Action4Canada - July 01, 2022


Scientists Question Safety of Vaccines (WHO Global Vaccine Safety Summit December 2019)

Topics
adjuvants and vaccine safety
Hosted by
Tanya Gaw
Mentioned
Marianne Lesson Walt
Vaxxed vs Unvaxxed Study 60 Minutes： Swine Flu 1976 Corruption

Episode Stats


Length

9 minutes

Words per minute

132.34

Word count

1,259

Sentence count

59


Summary

Summaries generated with gmurro/bart-large-finetuned-filtered-spotify-podcast-summ .

In this episode, Dr. Hans and Marianne discuss the dangers of adding adjuvants to vaccines and how to prevent them. They discuss the benefits of avoiding them, the risks of adding them, and what to look out for when using them.

Transcript

Transcript generated with Whisper (turbo).
Topics generated with Qwen2.5-3B-Instruct.
Hosts, guests, and mentioned names generated with spaCy (en_core_web_sm), reconciled against Wikidata.
00:00:00.000 There's a lot of safety science that's needed.
00:00:29.980 And without the good science, we can't have good communication.
00:00:37.600 So although I'm talking about all these other contextual issues and communication issues,
00:00:43.660 it absolutely needs the science as the backbone.
00:00:47.160 You can't repurpose the same old science to make it sound better
00:00:52.240 if you don't have the science that's relevant to the new problem.
00:00:55.240 So we need much more investment in safety science.
00:00:59.360 I think we cannot overemphasize the fact that we really don't have very good safety monitoring systems in many countries.
00:01:08.040 And this adds to the miscommunication and the misapprehensions
00:01:12.320 because we're not able to give clear-cut answers.
00:01:14.940 When people ask questions about the deaths that have occurred due to a particular vaccine,
00:01:19.040 and this always gets blown up in the media,
00:01:20.980 one should be able to give a very factual account of what exactly has happened and what the cause of deaths are.
00:01:28.380 But in most cases, there's some obfuscation at that level,
00:01:31.600 and therefore there's less and less trust then in the system.
00:01:36.280 Every time that there is an association, be it temporal or not temporal,
00:01:43.560 the first accusation is it is the adjuvant.
00:01:47.700 And yet without adjuvants, we are not going to have the next generation of vaccines.
00:01:52.160 And many of the vaccines that we do have, ranging from tetanus through to HPV,
00:01:56.960 require adjuvants in order for them to work.
00:01:59.180 So the challenge that we have in front of us is how do we build confidence in this?
00:02:04.840 And the confidence, first of all, comes from the regulatory agencies.
00:02:07.820 I look to Marianne.
00:02:09.660 When we add an adjuvant, it's because it is essential.
00:02:13.680 We do not add adjuvants to vaccines because we want to do so.
00:02:17.780 But when we add them, it adds to the complexity.
00:02:22.020 And I give courses every year on how do you develop vaccines, how do you make vaccines.
00:02:27.380 And the first lesson is, while you're making your vaccine,
00:02:31.760 if you can avoid using an adjuvant, please do so.
00:02:35.220 Lesson two is, if you're going to use an adjuvant, use one that has a history of safety.
00:02:40.900 And lesson three is, if you're not going to do that, think very carefully.
00:02:45.840 It seems to me that adjuvants multiply the immunogenicity of the antigens that they are added to.
00:02:56.440 And that is their intention.
00:02:59.400 It seems to me they multiply the reactogenicity in many instances.
00:03:05.680 And therefore, it seems to me that it is not unexpected if they multiply the incidence of adverse reactions
00:03:14.700 that are associated with the antigen, but may not have been detected through lack of statistical power in the original studies.
00:03:23.740 You are correct.
00:03:25.300 As we add adjuvants, especially some of the more recent adjuvants, such as the ASO1, sapin, and derived adjuvants,
00:03:31.860 we do see increased local reactogenicity.
00:03:35.960 The primary concern, though, usually is systemic adverse events rather than local adverse events.
00:03:43.760 And we tend to get, in the phase two and the phase three studies, quite good data on the local reactogenicity.
00:03:52.880 Those of us in this room that are beyond the age of 50 who have had the pleasure of having the recent shingles vaccine
00:03:58.940 will know that this does have quite significant local reactogenicity.
00:04:03.300 If you got the vaccine, you know that you got the vaccine.
00:04:05.600 But this is not the major health concern.
00:04:09.940 The major health concern which we are seeing are accusations of long-term effects.
