A second vaccine designed to protect against cervical cancer may soon be available in the United States.
A Food and Drug Administration panel last week gave its approval to GlaxoSmithKline PLC’s Cervarix vaccine, essentially recommending that the FDA approve the vaccine for use in females 10 to 25 years old. The recommendation is not binding; the FDA can reject the decision, but it generally accepts the opinions made by an outside panel of experts.
The vaccine protects against two strains of human papilloma virus (HPV) that are associated with 70 percent of cervical cancers.
Writing in the Wall Street Journal, Jennifer Corbett Dooren summarized the safety concerns the FDA raised about Cervarix, including “a higher rate of miscarriages among females who received Cervarix.” The FDA also “couldn’t rule out a ‘small effect’ on pregnancies.” (The vaccine is not approved for use in pregnant women.)
GlaxoSmithKline first sought approval in 2007, but the FDA asked for more information after reports suggested a higher miscarriage rate in pregnant women. Dooren writes:
The agency said it would require a post-marketing safety study to monitor the outcome of pregnancies in women who might receive Cervarix along with other potential safety concerns including the development of autoimmune diseases like rheumatoid arthritis and multiple sclerosis. In its 2007 review of Cervarix, the FDA said that it was concerned about an “imbalance” of possible autoimmune disorders seen in clinical trials. However, the agency said an additional review of the data by its own staff and an outside rheumatologist concluded the differences weren’t statistically significant.
Officials from Glaxo said they were planning a post-marketing study that would involve 100,000 women in the U.S., which would include a pregnancy registry. The company is also conducting another large post-marketing study in Finland.
Gardasil, the popular HPV vaccine manufactured by Merck & Co., was approved in 2006. One of the lead researchers for the drug recently started speaking out with concerns about its risks, benefits and aggressive marketing — namely that the protection may not last beyond five years, so girls who are vaccinated at an early age may still be at risk.
Last month, Rachel pointed to a Journal of the American Medical Association editorial on the risks and benefits of HPV vaccination and discussed a commentary in the same JAMA issue (abstract only) about the marketing of Gardasil. Describing the authors’ findings, Rachel wrote: “The company’s tactic was to encourage all girls within a certain age group to be vaccinated as a cancer avoidance measure, rather than to work with public health officials to target those girls at the highest risk.”
The Centers for Disease Control and Prevention recommends the vaccine for 11- and 12-year-old girls, and girls and women age 13 through 26 who have not yet been vaccinated. That recommendation becomes a mandate, however, for female immigrants between the ages of 11 and 26 seeking U.S. citizenship. Gardasil was added to the list of required vaccines in 2008.
Simone Davis, a 17-year-old girl in Florida who was born in Britain is seeking citizenship but she refuses to get the vaccine. ABC News has a comprehensive story about her refusal. A devout Christian who says she has no intention of having sex anytime soon (she mentions her virginity pledge as proof), Davis is seeking a waiver for moral and religious reasons. U.S. Citizenship and Immigration Services has rejected her claim.
“The decision to include HPV as a required vaccine was made by the CDC,” Citizenship and Immigration Services spokeswoman Chris Rhatigan told ABC News. “We follow the law … The objection to a waiver would have to be to all vaccines, not just Gardasil.”
A CDC spokesperson said the CDC is expected to publish new criteria to determine which vaccines should be recommended for U.S. immigrants in about a month.