At a time when the failure of childhood immunization has been at the root of the largest measles epidemic in decades, a little-known database offers a way to measure vaccine safety.
More or less the last twelve years in the USA, people have received about 126 million doses of measles vaccine, a disease that once infected millions of American children and killed 400 to 500 people each year. During this period, 284 people have applied the damage caused by these vaccinations through a federal program created to compensate people injured by vaccines. About half of these requests were rejected, while 143 were compensated.
The data comes from the National Vaccine Injury Compensation Program, a no-fault system established in 1988 after federal legislation established it as the place where claims for harm caused by vaccines must be filed and evaluated. It currently covers claims related to 15 childhood vaccines and the seasonal flu vaccine.
Over the past three decades, when billions of doses of vaccines have been administered to hundreds of millions of Americans, the program has compensated about 6,600 people for the injuries that would have been caused by the vaccines. About 70% of sentences have been settlements in cases where program managers has not found enough evidence of the vaccine's fault.
"Vaccine-related injuries are rare," said Renée Gentry, a lawyer who has been representing people who have been filing vaccine injury claims for almost 18 years. Nevertheless, she said, "These are pharmaceuticals and people can respond to them – you may have a bad reaction to aspirin. They are not magical. "
In recent years, many program payments have been linked to influenza vaccines, mainly involving adults.
A total compensation of $ 4.15 billion has been paid since the program's inception. A small proportion of claims involve deaths. In 30 years, about 520 deaths have been compensated. Nearly half of them involved an older pertussis vaccine that had not been used for two decades.
Centers for Disease Control and Prevention have estimated that vaccines prevented more than 21 million hospitalizations and 732,000 deaths among children over a period of 20 years.
The risk of serious harm if a person contracts measles is far greater than the risk of being injured from the measles vaccine, the data show. Sure According to the C.D.C., one in four people who contract measles is likely to be hospitalized and one to two out of every 1,000 people living with the disease are at risk of dying from the disease. In comparison, about two million doses of measles vaccine were claimed.
There were approximately two injury claims for one million doses of all vaccines dispensed in the United States from 2006 to 2017, during which time the injury compensation program contains dosage data. It says more than 3.4 billion doses of vaccine were distributed during this period.
The scarcity of claims is particularly notable because the program aims to facilitate the filing of a petition. He often pays the plaintiffs' fees for lawyers and expert witnesses, whether or not the claim is compensated, said Dr. Narayan Nair, who oversees the program as Director of the Division of Personal Injury Compensation Programs. Ministry of Health and Social Services.
The compensation of a death is capped at $ 250,000. In case of injury, there is no limit to what the program pays for medical expenses, lost wages and other costs. The two biggest awards so far have been enter $ 32 million and $ 38 million for child applications filed about 20 years ago, program officials said.
Dr. Nair described the program's approach as follows: "The vaccine is guilty if it is not proven innocent". a chart listing injuries and conditions that each vaccine could potentially cause within a certain time after receiving a vaccine. They include fainting, bowel obstruction and inflammation of the brain. Dr. Nair stated that if a person's state of health matches a description on the table, "it benefits from the presumption of causation".
The program may also settle cases without determining whether the vaccine caused the injury, or the case may go to what is unofficially called vaccine court, where special masters can claim compensation.
Autism is a disease that is not on the list of potential effects related to vaccination. In the early 2000s, after trying to link autism to vaccines, a now discredited study received several thousand claims. The case was exhaustive evaluation for several years by the federal courts, who finally ruled that the evidence demonstrated the presence of autism is not caused by vaccines and is not a legitimate claim for the injury program. Applications related to autism have been rejected.
The government is trying to publicize the existence of the program by printing its telephone number and website on the vaccine information statements that physicians are required to provide to patients when they are immunized. Its advisory board, made up of parents of children wounded by a vaccine, assesses any suggestion of condition or injury related to a previously unknown vaccine, said Dr. H. Cody Meissner, vice chair of the commission Advisory and Professor of Pediatrics at Tufts University School. of medicine.
Skeptics and opponents of the vaccine sometimes claim that the existence of the program suggests that vaccines are more dangerous than medical evidence suggests.
Some people consider that the amount of money paid to applicants throughout the program is alarming.
"If the vaccines do not cause injuries, why did the immunization trust fund pay $ 4,061,322,557.08 for the injuries caused by the vaccination?" Asked Bill Posey, Florida representative , in a letter defending the right of parents to make their own decisions to immunize their children.
But public health experts point out that the data is actually evidence of vaccine safety. "The overwhelming number of vaccine the injections are completely safe and are not associated with any adverse events, "said Dr. Meissner. "This is in stark contrast to what the anti-vaccine movement is trying to enact."
Ms. Gentry, who co-directs the Vaccine Injury Litigation Clinic at the George Washington University School of Law, said the vast majority of claims are made by people who are not skeptical about vaccines.
