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Cervical cancer vaccine market hots up in India with Merck’s Gardasil and GSK’s Cervarix

Wednesday, April 22, 2009, 20:05 This news item was posted in health, Pharma category and has 31 Comments so far.

Merck’s Gardasil and GSK’s Cervarix cervical cancer vaccines are poised for a tough battle in India.

Cervical cancer vaccine makers are betting big on India as the deadly cancer takes the lives of 8 women in India every hour.

WHO estimates that each year over 1.30 lakh Indian women are diagnosed with cervical cancer and over 74,000 die of cervical cancer .

Cervical cancer or cancer of the uterine cervix, is the most common type of cancer affecting women in India.

Worldwide, it was the second-most common cancer after breast cancer.

Glaxo’s head-to-head study, named HPV-010, measures which vaccine caused greater immune system response in more than 1,000 women seven months after the shot.

Causes of cervical cancer

Cervical cancer is a serious disease that can be life-threatening. This disease is caused by certain high-risk HPV types that can cause the cells in the lining of the cervix to change from normal to precancerous lesions. If these precancerous lesions are not diagnosed early and treated, they may turn cancerous after a few years.

Every year, almost 74,000 women die due to Cervical cancer in India, which is more than one fourth of the world deaths due to Cervical cancer. Woman in India have a 2.5% life time risk to get Cervical Cancer, which is double the risk as compared to the data worldwide (1.3%).

Though there is no known cure for cervical cancer, the recent advances in vaccine technology have made it more or less certain that cervical cancer can be prevented in majority of cases using vaccine.

The human papillomavirus, also called HPV, was a common pathogen predominantly affecting women. Approximately 80 per cent of women get one or more types of virus by the age of 50.

Reportedly, there are more than 100 types of HPV. Of these, about 15 high-risk types were known to cause virtually all cases of cervical cancer. “Two of these types (16 and 18) are believed to cause 70 per cent of these cases (76.7 per cent in Indian women).

Though there is no known cure for cervical cancer, the recent advances in vaccine technology have made it more or less certain that cervical cancer can be prevented in majority of cases using vaccine. The global market for cervical vaccine is estimated at more than $10 billion last year.

MSD Pharmaceuticals (India), the local affiliate of Merck & Co., Inc USA launched Gardasil a quadrivalent human papillomavirus vaccine.Gardasil is the only vaccine that helps protect against 4 types – types 6, 11, 16, 18 – of HPV. The vaccine helps prevent diseases such as cervical cancer; abnormal and precancerous cervical lesions, vaginal lesions, vulvar lesions; and genital warts, caused by these types of HPV, MSD said while announcing the launch.

Gardasil is recommended to be given to females aged between 9 to 26 years.

Announcing the launch, Dr. Naveen A. Rao, managing director, MSD India, said, “ With the launch of Gardasil,we have initiated the war against Cervical Cancer, the number one cause of mortality amongst Indian women due to cancer. In line with our commitment to putting patients first, MSD India will work with partners and communities to enhance awareness for the disease and access for the vaccine.”

The placebo controlled, double blind, randomized, multicentric studies done in more than 20,000 females across 5 continents show that in women who did not have evidence of exposure to HPV types contained in the vaccine Gardasil provides 98% protection against cervical pre-cancers caused by HPV types 16 & 18, which are responsible for 70% of all Cervical Cancer cases worldwide, said Dr. Neerja Bhatla from the All India Institute of Medical Sciences (AIIMS, New Delhi).

Similarly, in large placebo controlled, double blind, randomized, multicentric studies, the vaccine has also been proven to be 99% effective in the prevention of genital warts caused by HPV types 6 and 11, which are responsible for 90% of all genital warts cases worldwide. In India the number of cases is increasing every year.

“This is a very promising breakthrough but women must remember that they still need to visit their doctors for regular screening for cervical and other cancers” she added.

