Is Gardasil still FDA approved?

Yes, Gardasil (specifically Gardasil 9) is still FDA-approved in the United States for preventing HPV-related cancers and genital warts, with approvals extending to ages 9-45 for both males and females, though the original Gardasil (quadrivalent) was replaced by Gardasil 9. The FDA and CDC continue to monitor its safety, finding it safe and effective, with benefits outweighing risks, and it's routinely recommended for preteens.

Is Gardasil discontinued in the US?

Yes, the original Gardasil vaccine (protecting against 4 HPV types) is no longer available in the U.S.; it was replaced by the broader-spectrum Gardasil 9, which covers nine HPV types and is the standard vaccine used today, offering protection against most HPV-related cancers and genital warts. While the older version is discontinued in the U.S., Gardasil 9 provides superior protection and is the only HPV vaccine available.
 

Is the Gardasil vaccine FDA approved?

GARDASIL 9 is FDA approved and the CDC recommends it for certain age groups. The CDC notes that HPV vaccination for males and females may begin at age 9, and recommends it routinely for the 11- to 12-year-old age group.

Do doctors still give the Gardasil vaccine?

Yes. GARDASIL 9 can be given to appropriate girls and women who are ages 9 to 45, as well as boys and men who are ages 9 to 45. For more information on GARDASIL 9, talk to your doctor or find a pharmacist.

Why has China stopped buying Gardasil?

Accordingly, Merck decided to temporarily halt shipments of Gardasil in China to allow Zhifei to burn down existing inventory. Merck does not expect to resume shipments to China through at least the end of 2025. Gardasil sales are expected to decline significantly in 2025 from 2024 levels.

FDA Approves New HPV Vaccine

Why is Gardasil banned in Japan?

Suspension and litigation. In June 2013, Japan's Ministry of Health, Labour and Welfare suspended its recommendation for the HPV vaccine following media reports of alleged side effects. The suspension was widely reported internationally. The claimed side effects included chronic pain.

What replaced Gardasil?

The Gardasil vaccine was the first FDA-approved HPV vaccine. It protects against four HPV strains – 6, 11, 16 and 18. Although it's effective, it's no longer used in the U.S, having been replaced by Gardasil 9.

Do 90% of people have HPV?

More than 90 percent of sexually active men and 80 percent of sexually active women will be infected with HPV in their lifetime. Around 50 percent of HPV infections involve certain high-risk types of HPV, which can cause cancer. Most of the time, the body clears these infections and they do not lead to cancer.

What's the lawsuit against Gardasil?

Research has suggested that Gardasil may increase the risk of cervical cancer. Gardasil lawsuits also allege that the vaccine has caused postural orthostatic tachycardia syndrome (POTS).

What are the first warning signs of HPV?

Early HPV infection often has no symptoms, but when they appear, they are usually genital warts (small, skin-colored bumps or flat patches) or other warts (flat on face/body, or rough on feet/hands). High-risk HPV types usually show no signs until they progress to cancer, causing subtle symptoms like unusual bleeding (between periods, after sex) or persistent throat/pelvic pain.
 

Why do people say no to the HPV vaccine?

Reasons people hesitate to get the HPV vaccine include safety concerns (autoimmune, neurological issues, fertility), misconceptions about it encouraging earlier sexual activity, religious/moral objections (abstinence focus), lack of physician recommendation, or personal/family health conditions like severe allergies or moderate illness. While studies show the vaccine is safe and prevents cancers, concerns persist, leading some parents and individuals to delay or refuse vaccination, despite official recommendations for widespread use. 

Had Gardasil but still got HPV?

Although the HPV vaccine protects against the two strains of HPV that most commonly cause genital warts, it will still only prevent about 9 of every 10 cases of genital warts. Therefore, someone could still get genital warts if they are infected with a type of HPV that causes genital warts but was not in the vaccine.

Why don't they give Gardasil to people over 45?

