Tell the FDA to Revoke Vaxelis' Approval

Merck and Sanofi have teamed up to produce a 6-in-1 combo vaccine to market in the US. Despite the death of six infants in clinical trials and other evidence of dangerous side effects, the FDA has given the thumbs-up for this combo vaccine. This is another example of this agency prioritizing profitability over safety.

Write to the FDA with a copy to Congress, urging the agency to revoke approval of Vaxelis pending further safety studies.

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Please revoke Vaxelis' approval

Dear [Decision Maker],

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First, it's shocking and outrageous that six infants died in the trials and the vaccine was still approved. Of course, the manufacturers claim that the deaths were not related to the vaccine, but how could they know? Unlike drugs, where the trials can last months or years, vaccine trials only last a few days or weeks and the follow up period is also very short. The manufacturer claims that none of the deaths were related to the vaccine, but reports the following causes of death: two cases of Sudden Infant Death Syndrome (SIDS), asphyxia, sepsis, hydrocephalus, and an "unknown cause." So, the cause of death is unknown, but definitely not the vaccine?

Second, delivering six vaccines in one shot along with the associated adjuvants, is a substantial burden for a young immune system to handle. One study found that vaccines cause more adverse events in children than any other drug--and this is when vaccines are usually given one at a time.

Third, the approval of this vaccine could spell the end of parents' ability to follow alternative vaccine schedules. Some parents may choose to vaccinate for one disease but not another based on their research and the advice of their doctor. This possibility is diminished with the approval of multi-shot vaccines, which Merck and Sanofi will undoubtedly market to doctors as the next best thing in pediatric care. Doctors will be sold on the fact that fewer shots means less time per patient and more patients in the door. Less demand for single shot vaccines will mean manufacturers will stop offering them, so parents will face an all-or-nothing choice for vaccinating their child. If single shots become a thing of the past, this multi-shot vaccine creates de facto mandates for the polio and Hib vaccines, which are not currently required by most states, so children will be getting even more vaccines than they are currently.

We continually hear the refrain that vaccines have been studied over and over without any negative findings, so we should just keep quiet about vaccines. If that were true, why did the National Academy of Medicine, which advises the government on issues relating to medicine and health, conclude in a 2013 report that "key elements of the schedule--the number, frequency, timing, order, and age at administration of vaccines--have not been systematically examined in research studies"? Are proponents of vaccines not bothered by this lack of research?

Reasonable people can ask reasonable questions about vaccination--indeed, we must ask these questions given the risks that are involved. When the government pays out billions of dollars over the years to families damaged by vaccines, we have a right to call for safer vaccines.

Please reconsider the approval of Vaxelis pending further safety studies.

Sincerely,
[Your Name]
[Your Address]
[City, State ZIP]
[Your Email]