Sunday, May 16, 2010

FDA Says Use of Rotarix Should Resume

May 14, 2010 — The US Food and Drug Administration (FDA) announced today that it is revising its recommendations for rotavirus vaccines. The agency says that based on a careful evaluation of a variety of scientific information, it has determined that it is appropriate for clinicians and healthcare professionals to resume the use of Rotarix (GlaxoSmithKline) and to continue the use of RotaTeq (Merck). The agency reached its decision based on an evaluation of laboratory data drawn from the manufacturers and its own laboratories. In addition, the Vaccines and Related Biological Products Advisory Committee of the FDA convened on May 7 to discuss the findings of porcine circovirus 1 (PCV1) and PCV2 DNA in both rotavirus vaccines. Based on a thorough assessment of the information, a review of the scientific literature, and input from scientific and public health experts, the FDA has decided to reverse its recommendation to temporarily suspend the use of Rotarix. In making its decision, the FDA took into consideration that both rotavirus vaccines have strong safety records. To date, millions of children have safely received the vaccines, and clinical trials that involved tens of thousands of patients also demonstrated a strong safety record. Another factor is that there is no evidence that either PCV1 or PCV2 poses a safety risk; neither has been known to cause infection or illness in humans. In addition, the FDA has considered the fact that the benefits incurred by the vaccines are substantial and outweigh the risk, which is theoretical at this point.

A theoretical risk about which a parent truly has to been well informed. I'm concerned that we don't have enough information to make a well informed decision.
So, from Wikipedia, more information about the signs and symptoms of Rotavirus.
Rotavirus gastroenteritis is a mild to severe disease characterised by vomiting, watery diarrhoea, and low-grade fever. Once a child is infected by the virus, there is an incubation period of about two days before symptoms appear.[29] Symptoms often start with vomiting followed by four to eight days of profuse diarrhoea. Dehydration is more common in rotavirus infection than in most of those caused by bacterial pathogens, and is the most common cause of death related to rotavirus infection.[30]

Rotavirus A infections can occur throughout life: the first usually produces symptoms, but subsequent infections are typically asymptomatic,[4] as the immune system provides some protection.[2] Consequently, symptomatic infection rates are highest in children under two years of age and decrease progressively towards 45 years of age.[31][32] Infection in newborn children, although common, is often associated with mild or asymptomatic disease;[33][34] the most severe symptoms tend to occur in children six months to two years of age, the elderly, and those with compromised or absent immune system functions. Due to immunity acquired in childhood, most adults are not susceptible to rotavirus; gastroenteritis in adults usually has a cause other than rotavirus, but asymptomatic infections in adults may maintain the transmission of infection in the community.[35] Symptomatic reinfections are often due to a different rotavirus A serotype.[3][36]

Posted via web from GF Doctor-a slightly biased view of gluten free life.