Gardasil (HPV vaccine) isn't recommended for most over 45 because most people in that age range have already been exposed to HPV, limiting the vaccine's benefit, which is preventing new infections, not treating existing ones. While the FDA has approved Gardasil 9 for ages 9-45, the older you are, the less effective it may be as you've likely encountered some HPV strains, though it still protects against other types and can benefit those with few partners or high risk, requiring a doctor's discussion for personalized advice. 

Why was Gardasil recalled?

On December 16, 2013 CDC was informed by Merck that the company planned to implement a voluntary recall of one lot (lot J007354) of Gardasil [Human Papillomavirus Quadrivalent (types 6, 11, 16, and 18) Vaccine, Recombinant], due to the potential for a small number of vials to contain glass particles as a result of ...

What age is too late to get vaccinated for HPV?

There isn't a strict "too old," but the HPV vaccine is routinely recommended through age 26, with shared clinical decision-making for adults ages 27 to 45, and generally not recommended for most people over 45, though the FDA approved it up to age 45 for those at risk. The vaccine offers the most benefit before any HPV exposure, but can still prevent new infections in older adults who haven't been exposed to all high-risk strains, so discussing it with a healthcare provider is key.
 

Can Gardasil cause autoimmune issues?

Several studies have shown that there is no relationship between Gardasil and autoimmune disorders: A 2012 study and a 2014 study both found women and girls who received the Gardasil shot were not more likely to develop autoimmune disorders than those who were unvaccinated.

Why is the HPV vaccine banned in Japan?

The Japanese government suspended its proactive recommendation for routine HPV vaccination for nine years, from June 2013 to May 2022, due to concerns about unconfirmed reports of adverse events.

Why did China stop buying Gardasil?

Merck said it had stopped Gardasil shipments to China from this month. The company has previously said China's anti-bribery and anti-corruption drive , opens new tab had also hurt sales of the vaccine.

Do most females have HPV?

About 80% of women will get at least one type of HPV at some point in their lifetime. It is usually spread through vaginal, oral, or anal sex. Many women do not know they have HPV, because it usually has no symptoms and usually goes away on its own.

Why is HPV a caution?

But high-risk strains of HPV infection can cause precancerous cell changes. These cell changes can eventually lead to cancer if they aren't managed. This process, though, can take years or decades to happen. Screenings, like Pap smears, can help detect these precancerous cells before they turn to cancer.

Are all warts caused by HPV?

Yes, all common warts, plantar warts, flat warts, and genital warts are caused by different types of the Human Papillomavirus (HPV), a group of viruses with over 100 strains, though not all HPV types cause warts, and not everyone exposed to wart-causing HPV develops them. Different HPV strains prefer different skin areas, leading to various wart types, like hand warts or foot warts, and some HPV strains are sexually transmitted.
 

Is Gardasil being discontinued?

Yes, the original Gardasil (4-strain) vaccine was discontinued in the U.S. around 2017/2018 and replaced by the broader-spectrum Gardasil 9, which protects against nine HPV types, becoming the standard HPV vaccine for cancer prevention. While the older 4-strain version is gone from the U.S., Gardasil 9 offers wider protection, covering more cancer-causing HPV types, and remains the recommended vaccine. 

Is HPV the same as hepatitis B?

No, HPV (Human Papillomavirus) and Hepatitis B are not the same; they are distinct viruses, but both are sexually transmitted, can cause cancers (HPV: cervical, throat; Hep B: liver), and have effective vaccines for prevention, often recommended together for adolescents. Both are DNA viruses linked to various cancers, but target different organs and have different infection mechanisms.
 

Why not Gardasil?

People oppose Gardasil due to concerns about serious alleged side effects (autoimmune, neurological issues, chronic pain), claims of manufacturer cover-ups in lawsuits, moral/religious objections (promoting promiscuity), and misinformation, despite extensive scientific evidence from bodies like the CDC supporting its safety and effectiveness in preventing HPV-linked cancers.