No, WHO scientists did not “question the safety of vaccines” at the Global Vaccine Safety Summit

I have to grudgingly hand it to Del Bigtree. He is an excellent antivaccine propagandist. Whether it be his antivaccine propaganda movie disguised as a legitimate documentary, VAXXED, which he almost managed to have screened at the 2016 Tribeca Film festival (thanks to festival co-founder Robert De Niro’s bypassing the selection committee because of his antivaccine proclivities) to his YouTube show High Wire, to his antivaccine advocacy nonprofit ICAN, to his speaking at antivaccine protests, to his production of viral antivaccine videos, Bigtree is excellent at spouting pseudoscience, twisting facts and science, and weaving cherry picked facts and science into antivaccine conspiracy theories. I was going to ignore the most recent example of his talent at doing this. Truly, I was. However, after I saw it shared all over Facebook and Twitter a few too many times by credulous antivaxxers , I decided that it was my duty, as unpleasant as that duty was likely to be, to take a look at it. Basically, it’s a viral video that’s turned into multiple antivaccine memes claiming that at World Health Organization (WHO) Global Vaccine Safety Summit held in Geneva last month, WHO scientists “admitted” that vaccines are unsafe.

Spoiler alert: They didn’t.

Before I deconstruct the viral video, let’s first take a look at the Global Vaccine Safety Summit. This two-day conference was organized by the WHO and held at WHO’s headquarters in Geneva and held on December 2 and 3, 2019 to commemorate the 20th anniversary of the WHO’s Global Advisory Committee on Vaccine Safety (GACVS) and was intended to be an “opportunity to take stock of GACVS accomplishments and look towards priorities for the next decade.” Its attendees included:

The Summit is meant for vaccine safety stakeholders from around the world, including current and former members of the Global Advisory Committee on Vaccine Safety (GACVS), immunisation programme managers, national regulatory authorities, pharmacovigilance staff from all WHO regions, and representatives of UN agencies, academic institutions, umbrella organizations of pharmaceutical companies, technical partners, industry representatives and funding agencies.

Also, at the summit WHO presented its Global Vaccine Safety Blueprint 2.0 strategy for 2021-2030 to key stakeholders to collect their input for the final version, to be published this year.

Now here’s the thing. If you look at how antivaxxers are portraying this meeting, you’ll soon see that their characterization is very silly, basically a particularly brain dead conspiracy theory. Let’s look at the title of Del Bigtree’s viral video first, CAUGHT ON CAMERA: WHO Scientists Question Safety Of Vaccines. Oooh! “Caught on camera!” How’d you get that video, Del? Another antivax story about the meeting is entitled, BOMBSHELL closed door admission by TOP UN Scientist. (You’ll see what that “bombshell admission” is in a moment, unless you’ve already clicked on one or more of the links and watched the video or read the article.) If you read Del Bigtree’s or one of these other accounts, you’d think that antivaxxers had somehow managed to get a camera into the meeting and smuggle out secret footage that “they” (obviously, the pharma drones at the Global Vaccine Safety Summit) don’t want you to know about.

There’s just one problem. Video of the entire Global Vaccine Safety Summit was posted by WHO on its website. In fact, the the whole damned summit was live-streamed as it was happening, and the archived video is right here! Just scroll to the bottom of the page, and you can watch some 15-16 hours of the conference, basically all of it. Yes, if you have the intestinal fortitude, you can watch every scintillating minute. Each speaker’s slides are archived there, too! I didn’t listen to everything, because unfortunately I didn’t have the time, but I did watch selective parts of it. You know what I saw? I saw earnest scientists, regulators, and other stakeholders engaging in a sober, serious, science-based discussion of vaccine safety, where safety monitoring is lacking, how we can do better, and what’s coming up in the future with new vaccines. It was very open and honest, and it did not show, contrary to Del Bigtree’s claim, WHO scientists “questioning the safety of vaccines.” Quite the contrary.

