Inadequate Vaccine Safety Research and Conflicts of Interest

Vaccines are a multi-billion dollar industry internationally and for many pharmaceutical companies, it is the fastest–growing segment of their business. Even the Centers for Disease Control (CDC) make money from licensing of vaccines. There is also a swiftly revolving door between the CDC, the FDA and the vaccine manufacturers in terms of recruiting. For example, former CDC director, Julie Gerberding, is now the head of Merck’s vaccine division.

Truly unconflicted research in this area is rare and through FOIA requests we know that the CDC has massaged data in the past. The associations between autism and mercury and autism and vaccines are still open questions. The majority of the studies that claim to “prove” that autism is not associated with Thimerosal or MMR have significant conflicts of interest, have significant flaws in their methods and/or do not answer the whole question. On the other side of this debate, and rarely mentioned by the press, are the biological studies that continue to be published supporting these associations. There are also two published studies associating increased risk of autism and receiving special education services with having received the Hepatitis B vaccination at birth.

Ultimately, public health needs to be about both protection from infectious diseases and protection from chronic health conditions. In order to have informed consent and the greatest possible safety for our children, we must weigh both the risks and the benefits of any medical intervention, including vaccines. At this point, we largely know the benefits of vaccines, but the research on their potential risks is grossly inadequate. For years, advocates have asked that the government perform a large study of fully-vaccinated children compared to unvaccinated controls to assess their total health and to compare autism rates in the two populations. The standard response to our request has been silence or the argument that to leave children unvaccinated is “unethical.” Since populations who have chosen not to vaccinate for religious reasons already exist, we feel it is more unethical to inject 4 million infants a year in this country with a vaccine schedule that has not been subjected to a placebo-controlled clinical trial. This assumption of safety is analogous to arguing that because 10 individual drugs are safe for children, it is therefore safe to give a child all 10 at once. In addition, the safety and efficacy testing of a new vaccine is often performed only in comparison to a previously-approved vaccine, not to a true placebo. Regarding long-term outcomes, the use of hormone-replacement therapy comes to mind as an example of why it is critical not to assume safety of any widespread treatment without actually following patients over decades. Long-term safety studies of vaccines for outcomes other than infectious disease have not been completed. Until these situations are resolved, it is truly impossible for an accurate risk/benefit analysis of vaccines to be made.

The following is a sampling of studies that have not been done:

  • Safety of simultaneous vaccination vs. placebo
  • Mixing of vaccine adjuvants (for example, thimerosal and aluminum)
  • Follow up study of the higher rate of seizures from MMRV vs. MMR

There have been no studies of the remaining vaccines on the childhood schedule (beyond MMR and Hepatitis B) for associations with autism. This would include the following vaccines: Rotavirus, DTaP, Hib, PCV (pneumococcal), IPV (polio), Influenza, Varicella, and Hepatitis A. See the current U.S. vaccine schedules.

There have been no studies of the remaining ingredients in childhood vaccines (besides thimerosal) for associations with autism. It is worth noting that a finding of speech delays and tics associated with thimerosal-containing vaccines has been replicated in published studies. See a list of excipients.