Vaccine Safety

Vaccine maker MedImmune has voluntarily recalled 13 lots of vaccine against the pandemic H1N1 influenza because they have lost some potency since they were manufactured, the company said Tuesday. "This is not a safety issue," Norman Baylor, director of the Office of Vaccines Research and Review at the Food and Drug Administration, said in a conference call. "All lots passed pre-release testing for safety, purity and potency. There has just been a slight decrease in potency." The 13 lots recalled involved 4.7 million doses of the intranasal vaccine, which is based on a live, weakened virus, but officials believe most of them were administered in October and November when the product would have still been at full potency.

It took well over a year, but the federal government has finally realized that it was out of bounds to require immigrant women to be vaccinated against the sexually transmitted virus that can cause cervical cancer. In August 2008, authorities began requiring the vaccine for girls and women ages 11 to 26 who were applying for green cards. The vaccine is effective against the four strains of the human papillomavirus most likely to cause cervical cancer and genital warts. Most doctors recommend it for preteen and teenage girls; it is most effective when administered before a girl or woman has been exposed to HPV. But the vaccine is not required for citizens, and the virus is not spread through casual contact.

Contrary to the fears of some parents, a 10-year study by Danish researchers found no evidence that combination vaccines, such as the measles, mumps and rubella shot, weakened children's immune systems. The study, published today in the Journal of the American Medical Assn., tracked 805,206 children born in Denmark.

The Pentagon's recent decision to vaccinate every member of the armed forces against anthrax may have come too quickly. One study just reported by the National Academy of Sciences questions the vaccine's effectiveness against varied strains of the bacteria. Another suggests Russian scientists have already genetically engineered a strain that resists the available vaccine. And there are other concerns as well.

The federal government must perform more tests on adults before it can ethically move forward with controversial anthrax vaccine trials in children, members of a federal bioethics panel said.  "The safety of our children is paramount, and we have to get this right," said Amy Gutmann, chairwoman of the Presidential Commission for the Study of Bioethical Issues , in a phone call with reporters on Monday. "The commission concluded many steps would have to be taken before pediatric anthrax vaccine trials should be considered.

Just two years after the discovery of severe acute respiratory syndrome, or SARS, clinical trials for a vaccine are underway in the United States. SARS first broke out in China in November 2002 and had killed 774 worldwide by July 2003, according to the World Health Organization, before being brought under control. The National Institutes of Health launched the first U.S. trial of a SARS vaccine in mid-December. The vaccine is being tested on 10 healthy volunteers who will be followed for 32 weeks.

Americans will go to great lengths to protect themselves from medical risks -- even when the level of risk is unclear or unproven. The threat of mad cow disease drives some people to boycott beef, pesticide concerns lead others to eat only organic foods, and fears about vaccine safety prevent some parents from immunizing their children. Ironically, some of these same people fail to act against serious, and well-documented, medical risks.

A genetically engineered flu vaccine made in caterpillar cells is as effective as traditional vaccines and can be produced more efficiently, according to a preliminary study released Tuesday. This experimental method could make more vaccine per batch than the traditional method, which uses hens' eggs, and shave about a month off production time, said study leader Dr. John J. Treanor, a researcher at the University of Rochester in New York.