Review of US vaccine injury reimbursement program shows less than 3% of claims eligible for compensation

News brief
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report yesterday from the US Government Accountability Office (GAO) on federal response to medical countermeasure injury compensation claims—primarily about COVID and flu vaccines—reveals that, during the first few years of the COVID-19 pandemic, claims spiked to 27 times the typical number received, and less than 3% of the claims were eligible for compensation.

About half of the claims were related to COVID vaccination. The vast majority of money paid for claims, however—more than $6 million—was for harms tied to the H1N1 flu vaccine.

The Health and Human Services (HHS) Countermeasures Injury Compensation Program (CICP) review showed that the program received a surge of 13,333 injury claims, and 92 (2.6%) of the completed claims were eligible for compensation.

$6.5 million in compensation for H1N1 vaccine

To encourage the development of medical countermeasures like drugs and vaccines, the Public Readiness and Emergency Preparedness Act of 2005 limited the legal liability of manufacturers of certain countermeasures. It also authorized HHS to establish the CICP to compensate people who die or suffer serious physical injuries directly caused by these countermeasures.

The Health Resources and Services Administration (HRSA) within HHS made decisions on 25% of the total claims submitted as of June 2024 (the most recent data available); the remainder were under review or pending review. Of the 92 claims that completed the adjudication process, 52 (57%) were COVID-vaccine–related and 37 (40%) were for serious injuries caused by the H1N1 flu vaccine. 

"HRSA paid roughly $6.5 million in compensation for eligible claims as of June 2024, with most of that amount for serious injuries, such as Guillain-Barré syndrome, caused by the H1N1 vaccine," the GAO report said. "About $400,000 was paid for injuries related to COVID-19 countermeasures, such as myocarditis (inflammatory heart condition)."

HRSA paid roughly $6.5 million in compensation for eligible claims as of June 2024.

Challenges HRSA experienced operating the CICP stem from staff shortages, outdated information systems to process claims, and limited medical and scientific evidence on which to base decisions about injuries or deaths. To address these challenges, the HRSA hired more staff and launched a web portal for online claims submissions, among other things, the GAO said. 

Cases, deaths rise in illness outbreak in remote DR Congo

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In an acute febrile illness outbreak in a remote part of the Democratic Republic of the Congo (DRC), a man recently died following hemorrhagic fever symptoms, and samples have been sent to Kinshasa for testing, an official with Africa Centres for Disease Control and Prevention (Africa CDC) said at a briefing today.

blood testing
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Ngashi Ngongo, MD, PhD, who leads Africa CDC's mpox incident management team, said though malaria has been reported in several samples during follow-up testing, testing on more samples is under way, as is the epidemiologic investigation. On quantitative polymerase chain reaction (qPCR) testing, 25 of 29 samples were positive for malaria, and, on rapid testing, 55 of 88 samples were positive. Testing continues on samples from blood, sera, swabs, and stool to see if other pathogens are involved.

Earlier this week, the DRC's health ministry said preliminary lab tests suggested the outbreak's cause was a severe form of malaria, with malnutrition as one of the illness factors.

Officials weighing 2 scenarios

Ngongo said officials are weighing two hypotheses: that severe malaria is occurring against the background of malnutrition and viral infection or that a viral infection is occurring against a background of malaria and malnutrition.

Over the past week, 65 more cases were reported, along with 5 additional deaths. Though 37 deaths have been recorded in healthcare facilities, Ngongo said investigators are working to determine whether 44 deaths reported in the community are linked to the outbreak, which has a case-fatality rate of 62%. Overall, 592 cases have been reported, with the largest portion in children younger than 10 years old.

CDC ends probe into deadly E coli outbreak tied to organic carrots

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carrot bunches
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The Centers for Disease Control and Prevention said yesterday that it has closed its investigation into a 19-state Escherichia coli O121:H19 outbreak linked to organic carrots after 48 cases, 20 hospitalizations, and 1 death. Nine of the cases and 2 hospitalizations are new since its previous update on November 17.

In addition, the Food and Drug Administration (FDA) has increased the case counts in two other multistate E coli outbreaks.

Death was in California

Illness-onset dates for the carrot outbreak range from September 6, 2024, to November 10, 2024. Of the 20 patients who were hospitalized, 1 developed hemolytic uremic syndrome, a serious kidney condition. The death was in California.

Patients ranged in age from 1 to 75 years, with a median age of 26, and 69% were female. California and Washington had the most cases, with eight each.