HPV vaccination is now unequivocally recommended by the IAP Committee of Immunization (COI) for females over the age of ten. This decision is based on expected high impact on public health in future as it will help prevent mortality due to cervical cancer in women in their prime age and keep families united and safe.

According to the Indian Academy of Pediatrics Committee of Immunization (IAPCOI) 2008 recommendations: “This vaccine has a favorable tolerability profile and the IAP-COI recommends offering HPV vaccine to all females as per label. The recommended age for initiation of vaccination is 10-12 years and catch up vaccination is permitted up to the age of 26 years. It is recommended to be given in three doses at 0, 2 and 6 months.”

Merck’s Gardasil: Precautions & Side-effects

Gardasil contains recombinant virus like particle (VLPs) assembled from the L1 proteins of HPVs 6, 11, 16 and 18. Since VLPs lack the viral DNA, they cannot induce cancer. They do, however, trigger an antibody response that protects vaccine recipients from becoming infected with the HPV types represented in the vaccine.

As per available data, till February 2009, 40 million doses of Gardasil had been distributed worldwide. There is no evidence the vaccine has caused serious adverse effects. According to the Centers for Disease Control, the vaccine was tested in over 11,000 women and girls (ages 9 to 26).

Fainting is more common among adolescents receiving the Gardasil vaccine than in other kinds of vaccinations. Patients should remain seated for 15 minutes after they receive the HPV vaccine. It is also reported that the shot is more painful than other common vaccines. General side effects of Gardasil may include joint and muscle pain, fatigue, physical weakness and general malaise.

Gardasil cannot be taken if you have or have had an allergic reaction after getting a dose of Gardasil or  a severe allergic reaction to yeast, amorphous aluminum hydroxyphosphate sulfate, polysorbate.

Gardasil is not recommended for use in pregnant women,  have immune problems, like HIV infection, cancer, or you take medicines that affect your immune system,  have a fever over 100°F (37.8°C)

Gardasil is a shot that is usually given in the arm muscle. Three shots are given on the following schedule:

• Dose 1: at a date you and your health care provider choose.

• Dose 2: 2 months after Dose 1.

• Dose 3: 6 months after Dose 1.

Gardasil, sold in 109 countries, generated $1.4 billion for Merck.

Sales of Gardasil fell 33 percent worldwide to $262 million and 39 percent in the U.S. in the first quarter, Merck said. Gardasil, approved in 2006 in girls and women ages 9 to 26, hasn’t been embraced for older girls within that age group, Merck said.

MSD India is collaborating with the Indian Council of Medical Research, as a public-private partnership to bring Cervical Cancer vaccine to the Indian public sector at an affordable price.

GlaxoSmithKline’s Cervarix cervical cancer vaccine

Similarly, GlaxoSmithKline is also planning a large-scale launch its cervical cancer vaccine Cervarix in India.

Cervarix is a vaccine against certain types 16 and 18, which currently cause about 70% of cervical cancer cases.

Cervarix is a preventative cervical cancer vaccine, not therapeutic. Cervarix vaccine will not block infection from cervical cancer-causing HPV strains other than HPV 16, 18, 31 and 45

Developed  by researchers at Georgetown University Medical Center, the University of Rochester, the University of Queensland in Australia, and the U.S. National Cancer Institute Cervarix is using the L1 protein of the viral capsid. Recombinant activity in a baculovirus vector produces L1 protein spheres, which are very immunogenic. The viral proteins induce the formation of neutralizing antibodies. The vaccine contains no live virus and no DNA, so it cannot infect the patient.

Cervaris data from patients show that at 18 months after the first of a three-dose regimen, 100 percent of women up to age 55 vaccinated with Cervarix vaccine had antibodies present against the two most common cancer-causing human papillomavirus types, 16 and 18.

Phase 3 trial data also suggest that the vaccine, formulated with a proprietary adjuvant system called AS04, is highly immunogenic and generally well-tolerated, with antibody levels at least 10 times greater than those produced by natural infection.

