A federal program charged with compensating people for serious side effects from COVID-19 drugs and vaccines did not pay or reject any claims during the first year of the pandemic.
The 106 injury claims for vaccines, hydroxychloroquine and other COVID-19 treatments remained under medical review as of March 15, according to figures from the U.S. Department of Health and Human Services.
The Health Resources and Services Administration, the agency within HHS that runs the Countermeasures Injury Compensation Program, provided data to USA TODAY showing injury claims for 20 types of COVID-19 treatments.
More than half the claims alleged injury from COVID-19 immunizations. However, with just 58 claims out of 120 million-plus doses administered by mid-March, experts say the data adds to growing evidence of COVID-19 vaccine safety.
The next most common type of claim, with 15 cases, alleged ventilator injuries. Ventilators, mechanical devices that push air into the lungs of COVID-19 patients, were aggressively used during last spring’s outbreak in New York. Since then, doctors have been more careful about using ventilators and have turned to less-invasive oxygen delivery methods. They’ve also learned about cheap and effective treatments such as the steroid dexamethasone.
Ten claims were classified as “unknown” cause. Other claims cited injuries from the anti-malaria drug hydroxychloroquine, the antiviral remdesivir and convalescent plasma.
HRSA officials defended the pace of payouts, noting it takes months to process cases because individuals or families need to submit documents, including medical records, to support claims. The first case, filed in September, alleged injury from convalescent plasma but the agency still does not have all needed medical records, HRSA Director of Communications Martin Kramer said in an email.
“The most significant factor in the processing time for CICP claims is the time it takes for CICP to receive all required medical records from the requester,” Kramer said.
‘Exactly the wrong way’
Last March, former Health and Human Services Secretary Alex Azar declared all claims of injury from COVID-19 vaccines would be handled through the countermeasures program.
The program, established in 2010, handles injury claims from vaccines and other treatments authorized during a public health emergency.
Countermeasures has rejected 90% of injury claims over the past decade. In contrast, the federal government’s “vaccine court,” which handles claims mainly involving routine childhood vaccines, has paid about 70% of claims from 2006 through 2018.
Unlike vaccine court, the countermeasures program limits claims to one year after a person gets a treatment, doesn’t pay attorneys’ fees or expert testimony and does not conduct hearings.
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HRSA provides little public information about countermeasures’ cases and outcomes. On its website, HRSA lists the total number of cases since the program began in 2010, the number of cases paid and the total amount of awards. The website does not separate COVID claims.
Because the countermeasures program is being used to handle COVID-related injuries during the pandemic, some critics say the program should share more information about claims with the public.
Peter Meyers is former director of George Washington University Law School’s Vaccine Injury Clinic. He filed a Freedom of Information Act request and obtained details of 48 cases filed as of Feb. 16. Of those COVID-related cases, 26 involved deaths and 22 other injuries. Most of the harms from vaccine claims cited allergic reactions; only three cases alleged death after immunization.
The types of claims vary widely. One case tied use of an N-95 mask to a shoulder injury. Another claim connected the stay-at-home order and mask use to attempted murder and assault. More details about the cases, including names of claimants, dates or location, were not provided under the records request.
Meyers said the federal agency should be more forthcoming about cases and outcomes.
“To the extent the Biden administration is trying to build trust and confidence in the American public, deal with all the misinformation that’s out there, deal with all the vaccine hesitancy of so many people, it seems to me they are going about it in exactly the wrong way,” Meyers said.
Meyers said the relatively small number of vaccine-injury claims could provide more evidence of “how incredibly safe these vaccines really are,” but the agency has not posted this information on its website.
Katharine Van Tassel, a visiting professor of law at Case Western Reserve School of Law in Cleveland, said limited information about COVID claims is an “unforced error that could have a serious negative impact on public trust of vaccine programs moving forward.”
“Full transparency over vaccine injury claims made during a public health emergency will build the kind of trust that we as a country need as we face future public health disasters together,” Van Tassel said.
But others not involved in the program say public reporting about vaccine safety is so open and widespread that more details about the relatively small numbers of countermeasures claims will make little difference in swaying public opinion.
Dr. Cody Meissner, a pediatric infectious disease expert at Tufts Children’s Hospital, said the three FDA-authorized vaccines made by Moderna, Pfizer-BioNTech and Johnson & Johnson have undergone rigorous clinical trials to demonstrate they are safe and effective.
Even after vaccines hit the market, safety data is tracked through a database that collects “adverse events” reports from doctors and patients, ongoing monitoring of medical records and a voluntary program that allows immunized people to report side effects via a phone app.
“Everything is very public,” Meissner said. “There’s ‘s never been any vaccine that has been placed under such careful scrutiny as these COVID-19 vaccines are going through.”
Meissner cited some European nations recent decision to pause use of the AstraZeneca vaccine over concerns of blood clots in a small number of patients. Days later, Europe’s top drug regulator cleared the vaccine as safe and effective.
During the first month of COVID vaccines in the United States, there were 640 cases with serious side effects out of 13.8 million doses administered, according to a Centers for Disease Control and Prevention report.
Of 113 deaths reported by CDC after vaccination during the first month, two-thirds involved residents of nursing homes and other long-term care facilities. Of the non-nursing home deaths, researchers said the number was consistent with death rates in the overall population and not caused by vaccines.
Although attorneys representing injured patients have called for moving COVID claims from countermeasures to the more consumer-friendly vaccine court, Meissner doesn’t see that as a possibility for now.
The FDA authorized the vaccines under emergency use to quickly deploy in the middle of a pandemic that has killed more than 546,000 Americans. Drugmakers are expected to gather more data and file for biologics license applications, the process to apply for full Food and Drug Administration approval, but they have not done so yet.
The ongoing safety monitoring will allow the FDA and drugmakers to gather enough data on side effects linked to the vaccine.
For licensed vaccines to be added the vaccine court, they must be recommended for routine use in children and assessed a 75-cent tax per dose. This funding supports the the federal vaccine court, which provides quick compensation for legitimate injury victims and protects vaccine manufacturers from liability. The system ensures a steady supply of vaccine at low costs for immunizations that provide broad public health benefits.
“Before a vaccine can be added to (vaccine court), we have to have a very good understanding of what are the complications from the vaccine. You can’t just add it without knowing,” Meissner said.
But critics of the countermeasures program argue it will only sow distrust unless HRSA shares more information with the public about cases.
Unlike vaccine court, the countermeasures cases are decided by HRSA staff with little opportunity to challenge findings, Meyers said.
Because HRSA has not posted details about the COVID cases, the public does not know about the number of cases without media reports, Meyers said.
“They’ve not publicized this at all,” Meyers said. “How are they going about making decisions? What are the scientific information they are gathering? How long will it take? There’s an awful lot of secrecy and things that we don’t know.”
Ken Alltucker is on Twitter at @kalltucker, or can be emailed at [email protected]