As we expected, yesterday’s vaccine piece provoked a lot of discussion, almost all of it thoughtful and pertinent. Since we’ve already said we might be wrong, we thought we’d take some time to respond, using it as a way to keep thinking things through on our end. Writing is thinking and thinking is needed in this situation.
Over at FluTrackers.com (an excellent flu forum like Flu Wiki with highly informed people) there were a number of lengthy responses, most of them on the negative side. Since these folks follow events closely their opinions are also worth following closely. In addressing them I will also summarize the gist of yesterday’s post, which represents the Reveres’ joint opinion at this point.
1. We have been somewhat skeptical of the efficacy of influenza vaccination in the past. However reviewing the literature (we dealt with a good summary in this post recently) we have come to the conclusion that the vaccine works sufficiently that it is an important public health measure. Its efficacy varies but, depending upon the group, probably lies somewhere between 30% and 70%. In the case of a good match to a virus to which most of the population has no natural immunity, we believe 70% to be a good estimate considering the groups most at risk. This means that compared to an unvaccinated group, the vaccinated group will have 70% fewer infections. It means that 30% of those vaccinated who are exposed will still get the flu. Flu vaccine isn’t even close to 100% effective like DPT or MMR. But even 30% reduction in infection in a pandemic is a Big Deal in terms of demands on services, lost work time and productivity, pain and suffering, and of course, mortality, so we don’t think using the high end of efficacy makes much difference.
So that’s the first point that may separate us from others. We think the vaccine will work and we base that on experience with seasonal vaccine where numerous randomized clinical trials have been done (see the Basta-Halloran review we linked above; here it is again). Take a look at it and make up your own mind about this. If you don’t think the vaccine will work, then there’s no reason to get it. We think it will work (based on our review of the science) and that it will make a big difference to how well communities who use it sufficiently will get through whatever might come next.
2. Safety, adjuvanted or unadjuvanted. Yesterday’s post pointed out that it is not feasible to assure the advance safety of any product being consumed or administered to tens or hundreds of millions of people. No advance testing is possible for relatively rare adverse events that would still be numerous when that many people are exposed. But the mathematics of the adverse events versus the risks from flu, even if it is only the virulence of seasonal flu, is so overwhelmingly in favor of vaccination that we don’t think this is a hard call. True, there are various guesses that have to be made about how many people are infected, what the CFR will be, how well the vaccine will work, etc., and while we tried to be pretty conservative in most of them (we did use a high end number for vaccine efficacy because we thought the data for similarly placed populations merited it, but even if we’d used the lowest efficacy vaccines come out far ahead), and you might differ with some of them. At least you know what we assumed. But the major point is this. If you want to wait for assurances of safety, then you better have a definition of “safety” that is determinable ahead of time or you are just saying you won’t accept any vaccine. And for most of the rare events people talk about (e.g., Guillian-Barre Syndrome) there is no way to test for it in advance.
A related point was that there is no reason to trust vaccine manufacturers as they have a dismal record for honesty and probity. We agree and have complained bietterly about Big Pharma many times. But accepting this argument also means we reject essentially the entire modern pharmacopoeia since these folks also make all the other vaccines, antibiotics, hand sanitizers, etc., etc. We’ve argued frequently that influenza vaccines (and probably other vaccines) should be made by a regionalized network of international vaccine institutes outside the market system. We didn’t do that. So we are stuck with Big Pharma. It is what it is.
