Vaccine Injury Claims Spiked During COVID

report from the U.S. Government Accountability Office (GAO).

CICP received approximately 27 times more claims in response to the COVID pandemic than it had received in the whole first decade of the program, which began in 2009 -- a total of 13,333 claims compared to just 491.

The Health Resources and Services Administration (HRSA), which runs the CICP, had made a decision on 3,483 of those claims, or 25%, as of June of this year.

Of the decided claims, 92 (3%) were found eligible to receive compensation for a serious injury or death directly caused by a covered countermeasure. Fifty-two of these were due to COVID countermeasures, 37 due to the H1N1 vaccine, and three due to smallpox and anthrax countermeasures.

To encourage the development of vaccines and drugs against pandemic illness and other serious threats, the Public Readiness and Emergency Preparedness Act of 2005 authorized the establishment of the CICP while limiting the legal liability of manufacturers and others involved in the making, distribution, and administration of certain countermeasures.

Beyond COVID-19 vaccines and those noted above, other products covered under CICP include countermeasures for preventing or treating anthrax, acute radiation syndrome, botulinum toxin, pandemic influenza, Ebola and Marburg, Zika, and nerve agents or certain insecticides.

The CICP is modeled after the National Vaccine Injury Compensation Program, which pays for compensation of injuries or deaths from most routine vaccines: diphtheria, tetanus, and acellular pertussis (DTaP); seasonal flu; measles, mumps, and rubella (MMR); polio; etc.

"Instead of suing manufacturers or others, individuals can apply to CICP for compensation for serious physical injuries or deaths resulting from covered countermeasures," the GAO report explained.

As of June, HRSA had paid 51 of the 92 CICP claims found eligible for compensation, totaling nearly $6.5 million.

Most of the payments ($6.1 million) were for deaths or serious injuries, such as Guillain Barré syndrome, caused by the H1N1 vaccine. These payments ranged from $31 to nearly $2.3 million per claim.

Additionally, some $419,000 in payments went to 14 claimants for serious injuries caused by COVID countermeasures, such as myocarditis. These payments ranged from $1,032 to $370,376 per claim.

Among the 3,484 claims that completed the adjudication process as of July of this year, there were 486 requests to reconsider claim decisions. Nearly all of these requests were related to COVID countermeasures, and more than 80% were due to a claimant disagreeing with a decision made during administrative review, such as missing a filing deadline or supporting documentation.

HRSA's independent reconsideration panel reviewed 392 of these requests as of July, finding that 99% remained ineligible for compensation. Three claims did have a decision reversed, and were sent back to CICP for medical review.

A major challenge for the CICP was a shortage of staff to adjudicate the large influx of claims, including those needed to conduct administrative and medical reviews for COVID countermeasure claims. At the start of the COVID pandemic, CICP had only four staff members, according to the GAO report.

Another challenge was outdated information systems to process a large number of claims, including an initial reliance on mailed-in claims at the beginning of the COVID pandemic, and further reliance on certified mail for communications with claimants.

Finally, HRSA pointed to limited medical and scientific evidence on which to base decisions about injuries or deaths allegedly caused by COVID countermeasures.

"HRSA officials also told us the lack of medical and scientific evidence was challenging for medical reviewers to quickly determine whether there was causality between COVID-19 countermeasures and injuries and death," the report stated. "Instead, reviewers carefully considered the facts on a case-by-case basis to determine eligibility for benefits, adding time to the claim adjudication process."

Actions HRSA has since taken to help address these challenges have included hiring more full-time staff and contractors, and launching a web portal for online claims submissions, according to the GAO report.

HRSA officials also told GAO the agency began development of a countermeasure injury table to help with quicker reviews of medical evidence for COVID countermeasure claims, including requesting a report on evidence regarding potential harms from the National Academies of Sciences, Engineering, and Medicine.