HEALTH CARE BRIEFING: J&J Pause Risks Fomenting Public Hesitancy

Johnson & Johnson’s Covid-19 vaccine represents only a sliver of the current U.S. supply, but pausing its use could present new hurdles for a national immunization campaign that needs to overcome wider vaccine hesitancy to outpace fast-spreading variants.

The sidelining of J&J, however temporary, leaves the U.S. with two other vaccines that already made up the bulk of its campaign—from Pfizer and Moderna. Shots from those drugmakers account for 95% of the shots allocated in the U.S. this week. And Pfizer’s chief executive said yesterday that his company will speed up promised U.S. deliveries in the coming weeks.

The U.S. Centers for Disease Control and Prevention and Food and Drug Administration said yesterday in a joint statement that they would pause use of the J&J shot after six women who received it developed a rare form of blood clotting. The FDA signaled the pause would last a matter of days.

Related:

• Pause on J&J Covid Vaccine Signals U.S. Safety System Is Working
• South African Regulator to Discuss J&J Shot After U.S. Pause
• J&J Delay Slows Vaccine Rollout Across a World Needing Shots
• Pfizer Can Deliver 10% More Doses to U.S. by End of May: CEO

The White House said the vaccination campaign can continue at its current pace. President Joe Biden told reporters that, with Pfizer and Moderna, “there is enough vaccine that is basically 100% unquestionable for every single solitary American.” Jeff Zients, White House Covid-19 response czar, said at a briefing that “we have plenty of supply to continue our vaccination program and hit our goals.”

If the J&J pause lasts only several days as U.S. officials signal, cancellations and rescheduled appointments could create a similar slowdown to those from winter storms earlier this year. But doubt about the safety of any of the available coronavirus vaccines could thwart the U.S. vaccination campaign just as it hits its stride.

“This is going to scare a lot of people,” said Noel Brewer, professor of health behavior at the University of North Carolina at Chapel Hill. “We should all be concerned about the safety of medicines we receive. In this case, there is not a lot of reason for concern. The actual risk is vanishingly small.” Read more from Josh Wingrove and Angelica LaVito.

Clot Side Effect Puts Spotlight on Immune Reaction: Extremely rare cases of clotting seen with AstraZeneca’s and J&J’s vaccines have put the spotlight on an uncommon reaction that occurs when the body unleashes its immunity firepower against blood platelets. The clotting is highly unusual in that it involves low levels of platelets, the component of blood primarily responsible for coagulation, and has only been seen at low levels in vaccine recipients. Read more from John Lauerman and Robert Langreth.

• Pause to Educate: U.S. health officials urged the pause to give them time to educate doctors on how to treat the exceedingly rare disorder, said Peter Marks, a top official at the U.S. Food and Drug Administration, after six women between the ages of 18 and 48 developed cerebral venous sinus thrombosis. At least one woman died, and a second woman was in critical condition, officials said. The normal treatment for clots, the blood-thinner heparin, could make the disorder worse, or even kill a patient, officials said. Read more from John Lauerman.

Happening on the Hill

House Postpones Medicare Cuts, Teeing Up Likely Spending Debate: The House cleared a bill (H.R. 1868) by a vote of 384 to 38 to delay until 2022 cuts to Medicare, pushing off until next year a larger debate over federal spending.

House lawmakers March 19 voted to postpone the cuts and waive budget requirements of the $1.9 trillion stimulus package approved earlier in the month, but Senate Republicans in a March 25 vote only agreed to deal with the more-immediate threat to Medicare. Congress will be faced with more than $36 billion in pending reductions to Medicare in 2022. Read more from Alex Ruoff.

Lawmakers Seek Hospital Transparency Rule: Energy and Commerce Chair Frank Pallone, Jr. (D-N.J.) and ranking member Cathy McMorris Rodgers (R-Wash.), as well as Reps. Anna Eshoo (D-Calif.) and Brett Guthrie (R-Ky.), the leaders of the Health Subcommittee, wrote to HHS Secretary Xavier Becerra yesterday to urge him to conduct “vigorous oversight” of the implementation of HHS’s “Hospital Price Transparency Final Rule,” amid reports that some hospitals are moving slowly to comply with the rule. Read their letter here.

