Americans who suffer adverse reactions to coronavirus vaccines that the U.S. is racing to develop will have a hard time getting compensated for injuries from the drugs.
That’s because pandemic-related claims for vaccines will be routed to a rarely used federal program set up to encourage drugmakers to help combat public health emergencies. It spares pharmaceutical and device makers from costly liability lawsuits in exchange for taxpayers compensating injured patients -- though it doesn’t guarantee there’s funding to do so.
Since it began in 2009, the program has paid out less than $6 million, and it has yet to receive any dedicated U.S. government funding for Covid-19.
“In the best case scenario, this is going to be a big deal,” said Richard Topping, a former Justice Department attorney who represented the U.S. during disputes over the debunked link between vaccines and autism in children. “Worst case scenario? It will be a crisis.”
President Donald Trump is pushing drugmakers to develop a Covid-19 vaccine in record time under an initiative known as Operation Warp Speed that seeks to deliver 300 million doses by January 2021. However, most Americans are unlikely to actually receive a shot until much later next year, according to U.S. top infectious disease doctor Anthony Fauci. As the U.S. vies to be first, Russia this week said it will soon start mass inoculations -- even though safety and efficacy tests on its vaccine aren’t complete, causing concern in public health experts.
The U.S. Food and Drug Administration has said it won’t cut corners when it comes to safety testing as companies such as Moderna Inc., Eli Lilly & Co. and Pfizer Inc. rush to develop a vaccine. At the same time, scientists working with groups such as the Centers for Disease Control are trying to identify possible side effects -- but all medications carry risks and not every adverse reaction can be identified during trials.
“No vaccine or drug is 100% safe,” said Cody Meissner, head of the Pediatric Infectious Disease Division at Tufts Medical Center and former chairman of the Advisory Commission on Childhood Vaccines. But benefits exceed the risks. “An adverse reaction for any vaccine is much less than catching the illness and having complications.”
Congress earlier this year gave the Department of Health and Human Services $30 billion to fund the development of coronavirus “countermeasures” -- vaccines, treatments and devices that are used to deal with the pandemic. While the legislation allows HHS to transfer some of that money to the Countermeasures Injury Compensation Program, that hasn’t happened yet and it’s unclear how much would be needed.
HHS hasn’t received any Covid-19 injury claims to date and the compensation program hasn’t asked for funding, according to a senior administration official. Of the $30 billion Congress authorized, $10 billion has been awarded so far for research and the development of vaccines and treatments, the official said.
“When someone gets vaccinated they’re helping not only themselves, but society,” said Walter Orenstein, associate director of the Emory Vaccine Center in Atlanta. “And if they should be injured, in my opinion, society should compensate them.”