Experts Deemed Safety Testing Inadequate at 2019 WHO Vaccine Safety Summit

Leading vaccinologists and epidemiologists discussed concerns about insufficient safety testing for vaccines during a World Health Organization (WHO) Global Vaccine Safety Summit on December 3, 2019. This conference was held weeks before the COVID-19 pandemic broke out in Wuhan, China, about three months before American lockdowns. The admissions of poor safety standards and calls for more rigid studies first aired on The HighWire in January 2020. There was a reprise of the episode last week as part of a Thanksgiving Day special.

Dr. Soumya Swaminathan, the Chief Scientist of the WHO, spoke as part of a WHO advertisement promoting vaccines just days before the Global Vaccine Safety Summit. When speaking at the summit, she contradicted her public statements as part of the advertisement released days earlier.

In the ad, Dr. Swaminathan said, “If someone gets sick after vaccination, it is usually either a coincidence, an error in administering the vaccine, or very rarely a problem with the vaccine itself. That’s why we have vaccine safety systems. Robust vaccine safety systems allow health workers and experts to react immediately to any problems that may arise. They can examine the problem vigorously and scientifically, look at the data, and promptly address the problem. The WHO works closely with other countries to make sure vaccines can do what they do best: prevent disease without risks. Vaccines are one of the safest tools we have to prevent disease and ensure a healthy future for all children.”

During the summit, Dr. Swaminathan sounded the alarm by saying there are inadequate safety monitoring systems and that there are always risks involved with vaccination. Both of these statements directly contradict her claims in the marketing ad.

Dr. Swaminathan said, “We cannot overemphasize the fact that we really don’t really have very good safety monitoring systems in many countries and this adds to the miscommunication and the misapprehensions because we are not able to give clear cut answers when people ask questions about the deaths that have occurred due to particular vaccines.”

Dr. Swaminathan further stressed the need “to be able to monitor what’s going on and report back and for corrective action to be taken. Unexpected things could arise after introduction, and one always has to be prepared. As we’ve seen with the history of many drugs, we’ve learned about adverse events only after the drug has been licensed and introduced into the population. So, I think risk is 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.”

The ad and speech from Dr. Swaminathan aired at the end of The HighWire episode to which Bigtree said “Frankly, I probably could’ve just played the propaganda video and then what she actually said three days later and spared you all the details of this entire show, but I know your mind is blown.”

The other speakers at the vaccine summit revealed more concerns regarding vaccine safety, the increased skepticism among healthcare professionals, and the fact that a lot of vaccine “misinformation” is not actually misinformation.

The first speaker on the episode is Heidi Larson, founding Director of the Vaccine Confidence Project, who describes the increase in vaccine skepticism caused by safety concerns. Larson said one of the biggest problems is that healthcare providers are losing their confidence in the safety of vaccines. “We have a very wobbly health professional front line that is starting to question vaccines and the safety of vaccines,” Larson said. “That’s A huge problem because to this day, any study I’ve seen, and we’re constantly looking on any studies in this space. Still, the most trusted person on any study I’ve seen globally is the health care provider, and if we lose that, we’re in trouble.”

Larson added that healthcare providers lack the confidence regarding vaccine safety to “stand up to the person asking them the questions.” She pointed out that medical school and nursing school students are lucky if they receive a half day of vaccine education. In the following clip, Larson discusses the role of tech companies in filtering out misinformation, but she said much of the vaccine-skeptical information online is not misinformation.

“They have a lot of fingers pointing at them to fix the misinformation problem, but it’s not so simple,” Larson said. “The biggest problem is a lot of it’s not misinformation. Our problem is, as we’ve heard in the last 48 hours, that there’s not anything 100%. And what, actually, can legally without creating a censorship thing, can we actually say this is misinformation? Because we have a lot of ambiguity in the safety field, and we have to come to terms with that. So, we have to think about it differently than deleting misinformation, but building trust so people are willing to put up with a certain amount of risk, because they believe in it enough. They believe in our work, what we’re doing, and that it’s in their interest.”

Larson talked about the rapid speed of recruitment for vaccine-skeptics compared to the pro-vaccine groups. The data shows vaccine-skeptics recruit 500%, or 5 times, faster than pro-vaccine groups. She said it is important for doctors and health professionals to field questions from patients without judgment, even when the questions seem “crazy, stupid, or ignorant.” Larson also called for the end to hostile language, including the term “anti-vax.”

Larson then shared that the most significant concern regarding low vaccine uptake is that human civilization depends on vaccines for immunity. “We’re in a unique position in human history where we’ve shifted the human population to vaccine-induced – to dependence – on vaccine-induced immunity,” Larson said. “And that’s on the great assumption that populations would cooperate. And for many years, people lined up. The 6 vaccines: people were there. They saw the reason. We’re at a very fragile state now. We have developed a world that is dependent on vaccinations. We don’t have a choice, but to make that effort.”