Democrats Push for Mandated Sick Leave: Sen. Patty Murray (D-Wash.) and Rep. Rosa DeLauro (D-Conn.) re-introduced a bill yesterday that would require employers to offer one hour of paid sick leave for every 30 hours worked by employees. The two previously introduced the legislation in 2019, but it wasn’t considered by relevant panels. They said that the pandemic has made clear the need for sick leave for workers otherwise forced to choose between their health and a paycheck, Andrew Kreighbaum reports. Read text of the bill here.

Democrats Call for Eased Fetal Tissue Research: Vital scientific research on ALS, spinal cord injuries, and Parkinson’s disease are at risk of stalling if the Biden administration doesn’t lift restrictions to use fetal tissue in clinical research, 26 Democrats told HHS. The Department of Health and Human Services banned scientists who work for the National Institutes of Health from using fetal tissue in 2019. And a Trump-era policy also severely curbed access to federal funding for scientists looking to use fetal tissue in biomedical research. Jacquie Lee has more.

Health-Care Bills on Tap: The House plans to vote on several health-care bills today under suspension of the rules, which bars amendments, limits debate and requires a two-thirds majority to pass:

• Anti-Doping Agency Reauthorization: The U.S. Anti-Doping Agency would be reauthorized through fiscal 2030 under H.R. 172. The bill would authorize $15.5 million for the agency in fiscal 2022, reaching $23.7 million by fiscal 2030. The House Energy and Commerce Committee hasn’t acted on the bill, which Rep. Mike Thompson (D-Calif.) introduced on Jan. 4. For more, see the BGOV Bill Summary by Brittney Washington.
• Sesame Allergies: Sesame would be added to the Food and Drug Administration’s list of major food allergens beginning in 2023 under S. 578. There are currently eight major food allergens that must be clearly identified on any food label: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans. The Senate passed the bill by unanimous consent on March 3. For more, see the BGOV Bill Summary by Danielle Parnass.
• Minority Health Research: The National Institute on Minority Health and Health Disparities could provide research endowments to current and former “centers of excellence” at minority academic institutions under H.R. 189, which would be named for the late Rep. John Lewis (D-Ga.). The measure was introduced on Jan. 5 by Rep. Nanette Barragan (D-Calif.) and referred to the House Energy and Commerce Committee. For more, see the BGOV Bill Summary by Danielle Parnass.
• Stem Cell Research: Stem cell programs under the Health and Human Services Department would be reauthorized for five years, through fiscal 2026, under H.R. 941. It would include the C.W. Bill Young Cell Transplantation Program and the National Cord Blood Inventory Program. The measure was introduced Feb. 8 by Rep. Doris Matsui (D-Calif.) and referred to the House Energy and Commerce Committee. For more, see the BGOV Bill Summary by Danielle Parnass.
• Education on Biosimilars: The Health and Human Services Department would be directed to create a central website for educational materials on biosimilars under S. 164. The Senate passed the bill by unanimous consent on March 3. For more see the BGOV Bill Summary by Brittney Washington.
• New Chemical Entities: The criteria for a drug to receive exclusivity as a new chemical entity would be modified by S. 415 so that it applies to those with no previously approved “active moiety,” instead of active ingredient. An active moiety is the molecule responsible for the physiological or pharmacological action of the drug. The Senate passed the bill by unanimous consent on March 10. For more, see the BGOV Bill Summary by Danielle Parnass.
• Carbon Monoxide Monitors: The Consumer Product Safety Commission would provide grants to states to prevent carbon monoxide poisoning under H.R. 1460. The CPSC would use appropriated funding in fiscal 2021 through 2025 for the grants. The House Energy and Commerce Committee hasn’t acted on the bill, which Rep. Annie Kuster (D-N.H.) introduced March 1. For more, see the BGOV Bill Summary by Adam M. Taylor.
• Drug Registration Bans: The Drug Enforcement Administration, under a modified version of H.R. 1002, could prohibit any person from registering to manufacture or dispense controlled substances if the person has a history of suspended registrations. The measure was introduced by Rep. Bob Latta (R-Ohio) and referred to the House Energy and Commerce and Judiciary committees. For more, see the BGOV Bill Summary by Danielle Parnass.
• Drug Registration Transfers: Under H.R. 1899, the Drug Enforcement Administration would have to terminate a person’s registration to manufacture or dispense controlled substances if they die, terminate their business, or surrender the registration. Registrations could only be transferred with the DEA’s consent and according to any conditions the agency specifies. The measure is sponsored by Rep. Morgan Griffith (R-Va.). For more, see the BGOV Bill Summary by Danielle Parnass.

