Vaccine disasters spur antivaxxer doubts

Vaccines for Lyme disease, swine flu, HPV and dengue fever are some of the vaccines that have generated controversy and adverse side-effects

Vaccine disasters spur antivaxxer doubts.
  • Anti-vaxxer movements are gaining traction just as teams of researchers around the world are racing to find a vaccine for COVID-19. Vaccine disasters spur antivaxxer doubts and put the concerns of anti-vaxxers in context.
  • Anti-vaxxers often based their arguments on one of a handful of vaccine disasters over the past few decades. These vaccines disasters may support their views but it is important to put the numbers in context.
  • There have been just a handful of vaccine issues, given the billions of people who have been vaccinated and the 26 different diseases for which the World Health Organization has approved dozens of vaccines.

Vaccine disasters: Yes, they have happened. Vaccine disasters spur antivaxxer doubts.

It is important, however, to put them in context. The handful of vaccine disasters throughout history have been isolated cases. Tens of billions of doses of vaccines have been administered around the world for over two centuries and people have been the better for it, thanks to the immunity that vaccines provide against dozens of diseases.

About 1 billion children have been vaccinated just in the last decade, according to the World Health Organization. In 2019, about 116 million infants were vaccinated with 3 doses of diphtheria-tetanus-pertussis (DTP3) vaccine, about 85 percent of all children around the world.

These figures don’t reassure anti-vaxxers, many of whom are parents concerned about the ingredients that make up vaccines and the potential they perceive for adverse side effects, such as those recorded in some particular cases with specific vaccines. In short, vaccine disasters spur antivaxxer doubts.

To support their fears, they typically point to one or another of the vaccine disasters that have happened around the world. The WHO has given the go-ahead to vaccines for 26 different diseases and there are hundreds of individual products on the market made by dozens of companies around the world.

The handful of vaccines disasters listed below should be considered in the context of how relatively tiny their numbers are.

Lot-100 – a potential vaccine disaster

One of the best-known vaccine disasters is the one of Lot-100, a vaccine against the respiratory syncytial virus (RSV) made by Pfizer, a New York-based multinational pharmaceutical company.

Two infants who were part of a clinical study to test the vaccine, aged 14 months and 16 months, died as a result of being given the vaccine and what is known as enhancement phenomenon, when a vaccine causes or exacerbates the disease that it is trying to protect against. (See Covid-19 Vaccine: Need for speed, development challenges and enhancement dangers create hurdles).

“Lot-100 not only failed to protect against wild-type (wt) RSV disease but also induced an exaggerated clinical response to wt RSV infection in infants who were RSV naive before vaccination,” a study conducted by Robert Dudas and Ruth Karron and published in 1998 in Clinical Microbiology Reviews said.

Lyme disease vaccine troubles

In 1998 SmithKline Beecham (SKB), one of two companies that would eventually become the pharmaceutical giant GlaxoSmithKline (GSK), from Brentford, UK, received approval from the U.S. Food and Drug Administration (FDA) to market Lymerix, a vaccine to prevent Lyme disease, which is spread by ticks and mainly affects residents of rural areas of the Upper Midwest, Northeast, and Pacific Northwest regions of the U.S. and Canada but is also present in 80 other countries.

Things didn’t go as planned for SmithKline Beecham, which was sued in late 1999.

“SKB, manufacturer of Lymerix, the Lyme vaccine, failed to warn doctors and the public at large that about 30% of the general public could possibly be predisposed to degenerative autoimmune arthritis that can be triggered by the vaccine,” the Lyme Disease Association explained.

“According to the complaint, the autoimmune reaction, once triggered, is unstoppable, and the victim can only be treated for symptoms thereafter,” it added.

According to Keller & Keller, one of the law firms that took part in the class action suit against SKB, 905 adverse event reports were filed during the vaccine’s first two years on the market.

“There are concerns regarding severe rheumatologic, neurologic, autoimmune and other adverse events and the use of Lymerix,” said Keller & Keller. “Many of the patients may have had a prior exposure and infection that Lymerix was triggering, or reactivating the damage caused by old and presumably cured Lyme disease.”

Brian Resnick, a senior science reporter at Vox described Lymerix´s case as a “stark reminder of how the anti-vaccine mania of the past few decades is leaving us all more susceptible to disease.”

“Hundreds of thousands of people got it — until vaccine fear knocked it off the market,” he wrote.

Eventually, GlaxoSmithKline withdrew the vaccine from the market but not before reaching a $1 million deal with the law firms to pay for legal fees. No compensation was paid to patients.

“Although the FDA did not revoke the license, the manufacturer withdrew the product amidst falling sales, extensive media coverage, and ongoing litigation, even though studies indicated the vaccine represented a cost-effective public health intervention for people at high risk of acquiring Lyme disease,” Lise E. Nigrovic and Kimberly M. Thompson wrote.

