MSD’s Gardasil Vaccine Faces Legal Investigation Over Side Effects

(Seoul = News 1) Bio-specialist Jae-Jun Seong = Some of the cervical cancer vaccine ‘Gardasil’ (component recombinant human papilloma virus) inoculated by MSD (Merck & Company) in the United States filed a lawsuit claiming that side effects occurred after vaccination.

However, it was found that related organizations and experts, including the US Food and Drug Administration (FDA), still recommend ‘Gardasil 9’ (human papillomavirus 9-valent vaccine) vaccination.

On the 25th, local media such as Biospace, an American medical magazine, reported that MSD Gardasil is under legal investigation, although there is insufficient evidence to support the lawsuit.

This is because of the fact that in April, a US federal court ordered MSD to submit detailed research data on side effects that occurred in the Gardasil clinical trial.

In this regard, Biospace explained, “It means that the court is taking the claimant’s claim sufficiently seriously.”

Harry Nelson, partner of Nelson Hardiman Healthcare Law Firm, said in an interview with the media, “The biggest question is whether the jury will accept the plaintiff’s claim despite the lack of rigorous scientific evidence.” In one or two of the cases, the plaintiffs may be forced to come out with a big win,” he said.

Since 2020, MSD has experienced more than 80 lawsuits related to human papillomavirus (HPV) vaccines. Plaintiffs argued that Gardasil was causing side effects as serious as cancer, including autoimmune disease, early menopause, and chronic fatigue, and that MSD misrepresented its safety and efficacy. They also accused MSD of downplaying the risks associated with Gardasil and putting private interests ahead of public health.

MSD countered that Gardasil had undergone a rigorous validation process and was proven to prevent HPV-related diseases. In addition, reported side effects occur extremely rarely, and the opinion is that the benefits of vaccination outweigh the potential risks (side effects).

“Overwhelming scientific evidence, including more than 20 years of research and development, continues to support the safety and efficacy profile of the HPV vaccine,” a MSD spokesperson told The Associated Press in March. .

On the other hand, most of the related institutions do not seem to be very concerned about Gardasil vaccination.

Again this year, the FDA issued guidance recommending that people between the ages of 9 and 45 get the HPV vaccine. Relevant organizations such as the American Academy of Pediatrics, the American Cancer Society, the American College of Obstetrics and Gynecology, and the World Health Organization also agree with the FDA guidelines.

The Centers for Disease Control and Prevention (CDC) says the HPV vaccine can cause side effects such as fainting, nausea and headaches. It also explained that all vaccines are being monitored for safety issues.

However, the CDC also said in a report that “the vaccine is made from a protein of the virus and is not contagious, so it cannot cause HPV infection or cancer.”

The CDC also said that the vaccine did not cause fertility problems or other serious side effects. It has been proven that the vaccine is safe,” he added.

Gardasil is a vaccine that prevents and treats HPV infection, which causes cervical cancer. HPV is difficult to culture, so the virus gene was cloned. Gardasil 9 is a 9-valent vaccine developed by recombining 9 HPV types.

The FDA first approved Gardasil in 2006 for ages 9 to 26, and later expanded the scope to 45 years of age in 2018. Currently, about 125 countries have introduced Gardasil. There are only two cervical cancer vaccines, MSD Gardasil and GSK ‘Cervarix’ for the purpose of preventing and treating cervical cancer.

The CDC emphasized that Gardasil can effectively prevent HPV infection associated with several cancers in both men and women. According to a CDC report, HPV-related diseases, including cervical, vaginal and anal cancers, as well as genital warts, were reduced by 88% among teenage females after HPV vaccination.

In Korea, a plan to expand the scope of HPV vaccine for National Required Immunization (NIP) from female youth aged 12 to 17 and low-income females aged 18 to 26 to males of the same age was also discussed.