Four Seasons Pediatrics

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Rotavirus Vaccine News

May 16, 2010 – Four Seasons Pediatrics has reinstated the Rotateq (Merck Rotavirus vaccine). Within the last two months, the FDA became aware of the presence or a porcine virus (PCV1) in Rotarix and DNA from PCV1 and PCV2 in RotaTeq. These viruses are not known to cause any infection or illness in people. Based on a careful review of a variety of scientific information, the FDA has determined it is appropriate for clinicians and public health professionals in the United States to use these vaccines. All available evidence supports the safety and effectiveness of Rotarix and RotaTeq, which have been extensively studied, both before and after approval.

Four Seasons Pediatrics suspended the use of the Rotateq until we were able to see and review the FDA opinion. We also sought to review the basis for the opinion and any further scientific information that was used in the FDA opinion. Our independent review of the available information concurs that use should be continued. Over 100 million doses have been distributed worldwide. The benefit of saved lives exceeds the risk of DNA fragments found that have not been shown to cause any disease in humans. If you missed this vaccine last week, when we suspended the use, please call us to schedule a nurse visit to get the vaccine. Thank you for your understanding – Dr. Miller and Dr. Elmer on behalf of Four Seasons Pediatrics.

For more information, please see this link:

FDA Link for information

It has been determined that the Merck vaccine contains two strains of a porcine (pig) virus DNA.  Neither of these strains causes disease in humans and one of the strains is found in meat that is consumed by humans and felt to be safe.   The product used by Four Seasons Pediatrics (Rotateq) was one of the most extensively tested vaccines before it came to the market.  Four Seasons Pediatrics waited one year after FDA approval before we used this vaccine.    Approximately 6 million doses of Rotateq have been distributed in the United States and have dramatically reduced this diarrheal illness in the United States.

A rotavirus vaccine protects children from rotaviruses, which are the leading cause of severe diarrhea among infants and young children.   Each year more than 500,000 children die from diarrheal disease caused by rotavirus, and another two million are hospitalized.  Nearly every child in the world will suffer an episode of diarrhea caused by rotavirus before age five.  Although the severity of rotavirus infections differs between children living in developed and developing countries, the rates of infection is similar in both settings.   Clean water supplies and good hygiene have little effect on the transmisssion of infection, and further improvements are unlikely to prevent disease.

Based upon the effectiveness of the vaccine, a 2009 review estimated that vaccination against rotavirus would prevent about 45% of deaths due to rotavirus gastroenteritis, or about 228,000 deaths annually worldwide.  Since there are about 20-60 deaths in the United States from rotavirus infection, this translates to saving about 9 to 27 deaths per year in the United States.

Practice Comment From Dr. Miller and Dr. Elmer:

 A scientific review at this time shows that the risk of the virus itself (a known risk), exceeds the risks of the DNA of the porcine virus in the vaccine (no evidence of any disease in humans).  More than 6 million doses of vaccine have been distributed in the United States, and 106 million doses have been distributed worldwide. This gives us great comfort, as we have not seen any significant problems with the vaccine and the vaccine is highly effective.

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