Vaccine Officials Struggle With Public Trust Amid Lacking Science

Better safety monitoring and regulation key to ensure vaccine effectiveness and public participation
April 6, 2020 Updated: April 6, 2020

News Analysis

The pandemic that began in China after the Chinese Communist Party (CCP) suppressed news of the virus, now threatens the lives of millions of people. But what will it mean to the world’s people when a vaccine for this CCP virus becomes available?

For those that catch and survive the CCP virus, often called the novel coronavirus, future infection will be less of a worry. For those that escape catching it, they must ask themselves whether catching the virus, and gaining natural immunity to it, is worth the risk should a vaccine become available.

The answer will hinge on good information. For example, what is the quality of the vaccine, what are its side effects, and importantly, what is the risk should they catch the virus.

Unfortunately, that information will not likely be available in the needed quality or quantity, as in general hard data on vaccine safety is hard to come by.

When a vaccine does become available, it is possible it will be rushed and heavily marketed. While that may comfort some, it will likely further unsettle those concerned about vaccine safety.

Public vaccination programs are facing a fall in public trust in the United States, which mandates double the number of vaccines of many other developed nations. For drugmakers, the financial immunity granted to them by the 1986 National Childhood Vaccine Injury Act means the risk of putting out a bad vaccine is minimized, while getting a new vaccine mandated is highly profitable.

That scenario is one fact contributing to public uncertainty. Now public health officials are struggling to find a way to restore public trust as problems in the regulation, marketing, and development of vaccines become more widely known.

Public Relations Versus Internal Concerns

The World Health Organization (WHO) released a video on Nov. 28, 2019, designed to bolster vaccine confidence. The video features WHO Chief Scientist Dr. Soumya Swaminathan describing vaccination as a medical treatment with virtually no downside—only benefits. She explains that vaccines “prevent disease without risks” because of “robust vaccine safety systems” that “allow health workers and experts to react to any problems that may arise.”

WHO Chief Scientist Dr. Soumya Swaminathan.
WHO Chief Scientist Dr. Soumya Swaminathan. (Ministry of Health and Family Welfare (GODL-India))

Vaccines are one of the safest tools we have to prevent disease and ensure a healthy future for all children,” Swaminathan said.

The video assures viewers that hard data and rigorous science underlie all vaccination programs. But just five days after the video’s release, at the WHO’s annual Global Vaccine Safety Summit in Geneva Switzerland, Swaminathan painted a far less reassuring picture. Before a panel of world health experts, Swaminathan said the evidence needed to substantiate vaccine safety claims was not nearly rigorous enough.

“I think we cannot overemphasize the fact that we really don’t have very good safety monitoring systems in many countries,” Swaminathan said to the panel. “And this adds to the miscommunication and the misapprehensions because we’re not able to give clear cut answers when people ask questions about the deaths that have occurred due to a particular vaccine, and this always gets blown up in the media.”

Swaminathan called for several steps needed to bridge the gap between claim and reality, such as more cohort studies and close monitoring of new vaccines. She says such efforts would allow for quick corrective actions when necessary, and clear explanations that quell concerns when they arise.

Safety Science and Public Awareness

This call for more facts and transparency in regard to vaccines was a major theme at the WHO vaccine summit. The approach comes as officials discover that, in an age where people can easily access sources and figures that challenge the statements of governments and drug companies, public trust no longer comes as easily as it used to.

Previous efforts to simply denounce vaccine skeptics as irrational anti-vaxxers have also begun to backfire, warned Heidi Larson, head of the Vaccine Confidence Project at the University of London.

“One of our biggest challenges I think now is getting rid of the term ‘anti-vax,’ getting rid of the hostile language, and starting to have more conversations,” she said.

“There’s a lot of safety science that’s needed. And without the good science, we can’t have good communication,” she said.

Experts believe a more open strategy will ultimately win back public trust, even if the record it shows isn’t perfect. Swaminathan said the public has shown it understands that reality.

“As we’ve seen in the history of many drugs, we learn about adverse events only after the drugs have been licensed and introduced into the population. So I think that risk is all always there, and the population needs to understand that, and feel confident that mechanisms are being put in place to study some of those things,” she said.