Hearings Today:

• Pandemic Preparedness: The Senate Homeland Security and Governmental Affairs Committee plans a hearing on the initial Covid-19 preparedness and response.
• FEMA Response: The Senate Appropriations Homeland Security Subcommittee meets for a hearing on the Federal Emergency Management Agency’s Covid-19 response.
• Covid-19 in Native Communities: The Senate Indian Affairs Committee scheduled a hearing on Covid-19 response in native communities and native health-care systems.
• Substance Abuse Bills: The House Energy and Commerce Subcommittee on Health meets for a hearing on bills targeting opioid, methamphetamine and other substance use and misuse.

The Coronavirus Pandemic

U.S. Trade Chief Meets on WTO Vaccine Waiver: Biden’s trade representative yesterday met with groups seeking a waiver for parts of the World Trade Organization’s intellectual-property rules to improve vaccine access for lower-income nations. U.S. Trade Representative Katherine Tai told the groups, including Public Citizen and Human Rights Watch, that the White House is committed to increasing the production and distribution of vaccines, according to statements from the USTR, which didn’t contain any commitment to changing the U.S. stance at the WTO. Read more from Eric Martin.

B.1.1.7 Strain May Be Less Deadly Than Feared: The Covid-19 variant that emerged in the U.K. and became the dominant strain in the U.S. isn’t as deadly as earlier research indicated, though it is confirmed to be faster-spreading than other versions, according to a new study. Among 339 patients with the virus, 36% of those infected with the B.1.1.7 strain that arose in the U.K. became severely ill or died, according to research published yesterday in the Lancet Infectious Diseases journal, compared to 38% of those who had non-B.1.1.7 infections. Read more from Elaine Chen.

More Headlines:

• U.S. Advisers Spoke to Argentina President to Acquire Vaccines
• Cardinal to Stock 80,000 Pallets of Covid-19 Protective Equipment
• Covid-19 Test Maker Cue Health Is Said to Tap Banks for IPO
• Hong Kong Vaccine Bookings Double After Lam Offers Benefits

What Else to Know

Fentanyl Ban Complicates Biden’s Drug Policy Shift: Biden is facing a crucial test of his promise to reduce overdose deaths in the U.S. through addiction treatment, civil rights and drug policy groups say. Biden has signaled he wants to take a different approach from previous administrations that embraced addiction treatment and crack-downs on the opioid trade.

The House Energy and Commerce Committee today will consider Republican-led legislation (H.R. 1910) to make permanent the temporary classification of fentanyl-like substances as one of the most-strictly controlled drugs. That classification expires on May 6.

Advocates for changing drug rules have welcomed the administration’s stance, but civil rights groups say action will speak the loudest. They’re urging the Biden administration and Congress to let the temporary ban on fentanyl-like substances lapse. Read more from Alex Ruoff.

SCOTUS Poised to Review Down Syndrome Abortions: Ohio will no longer be blocked from enforcing a law criminalizing abortions when a provider knows a woman wants the procedure because of a fetal diagnosis of Down syndrome, a split full Sixth Circuit said yesterday in a suit almost certain to make its way to the U.S. Supreme Court. This is the first appeals court ruling holding valid a restriction based on a fetal diagnosis of Down syndrome. It conflicts with those of the Seventh and Eighth circuits. Read more from Mary Anne Pazanowski.

More Headlines:

• FTC Taps Pharma Expert Marta Wosińska to Top Economist Job
• FTC’s Cease Order on Impax’s Pay-for-Delay Pharma Deals Upheld
• FDA Appeals Order to Redo Its Review of ‘Frankenfish’ Salmon
• FDA Gives Fast-Track Approval for Imminomedics Cancer Drug
• J&J Units Lose Antitrust Appeal Over Blood Pressure Drug
• FDA Weighs Virtual Drug Factory Inspections to Clear Backlog

With assistance from Andrew Kreighbaum

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