HEALTH CARE BRIEFING: Vaccine Injury Victims Wonder Who Will Pay

High school senior Emma Burkey received her “one and done” Johnson & Johnson coronavirus vaccine on March 20, and within two weeks was in an induced coma following seizures and clotting in her brain.

She’s making a slow recovery, having recently been transfered from the hospital to a rehabilitation center, and the first round of bills totaled $513,000. The 18-year-old’s family friends in the Las Vegas area started a GoFundMe account to help with medical expenses from the very rare vaccine reaction.

“We don’t know what’s going to happen with Emma, how long it will it take for her to return to a normal life,” said Bret Johnson, the family’s minister, who’s acting as spokesman for the Burkeys. He said the family believes her condition is linked to the vaccine but hasn’t yet been contacted by the company or U.S. health regulators, and that a connection hasn’t been independently confirmed.

Burkey’s family can’t look to J&J to cover the medical costs not picked up by her insurance because a 2005 law — extended last year to include the Covid-19 pandemic — shields manufacturers and health-care providers from state and federal liability in instances of public health and bioterrorism emergencies. In exchange for immunity for vaccine makers, the federal government pledged compensation for adverse reactions to coronavirus treatments and vaccines, but it’s a program with a history of rejecting claims and a relatively high bar for recovering costs.

The Countermeasures Injury Compensation Program, run by an obscure office within the Health and Human Services Department, covers medical costs and lost wages not paid by insurance. Some 445 claims had been filed for Covid-related adverse reactions as of April 26, according to the Health Resources and Services Administration, which runs the program.

Only about a quarter of the Covid-related reactions reported to the countermeasure program so far are from vaccines, while more than half were from various treatments, according to HRSA. Those treatments include ventilators, convalescent plasma, and hydroxychloroquine — the anti-malarial drug touted by former President Donald Trump that was found to have greater risks than benefits in treating coronavirus. Susan Decker has more on the program.

Happening on the Hill

Schumer Says Supports Lowering Medicare Age: Senate Majority Leader Chuck Schumer (D-N.Y.) said Medicare should negotiate with drug companies on pricing and use that money to expand, The Ink reports. “I’d be for either of those, both of those,” Schumer told The Ink in a Friday story when asked if he’d back a reduction in the Medicare eligibility age and adding a public option. Read more from The Ink.

Hearings This Week:

• Lowering Drug Costs: The House Education and Labor Health, Employment, Labor, and Pensions Subcommittee will meet Wednesday to discuss expanding access to affordable health care.
• The House Energy and Commerce Health Subcommittee meets for its own hearing tomorrow on legislation to lower the prices of prescription drugs.
• Organ Transplants: The House Oversight and Reform Subcommittee on Economic and Consumer Policy plans a hearing tomorrow on reforming the organ transplantation system.
• Black Maternal Health: The House Oversight and Reform Committee scheduled a hearing Thursday on Black maternal health.

The Coronavirus Pandemic

Mask Mandate Extended for Airplanes, Other Transit: Passengers on airplanes, buses and railroads in the U.S. will have to keep wearing masks to guard against the spread of Covid-19 as federal officials extended a mandate set to expire in days through the busy summer travel season. The Transportation Security Administration on Friday announced it was extending the mandate through Sept. 13. That move is in step with the latest guidance from the Centers for Disease Control and Prevention, which still advises face coverings to curtail the spread of the coronavirus. Read more from Alan Levin.

Biden Blocks Travel From India: Biden banned most travel to the U.S. from India beginning tomorrow as the country struggles to combat the worst surge of coronavirus cases in the world, the White House said. White House Press Secretary Jen Psaki said that the CDC recommended the travel ban, which will not apply to U.S. citizens or permanent residents. Read more from Josh Wingrove.

• The travel bans imposed by the U.S. on countries including India, China and the U.K. lack a clear sense of purpose and don’t make sense, said former FDA commissioner Scott Gottlieb. “I’m not sure what we are hoping to accomplish. If the goal is to try to prevent the introduction of virus into the U.S., there’s plenty of virus here,” Gottlieb said on CBS’s “Face the Nation” yesterday. Read more from Yueqi Yang.
• Related: EU Proposes End to Travel Restrictions for Vaccinated Tourists

Biden Launches Website to Locate Vaccines: The Biden administration has launched a new website, text-message tool and phone hotline to link Americans with Covid-19 vaccines close to them as the pace of vaccinations in the U.S. has plateaued. An existing vaccine site, VaccineFinder.org, has relaunched as Vaccines.gov. People in the U.S. will be able to text their ZIP code to GETVAX (438829) to see locations near them with available shots, or call a toll-free number with service in more than 150 languages. Read more from Josh Wingrove.