3. The adjuvant question. Two weighty objections to our advocacy of adjuvants have been advanced, one at FluTrackers and one by Jody Lanard here. They are slightly different but we will take them together. Vibrant62 at FluTrackers observes that the safety of adjuvants has been tested more often in the older age groups (where the immune response is more sluggish and adjuvants are more needed), not well tested in the young age groups. Vibrant62 suggests the decision doesn’t have to be “all or nothing” but we could use unadjuvanted vaccine for some age groups (or pregnant women) and adjuvanted vaccine for others. Let’s assume this is economically feasible (i.e., that two different vaccine could be made and distributed efficiently). If children and young adults really, on average, react quite differently to a particular adjuvant, then this will be seen in the safety and efficacy trials, unless it is rare, in which case we are in the same box we were earlier regarding trade-off with the benefit. There has been quite a lot of experience with adjuvants and influenza virus and also some with this particular virus. I will refer you to the excellent post by Vincent Racaniello at Virology Blog. Before giving my full answer to this, though, I want to address Jody Lanard’s objections, since my answer is the same to both.
Jody Lanard and Peter Sandman are among the most experienced and thoughtful practitioners of risk communication anywhere, so their views are of special significance. We usually agree, although not always. This seems to be one of the “not always” times. Jody’s concern has to do with how the US public will react to the idea that a relatively untested vaccine will contain an even more untested additive, especially after the 1976 swine flu debacle where it is widely reported that the vaccine was worse than the disease (although not reported that one reason this is so is that the disease never got out of Fort Dix so there was no disease averted by the vaccine). This comes at a time of high anxiety about vaccines among certain segments of the population, some of it sincere, much of it fed by paranoid conspiracy theorists who see monsters under every bed. The bad behavior of Big Pharma and the demonizing by the Far Right Noise Machine of any health measure promoted by government adds to the problem. The result is that the anti-vaxxer movement is killing and disabling children. The fear is that a government program with an adjuvanted vaccine will pour gasoline on this fire:
There is a great deal of undue — but thoroughly unmitigated — anti-vaccine feeling and fear in the U.S. The anti-vaccine activists and the vaccine-causes-autism activists are ready to roll with every flu vaccine Teachable Moment that comes along.
The more traction they can get by encouraging doubt and skepticism about flu vaccine among parents, the more children will end up unvaccinated against the “usual” childhood diseases.
So in the U.S., this is a really bad time to change the flu vaccine any more than necessary (a strain change is necessary, of course). (Jody Lanard in the Comment Thread of yesterday’s post)
In essence (and read the whole comment here), Dr. Lanard is saying it will backfire and make things worse. Instead of more people being vaccinated because of antigen sparing, fewer in the US will be vaccinated because parents will refuse the vaccine and it will have a spillover effect on other important childhood vaccination programs.
I understand this point of view and it comes from what I consider an authoritative source. But here’s where the question of “balance” that I discussed in yesterday’s post comes in. Jody and I have struck different balances on this. For us, the principal point of using adjuvant is to increase the number of people in the world who can be vaccinated, not just the number of people in the United States. Most of the viral antigen is made outside the US. We are rich so we bought it up and now less rich countries can’t get it. Our only entitlement to it is through the fact that the ability to live without influenza infection has become a commodity and the US has the means of exchange (money) to buy it. Adjuvants would make it more available to more people.
I am opposed to mandatory vaccination, even though I believe vaccination is an important public health measure that will save millions of lives. But there isn’t enough vaccine for everyone in the world, so if people in the US don’t want it, then any unused stock (keeping a small reserve) should be released by a date certain (say January 15 for the sake of argument) and given to others. I believe this will doom many Americans to severe sickness and some to a fatal illness, but the compensation is that many others, children and adults, in poorer parts of the world will be saved. Their lives are worth no less than American lives. If someone in this country, for whatever reasons, doesn’t wish to receive the vaccine, someone who wants it and needs it will be waiting.
There are real imponderables and trade-offs here with no easy answers. It is clear that our answer is not the same as others who have followed the issue as assiduously as we have and who have great expertise. That doesn’t make them right, or us right, or the US government’s position right. And different governments are making different decisions. We may never know what the right thing to do was because we will be dealing with a counterfactual: what would the world have been like if we’d done X instead of Y?
But the US is a big player in this high stakes game. It has ordered (and hence pre-empted for others) a lot of antigen, so it’s something worth discussing. So we’re discussing it.