Bacon With Your Vaccine?

By Jim McVeagh 09/05/2010 5


In a move that defies all logic, the FDA advisory panel investigating the contamination of Rotavirus vaccine with pig virus has recommended that vaccine use be continued because “The vaccines offer a clear public health benefit that far outweighs a “theoretical” risk from PCV (Porcine Circo-virus)”. How very reassuring. Not.

PCV type 1 was found as a contaminant in the Rotarix vaccine in March and a temporary halt was placed on its use. Last week PCV type 1 and 2 were found in the rival vaccine RotaTeq. Clearly this is a manufacturing process problem. We have absolutely no idea whether these viruses could be harmful, although we do know that they do not appear to cause any immediate diseases. In the face of large numbers of unknowns, it is usually clinically prudent to stop the use of the vaccines altogether until the manufacturing problem can be solved or the PCV virus proved definitively harmless.

Apparently not for the FDA. Such a decision only calls into question the known incestuous links between the FDA and the pharmaceutical manufacturers. In case you think I am being a bit harsh in my judgement, take a look at the decision process of the advisory committee. they base their judgement on:

It seems unlikely that the FDA’s warning to avoid Rotarix will stand given that no data indicate the virus is harmful to people and that Merck’s vaccine also contains the virus.

GlaxoSmithKline scientists presented data to the panel indicating the PCV1 virus is not harmful to humans, at least in the short term.

“PCV1 infection is widespread but does not cause any disease in pigs or other animal species including humans,” X.J. Meng, MD, PhD, of GlaxoSmithKline, told the committee.

There was less information on PCV2, but an FDA official said it has been known to cause illness in pigs, although not in humans.

The argument runs that the other vaccine is contaminated, so lets un-ban the first one. Logically, we should be stopping use of both vaccines. The statement “PCV1 virus is not harmful to humans, at least in the short term” means only that it does not cause immediate disease. But what about recombinant effects? We spent weeks worrying about Swine flu mutating into a more deadly strain and seem completely unconcerned about injecting our children with a xeno-virus. How about long term slow-virus effects? I do not know enough virology to know if that is a concern, but it seems that the GSK virologist seems a little blase about the whole deal. The very fact that this is a virologist from the actual drug company is a concern. Is this not a little like taking assurances from the tobacco company researchers that smoking does not cause lung cancer? Why is there not an independent risk assessment from a virologist with no Big Pharma interests?

But this is not the only dangerous part of their logic. Recall that this is the FDA. They are only setting approval for drug use in the US. That makes the statement below a particularly stupid argument:

RotaTeq and Rotarix are administered orally to millions of infants worldwide to prevent rotavirus, which can cause severe diarrhea and dehydration and is deemed responsible for the deaths of more than 500,000 infants each year, primarily in low- and middle-income countries. [emphasis mine]

It seems to have escaped the attention of the advisory committee that the US is a first world country. Deaths from Rotavirus infection are relatively rare. It is therefore by no means certain that use of this vaccine outweighs the risk.

I might be excessively paranoid here, but it seems to me that the interests of the pharmaceutical companies are being considered ahead of medically prudent safety measures. That is unconscionable from a government organisation that is supposed to ensure the safety of medicines for public use.

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5 Responses to “Bacon With Your Vaccine?”

  • But what about recombinant effects? We spent weeks worrying about Swine flu mutating into a more deadly strain and seem completely unconcerned about injecting our children with a xeno-virus.

    It seems to me that recombination is such an obvious thing to think of, that I think it would be most unlikely that the panel would “overlook” it. I would think it’s more likely that they just know their virology better than you or I 🙂

    Food for thought:

    I’m not a virologist (but then neither are you), so I’m not up to speed on the details, but it seems obvious to me that the swine flu “recombination” (re-assortment and recombination) possibilities and recombination between rotavirus and PCV two are quite different stories and not comparable. More to the point—I’m happy to stand corrected—I suspect that the case is that rotavirus and PCV are barely able to recombine.