For instance, this presentation by Laura Conklin, Team Lead of the Immunization Safety Team in the Global Immunizations Division (GID) at the Centers for Disease Control and Prevention (CDC), reviewed vaccine safety issues that the GACVS had examined between 1998-2019, which included:

  • Use of thiomersal in multi-dose non-live vaccines
  • Aluminium adjuvants used with several non-live vaccines
  • Autism and autoimmunity as a possible consequence of vaccination
  • A risk of immune overload with increasing numbers of vaccinations
  • Nonspecific detrimental effects of vaccination

GAVCS conclusions included:

  • Evidence on the safety of aluminum adjuvants is overwhelmingly reassuring.
  • Cumulative exposure from childhood vaccinations does not result in toxic levels of ethylmercury.
  • Thiomerosal-containing vaccines do not increase the risk of autism or other neurodevelopmental disorders.
  • Based on an “abundance of high quality data,” vaccines do not cause autism.
  • There is a small elevated risk of Guillain-Barré after influenza vaccination but lower than natural infection.
  • Temporal association is not sufficient to support causal relationship.
  • Global evidence supports the fact that vaccines do not increase the risk of auto-immune diseases.
  • There is strong evidence on the ability of the immune system to handle multiple vaccinations.
  • Available evidence does not support the hypothesis that vaccines weaken the immune system.
  • Caution is warranted regarding bias, but evidence on nonspecific effects are not sufficient to warrant changes in global policy.
  • Claims of DTP increasing childhood mortality are not based on known biological mechanisms and have not been shown to be scientifically reproducible.
  • Further studies specifically designed to address both positive and negative nonspecific effects of specific vaccines are needed.

These sure don’t sound like any sort of “admission” that vaccines are unsafe. The closest Conklin gets is on the question of whether nonspecific effects, positive or negative, are a real thing. I must admit that I was a bit confused, given that I’ve thought the evidence for nonspecific positive effects of MMR vaccination on mortality because of how measles can cause immune amnesia was pretty strong, but likely the latest study was too recent to be included in that GACVS report.

Of course, this being a Global Vaccine Safety Summit, there were talks on unanswered questions in vaccine safety. For example, Daniel Solomon of the Institute for Vaccine Safety at Johns Hopkins listed some areas that might benefit from more research, although most of them, at least to me, seemed fairly settled, such as HPV and postural orthostatic tachycardia syndrome (POTS). Indeed, Sullivan noted that “data mining efforts from two large US health plan studies did not identify any signals for POTS,” nor did the Vaccine Adverse Event Reporting System (VAERS).

So let’s look at Del Bigtree’s video, in light of the Global Vaccine Safety Summit:

And his Tweet of the link:

Notice the first part of the video, in which Bigtree claims that “cameras captured top health officials admitting they don’t know if vaccines are safe.” No, they didn’t, and there isn’t a facepalm big enough to be an adequate reaction to Bigtree’s lie, but this one will have to do:

Godzilla facepalm

You know what I need? I need a facepalm meme with Ego, The Living Planet. Making one might be difficult, though, at least if you use the comics version, given that Ego doesn’t have arms or hands. I guess you’d have to use the Marvel Cinematic Universe version, played by Kurt Russell, but his human form isn’t planet-sized.

Yes, I know I’m a geek.

Let’s look at the quotes. Bigtree, of course, must have sat through all 16 hours or so in order to carefully cherry pick quotes that he thought would show top WHO, CDC, and international scientists “admitting” that vaccines weren’t safe and “admitting” that we don’t monitor vaccine safety very well. Presumably, these are the “most compelling” and “best” examples of “WHO scientists questioning vaccine safety” that Bigtree could find in 16 hours of video. They’re really, really thin gruel, but Bigtree loves to fling watery gruel about and see if any of it sticks, and that’s just what he does.

Let’s look at the first quote, which comes from Heidi Larson, an anthropologist and Director of the WHO’s Vaccine Confidence Project. Here, she says:

There’s a lot of vaccine safety science that’s needed, and without the good science we can’t have good communication. So, although I’m talking about all these other contextual issues and communication issues, it absolutely needs the science as the backbone. You can’t repurpose the same old science that’s relevant to new problems. So we need much more investment in safety science.