AstraZeneca Still Seeks U.S. Vaccine Clearance: AstraZeneca remains committed to getting U.S. emergency clearance for its coronavirus vaccine whose public acceptance has been hurt by a series of missteps and rare side effects. The U.K. drugmaker, which has promised not to profit from its coronavirus shot during the pandemic, said it’s still seeking an emergency use authorization in the first half of 2021 and working with U.S. officials on the filing. AstraZeneca had previously said that it would apply for the authorization by mid-April. Suzi Ring has more.

Report Underscores Need for Second Dose: People who haven’t fought off Covid-19 before are still vulnerable to infection from variants after getting the first dose of Pfizer-BioNTech’s vaccine, underscoring the need for fast and full inoculation regimens, a U.K. study published Friday found. Among people who previously had mild or asymptomatic cases of Covid-19, the protection was “significantly enhanced” after a single dose against the variants found in the U.K. and South Africa, researchers said. Read more from Tim Loh.

More U.S. Headlines:

• Covid-19 Vaccines Come in Bulk but the World Needs Single Servings
• Fully Vaccinated Construction Workers May Now Opt to Avoid Masks
• Converge Gets Covid-19 Test FDA Clearance

Moderna to Supply 500 Million Vaccine Doses to Covax Effort: Moderna agreed to provide as many as 500 million doses of its Covid-19 shot to the program known as Covax in a boost for the global vaccination effort, but most of the shipments won’t arrive until next year. Moderna is joining developers including AstraZeneca, Pfizer and Johnson & Johnson in supplying Covax, which has faced setbacks in its bid to help lower-income nations. The vaccine last week was cleared for emergency use by the World Health Organization, making it eligible for Covax, according to Gavi, the Vaccine Alliance, one of the partners in the initiative. Read more from James Paton.

U.S. Wants Taiwan at World Health Assembly: The U.S. said Taiwan deserves to be heard at a key World Health Organization event next month due to its contributions to global health, a call likely to anger Beijing after it blocked the island’s participation in recent years. “Taiwan’s outstanding control of Covid-19 and its donations of PPE demonstrate its strong contribution to global health,” State Department spokesman Ned Price said Friday, David Wainer reports.

WHO Told to Look Beyond Animals on Virus Origin: The World Health Organization should launch another investigation into the origins of the coronavirus pandemic that looks beyond animal sources, a group of scientists said in an open letter. The signatories proposed specific steps on what any new probe should take into account. Suggestions include making sure that a team can undertake studies without the “unnecessary presence” of government officials of the host country. Read more from Corinne Gretler.

More Global Headlines:

• J&J, U.S. Trade Chief Discuss Global Vaccine Supply
• Canada to Review Initial Johnson & Johnson Shots for Quality, Safety
• After Sluggish Start, Are Europe’s Vaccine Issues Coming to an End?
• Delhi Extends Lockdown by a Week to Control Coronavirus Outbreak
• Pfizer to Ship 4.5 Million Covid-19 Vaccine Doses to South Africa by June
• Kenya Lifts Domestic Movement Restrictions as Covid-19 Cases Drop

What Else to Know

HHS Lowers Obamacare Out-Of-Pocket Maximum: The Department of Health and Human Services released on Friday a final rule that lowers the maximum out-of-pocket expenses for Obamacare enrollees by $400 from what it originally projected last year. The rule sets the pay structure and other policies for Obamacare plans in 2022. Patients’ cost-sharing—deductibles, co-payments, etc.—will be capped at $2,900 for people with self-only coverage between 100% and 200% of the federal poverty level. The cap for self-only coverage is $6,950 for people who make more. Read more from Sara Hansard.

More Headlines:

• McKesson, Cardinal to Test Opioid Defense in West Virginia Trial
• Black Cops Fear FDA Menthol Ban Will Spur Strict Police Crackdown
• Higher Dose of Naloxone Spray Available as Opioid Epidemic Rages
• Pharmacies Sue to Stop Trump Action on Washington Medicaid Pay
• Bristol Myers Squibb’s sBLA for Opdivo Nabs Priority Review at FDA
• Behavioral Health: Patient Access, Provider Claims Payment, and the Effects of the COVID-19 Pandemic (GAO)

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