AstraZeneca’s COVID-19 vaccine has now been shown to be slightly less effective than previously thought.
A federal program to compensate people for serious side effects from COVID-19 drugs and vaccines has neither paid nor rejected any claims in the pandemic’s first year.
The Health Resources and Services Administration, the agency within HHS that manages the injury countermeasures compensation program, provided data to USA TODAY showing injury claims for 20 types of COVID-19 treatments.
More than half of the complaints alleged injuries from COVID-19 vaccinations. However, with just 58 claims out of the more than 120 million doses administered in mid-March, experts say the data adds to the growing evidence for the safety of the COVID-19 vaccine.
HRSA officials have defended the pace of payments, noting that it takes months to process cases because individuals or families must submit documents, including medical records, to support claims. The first case, filed in September, alleged an injury from convalescent plasma, but the agency still does not have all the necessary medical records, HRSA communications director Martin Kramer said in an email.
‘Exactly in the wrong way’
Last March, former Health and Human Services Secretary Alex Azar said all injury claims from COVID-19 vaccines would be handled through the Countermeasures Program.
The program, created in 2010, handles injury claims related to vaccines and other authorized treatments during a public health emergency.
Countermeasures has dismissed 90% of injury claims over the past decade. In contrast, the federal government’s “vaccine court”, which deals with claims primarily for routine childhood vaccines, paid about 70% of claims from 2006 to 2018.
Unlike the vaccine tribunal, the countermeasures program limits claims to one year after a person has received treatment, does not pay attorney fees or expert testimony, and does not hold hearings.
Suite: ‘Worst possible moment’: HHS gives coldness to victims of common vaccine injury
HRSA provides little public information on the cases and results of countermeasures. On its website, HRSA lists the total number of cases since the program started in 2010, the number of cases paid and the total amount of compensation. The website does not separate COVID claims.
Since the countermeasures program is being used to treat COVID-related injuries during the pandemic, some critics say the program should share more information about the claims with the public.
Peter Meyers is the former director of the vaccine injury clinic at George Washington University Law School. He filed a Freedom of Information Act request and obtained details of 48 cases filed as of February 16. Of those COVID-related cases, 26 involved death and 22 other injuries. Most of the harms related to vaccine claims cited allergic reactions; only three cases reported death after vaccination.
Meyers said the federal agency should be more open about cases and results.
“As the Biden administration tries to build trust in the American public, to deal with all the misinformation that is out there, to deal with all the reluctance of so many people towards vaccines, it seems to me that they do exactly that. the wrong way, ”Meyers said.
Meyers said the relatively low number of vaccine-related injury claims may provide more evidence of “the incredible safety of these vaccines,” but the agency did not publish this information on its website.
Katharine Van Tassel, visiting professor of law at Case Western Reserve School of Law in Cleveland, said the limited information on COVID allegations is an “unforced error that could have a serious negative impact on public confidence in law. vaccination programs in the future ”.
But others not involved in the program say public reports on vaccine safety are so open and widespread that more details about the relatively small number of requests for countermeasures will make little difference in influencing the outcome. public opinion.
Dr Cody Meissner, an expert in pediatric infectious diseases at Tufts Children’s Hospital, said the three FDA-cleared vaccines manufactured by Moderna, Pfizer-BioNTech and Johnson & Johnson have undergone rigorous clinical trials to demonstrate that they are safe and effective.
Meissner cited the recent decision by some European countries to suspend use of the AstraZeneca vaccine due to blood clots in a small number of patients. Days later, Europe’s main drug regulator said the vaccine was safe and effective.
In 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 report from the Centers for Disease Control and Prevention.
Of 113 deaths reported by CDC after vaccination in the first month, two-thirds were residents of nursing homes and other long-term care facilities. Among the deaths unrelated to nursing homes, the researchers said the number was consistent with death rates in the general population and was not caused by vaccines.
The FDA has cleared vaccines under emergency use to deploy quickly amid a pandemic that has killed more than 546,000 Americans. Drugmakers are expected to collect more data and file biologics license applications, the Food and Drug Administration’s full approval application process, but they have yet to do so.
For licensed vaccines to be added to the vaccine court, they must be recommended for routine use in children and taxed at 75 percent per dose. This funding supports the Federal Vaccine Court, which provides prompt compensation to victims of legitimate injuries and protects vaccine manufacturers from liability. The system ensures a steady supply of low-cost vaccines for immunizations that provide broad public health benefits.
But critics of the countermeasures program argue it will only create suspicion unless HRSA no longer shares information with the public about the cases.
Unlike the vaccine court, countermeasures cases are decided by HRSA staff with little opportunity to challenge the results, Meyers said.
Because HRSA has not released details of the COVID cases, the public does not know the number of cases without media reports, Meyers said.
Ken Alltucker is on Twitter at @kalltucker, or can be emailed to [email protected]