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Hepatitis B Vaccine

While consumer groups have for years questioned the safety of mercury in selected vaccines, the U.S. Food and Drug Administration (FDA) did not formally investigate these concerns until recently. In December 1998 and April 1999 the FDA finally asked vaccine manufacturers to reveal the specific mercury content of their vaccines, the agency responding to a directive by Congress in the FDA Modernization Act of 1997. This act directed the FDA "to review and assess the risk of all mercury containing food and drugs" (1). Since some vaccines use the mercury containing preservative thimerosal, these vaccines were part of the FDA review.

The results of the FDA review showed that the total mercury level in vaccines recommended for American babies in their first six months of life exceeds the Environmental Protection Agency (EPA) limit for methyl mercury. Since methyl mercury can cause neurological and other toxicity 12), the FDA, Centers for Disease Control and Prevention (CDC), and the American Academy of pediatrics found themselves in an embarrassing Situation. Shifting into typical damage control mode, they issued carefully worded public statements to reassure parents to keep vaccinating their children. For vaccine advocates to admit a potential problem with vaccines reflects the seriousness of the mercury problem in vaccines. And, with more vaccines in the research pipeline, something had to be done to protect babies from possible vaccine induced mercury intoxication.

Among the actions being taken to solve the problem, the FDA "formally requested" manufacturers to "eliminate or reduce as expeditiously as possible the mercy content of their vaccines (1). In addition the National Vaccine Advisory Committee will sponsor a workshop on thimerosal in vaccines on August 11-12, 1999 to "review use of thimerosal in vaccines and its reduction and elimination from vaccines"(3).

Of most immediate concern to parents is the directive to, "postpone the first dose of hepatitis B vaccine from birth until 2 to 6 months of age when the infant is considerably larger. " Immature babies should "ideally" not receive hepatitis B vaccine until they weigh at least 5.5 pounds and they reach "term gestation age" (their original "due date"). These directives apply only to babies whose mothers are negative for hepatitis B surface antigen (Hasbro), which represents more than 99 percent of American moms. Babies born to Hasbro positive mothers are still recommended to be vaccinated at birth, as are babies born to "populations where Hasbro screening of pregnant women is not routinely performed" (1).

What should you do? To avoid unnecessary hepatitis B vaccination of your newborn baby in the hospital, mothers should know their own Hasbro status. Some states routinely screen for this. Ask your doctor. But remember that in the U S., hepatitis B is mainly an adult disease of promiscuous homosexuals, heterosexuals, and intravenous drug abusers. Chances are, your baby will never need hepatitis B vaccine, despite what government health officials tell you. 2.

Rotavirus vaccine Due to reports of intussusception (a bowel obstruction in which one segment of bowel becomes enfolded within another segment) in 20 (and likely more) infants who had just received rotavirus vaccine, the manufacturer of the recently licensed rotavirus vaccine (RotaShield) is suspending shipments of the vaccine. While no children died, about half of the babies required surgery to correct the condition. The manufacturer and the CDC also advised doctors to postpone giving the vaccine to children for a few months until the CDC researches the issue. The vaccine had been recommended at ages 2, 4, and 6 months of age. The risk of bowel obstruction was observed in pre licensing clinical trials and appears in the manufacturer's package insert.

Rotavirus causes vomiting and diarrhea and can result in hospitalization. If treated, virtually all children recover. In the U. S., the death rate from rotavirus is extremely low, but in underdeveloped countries, rotavirus kills a large number of children. If babies are breasted, their risk of catching rotavirus is substantially reduced.

Again, in typical damage control fashion, the CDC and the vaccine manufacturer deny any "causal" link between the bowel obstruction cases and the vaccine. However, the CDC advises parents of recently vaccinated babies to contact their doctor if the baby develops signs of intussusception (persistent vomiting, bloody stools, black stools. abdominal distention, and/or severe colic pain) (4). American Home Products, the only rotavirus vaccine manufacturer, sold about $43 million worth of this vaccine in 1998, and $30 million in the first half of 1999 (5).

References:
(1) Thimerosal in Vaccines: A Joint Statement of the American Academy of Pediatrics and the Public Health Service.MMWR July9,1999/ 48(26), 563 ?565. (See www.cdc.gov ? en click on MMWR)
(2) Har ?vey, S.C., Heavy Metals, in Goodman, LS and Gilman, A., The Pharmacological Basis of Therapeutics, 5th ed., Macmillan, 1975, p.937.
(3) Notice to readers: National Vaccine Advisory Committee Workshop on Thimerosal in Vaccines, MMWR, July 23, 1999 / 48(28); 619.
(4) Intussuscepbon Among Recipients of Rotavirus Vaccine ? United States, 1998 ? 1999, MMWR, July 16,1999 / 48(27); 577 ?581. (5) American Home Products Suspends Shipments of New Rotavirus Vaccine," Wall St. J., July 16,1999, p.B6, col. 2.
-Leslie Lechner