Bigtree, of course, didn’t say from which talk or what minute mark this quote came from, but it must have come to from her talk for which the slides are here. She’s so blurry in Bigtree’s video because the WHO video shows her slides and just a tiny image of her in the corner. Bigtree blew up that little box used to show her along with the slides, and—voilà!—you have super pixelated Larson. In any event, if you peruse Larson’s slides, you will not get the feeling that she thinks that vaccine safety science is severely lacking. She also showed a lot of examples of antivaxxers spreading misinformation and seeding doubt around the world. If you listen to her talk, you’ll see that she spends a lot of time talking about difficult it is to communicate ambiguity.

She also says another thing quoted by antivaxxers a lot, namely that she thinks it’s time to get rid of the word “antivaccine” or “antivaxxer.” I can sympathize with her to some extent, but, to be honest, there’s no really good other way to describe hard core antivaxxers, and the leaders of the antivaccine movement are not going to be persuaded, no matter how “respectful” we are of them. It is the vaccine hesitant, the fencesitters, who are reachable, which is why I find it useful to distinguish, using the word “antivaxxer” for leaders of the movement and the very committed, and using another term (e.g,, “vaccine-hesitant”) to describe those who might still be reached.

Be that as it may, I don’t interpret Larson’s statement above as an admission that vaccines are unsafe or that vaccine safety monitoring is insufficient, but rather is asking for more certainty, which will cost money. Of course, for many antivaxxers, there will never be enough certainty. You can invest as much as you want in newer, greater vaccine safety monitoring systems and it will never sway them. We already have four vaccine safety monitoring systems in the US, one passive (VAERS) and three active (Vaccine Safety Datalink, CISA, and PRISM) that, together, are quite robust, and we still have considerable antivaccine sentiment.

The next quote comes from Dr. Soumya Swaminathan, pediatrician and Deputy Director General for Programs for the WHO:

I don’t think we can overemphasize the fact we really don’t have very good safety monitoring systems in many countries and this adds to the miscommunication and the misapprehensions. Because we’re not able to give very good 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. One should be able to give a very factual account of what exactly is happening, what the cause of deaths are, but in most cases there’s some obfuscation at that level and therefore there’s less and less trust in the system.

First of all, notice the bait and switch. Dr. Swaminathan isn’t saying that vaccines aren’t safe or that we don’t have good vaccine safety monitoring systems. She says that many countries don’t have very good vaccine safety monitoring systems. Which countries might those be? As I mentioned before, the US has four vaccine safety monitoring systems. Canada has one, The European Union has one. Basically, wealthy industrialized countries all have very robust vaccine safety monitoring systems. What Dr. Swaminathan is obviously referring to are poor countries, Third World countries, the countries that most need effective vaccination programs.

What I think she probably really meant is that when deaths occur associated with a vaccine, health officials in these poor countries are often, at least initially, unable to give a good answer to the question of whether the vaccine caused it or not, leaving the press to go wild and rumors to fly. Think about those babies who died after vaccination with MMR in Samoa. They died because the nurses screwed up badly mixing up the vaccine, not because the vaccine itself was dangerous, and until that error was identified, there was considerable fear and a lot of wild speculation in the press. Also, in these countries, refrigeration is often lacking and vaccine contamination can be a major problem. Bigtree is intentionally conflating statements clearly meant to address issues with vaccine safety in underdeveloped countries with vaccines in all countries. Here’s a hint: His audience is not from Third World countries. I also note that one of the explicit goals of the WHO is to have robust vaccine safety monitoring systems in all nations that communicate with each other.

Yes, I think Bigtree is quite deceptive.

The next quote comes from Dr. Martin Howell-Pride, Coordinator, Initiative for Vaccine Research, WHO:

Every time that there is an association, be it temporal or not temporal, the first accusation is that it is the adjuvant. And yet, without adjuvants, we are not going to have the next generation of vaccines. And many of the vaccines that we do have, ranging from tetanus through to HPV, require adjuvants in order for them to work. How do we build confidence in this? And the confidence, first of all, comes from the regulatory agencies. I look to Marion. 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. And I give coures every year on: How do you develop vaccines? How do you make vaccines? And the first lesson is, while you’re making your vaccine, if you can avoid using an adjuvant, please do so. Lesson two is, if you’re going to use an adjuvant, use one that has a history of safety. And less three is, if you’re not going to do that, think very carefully.

