HEALTH CARE BRIEFING: FDA Clears Some Additional Covid Boosters

U.S. regulators cleared second booster doses of Covid-19 vaccine from Moderna and the partnership of Pfizer and BioNTech for adults 50 and older, making millions more people eligible for the shots as concern grows about a potential new wave of infections.

Those who have received a first booster dose of the drugmakers’ shots at least four months earlier can now get another, the Food and Drug Administration said Tuesday. For most people, the second booster will be a fourth shot, while it will be the third for those who got initial single-shot immunizations from Johnson & Johnson.

While highly transmissible omicron has declined overall, the virus’s BA.2 strain has become dominant, leading to concerns about a resurgence and the need for additional safeguards. In many countries in Europe, cases remain at very high levels thanks to the even-more-transmissible subvariant. Booster doses are becoming an increasingly relied-upon tool in the fight against Covid, especially as states and companies cut back safeguards such as masking and work from home.

“Current evidence suggests some waning of protection over time against serious outcomes from Covid-19 in older and immunocompromised individuals,” Peter Marks, who leads the FDA center that oversees vaccines, said in a statement. “Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna Covid-19 vaccine could help increase protection levels for these higher-risk individuals.”

The Centers for Disease Control and Prevention chose not to convene a panel of outside advisers who make vaccine use recommendations, as it did with the first rounds of Covid shots. Instead, the agency gave its recommendation for the additional booster dose in a statement shortly after the FDA’s action.

“Boosters are safe, and people over the age of 50 can now get an additional booster four months after their prior dose to increase their protection further,” CDC head Rochelle Walensky said in a statement. Fiona Rutherford, Robert Langreth and Josh Wingrove report.

Happening on the Hill

Senate Floor: Senators today are scheduled to vote to limit debate on the nomination of January Contreras to be assistant secretary for family support at the Department of Health and Human Services.

Bedoya Vote to Move to Senate Floor: The Senate will vote to discharge the nomination of Alvaro Bedoya to join the Federal Trade Commission today. The Senate Commerce, Science, and Transportation Committee deadlocked along party lines in a vote on his nomination earlier this month. If the discharge vote passes, the Senate will be able to hold a floor vote on his nomination. If confirmed, Bedoya would cement the agency’s Democratic majority and would get involved in a probe of health insurers’ prescription drug managers, Sarah Babbage reports.

A final confirmation vote, however, won’t likely take place until after the Senate’s two-week Easter recess, as Schumer plans to spend next week on confirming Supreme Court nominee Ketanji Brown Jackson. Read more from Brody Ford.

Schumer, Romney Talk Covid Offsets: Senate Majority Leader Chuck Schumer (D-N.Y.) and Sen. Mitt Romney (R-Utah) have continued to discuss ways to offset the cost of a Covid-19 funding measure, the two senators told reporters yesterday, Jack Fitzpatrick and Emily Wilkins report.

“If we can get a time agreement on it, we can move it rather quickly,” Schumer said of the supplemental spending bill. “That’s our goal. It can’t wait.” Schumer teed up a House-passed bill (H.R. 4373) to serve as a vehicle for a potential Covid-19 funding measure if Senators come to an agreement on the legislation this week.

Romney said he’s trying to assemble a menu of potential pay-fors, including Covid-19 relief funds from the American Rescue Plan (Public Law 117-2), CARES Act (Public Law 116-136), and other measures. He couldn’t predict if there will be a deal this week.

Shaheen Says Progress on Insulin Price Legislation: Sen. Jeanne Shaheen (D-N.H.) told reporters Tuesday there’s an agreement “in principle” with Sen. Susan Collins (R-Maine) on how to tackle the price of insulin. Shaheen didn’t offer details but noted the pair are making progress, Alex Ruoff reports. A spokeswoman for Shaheen said the bill they two are crafting is not yet finalized. A Collins’ spokesperson said the pair has contacted the Congressional Budget Office for feedback to help refine the policy impact. The senators were tasked by Senate Democratic leadership to craft an insulin bill that could garner bipartisan support after Sen. Raphael Warnock‘s (D-Ga.) proposal to cap what Americans with insurance pay for the medicine at $35 per month failed to get Republican support.

