yesterday at the White House after J&J and one of its subcontractors, Emergent BioSolutions, acknowledged that a batch of drug substance had been spoiled. She said the U.S. doesn’t expect J&J to miss any delivery targets, and alluded to having some room with a larger supply of Pfizer and Moderna. The U.S. has said it will have enough vaccine doses for all American adults in May from those companies.

“We have been assured that they expect to meet those deadlines,” Psaki said, when asked about J&J. “We are looking forward to that. Obviously, these are doses that the U.S. government has purchased but we also have plenty of doses from Pfizer and Moderna, regardless.”

The disruption affected a batch of drug substance at a Baltimore plant that isn’t yet authorized to produce doses, and has not provided any to the U.S. so far. It’s not expected to affect Biden’s May target, several people familiar with the matter have said.

Psaki said the Department of Health and Human Services informed the White House late last week, but didn’t say when HHS learned of the problem at the facility.

In a statement yesterday, Emergent said it has set up rigorous quality checks that caught the flawed batch. “Through these checks a single batch of drug substance was identified that did not meet specifications and our rigorous quality standards. We isolated this batch and it will be disposed of properly,” it said. Read more from Josh Wingrove.

Happening on the Hill

Warren Says Amazon May Mislead on Face Masks: Amazon’s policies and procedures “appear to be increasing risks for many individuals that are purchasing Covid-19 masks and other protective gear,” Sen. Elizabeth Warren (D-Mass.) said in a letter to Amazon CEO Andy Jassy. Warren cited an investigation by her staff that she says revealed consumers searching for these items on Amazon website “may be misled by Amazon’s search algorithms and lack of quality control standards,” Kathleen Miller reports.

Lawmakers Attack Drug Companies After Remdesivir Report: Two key Democrats yesterday scoffed at a watchdog report showing the government has no patent rights over a Covid-19 drug, despite spending $162 million supporting its development, Alex Ruoff reports. Sen. Debbie Stabenow (D-Mich.) said the report demonstrates how pharmaceutical companies reap the benefits of government-supported research without any price controls. She said in a statement it’s time for that to change. “This report exposes how the American people are being ripped off by drug companies who use taxpayer-funded research to develop lifesaving prescription drugs, then turn around and charge exorbitant prices for these drugs when people need them the most,” Stabenow said. “I intend to continue working to put an end to this and other practices that allow the drug industry to gouge families for life-saving prescription drugs.”

She was joined by Rep. Carolyn Maloney (D-N.Y.), chair of the House Oversight and Reform Committee, in calling for more transparency around federal spending to support drug development.

The Government Accountability Office report, requested by the pair of lawmakers, found that federal funding for studies and clinical trials involving Gilead’s remdesivir totaled about $162 million. The federal contributions didn’t result in government patent rights because federally-supported research did not generate new inventions, the report concluded.

Nursing Homes Seek $8.5 Billion to Improve Housing: A group representing service providers for seniors wants the federal government to invest $8.5 billion to improve and expand affordable senior housing.

The proposal by LeadingAge, outlined in a letter sent yesterday to congressional leaders, calls for $2.5 billion in funding to build roughly 54,000 new affordable housing units, $1 billion to fund age-friendly, in-home accessibility features for seniors, and $5 billion to expand broadband access by making it a subsidized utility. Read more from Tony Pugh.

The Coronavirus Pandemic

Vaccine Trickle Becomes Torrent: It’s taking some effort and some patience. But just as eligibility is opening to millions of people across the U.S. after months of cutthroat competition to find Covid-19 shots, vaccines are starting to stream into people’s arms. Biden staked his bid on an effective battle against the coronavirus that would center around mitigation measures and assisting states with the swift dispersal of vaccines. States are offering shots to millions of people who want to return to life as it was before Covid-19, and officials in charge are reporting that the campaign is rounding into form. Nearly half of U.S. states will have opened vaccination to everyone 16 and older by the end of this week. That will rise to about three-quarters, or 35 states, by the end of next week. Read more from Angelica LaVito.