Personally, I laughed when I watched this. Bigtree thinks this statement, made at the Global Vaccine Safety Summit, is scary, that it’s evidence that WHO scientists think that vaccines are unsafe? All Dr. Howell-Pride is saying that we’d prefer not to use adjuvants, but for many vaccines we have to. He’s also saying to use safe adjuvants when you have to use adjuvants. Since aluminum is a very safe adjuvant, it should be fine for many purposes. Of course, antivaxxers like to engage in fear mongering about adjuvants, and it’s only in this context that the statement above can possibly be construed as scary.

This continues with the next cherry picked quote, from Dr. Stephan Evans, Professor of Pharmacoepidemiology, London School of Hygiene and Tropical Medicine:

It seems to me that adjuvants multiply the immunogenicity of the antigens that they are added to, and that is there intention. Tt seems to me they multiply the reactogenicity in many instance, and therefore it seems to me that it is not unexpected if they multiply the incidence of adverse reactions that are associated with the antigen, but may not have been detected through the lack of statistical power in the original studies.

Note that he says it wouldn’t be unexpected if they increase the incidence of adverse reactions associated with the antigen, not that they do or that we don’t monitor adverse reactions, or that vaccines are unsafe.

Here, Martin Howell Friede, Coordinator, Initiative for Vaccine Research, WHO, chimes in:

You are correct. As we add adjuvants, especially some of the more recent adjuvants, such as the AS01, saponin-derived adjuvants, we do see increased local reactogenicity. The primary concern, though, is systemic adverse events rather than local adverse events. And we tend to get in the Phase II and Phase III studies quite good data on the local reactogenicity. Those of us in this room who are beyond the age of 50 who have had the pleasure of having the recent shingles vaccine, will know that this does have quite significant local reactogenicity. If you got the vaccine, you know that you got the vaccine. But this is not the major health concern. The major health concerns which we are seeing are accusations of long-term effects. So to come back to this, I’m going to once again point to the regulators. It comes down to ensuring that we conduct the Phase II and the Phase III studies with adequate size and with the appropriate measurement.

Once again, Dr. Friede is not saying that vaccines are unsafe. He’s not saying that vaccine safety monitoring systems are inadequate. He’s simply pointing out that adjuvants can increase the incidence of local inflammatory reactions and that it is up to those who design clinical trials and the regulators who do postmarketing surveillance to design studies and systems that don’t miss systemic adverse reactions.

The next cherry picked quote comes from David Kaslow, VP, Essential Medicines, Drug Development, Program PATH Center for Vaccine Innovation and access:

So in our clinical trials, we are actually using relatively small sample sizes, and when we do that we’re at risk of tyranny of small numbers, which is, you just need a single case of Wegener’s Granulomatosis, and your vaccine has to, solve Walt’s, How do you prove a null hypothesis? And that takes years and years to try to figure that out, so it’s a real conundrum, right? Getting the right size, dealing with the tyranny of small numbers, making sure that you can really do it. And so I think one of the things that we really need to invest in are kind of better biomarkers, better mechanistic understanding of how these things work so that we can better understand adverse events as they come up.

I hate to be so repetitive, but nothing here says that vaccines are unsafe, that current safety testing is inadequate, or that adjuvants are dangerous. All Kaslow is saying is that prelicensure studies can be underpowered to detect uncommon events or to rule out causation when a strange adverse event (the example of Wegener’s granulomatosis) is observed that might or might not be due to the vaccine and has to be further evaluated. He’s also pointing out best practices and how better biomarkers and mechanistic understanding could help us understand adverse events. There’s nothing ominous here.

Next on the hit parade of cherry picked quotes, Marion Gruber (the Marion mentioned before), Director, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA:

One of the additional issues that complicates safety evaluation is that if you look at, and you struggle with, the length of followup that should be adequate in, let’s say, a pre-licensure or even a post marketing study, if that’s even possible. And, again, as you mentioned, prelicensure clinical trials may not be powered enough. It’s also the subject population that you administer the adjuvant to, because we’ve seen data presented to us where an adjuvant, a particular adjuvant, added to a vaccine antigen did really nothing when administered to a certain population, and usually the elderly, you know, compared to administering the same formulation to younger aged. So these are things which need to be considered as well and further complicate safety and effectiveness evaluation of adjuvants combined with vaccine antigens.