"We've been called all kinds of crazy things, including anti-vax," she said. "Were not." My legal partner's sister spent her life in a wheelchair because of polio, I would have liked that she had this vaccine.
A growing proportion of recent claims, about half of all petitions since 2017, do not concern the content of the vaccines themselves. Rather, it is shoulder injuries, usually to adults, caused by the injection of a health care provider. a vaccine too high on the shoulder or in the joints rather than in muscle tissue. This can cause an inflammatory reaction leading to shoulder pain and limited movement.
Angela Barry, a fifth grade teacher in Niceville, Florida, said she immediately felt intense pain and that she could barely lift her arm after receiving a tetanus injection at a pharmacy clinic where her cat was scratched her face in 2015. She later learned that the person who had administered the injection had just graduated from a medical program. medical assistants and had apparently injected the vaccine in the wrong place.
Ms. Barry finally needed cortisone injections, surgery and several months of physical therapy, she said.
She said that she had quickly reported the incident to the Vaccine-related adverse event reporting system sponsored by C.D.C. and the Food and Drug Administration. During this process, she became aware of the personal injury compensation program, which agreed that her injury was vaccine-related and covered her medical expenses and potential future expenses.
Ms. Barry said that she always gets vaccinated. "I would not want anyone to hear this story and say," Oh, there is another reason not to get vaccinated, "she said.
Dr. Meissner said public health authorities are now focusing on training health care providers to administer vaccines without hurting people's shoulders.
Many shoulder injury claims involve the influenza vaccine, which the program has been covering since 2005. Influenza vaccines – recommended annually by federal authorities for adults and children – accounted for about two-thirds of claims awarded from 2006 to 2017. accounted for approximately 44% of total vaccine doses in the country.
Because of influenza vaccines, the program's claims now mostly involve adults rather than children.
The influenza vaccine has also resulted in a significant number of claims involving Guillain Barre syndrome, a rare neurological disorder in which the immune system begins to attack the body.
Of all vaccines, the largest proportion of claims – 26% – claim an injury that is not listed as a vaccine-related condition. People can still be compensated for these claims if they prove that the vaccine caused the injury.
Medical experts say the results of the program are proof that vaccines are well studied before being approved for public use.
For example, from 2006 to 2017, 311 claims in issue the HPV vaccine, which was approved in 2006 and prevents cervical cancer. Less than half were compensated. During this period, approximately 112 million doses were administered, or approximately three requests per million. In comparison, According to federal statistics, more than two out of every 100,000 American women die from cervical cancer.
The tetanus vaccine is considered so vital that 576 million doses containing it (often with diphtheria and pertussis) have been eliminated. administered from 2006 to 2017 – and 719 injury claims were compensated, according to the data.
Getting tetanus can be devastating, as has shown a case in 2017 in Oregon. According to a C.D.C. report on this case, a 6-year-old boy who had not been vaccinated contracted tetanus as a result of a cut at the front and had to spend 57 days in the hospital. For much of that period he was in so much pain caused by muscle spasms that he had to be kept in a dark room, wearing earplugs. His care cost more than $ 800,000. The cost of a five-dose treatment of the tetanus vaccine, which would have prevented its suffering, is about $ 150.
In very rare cases, vaccines can cause death. A person may experience anaphylactic shock or a fatal case of Guillain-Barré syndrome. Since 1988, more than half of the 1,300 death claims have been rejected because the program found insufficient evidence of vaccine liability.
About 90 of the 520 compensated death claims were for the influenza vaccine. Almost Half of the claims for death were for DTP, an early vaccine against diphtheria, tetanus and whooping cough (also known as whooping cough). The pertussis formulation, known as the whole cell, was replaced in the 1990s by acellular versions contained in the current DTaP and Tdap vaccines.
The vaccine compensation program was created following a flood of lawsuits, particularly from DTP, encouraging pharmaceutical companies to abandon the vaccine sector. Public health officials and Congress feared that there were not enough manufacturers providing essential vaccines.
A 1986 law created the compensation fund, funded by a tax paid by vaccine manufacturers 75 cents per dose. The law acts as a shield of responsibility for pharmaceutical companies: Individuals claiming to have suffered an injury must first seek redress from the Federal Court of Claims Program of the United States and the Ministry of Health and Social Services before they can sue a manufacturer.
There are about 2,800 pending cases to be resolved, which takes on average two to three years.
If people refuse compensation or if their claim is rejected, they may sue the vaccine manufacturer, although Ms. Gentry has stated that, as the program requires "a less burdensome burden of proof" than that required by a doctor. civil court, it would be difficult to win the case on the basis of a trial. the same claim.
"Once you've gone through this process, if you lose," she said, "you're probably not going to sue and sue."