    When two (or more) flu Influenza viruses infect the same cell the RNAs can recombine to create recombinant RNAs that are made of portions of different RNAs. In addition to this, they can re-assort their genome, packaging a mixed set of the ssRNA molecules that make up their genome, with some from one of the influenza viruses in the cell and some from the other. (I’ve seen popular accounts refer to the latter as recombination; while both generate genetic variation, they are different processes.) Influenza viruses can do these things because the two viruses in the cell are genetically (very) similar and have the same type of genome. (The full story is too complex for a blog comment. In particular, the details of how RNA recombination occurs is a field in it’s own right and one I know little about.)

    Rotavirus is a dsRNA virus. PCV is a ssDNA virus. Not only are they not the same general type of viruses (in the influenza example they were both influenza viruses), they don’t have the same type of molecule for a genome.

    I’ll leave you to chase after the details, but you’ll want to check their life cycles to see if they are able to recombine. In particular, I suspect that the PCV virus life cycle may not involve an RNA intermediate and vice versa the rotavirus life cycle may not involve a DNA intermediate. But you can check that 😉 With these in mind, I wouldn’t be surprised to learn that they barely can recombine at all.

    A few others things, quickly:

    1. What was found from the tests: intact viruses, intact whole viral DNA or viral DNA fragments? (I’m guessing the initial tests are some kind of PCR-based DNA or RNA test; more work would be needed to show complete viruses were present.)

    2. What amounts are involved? (It seems to me that they must be v. small.)

    3. What amounts are needed to establish infection?

    4. Does PCV replicate in humans?

    Etc.

    Not trying to (just) nay-say you, but point to things I’d prefer to first lay out as substance to base to then a case for concern on.

    Any virologists are most welcome to expand on my tentative start 🙂

  • I was not actually thinking about recombinant effects between PCV and Rotavirus in particular. I was thinking more along the line of concomitant herpes or adenovirus infections (both dsDNA viruses and much more plausible suspects)

    My understanding is that these are DNA fragments, rather than whole viruses. It is unlikely that PCV will cause a significant infection, so that is not the issue. Neo-virus production is the only serious concern

    My point is that we still know way to little to have the level of assurance exhibited by the panel. Our knowledge of these interactions has not changed significantly since the original halt on Rotarix. I can see no reason to resume vaccination until the issue is resolved definitively.

  • I see that Vincent Racaniello (on your syndicated blog) has confirmed my general suspicion that recombination with herpes or adenovirus was unlikely to pose a substantive risk. (Disclosure: I asked if he might clarify.)

    As far as “your point” goes, in the original article my reading was that is was what you closed on: “it seems to me that the interests of the pharmaceutical companies are being considered ahead of medically prudent safety measures”.

    This is getting close to conspiracy stuff. My own impression is that decision was based on health risk. With one vaccine less than optimal, they could call on the other. With both in the same boat, the decision shifts to a balance of risks of using a less than optimal vaccine against none. Nothing to do with favouring companies in there.

  • With both in the same boat, the decision shifts to a balance of risks of using a less than optimal vaccine against none

    Indeed. And the point there would be that the mortality risk from Rotavirus in the US is very low. I have no objection to vaccine use in third world countries where the mortality is much, much higher and the relative risk equation much more favourable.

  • While I take your point, I am wary of working only citing mortality. I’ve seen that used too often to excuse not accepting vaccines in shaky ways. (Sorry, but it is abused.) For example, the FDA cites: “rotavirus infection causes an estimated 55,000 hospitalizations a year of infants and young children” in the USA. I presume that would be considered somewhere in there.

    If this vaccine is not compulsory in the USA then provided people are informed they are able to choose.

    I believe there is some other processes yet to come with impact on public distribution in the USA that make up the full picture, i.e. this ruling isn’t the full story from what I read a when you first posted this. (I haven’t time to look this up again.)

    I believe that FDA rulings used as basis for other countries’ decisions, so I’m unsure that your “in the USA” argument really holds.