One more time, nothing here is “admitting” that vaccines are unsafe or that safety monitoring and testing of vaccines are inadequate.

The next question, whether Bigtree realizes it or not, rather backfires on him. Dr. Bassey Okposen, Program Manager, National Emergency Routine Immunization Coordination Centre, Nigeria asks about the possibility of crossreactivity between the adjuvants, antigens, and preservatives of different vaccines made by different manufacturers. He’s answered by Dr. Robert Chen of the Brighton Collaboration:

Now the only way to teas that out is if you have a large population database like the Vaccine Safety Datalink, as well as some of the other national databases that are coming to being worthy. Actual vaccine exposure is tracked down to that level of specificity of how is the manufacturer? What is the lot number? Etc. Etc. And there’s an initiative to try to make the vaccine label information barcoded so that it includes that level of information, so that in the future when we do these types of studies we are able to tease that out. And, in order to be, and each time you subdivide, then the sample size becomes more and more challenging. And that’s what I said earlier today, only in the beginning of the era of large datasets where hopefully you can start to kind of harmonize the databases from multiple studies, and there is actually an initiative under way—Helen there may want to comment on it—to try to get more linked together, so questions that you just raised…[cuts off midsentence]

So the US has a very large, very robust vaccine safety monitoring database (VSD), one of four, one passive and three active, and the WHO is working to get more such databases set up, with easier data entry (barcoding), and linkage between the databases? Where’s the indication that vaccines are unsafe? There is none. There is only Dr. Chen explaining how the WHO and various nations are working to to make a good system better, to allow it to tease out the answers to more complicated questions that were not easily answerable before.

Finally, we have Heidi Larson again:

The other thing that’s a trend and an issue is not just confidence in providers but confidence of health care providers. We have a very wobbly health professional frontline that is starting to question vaccines and the safety of vaccines. When the frontline professionals are starting to question or they don’t feel like they have enough confidence about the safety to stand up to it to the person asking them the questions. I mean, most medical school curriculums, even nursing school curriculums, I mean in medical school, you’re lucky if you have a half day on vaccines, never mind keeping up to date with all this.

Of course, I can’t argue with Dr. Larson when it comes to the “wobbliness” of certain health care professionals. Hell, there are antivaccine doctors and nurses whom I’ve castigated on this very blog for spreading antivaccine pseudoscience—and they deserved it, too. On the other hand, I call bullshit on her claim about medical school curriculum. For one thing, there’s a lot more that relates to vaccines than just studying the vaccines. We study immunology, pathology, microbiology, and more, and we spend many months doing it. Second, we learn more about how to interpret clinical trials in residency than in medical school. Be that as it may, just because there are antivaccine physicians and nurses and because some providers have started to “question” vaccines does not mean that vaccines are unsafe. Rather, it’s a function of the unrelenting flood of antivaccine propaganda assaulting us on social media all the time. Let’s just put it this way: Because “Dr. Bob” Sears, Dr. Paul Thomas, etc. “question” vaccines is meaningless. They’re quacks. It doesn’t mean that vaccines are unsafe.

Naturally, Del Bigtree can’t resist finishing with:

If the top health professionals in the world are questioning the safety of vaccines, then why aren’t you?

Except that the top health professionals in the world are not questioning the safety of vaccines. Del Bigtree cherry picked nine minutes’ worth of quotes from the 16 hour Global Vaccine Safety Summit, and even then he couldn’t find any quotes of scientists “questioning the safety of vaccines.” All he found were scientists seeking to improve vaccine safety monitoring even more and bring the quality vaccine safety monitoring we have in advanced industrialized countries like the US, Canada, the EU, etc., to the rest of the world.

He sure did try to deceptively spin it otherwise, though. It’s what he does best, unfortunately. Hilariously, he didn’t do that great a job here. Unfortunately, the vast majority of antivaxxers sharing this video and making it go viral never bothered to watch it, and those who did didn’t bother to think critically because they didn’t want to. They just wanted cherry picked evidence to support their beliefs.