Cervarix study showed that antibody levels in women ages 26 to 55 against cancer-causing virus types 16 and 18 were in the same range as observed in a separate study. That study demonstrated that the GSK cervical cancer vaccine provided 100 percent sustained protection against precancerous lesions caused by these virus types for up to 5.5 years in women ages 15 to 25.

Gardasil Sales

Cervarix vaccine is approved and sold in more than 60 countries, including Australia (for women ages 10 to 45),  Philippines and European Union, among other countries. Cervarix had sales of 125 million pounds ($182 million) last year. Cervarix has received approval by the UK government for its national programme of vaccination for teenage girls. Glaxo has also won exclusive contracts to provide Cervarix to young girls and women in the Netherlands and the U.K.

Cervarix  is awaiting approval in United States of America. On March 29, 2007 GlaxoSmithKline submitted a Biologics License Application (BLA) for Cervarix to the FDA. However, US FDA sought more data and GSK awaiting results of further trials to submit to the FDA. Approval is not expected before late 2009.

Sales for Glaxo’s Cervarix amount to less than 10 percent of those garnered by Merck’s similar vaccine.

Cervarix Vs. Gardasil: Which is the better cervical cancer vaccine?

Cervarix  is bivalent –effective against only two strains of the virus –vaccine. While  Gardasil is quadrivalent vaccine (effective against four common strains of HPV).

The question now arises which vaccine to be the vaccine of choice.

  1. On the face of it a quadrivalent vaccine seems to be the better choice. In reality that is not so. The vaccine protects against the HPV viruses 16,18, 6, 11, of which only the first two are responsible for cervical cancer, while the other two are responsible for genital warts.
  2. On the other hand Cervarix gives protection against 16 and 18. It is better because, there is cross-reactive protection against the virus strains 45 and 31, two other viruses causing cervical cancer.
  3. Cervarix is formulated with AS04, a propriety adjuvant that boosts the immune system response for a longer period of time.
  4. Both vaccines are against the human papilloma virus but Cervarix seems to be more effective against cancer cervix.
  5. Cervarix can be given to females between 10 to 45 yrs old, whereas Gardasil can be given to females between 16 to 26yrs only.
  6. Both the vaccines are given in the schedule of 0,1,6 months. Cervarix is the costlier one being priced at Rs.3200 per dose. Cervarix seems to win against Gardasil because of its stronger immune response and broader protection.

Though there is no clinical data comparing the efficacy of both Garadasil and Cervarix, GlaxoSmithKline Plc is planning to release the first study to compare its cervical cancer vaccine with Merck & Co.’s blockbuster Gardasil.

Glaxo also plans to release another key Cervarix study, known as HPV-008, which tracks the effect of the vaccine on more than 18,600 women.

Glaxo’s head-to-head study, named HPV-010, measures which vaccine caused greater immune system response in more than 1,000 women seven months after the shot.

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31 Responses to “Cervical cancer vaccine market hots up in India with Merck’s Gardasil and GSK’s Cervarix”

  1. YAEL said on Thursday, April 23, 2009, 6:49

    JUST A QUESTION – IS THE CERVARIX VACCINE VERY PAINFUL?

  2. Ekta Dhawan Rampal said on Monday, July 13, 2009, 10:45

    The information is really beneficial for women to decide which one vaccine to opt for. Additionally looking at less awareness of Cervical Cancer, it is our social responsibility to spread this to as many women as possible to avert the risk later in life. Thank you very much for throwing light on this crucial subject.

  3. SAILAPATI BHATTACHARYYA said on Thursday, September 3, 2009, 3:10

    centre for TEST, TREATMENT and VACCINE in KOLKATA? PLEASE INFORM ME IN MY E-MAIL OR IN MOB. NO.- 9830289099 AND IF POSSIBLE TO MY FRIEND WHO’S WIFE HAS BEEN EFFECTED WITH IN MOB NO.- 9831059199 WITH THIS ASSURANCE THAT IT IS CURABLE.