If health experts can’t deliver clear answers, skeptics and critics can take the opportunity to spotlight the risk of side effects and adverse reactions associated with a vaccine, Swaminathan said. This can severely hurt public support and vaccine compliance.

One example is found in India, with resistance to the HPV vaccine. In 2010, seven girls died during a pilot program to introduce the product to the country.

A government investigation concluded that the deaths were unrelated to the vaccine, but the incidents made the public extremely hesitant to try it for themselves.

“The HPV vaccine introduction basically got derailed by over a decade now, because of the association, so it can be very, very damaging for a country’s introduction,” Swaminathan said.

Calculating Risk

At the heart of the vaccine debate is the issue of adverse events. The conventional wisdom is that genuine vaccine injuries are extremely rare. But this belief is held while hard evidence is scanty.

Identifying a clear number of injuries that could end this argument is impossible because objective data is poor. Experts at the WHO summit highlighted the lack of “good science” and the inability of vaccine clinical trials to provide meaningful information about safety and risk.

One major issue is the comparative lack of safety testing that vaccines are subjected to compared to pharmaceuticals, even though vaccines are administered to pregnant women and infants at critical stages of development with relatively weak immune systems.

Vaccines are classified as biologics rather than drugs. For that reason, they aren’t put through double-blind placebo testing as drugs are, and vaccinated populations aren’t compared to unvaccinated populations, which would provide assurance that vaccines don’t cause secondary illnesses or compromise immunity to other diseases.

One verifiable measure is the over four billion dollars the U.S. government has paid out to victims identified by the federal vaccine court the 1986 National Childhood Vaccine Injury Act tasked with compensating individuals who have been injured by vaccines.

While health experts insist that adverse events are rare, the true scope of injury remains unclear. A study funded by the U.S. Department of Health and Human Services concluded that in the United States, fewer than one percent of vaccine injuries are reported.

HPV Vaccine Injuries

How to identify a true adverse reaction is also in dispute. Doctors and patients from several countries point to alarming numbers of injuries associated with the HPV vaccine in particular. But Larson claimed that girls in countries around the world were having similar psychosomatic reactions to the HPV vaccine because of watching YouTube videos showing the reaction.

According to a WHO database from April of 2018, over 85,000 reports of adverse reactions were linked to the HPV vaccine, the majority of which resulted in nervous system disorders. But later that year, the WHO revised how adverse events were classified. They declared that only reactions that have been acknowledged in epidemiological studies are regarded as a genuine vaccine-related reaction.

New WHO rules state that any deaths observed during post-marketing surveillance are not considered to be “consistent with causal association with vaccine,” if there were no statistically significant increase in deaths recorded during trials.

This means that, after a vaccine is licensed, any supposed reaction not detected in trials is labeled as “coincidental deaths/events” or “unclassifiable.”

Safety Monitoring

Meanwhile, the post-licensing surveillance system in the United States, the Vaccine Adverse Event Reporting System (VAERS), was found unreliable by the IOM (Institute of Medicine) in its 2012 Adverse Effects of Vaccines- Evidence and Causality study.

The IOM rejected the findings of a study that seemed to link neurodevelopmental disorders to a thimerosal-containing DTaP vaccine.

“This one study (Geier and Geier, 2004) was not considered in the weight of epidemiologic evidence because it provided data from [the VAERS] passive surveillance system and lacked an unvaccinated comparison population,” read the study.

While problems with post-licensing are acknowledged, they have yet to be addressed.

Meanwhile, the WHO’s new classification helped improve the perception of safety but an article published in the journal F1000Research suggests that actual safety measures may suffer as a result.

“The Global Advisory Committee on Vaccine Safety has documented many deaths in children with pre-existing heart disease after they were administered the Pentavalent vaccine. The WHO now advises precautions when vaccinating such children. This has reduced the risk of death. Using the new definition of causal association, this relationship would not be acknowledged and lives would be put at risk,” wrote Drs. Jacob Puliyel and Pathik Naik.

With the world now experiencing the consequences of a pandemic, inconsistencies like these—which seem to put public safety secondary to public confidence in vaccine programs—exemplify the problems that Swaminathan and Larson have pointed toward. This will likely pose a major challenge to any future vaccine marketed in response to the CCP virus.

Follow Conan on Twitter: @ConanMilner