The Global Lyme Alliance estimates that there are 427,000 cases of Lyme disease every year in the U.S. There is no vaccine for Lyme disease on the market at the moment, not for humans. There are vaccines for dogs. Lymerix prevented between 76% and 92% of infections, which would have added up to between around 324,000 and 392,000 cases.

Swine flu vaccine troubles

Also produced by GlaxoSmithKline is an H1N1 swine-flu vaccine called Pandemrix that faced serious challenges in the market after European studies linked it to some cases of narcolepsy.

The European Committee for Medicinal Products for Human Use (CHMP) “considered that the epidemiological studies relating to Pandemrix in Finland and Sweden were well designed and the results show an association between Pandemrix vaccination and narcolepsy in children and adolescents in those countries,” the European Medicines Agency (EMA) said. The CHMP is part of the EMA.

In 2011 the European regulator recommended a restriction on the use of Pandemrix in  people under the age of 20.

“After the Pandemrix vaccination campaign in 2009–2010, the risk of narcolepsy was increased 5- to 14-fold in children and adolescents and 2- to 7-fold in adults,” according to a paper published in 2018 by Tomi Sarkanen, Anniina Alakuijala, Ilkka Julkunen and Markku Partinen.

“Several studies from different countries using alternative methods have confirmed the association between narcolepsy and Pandemrix vaccination. This provides strong evidence of a true association even if the possible diagnostic biases may somewhat reduce the risk,” the researchers explained.

Pandemrix was manufactured and marketed in Canada as Arepanrix, but the company did not renew the license once it expired in the North American country.

Eventually, the World Health Organization removed the vaccine from its prequalified list of monovalent H1N1 vaccines.

“This decision is not related to any quality issue or other problem with the vaccine, it is rather a consequence of the expiry of the market authorization in Canada,” the WHO noted.

In 2015 the license of Pandemrix expired in Europe and GSK did not renew it.

The HPV vaccine

In Carmen de Bolivar, a town in the Caribbean coast of Colombia, about 700 teenagers who received an HPV vaccine in 2014 showed symptoms and suffered adverse events.

Merck Sharp & Dohme (MSD), from Kenilworth, NJ, the manufacturer of Gardasil, the vaccine used in Carmen de Bolivar, was sued by the parents of the teenagers. The class-action suit is still moving forward through a Colombian court.

The Gardasil issue brought a cascade of lawsuits, not only against MSD, but also to challenge laws related to vaccination campaigns.

In a 2015 decision against the mandatory vaccination for HPV in Colombia, the Constitutional Court decided not decide the case.

In a second lawsuit decided by the same court two years later, the Constitutional Court did not prohibit the administration of the Gardasil vaccine and did not adopt the claims of the Carmen de Bolivar patients and their relatives, who argued that their injuries and the side effects that the minors experienced were a consequence of the aluminum hydroxyphosphate that the HPV vaccine has. Dismay, seizures, paresthesias, and tachycardia, were the main adverse events reported in the town.

Dengue vaccine

A vaccine to prevent dengue fever, a mosquito-borne viral disease for which there is no treatment, was developed by Sanofi, from Paris, France and marketed in many tropical countries under the Dengvaxia brand. The vaccine first entered the market in the Philippines in 2015. Two years later, Sanofi acknowledged the risks posed by the vaccine to those who were not previously infected with the virus.

“The analysis confirmed that Dengvaxia provides persistent protective benefit against dengue fever in those who had prior infection. For those not previously infected by dengue virus, however, the analysis found that in the longer term, more cases of severe disease could occur following vaccination upon a subsequent dengue infection,” the company said.

In the Philippines, 10 government officials were indicted in 2019 for the vaccination campaigns with Dengvaxia. Among the indicted is former Department of Health (DOH) Secretary Janette L. Garin

“If convicted, Garin and the other respondents face a penalty of, among others, up to six years imprisonment for each count,” the Department of Justice of the Philippines said.

“A panel of six investigators conducted the preliminary investigation of the first set of complaints involving the death of 10 children,” the entity said in its release.

Twenty people in the Philippines are facing charges of alleged reckless imprudence resulting in homicide.

Vaccine disasters spur antivaxxer doubts

The five vaccine disasters spur antivaxxer doubts. The vaccine tragedies above are not the only occasions where vaccines or the process of vaccination have caused injury or worse to those being vaccinated. They are, however, by far and away the cases where the greatest numbers of people have been harmed.

Tens of billions of children and adults have been vaccinated across over 200 years, with remarkably few serious reactions and side effects: The BCG vaccine for tuberculosis has the highest rate of severe reactions (a serious reaction is usually an strong allergic response) at one in 25,000. Oral polio vaccines are one in 750,000 for the first dose and one in around 2.5 million for overall doses; measles stands at one severe reaction per million doses and DTP at one in 750,000.

Fatalities from vaccination in contemporary times are so low as to be nearly uncountable.