Merck’s Gardasil made big news late last week - and it wasn’t all good. First, the FDA endorsed the vaccine to thwart genital warts in boys and young men. This is a mild plus for the drugmaker; Gardasil is already approved to ward off the human papillomavirus, or HPV, in girls and young women, and GlaxoSmithKline simultaneously last Friday received FDA approval to market its own Cervarix in the US to combat HPV, which can lead to cervical cancer.

At the same time, though, a possible link was reported between Gardasil and two fatal cases of amyotrophic lateral sclerosis, or ALS, which is also known as Lou Gehrig’s disease. Both the timing of the symptoms and autopsy results “suggest a link,” according to Dr. Ctherine Lomen-Hoerth, who directs the ALS Center at the University of California San Francisco Medical Center. “We don’t know for sure if it’s coincidence or if they’re connected (to the vaccine),” she tells WebMD. “We hope that by raising awareness, we will become aware of any other cases.”

A Merck spokeswoman, Pam Eisele, says the drugmaker can’t comment specifically on the cases without having seen the data. “However, after carefully reviewing all the information available to us about reported adverse events, including reports of deaths, Merck does not believe these events have been caused by Gardasil,” she tells WebMD.

The vaccine has been given to more than 7 million girls and young women nationwide, but a web site was created by the parents of one of the girls, Jenny Tetlock, to publicize her case and get others with similar symptoms to come forward. Called Jenny’s Journey, the site prompts visitors to sign a petition to improve the vaccine adverse event reporting system, or VAERS.

Meanwhile, another report issued earlier this month in The BMJ that concludes the cost of giving boys an HPV vaccine would outweigh any health benefit after comparing a girls-only vaccination program with a co-ed vaccination program. “This study found that while vaccine coverage and efficacy are high in girls, including boys in an HPV vaccination program generally exceeds what the U.S. typically considers good value for money,” researcher Jane Kim, an assistant professor at the Harvard School of Public Health told HealthDay. And this was released just as the CDC’s Advisory Committee on Immunization Practices this week reviews the cost-effectiveness of male vaccination (see agenda).