">How Safe is the Swine Flu Nasal Spray Vaccine?

(Originally Published on FaceBook) October 28, 2009

Several people have asked me about MedImmune's swine flu nasal spray vaccine. Of the four swine flu vaccines that have been licensed for use in the United States, the vaccine that is sprayed up the nose is the only one that is mercury-free. (The injectable swine flu vaccines contain 25mcg of mercury per dose when administered from a multi-dose vial. This is more than 80 times the mercury content found in vaccines containing "trace amounts of mercury.") Yet, the nasal spray, mercury-free vaccine may be more risky.All four of the U.S. licensed swine flu vaccines were made by mimicking earlier seasonal flu vaccines (and by adding the new swine flu virus). However, the manufacturers admit in their product inserts that these new swine flu vaccines were NOT tested for safety or efficacy. The FDA allowed them to be rushed to market assuming that they will be similar in safety and efficacy to previous flu vaccines. Thus, MedImmune's swine flu nasal spray vaccine should be similar in safety and efficacy to its seasonal flu nasal spray vaccine, FluMist.The following information on FluMist was excerpted from my recently updated Vaccine Safety Manual, 2010 copyright. All of the data is properly referenced in the book.

Excerpt from the Vaccine Safety Manual, 2nd Edition: The American drug maker MedImmune recently submitted a confidential briefing document to the FDA containing safety data from studies that it conducted on its own vaccine. MedImmune was seeking permission to vaccinate children under 5 years of age with its live-virus nasal spray FluMist vaccine (the one that is squirted up the nose). When this vaccine was originally licensed in 2003, the FDA only permitted it to be given to children 5 years of age and older because a large study conducted in 31 clinics showed that it caused "a statistically significant increase in asthma or reactive airways disease" in children under 5 years of age. In addition to this confidential briefing document, the FDA also had access to data from studies that were not conducted by the manufacturer. According to the FDA, FluMist can cause "medically significant wheezing" and pneumonia. In fact, 3 percent of all children 6 months to 1 year of age who received the vaccine ended up in the hospital with respiratory problems! (With the inactivated flu shot, 1 of every 100 vaccinated children in this age group had to be rushed to the hospital.) In addition, of all children between 6 months and 1 year of age who developed "protocol-defined wheezing" after their FluMist vaccinations, 9 percent required hospitalization. This figure was 7 percent for children between 1 and 2 years of age. The median duration of hospitalization in children 6 months to 2 years of age was nearly 5 days with most requiring bronchodilators and steroids. Many of these children had multiple wheezing episodes. Nevertheless, in September 2007, the FDA licensed this vaccine for children as young as two years of age.

For additional information regarding flu vaccine safety and efficacy, read the entire chapter on influenza in the Vaccine Safety Manual or visit the Thinktwice Global Vaccine Institute.