"People reported buying different brands of carrots from multiple stores," the CDC said. "FDA's traceback of some of these purchases identified Grimmway Farms as the common supplier of organic whole and baby carrots in this outbreak." Grimmway Farms is headquartered in Bakersfield, California.

Two other E coli outbreaks

Food Safety News reported today that, in an E coli O157:H7 outbreak traced to a blend of iceberg and romaine chopped lettuce, the FDA reports that the number of ill people has increased to 86, up from 75 a week ago. People in 12 states have been sickened in this outbreak.

In addition, the patient count in an E coli O145:H28 outbreak with an unknown food source has increased to 8, up from 7 a week ago. In this outbreak, which the FDA first noted on December 11, the agency has not named the affected states.

The CDC said in an email today that it has led 63 probes into multistate foodborne disease outbreaks this year. The CDC lists 13 active investigations: 6 Listeria outbreaks, 4 Salmonella, and 3 E coli.

Africa's mpox outbreak nears 70,000 cases as officials lay out response priorities

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Mpox activity in Africa continues at a steady pace, with 3,095 cases reported over the past week, 2,632 of them from the main hot spot, the Democratic Republic of the Congo (DRC), a top official from Africa Centres for Disease Control and Prevention (Africa CDC) said today at a briefing.

mpox virus particles
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Ngashi Ngongo, MD, PhD, head of Africa CDC's mpox incident management team, said 31 more deaths were reported, 29 of them in the DRC. Since the first of the year, the region has reported nearly 70,000 cases in 20 countries. As activity continues to fluctuate, Guinea moved from the controlled stage to active transmission last week, with five countries remaining in the controlled stage: Gabon, South Africa, Morocco, Zambia, and Zimbabwe.

Ngongo said the first 50,000 doses of the LC16 vaccine donated by Japan are expected to arrive in Kinshasa this week, with as many as 3 million doses available starting in February. Japanese experts are hosting workshops this week with the health ministry on use of the vaccinec, which is administered with a bifurcated needle and requires extra healthcare worker training. The vaccine from Japan's stockpile had been used in children before, and the product will fill a gap in vaccinating young children, since it can be used on children as young as 1 year old.

Review identifies response priorities

Ngongo said Africa CDC and the World Health Organization (WHO) this week led a continental review of the mpox response, which included officials from nine affected countries and seven response partners. 

The group identified eight priorities that are urgently needed to tackle the ongoing outbreak, including mobilizing more resources, intensifying support for the hardest-hit countries, improving data management systems, and speeding and expanding vaccination. Other key priorities were focusing an integrated approach to the response that focuses on the community, addressing coinfections such as measles, sharing lessons learned among countries, and improving surge staffing support.

CWD invades 2 more hunting districts in Montana

News brief
Mule deer in snow
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Montana officials yesterday announced chronic wasting disease (CWD) identifications in two hunting districts (HDs) with no previously reported cases.

The affected animals were a mule deer buck in HD 515 north of Columbus and a male white-tailed deer in HD 525 west of Nye. Both were harvested by hunters, Montana Fish, Wildlife and Parks (MFWP) said in a news release.

CWD, a fatal neurodegenerative disease of cervids such as deer and elk, was first found in Montana's wild herds in 2017. Since then, it has been detected in different regions of Montana, including multiple other HDs in the south-central part of the state.

So far this year, nearly 9,000 CWD samples have been collected from deer, elk, and moose from across Montana, leading to the identification of 321 positive cervids. Most samples were from hunter-harvested animals, but some were collected from roadkill and animals displaying CWD symptoms. 

Hunters should test, properly dispose of carcasses

Hunters can still get their harvested cervids tested for CWD throughout the muzzleloader heritage season and the elk shoulder season, MFWP said.

Hunters can help slow the spread of CWD by disposing of animal carcasses properly after harvesting the meat.

"Hunters can help slow the spread of CWD by disposing of animal carcasses properly after harvesting the meat," the news release said. "This includes leaving carcass remains at the kill site when possible or bagging the carcass and disposing of it in a Class II landfill."

CWD is caused by misfolded infectious proteins called prions, which are extremely resilient and can persist in the environment for years. CWD can spread from animal to animal and through environmental contamination.

While no human CWD cases have been reported, the Centers for Disease Control and Prevention and the World Health Organization advise against eating meat from sick cervids and urge taking precautions when handling carcasses. 

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