HPV9 Vaccine Contraindications

HPV Vaccination FAQ

1) What if the second dose of the HPV 4 vaccine is out of supply after I take the first dose? Will the length of waiting affect the vaccination effect?

According to the instructions for Gardasil, or the HPV4 vaccine: “Based on clinical research data, the first dose and the second dose should be taken at least one month apart, and the second dose and the third dose at least three months apart. All the three doses should be completed within one year.” Therefore, as long as you take all the three doses within one year, delayed vaccination in between won’t affect the overall vaccination effect.

2) When will the supply of Gardasil be resumed?

Merck and interested parties, including the government authority overseeing disease control, are actively working to ease and eventually solve the supply issue. Once we have the latest news about vaccine supply, we will inform you right away.

3) Does the 0-2-6 schedule of HPV vaccination allow advances or delays?

Advance vaccination is not allowed. If the vaccine cannot be administered on time due to short vaccine supply or other reasons, it can be postponed as appropriate. As long as the three doses are administered within one year, the overall protection effect will not be affected.

4) I have learnt that the HPV-9 vaccine has been approved. Can I refund the HPV 4 vaccine I have booked and change for the HPV 9 vaccine? How long do I need to wait to get the HPV9 vaccine?

The HPV 9 vaccine wasn’t approved by the drug administration of Chinese mainland until late April. Next it needs to go through some essential procedures, such as inspections and logistics bidding. It will be some time before the vaccine reaches the administering units.

5) I have got a shot of the HPV4 vaccine but I have heard that the HPV9 vaccine has been approved. Can I switch to the HPV 9 vaccine? If yes, how soon can that happen?

 

There is no clinical data supporting the switch among HPV2, HPV4 and HPV9 vaccines, so we advise you not to do so.

 

The clinical safety analysis of the 12- to 26-year-old women who already took three doses of the HPV4 vaccine and then received three doses of the HPV9 vaccine 12 months later shows that the vaccine is safe and well tolerated. At the same time, the immunogenicity results indicate that four weeks after the last dose of the HPV9 vaccine, the positive rate of serum anti-HPV type 6, 11, 16, 18, 31, 33, 45, 52 and 58 reaches 98.3% to 100%, showing good immunogenicity against nine HPV subtypes. Among them, the antibody levels to type 6, 11, 16, and 18 are higher than those in women who did not receive the HPV4 vaccine, but the antibodies to the other five subtypes are relatively low. The relevant clinical significance is not yet identified. (1)

 

Based on the above findings and the approved cohorts in China’s mainland (HPV4: aged 20-45, HPV9: aged 16-26):

• For females who have already received HPV4 vaccines and are over 26 years of age, please continue to complete the three doses of HPV4 vaccine.
• Females who have already received HPV4 vaccines and are under 26 years of age* have the following choices according to their own health and economic conditions.

– Complete HPV4 vaccination;

– Complete HPV4 vaccination and receive three doses of HPV9 vaccine after one year;

– Terminate the HPV4 vaccination and receive three doses of HPV9 vaccine (at least one month between the first dose and the second dose, and at least three months between the second dose and the third dose).

*Please note that the three doses of HPV9 vaccine must be completed before one’s 27^th birthday.

 

Source:

• Product instruction
• Chesson HW, Laprise JF, Brisson M, Markowitz LE. Impact and cost-effectiveness of 3 doses of 9-valent human papillomavirus (HPV) vaccine among US females previously vaccinated with 4-valent HPV vaccine. J Infect Dis 2016;213:1694-700
• VanDamme, Pierre. Use of the nonavalent HPV vaccine in individuals previously fully orpartially vaccinated with bivalent or quadrivalent HPV vaccines.  Vaccine 34 (2016) 757–761
• ACIP recommendation

 

The HPV-9 vaccine approved in China’s mainland is not recommended for those who are:

1. Over 26 or under 16, including those who turn 27 when the last dose is taken;
2. Currently suffering from acute diseases (including fever);
3. Known to be allergic to active or excipient ingredients of the HPV4 and HPV9 vaccines;
4. Pregnant or planning for conception;
5. Pregnant or still lactating;
6. Male.

Further consultation with a doctor is recommended for those who:

1. Have been diagnosed with cervical cancer;
2. Are using immunosuppressive drugs;
3. Have severe congenital or hereditary diseases;

No restriction is applied for those who

1. of menstruating age;
2. have had sexual experience;
3. used to be or are infected with HPV*

* Vaccines are for prevention only, not for the treatment of existing HPV lesions.