  4. dr akshay said on Wednesday, December 2, 2009, 2:49

    what is the cost of 3 doses of vaccine

  5. jyoti said on Wednesday, December 9, 2009, 6:29

    I am 36 years I want to take the vaccine fo cervical cancer would please tell me which one should i take & what is the cost. i am from belgaum (karnataka) in which nearest place is it available.my email id is jyoti_ban@yahoo.com

  6. sindhuja said on Friday, December 11, 2009, 16:12

    please send the details regarding vaccines a, cost of the vaccines and manufacturers of the vaccine list.
    thank you.

  7. dr. gopal manpure said on Sunday, December 13, 2009, 16:07

    regarding prise

  8. Bela Ashar said on Monday, December 14, 2009, 7:16

    what is the cost of cervical cancer vaccine?where do it will be available in ghatkopar [mumbai]

  9. DR ASOK KUMAR MANDAL said on Monday, December 14, 2009, 16:22

    Informations provided in the article are brief and adequate. Please inform me as soon as Cervarix is marketed in India by gsk Ltd

  10. pushkar said on Monday, December 14, 2009, 17:27

    Though the fact that HPV vaccines are recommended to prevent cervical cancers, the fact highlighted in this article that there is no cure for cervical cancer is incorrect and greatly misleading. Radical Radiotherapy with concurrent Cisplatin chemotherapy has very good cure rates with even advanced Stage 3 cancers have survival rates of around 45-50%, let alone the stage 1 cancers that have more than 90% cure rates.

  11. A.W.Belgaumi said on Wednesday, December 16, 2009, 2:46

    my wife is 36yrs can she take the vaccine? upto what age is this vaccine recommended?

  12. rakesh said on Wednesday, December 16, 2009, 17:13

    i would like to know the price of diffrent manufractureres of this vaccine .waiting for ur reply,thanking you.

  13. anjana said on Thursday, December 17, 2009, 14:28

    i am 29 years old i want to know wether Cervarix is better or Gardasil for me
    and my both daughters eged 8 year and 6 year. and cost of all 3 doeses.

  14. sughanthi said on Wednesday, December 23, 2009, 18:34

    I am 36 years I want to take the vaccine fo cervical cancer would u please tell me which one should i take & what is the cost.

  15. dr k n singh said on Monday, December 28, 2009, 7:49

    send me cost and side effect of cervarix

  16. mahesh said on Monday, December 28, 2009, 16:33

    i am agree that cervarix win the race because of its long term portection and cross protection for HPV 31 33 45 also, i also agree that adjivant system AS04 have more advantage than normal Al (OH3). thats why to my sister and wife also vaccinated with only CERVARIX.
    I ALSO RECOMMEND ONLY CERVARIX FOR THE BETTER PROTECTION.

  17. Sanjana said on Thursday, January 7, 2010, 19:01

    I am 24yrs old. I want to take the cervical cancer vaccination but would like if few of my doubts are cleared-
    1) I have had an abortion 7.5 months ago. Would this vaccination be applicable in my case or is it for unmarried women only?
    2) During the course of the 0,1,6 months term of the vaccine, can I plan a pregnancy? Will the vaccine then go to waste or harm me or my child?
    3) During the course of the vaccine can one indulge in intercourse?

  18. Alka singh said on Thursday, January 14, 2010, 8:29

    I am 31 years old, In that case would the vaccince would be effective and if yes then i should go for which one of two: GSK’s or MERC’s

  19. supriya chiddarwar said on Sunday, January 17, 2010, 4:41

    I am a 45 years women having two children. Can I take cervarix vaccine? please reply.

  20. rasika said on Tuesday, February 2, 2010, 11:17

    In which age we can take this vaccine?

    i m 29 year old..