Bigtree chimed in and asked the audience, “Did you vote on that?  I don’t remember a ballot saying ‘I want to vote and leave natural immunity where no one’s dying and I get lifelong immunity.’ I wanna leave that and go to an inferior immunity system that keeps wearing off.”

In a final clip by Larson, she claims there is a shortage of science backing up the safety profile of vaccines and she calls for more investment in safety science. “There’s a lot of safety science that’s needed,” Larson said. “Without the good science, we can’t have good communication. Although I’m talking about all of these other contextual issues and communication issues, it absolutely needs the science as the backbone. You can’t repurpose the same old science to make it sound better if you don’t have the science that’s relevant to the new problem. We need much more investment in safety science.”

The Informed Consent Action Network (ICAN) has a chart that shows the pre-licensing clinical trials for each vaccine, including the length of follow-up time for each vaccine on the childhood schedule. There are four vaccines recommended for the first year of life that have been approved with only 3-5 days of follow-up safety testing. ICAN Attorney Aaron Siri said the new 2025 childhood vaccine schedule contains 70 routine vaccinations. Only the COVID-19 vaccine and Dengue vaccine conducted tests that included a placebo control group.

The next summit speaker in the episode is Marion Gruber, the Director of Office of Vaccines Research and Review Center for Biologics Evaluation and Research in the FDA at the time of the summit. Gruber worked in the FDA from 1992 to 2021 and now works for IAVI (International AIDS Vaccine Initiative), a non-profit that “develops vaccines and antibodies for HIV, tuberculosis, and emerging infectious diseases.”

“The risk management plan for each particular vaccine will need to take into the consideration the pre-licensure safety database, potential safety signals that may have been identified in pre-licensure clinical safety trials,” Gruber said. “Other perhaps even theoretical safety concerns, and also need to take into consideration the disease to be prevented, the target population and the proposed indication in order to really inform risk management.”

Bigtree commented again, emphasizing the word “will” in Gruber’s comment, implying the risk management plan in place for vaccines does not currently consider the safety data they have available.

The next speaker was Dr. Martin Howell Friede, Coordinator for the WHO’s Initiative for Vaccine Research. Dr. Friede spoke at length about the need for adjuvants in vaccine development and the struggle with skepticism regarding adjuvant safety.

“So the challenge that we have ahead of us is ‘how do we build confidence in this?’” Dr. Friede said. “And the confidence, of course, comes from the regulatory agencies. When we add an adjuvant, it’s because it is essential. We do not add adjuvants to vaccines because we want to do so. But when we add them, it adds to the complexity.”

Dr. Friede said he teaches vaccine development, and there are three lessons he teaches his students about adjuvants. “The first lesson is while you’re making your vaccine, if you can avoid using an adjuvant, please do so,” Dr. Friede said. “Lesson two is if you’re going to use an adjuvant, use one that has a history of safety. Lesson three is if you’re not going to do that, think very carefully.”

Dr. Friede also discussed the difference between local reactogenicity and systemic reactogenicity, which are the two categories of adverse side effects caused by vaccination. A local adverse event is pain, itching or swelling at the injection point. Systemic adverse events are longer-term health effects, including autoimmune diseases.

“The local reactogenicity, you’re correct, as we add more adjuvants we do see increased local reactogenicity. The primary concern, though, usually is systemic adverse events rather than local adverse events. We tend to get in the phase 2 and phase 3 studies quite good data on the local reactogenicity. This is not the major health concern. The major health concern, which we are seeing, are accusations of long-term effects. It comes down to ensuring that we conduct the phase 2 and the phase three studies with adequate size and appropriate measurement.”

Dr. Friede’s statement reflects the need to conduct studies that adequately test for the most severe long-term chronic health effects from vaccination, which are systemic effects. During the vaccine summit, the speakers also expressed the need to conduct safety studies to take multiple vaccines at the same time. In this case, multiple antigens and adjuvants can be given simultaneously, but there aren’t studies to determine if this is a safe practice.

Jay Bhattacharya, one of the three authors of the Great Barrington Declaration, was censored during the COVID-19 pandemic for sharing factual information and opinions. The HighWire reported last week about his new role as NIH Director for the new Trump administration. This Global Vaccine Summit took place just before the COVID-19 pandemic began, and Larson expressed the difficulty of legally removing vaccine-skeptical information because it is not actually “misinformation.”

This episode of The HighWire showcases several vaccine experts admitting there is not enough safety testing for these products. It also reflects a growing distrust of the vaccine manufacturers and federal health agencies. The experts expressed concern regarding increased skepticism among health professionals during this conference five years ago. A study earlier this year found that the distrust in vaccine safety and effectiveness continues to grow in the aftermath of the COVID-19 pandemic and vaccine rollout.