00:04:16.580 So to come back to this, I'm going to once again point to the regulators.
00:04:20.860 It comes down to ensuring that we conduct the phase two and the phase three studies with adequate size
00:04:27.700 and with appropriate measurement.
00:04:30.520 So in our clinical trials, we are actually using relatively small sample sizes.
00:04:36.900 And when we do that, we're at risk of tyranny of small numbers,
00:04:40.540 which is you just need a single case of Wegner's granulomatosis,
00:04:44.780 and your vaccine has to solve Walt's how do you prove a null hypothesis.
00:04:51.800 And it takes years and years to try to figure that out.
00:04:55.700 So it's a real conundrum, right, getting the right size, dealing with the tyranny of small numbers,
00:05:03.080 making sure that you can really do it.
00:05:04.640 And so I think one of the things that we really need to invest in are kind of better biomarkers,
00:05:10.780 better mechanistic understanding of how these things work
00:05:14.120 so we can better understand adverse events as they come up.
00:05:18.400 One of the additional issues that complicates safety evaluation is if you look at and you struggle
00:05:25.780 with the length of follow-up that should be adequate in a, let's say, pre-licensure
00:05:30.460 or even post-marketing study, if that's even possible.
00:05:34.280 And again, as you mentioned, pre-licensure clinical trials may not be powered enough.
00:05:40.180 It's also the subject population that you administer the R2-1 to,
00:05:44.220 because we've seen data presented to us where an adjuvant, a particular adjuvant,
00:05:51.800 added to a vaccine antigen did really nothing when administered to a certain population,
00:05:58.060 and it's usually the elderly, you know, compared to administering the same formulation to younger age strata.
00:06:06.340 So these are things which need to be considered as well
00:06:10.160 and further complicate safety and effectiveness evaluation of adjuvants combined with vaccine antigens.
00:06:16.480 I cast back my mind to our situation in Nigeria,
00:06:20.620 where at 6 weeks, 10 weeks, 14 weeks,
00:06:24.300 a child is being given different antigens from different companies,
00:06:28.680 and these vaccines have different adjuvants, different preservatives, and so on.
00:06:32.800 Something crosses my mind.
00:06:35.880 Is there a possibility of these adjuvant preservatives cross-reacting amongst themselves?
00:06:41.640 Have there ever been a study on the possibility of cross-reactions from the panel members
00:06:48.760 that you can share the experience with us?
00:06:51.140 Now, the only way to tease that out is if you have a large population database,
00:06:57.560 like the Vaccine Safety Data Link, as well as some of the other national databases that are coming to being,
00:07:04.860 where the actual vaccine exposure is tracked down to that level of specificity
00:07:10.240 of who is the manufacturer, what is the lot number, et cetera, et cetera.
00:07:16.000 And there's an initiative to try to make the vaccine label information barcoded
00:07:23.720 so that it includes that level of information so that in the future,
00:07:29.060 when we do these type of studies, we're able to tease that out.
00:07:35.300 And in order to, each time you subdivide,
00:07:38.880 then the sample size gets becoming more and more challenging,
00:07:42.280 and that's what I said earlier today about that we're really only in the beginning
00:07:47.080 of the era of large data sets where hopefully you could start to kind of harmonize the databases
00:07:54.800 for multiple studies, and there's actually an initiative underway.
00:08:00.320 Helen there may want to comment on it to try to get more national vaccine safety database linked together
00:08:09.120 so we could start to answer these type of questions that you just raised.
00:08:12.520 The other thing that's a trend and an issue is not just confidence in providers,
00:08:20.400 but confidence of health care providers.
00:08:24.060 We have a very wobbly health professional front line
00:08:29.220 that is starting to question vaccines and the safety of vaccines.
00:08:33.540 When the front line professionals are starting to question
00:08:37.720 or they don't feel like they have enough confidence about the safety
00:08:43.020 to stand up to it to the person asking them the questions.
00:08:49.040 I mean, most medical school curriculums, even nursing curriculums,
00:08:53.280 I mean, in medical school, you're lucky if you have a half day on vaccines,
00:08:58.040 never mind keeping up to date with all this.
00:09:00.840 We'll see you next time.
00:09:01.840 We'll see you next time.