  21. rasika said on Tuesday, February 2, 2010, 11:19

    what is cost of such vaccine

  22. swapna said on Tuesday, February 2, 2010, 11:33

    i am 29 ,unmarried & would like to go for vaccine t o prevent cervical cancer. could u plz send me which type of vaccine should i take &details regarding price&dose

  23. kruti boricha said on Thursday, February 4, 2010, 8:37

    what is the cost of cervical cancer vaccine and where to go in my city surat to take it ?
    Thank you

  24. SD said on Saturday, February 6, 2010, 21:51

    My wife (35yrs) had the first shot of Cervarix in Jan,2010. Had a high fever for two days following the vaccine. Other symptoms started two weeks later include irregular period, fatigue, dry mouth/thirst, weight-loss, joint pain. We saw a GYN about the irregular (advanced by 1 week) period and other symptoms but the gyn looked quite un-informed (apart from what GSK reps may have taught her). So we did our research on how to fight/flush the toxin.

    The situation is somewhat better now after she made certain enhancements to her diet. This is specific to her but may help others as well.

    1. Don’t eat wheat products. Eat rice instead.
    2. Drint 4 glasses of fresh fruit juice every day
    3. Drink lots of water.
    4. Drint coconut water
    5. Lots of butter, yogurt and full-cream milk, country chicken/duck eggs
    6. A good multivitamin, specially vitamin B-Complex
    7. Plenty of vegetables
    8. Try to maintain physical activities
    9. Fish
    10. Sesame seed paste (mix with milk shake)

    She had the correct weight for her age and has lost four pounds in last week. Never had an irregular period before this. Looks like the vaccine is impairing the lipid metabolism of the body amongst other things. Lipid is also vital to the wellness of the nervous system – so there could be a connection of the adverse neurological effects reported everywhere wrt Gardasil/Cervarix.

    Anyone has any other idea on how long does it take to detox and what is the most effective way to do so?

  25. SD said on Saturday, February 6, 2010, 21:59

    The real Gardasil/Cervarix horror stories that the pharma execs or IMA won’t tell you.
    At Rs. 3200 imagine the commission money it generates.

    http://www.cynthiajanak.com/Gardasil.html
    http://www.brockovichblog.com/2008/08/gardasil.html

    “Sales of Gardasil fell 33 percent worldwide to $262 million and 39 percent in the U.S. in the first quarter” — wonder why?

    What is the plan for controlled clinical trial of this vaccine (my sympathy goes to those who volunteer to test this toxin) ? I wonder if “Dr. Naveen A. Rao” or any of the “experts” would ask their daughters and wives to volunteer first to test the full dosage of the vaccine?

  26. charushila choche said on Monday, February 8, 2010, 6:01

    i am 29 ,unmarried getting married in End of May or begining of june & would like to go for vaccine to prevent cervical cancer. could u please let me know which type of vaccine should i take &details regarding price&dose and also the side effect which i can undergo through vaccination

  27. Dr P Damayanthi MB, MD(OG), DGO said on Friday, February 12, 2010, 5:26

    I find this article very interesting and useful. I am practising in Chennai (Ph.91-94440 60310 / 044-2225 3456). I would like to know the availability and cost of GARDASIL / CERVARIX . These info will be very useful to my patients.
    Thanks.

  28. anon said on Saturday, February 13, 2010, 15:10

    Damayanthi, do not blindly push this vaccine. Study the reported side-effects. Make sure you understand its mechanisms first. The neurological impact of this vaccine is scary and often lethal. If you like this vaccine so much, inject it into your own body first and see what happens.

    Watch these videos and you will feel like crying too:
    http://www.youtube.com/watch?v=0gCVCP8BFrU
    http://www.youtube.com/watch?v=R2z6RK2uTWc&feature=related
    http://www.youtube.com/watch?v=8xc4yBNV-U0&feature=fvw

    Chances are you will get a real public beating if your patient happens to die because of this vaccine and her relatives are not as well behaved as the hapless Americans/Brits. Remember, this is India and people still can fix things by their own hands that law won’t fix for them. There are very few experts in India who knows how to prepare a woman to receive this vaccine and test if this is at all suitable for her and how to help her recover from its side effects.