FDA Oks Rapid Covid Tests For Home Use Without Prescription: U.S. regulators authorized rapid Covid-19 tests made by Abbott Laboratories and Quidel for use at home without a prescription, making self-monitoring for the disease even more accessible. The Food and Drug Administration clearance of the tests opens the door to their wide availability at retail stores, allowing consumers to keep them on hand for routine use. The move will help solidify Abbott and Quidel’s positions in the rapid test space, where only a few small companies have won over-the-counter authorizations. Read more from Emma Court and Michelle Fay Cortez.

Pfizer Shot More Than 91% Effective After Six Months: The Pfizer-BioNTech vaccine remained highly effective against Covid-19 after six months, according to new long-term results that Pfizer said could be used to seek an expansion of the shot’s regulatory status. Follow-up data from a final-stage trial of 46,307 people showed the vaccine was 91.3% effective in preventing symptomatic cases starting one week after the second dose through as long as six months. In the U.S. alone, the efficacy rate was 92.6%, according to a report yesterday by the two companies.

At the same time, the companies provided some of the first data on how their vaccine might handle the immune-evading B.1.351 variant that arose in South Africa. Nine of 800 trial participants in that country got sick with Covid-19, including six infected with B.1.351. However, all were in the placebo group, suggesting the shot retains efficacy against the variant. Read more from Robert Langreth.

Shots That Make Teens Coronavirus-Proof Pressure Schools: The 100% efficacy of Pfizer vaccine in early teens is intensifying pressure on schools to decide whether to make shots mandatory when students return. New Covid-19 variants are spreading fast among adolescents. Momentum is gathering among advocates to make shots a requirement should the Food and Drug Administration approve them for those under 16. “The writing is on the wall. It’s going to happen,” said Peter Chin-Hong, an infectious disease doctor and professor at the University of California-San Francisco. “B.1.1.7. has raised the specter of needing young people to be immunized. Colleges are talking about mandating it.” Read more from David Welch and Josh Wingrove.

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What Else to Know

Biden Drug Addiction Plan Focuses on Treatment Access, Inequity: The Biden administration unveiled its first-year plan to address the U.S. drug addiction crisis, focusing on treatment access and ending racial, gender, and economic inequities in drug policy and the criminal justice system. Relying more on treatment than on incarceration for individuals using drugs such as opioids and targeting unmet substance use needs in diverse communities are among the ways the Biden administration plans to reduce drug overdoses, according to a notice yesterday from the Office of National Drug Control Policy.

The announcement comes at what ONDCP called a “critical” moment, pointing to Centers for Disease Control and Prevention data that show 88,000 people died from an overdose in the 12 months ending in August 2020. Addiction experts contend that the pandemic has led to more addictions and deaths. Read more from Ian Lopez.

Novel Health Plan for ‘Working Owners’ Is a Sham, DOL Says: The Biden Labor Department says a federal trial court in Texas erred last year when it signed off on a low-cost group health insurance alternative that some experts say could serve to undercut the Affordable Care Act. The department submitted its opening foray this week in an appellate battle over whether health coverage two data mining partnerships offer in exchange for stats on internet usage qualifies as an employer-sponsored benefit plan under the Employee Retirement Income Security Act.

The novel limited-partnership business model threatens to undermine a major tenet of the Obama-era health law by steering enrollees away from state-sponsored insurance exchanges in order to subvert the ACA’s goal to keep health-care costs affordable by grouping healthy and sick people together. Read more from Austin R. Ramsey.

White House to Discuss Chip Shortage with Industry: Biden’s top national security and economic advisers plan to meet April 12 with semiconductor and medical device firms to discuss the global shortage of microprocessors, according to people familiar with the matter. National Security Adviser Jake Sullivan and National Economic Council director Brian Deese will discuss the impacts of the shortage and a path forward with industry leaders, an administration official said. Read more from Jenny Leonard.

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To contact the reporters on this story: Zachary Sherwood in Washington at zsherwood@bgov.com; Alex Ruoff in Washington at aruoff@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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