• Earlier: House to Vote on Insulin Cap as Senators Seek Bipartisan Deal

HSGAC Markup: The Senate Homeland Security and Governmental Affairs Committee meets on several bills, including S. 3904, which would direct the Cybersecurity and Infrastructure Security Agency to collaborate with the Health and Human Services Department to improve cybersecurity in the health care industry, including through information sharing.

Mental Health: The Senate Finance Committee is holding a hearing on behavioral health care. The panel released a report yesterday on mental health care in the U.S. Chair Ron Wyden (D-Ore.) wrote in the report that it was the panel’s “next step in the bipartisan effort to understand the mental health care crisis in the U.S. and, further, to craft a legislative package, which the Committee intends to consider this summer.”

Budget Hearing with Becerra: The House Ways and Means Committee scheduled a hearing on the proposed fiscal year 2023 budget with Health & Human Services Secretary Xavier Becerra on April 5, according to a press release.

Biden’s Fiscal Year 2023 Budget Proposal — BGOV Webinar: Today at 11a.m., Bloomberg Government’s expert analysts lead a deep dive review of and provide insights on Biden’s budget proposal for fiscal year 2023 in a webinar, and answer your questions on the administration’s top priorities. Topics include topline agency funding levels, new spending initiatives and revenue proposals, and next steps in the budget process. Register here.

The Coronavirus Pandemic

Mask Mandate on Planes, Trains Draws Lawsuit From GOP States: Almost two dozen U.S. states are suing to overturn the federal mask mandate on public transportation, accusing the Biden administration of ignoring “loss after loss” in court and having “outright disdain” for the limits of its power amid the Covid-19 pandemic. The lawsuit, filed Tuesday in federal court in Tampa, Florida, claims that Walensky and Becerra lack the authority to force passengers on airplanes, trains and ships to wear face masks. Erik Larson has more on the suit.

CDC Releases Quarantine, Isolation Online Calculator: Quarantine and isolation have become household words but there’s considerable confusion over the difference between them and when and for how long each should be practiced, especially as policies have been changing with virus variants. To clarify the situation, the CDC created an online calculator for the infected and exposed even as the pandemic wanes. Read more from Angel Adegbesan.

What Else to Know

Health-Care Dealmaking Slows Amid Inflation, Russian Invasion: Health-care mergers and acquisitions in February dipped to the lowest monthly level since November 2020 amid economic headwinds and uncertainty arising from the Russian invasion of Ukraine. Rising inflation and interest rates, supply chain problems, and geopolitical uncertainty are leading many investors to take a pause from dealmaking, said Hector Torres of FocalPoint Partners in Chicago. Read more from Christopher Brown.

Boehringer Reported to HHS Watchdog Over Drug Discount Limits: The Health Resources and Services Administration reported Boehringer Ingelheim to an HHS watchdog agency Tuesday for limiting drug discounts to health-care providers serving low-income patients. Boehringer is the seventh drugmaker referred to the Health and Human Services Office of Inspector General for allegedly failing to comply with its obligations under the 340B drug pricing program. Read more from Christopher Brown.

EV Shift Would Spur Trillions in Health Benefits, Report Says: Widespread transition to zero-emission vehicles would yield more than $1 trillion in public health benefits, according to research from the American Lung Association. A nationwide switch to electric cars and other vehicles would save 110,000 lives and 13 million workdays over the next thirty years—the equivalent of $1.2 trillion in benefits, according to “Zeroing in on Healthy Air,” a report released Wednesday. Read more from Jennifer Hijazi.

More Headlines:

• J&J Recalled Sunscreen Settlement Gets Judge’s Early Approval
• Novo Nordisk Beats Appeal in Diabetes Drug Cancer Litigation
• Blue Cross Blue Shield Ducks Claims Over Disclosed Medical Info
• Covid-19: Information on HHS’s Public Education Campaign (GAO)
• Defense Health Care: DOD Expects New IT System Capabilities to Improve Other Health Insurance Processing (GAO)

With assistance from Alex Ruoff, Sarah Babbage, and Emily Wilkins

To contact the reporter on this story: Michaela Ross in Washington at mross@bgov.com

To contact the editor responsible for this story: Giuseppe Macri at gmacri@bgov.com