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For more information on the FDA's actions, see Vaccines and Related Biological Products Advisory Committee Meeting Background Material: Porcine Circovirus and Rotavirus Vaccines.
Tuesday, May 11, 2010
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Posted at AoA on May 11, 2010 at 1:17pm (EDT)
ReplyDelete@JB Handley
"Of all the sales of Paul Offit’s Rotateq vaccine, 90% come from the United States, because so few other first world countries even buy the shot. 90%!...With 90% of his shot being sold right here in the USA"
Do you have exact numbers of the volume of vaccines that are sold in the U.S. vs. other countries? What you present is the total dollars, which is not necessarily representative of the quantity. The companies may sell the vaccine at a much lower price to poorer countries, while charging more in the U.S. But, without knowing the quantities involved, we cannot reasonably evaluate the dollar figure distribution. Alternatively, the discrepancy could be because the manufacturers are not altering their prices for poorer countries, resulting in those countries not being able to afford the vaccine and thus not buying it and raising the extra-U.S. sales figures. Then there is also the fact that many developing countries are working on getting drug regulations established, which may differ from those of the U.S., Europe, etc., leading to different marketing requirements for the manufacturers.
"Yet, somehow, the existence of PCV-2 is causing the FDA panel to recommend keeping both of the brands of the shot on the market, including reversing the original Rotarix decision!"
No, the presence of PCV2 is not causing the panel to recomment keeping both brands on the market. The extremely low probability of PCV1 and PCV2 to cause illness in humans has figured into the risk-benefit analysis for the vaccines. The benefits of the vaccine outweigh the risk of the porcine virus. Further, you fail to note that it is fragments of the DNA, not the full virus itself, thus reducing the risk even further.
"Perhaps a proper analogy would go something like this: Parents, please stop your kids from drinking Coke, we found some lead in it. Oh, never mind, they can drink Coke & Pepsi, we just discovered Pepsi is filled with lead and mercury, too!"
Bzzt! Wrong. You are comparing something that does not cause illness in humans (PCV DNA fragments) to something that can, in sufficient quantities, cause illness in humans (lead and mercury). False analogy.
"The Rotateq vaccine is used in only 3 of 30 first world countries."
Your implication being that the other 27 countries don't use it because it is not a good vaccine. There are several other possibilities: the companies have not sought market approval in those countries yet; the companies have sought approval but have not obtained it yet; the countries feel that rotavirus is not at a level that would require inoculation; etc.
"It contains a virus, PCV-2, known to kill pigs, and a more benign virus that contaminated its competitor’s vaccine was enough for the FDA to recommend not using Rotarix just 2 months ago."
Again, you mislead. The vaccines contain DNA fragments, not whole viruses; the virus is not known to cause illness in humans (let alone fragments of the virus causing illness); and, the FDA recommended the withdrawal of Rotarix because the PCV1 contamination was a new discovery leading to a cautious approach. When further evidence was found, the FDA judged that the risks did not outweigh the benefits.
That said, of course further study should be done and the manufacturers should develop methods to prevent such contamination in the future. Rational inquiry is what is called for, not knee-jerk anti-vaccine zealotry, fear-mongering and blatant distortion of facts.
This is being cross-posted to Silenced by Age of Autism.
I am listening to the most recent This Week in Virology podcast, http://www.twiv.tv/2010/05/09/twiv-81-be-a-virus-see-the-world/. There was a mention of the rotavirus vaccines.
ReplyDeleteApparently the RotaShield vaccine is more effective than the other two in developing nations. There is a thought that the problems with intussusception were not has bad as previously thought. Especially now with new techniques to deal with it (using air, not surgery).
Not a comment at AoA, but worth note:
ReplyDeleteHandley keeps calling Rotateq a "shot". But it's not injected; it's an ORAL vaccine. I think Handley's words show that the anti-vaccine movement is motivated in no small part by phobias about injections of any kind.
David,
ReplyDeleteGood catch. That brings up the question of whether or not Handley purposefully used the term "shot". Is he feeding into people's fears of needles or does he just not know?
I'm pretty sure I've seen Handley call the oral vaccine a "shot" before. Another odd thing about references to "shots" is that oral vaccines may have a worse safety record: In the case of polio, US authorities finally decided that the oral vaccine was doing more harm than the disease, and switched to an injected one they deemed safer.
ReplyDeleteDavid,
ReplyDeleteTrue. Live vaccines (typically oral or nasal administration) do carry somewhat higher risks than "dead" vaccines. However, they also tend to be more effective.
In the case of polio, the oral (live, weakened) version was as close to 100% effective as you can get, and it also allowed those who did not receive the vaccine to be inoculated, since vaccine virus particles were shed in the stool of the vaccinees. However, it did carry a risk of causing vaccine acquired paralytic poliomyelitis (VAPP). Where polio is endemic and vaccination rates are low, the benefits tend to outweigh the risks. However, as vaccination rates increase and disease incidence decreases, then you don't need a vaccine that is near 100% effective, especially if it carries the risk of VAPP. Enter the "killed" virus, injectable vaccine. It is not quite as effective, nor is immunity transmissible to unvaccinated family members, but it does not carry the risk of VAPP.
Likewise, inhaled flu vaccine is slightly riskier than the injected vaccine and is not recommended for people with asthma.
In general, though, whether a vaccine uses a live, weakened virus, a dead virus or virus parts, the risk of not vaccinating (i.e., risk from the disease) tends to be greater than the risk from the vaccine itself.