Ending a 14-month fight, the Department of Health and Human Services (HHS) today killed a rule that would have made it much more difficult for people who sustain shoulder injuries during vaccination to win compensation from a $4.1 billion government fund. The rule had been finalized on 19 January, the last day of former President Donald Trump’s administration, but President Joe Biden’s administration had frozen its implementation on 20 January.
In its announcement rescinding the rule, HHS said the previous administration had been “irregular in its haste” last year when it proposed removing shoulder injuries from a table of injuries eligible for government compensation under a 1986 law. Injuries listed on the table have a lower bar for winning a government payout because the petitioner does not have to prove a vaccine caused the injury. Under Trump, HHS sidelined a key advisory committee that had voted unanimously against the change, HHS now writes, and did not give timely notice of public comment opportunities before publishing the final rule.
The rule change had been set to take effect on 22 February; the Biden freeze stopped that from happening. Biden’s HHS today cited concerns that the change could negatively affect the COVID-19 vaccination campaign by making vaccine administrators, such as pharmacies and doctor’s offices, vulnerable to civil lawsuits, which might dampen their willingness to take part in vaccination drives of any kind.
In its proposed rule, the Trump administration argued that shoulder injuries—which can happen when vaccines are administered too high on the arm—were not caused by the vaccines per se and therefore were not compensable injuries under the National Vaccine Injury Compensation Program (VICP). “The [law] should be read as not applying to cover injuries … which involve negligence by the vaccine administrator,” the proposed rule argued.
Shoulder injury claims under the program have surged in recent years and now account for more than 54% of all claims filed. Most shoulder injury claims come from adults who received flu injections.
“I applaud HHS for clearly doing the right thing by reconsidering its position and rescinding its own rule before it was too late,” says Leah Durant, a vaccine injury lawyer in Washington, D.C. “The rule … was contrary to our nation’s vaccine policy and would only serve to cause greater vaccine hesitancy during a global pandemic.”
Had it taken effect, the rule change would not immediately have applied to shoulder injuries sustained during COVID-19 vaccine administration, which for now fall under a different HHS program, the Countermeasures Injury Compensation Program. But after winning formal approvals from the U.S. Food and Drug Administration, COVID-19 vaccines could in principle be added to the VICP.
*Correction, 26 April, 12:20 p.m.: This story has been updated to reflect that the proposed rule change would not have barred claims for shoulder injuries, but would have made them much harder to win.