    Trust me it is scary. For a week my wife thought she is going to die.

    The vaccine costs 3200/- a shot (so 9600/- total) but that’s peanuts compared to the cost of recovery therapy and the nervous system damage. Don’t endorse this toxin. GSK/Merck has fudged the clinical trial reports. It is surprising how quick this drug went though FDA approval compared to other known vaccines like HepaA/B. It is a complete scam. I regret not having done enough research before talking my wife into it.

    ———–

    My strong healthy hyperactive 35year old (not underweight, not overweight) wife had the first shot of Cervarix (Gardasil equiv) in mid Jan 2010 and is having a severe reaction since then. This vaccine really messes up the nervous system, metabolism and the immune system. This is what she suffered:

    Dizzyness, frequent headache, joint pain, frequent fever, throat infection, dry upper/inner mouth, flutters in ear, severe weakness, irregular and messed up period and most importantly (this was the clue) massive loss of body fat in a very short period of time. The skin of her hands started shriveling like an old woman (hint: sub-cutaneous fat). Dry skin and mild rashes all over. She was so weakened that she was almost bedridden for a few days.

    Good thing is that now she is regaining strength and on the way to recovery. She is still not able to read/write/work for long durations without getting severe headache. This is what we and our good family physician (specialist in Internal medicine and gastro-entr) had to do.

    1. MUST: Don’t eat any wheat products. Eat rice instead. Stop any form of dieting and go to full nourishing meals.
    2. Drink lots of water, 4 glasses of fresh fruit juice every day. Drink coconut water if you can get it.
    3. Lots of butter, yogurt, curd, full-cream milk, fish. Have two country chicken/duck eggs everyday
    4. MUST: A good multivitamin, specially vitamin B-Complex syrup (Polybion) 3 times a day
    5. Plenty of vegetables, specially carrots and beet-root (semi-boiled)
    6. Try to maintain basic physical activities but do not exert. Take good rest.
    7. Eat fish
    8. Sesame seed paste (mix with milk shake/yogurt)
    9. MUST: Have this “muscle builder” supplement 3 times a day for 5 days (no more): “Carnitin Ornitate” (may be available under different brands).
    10. Get a good protein supplement with essential amino acids.

    According to our doctor, the recovery would take a month or two.

    This post may help others to cope with the after effects. The treatment may already be known to many doctors but I could not find any on the net. Hence the posting.

    Always consult a “really good expert” specializing in Internal Medicine and Immunology. I mean the type of doctors (a rarity these days) who have not yet lost their brains (and heart), who try to understand things in terms of the underlying body chemistry and keep themselves updated with research and open issues. If you think the doctor is not paying attention to the effects/suffering and is dismissing you after routine stuff, change the doctor immediately. He/she probably does not know any more than what has been spoon-fed by the Merck/GSK sales folks.

    And when you recover, get together with others and sue the living daylights out of GSK and Merck. I am very sure they fudged/cooked their clinical trial reports or what they tried is not what they are selling. Enron of medicine? Why not. The vaccine may or may not be effective against HPVs (time will tell) but the way they have set the dose and the turbo-charged it with the adjuvents, definitely does not suit all human beings.

    PS. If your body already shows such a violent reaction, do not go for the next injections. Your immune system will remember this viral-protein till you die at a ripe old age.

  29. Anwar said on Wednesday, March 24, 2010, 18:03

    In which age we can take this vaccine?Plz
    ..send me cost and side effect of cervarix .where do it will be available in Patna (Bihari)

    .

  30. Neeta said on Tuesday, April 27, 2010, 13:58

    I have one question: I am 28 year old…in my office they are conducting one Cervical Cancer Vaccination camp as above mentioned the age group should be 9-26 yrs, then it is advisable for me?

  31. sukoon said on Thursday, May 20, 2010, 17:10

    i am 21 years old.i want to know if i can still go for the vaccine for cervical cancer and it’ll be effective even after first time sex if there was abnormal bleeding for a day?

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