In twin votes likely to add considerable force to U.S. marketing efforts for HPV vaccines, an FDA expert panel has voted to back GlaxoSmithKline’s long delayed application to market its HPV vaccine Cervarix to women and soon after supported Merck’s application to extend the use of Gardasil to males. Glaxo shares gain 0.5 pct, Merck shares gain 1.9 pct.

Glaxo had originally tried and failed to gain FDA approval for Cervarix back in 2007 but was thwarted by the agency’s desire to see more information on potential side effects, particularly a heightened risk of miscarriage. Since that time the pharma giant has gained approvals in more than 100 countries, while biding its time with the FDA. And while the panel concluded that the link between Cervarix and miscarriages is tenuous, the experts suggested a warning to prevent pregnant women from getting the vaccine. The panel vote makes it all but certain that Glaxo will gain final marketing approval from the FDA, opening the door to the world’s biggest drug market and finally offering Merck some competition for Gardasil. Glaxo’s shares were buoyed by the news.

Food and Drug Administration advisers, in an 11-1 vote, said Cervarix appeared safe despite miscarriages reported around the time of vaccination and a small number of autoimmune problems such as rheumatoid arthritis and lupus. Panelists urged monitoring for those issues after approval to see if there was any link to the vaccine.Merck, meanwhile, is seeking an FDA approval to use its HPV vaccine to guard against genital warts in boys and men. The panel gave Merck its support, but there was widespread agreement that the use of an HPV vaccine for males 9 to 26 offered little protection against cancer, as HPV-related penile and anal cancer cases are extremely rare. The FDA has indicated that any final approval on Gardasil’s use in males will require post-marketing safety studies.

Check out full story in  the Los Angeles Times
Read  Reuters Report

©2012 An Inconvenient Woman. All Rights Reserved.

When GlaxoSmithKline announced that it would unveil head-to-head trial data on its HPV vaccine long after the fact and at a lesser-known meeting, folks speculated that the drugmaker might be embarrassed of the trial’s outcome. Not so–emphatically not so. The company trumpeted the comparative study, saying that its Cervarix vaccine prompted a much stronger immune-system response than Merck’s Gardasil did.

The Glaxo shot generated two times as many antibodies for one HPV strain than Gardasil did, the data showed, and more than six times as many for another. Plus, Cervarix  patients produced 2.7 times more memory B cells for HPV than patients who received the Merck vaccine. Another study due to be presented at the same conference found that Cervarix provided sustained antibodies against HPV through more than seven years of follow-up, the company said.

“The presence of neutralising antibodies at the location of the infection (the cervix) appears to be an important part of vaccine-induced protection against HPV,” said Glaxo’s R&D chief Thomas Breuer in a statement. “This study offers the first evidence that these two vaccines do not generate the same immune response.”

Merck was ready to rumble though; the Gardasil maker said that the comparative data isn’t clinically relevant because there’s no evidence a higher immune response actually made much difference to the long-term risk of developing cancer, Reuters reports. Sanofi Pasteur MSD, a joint venture between Merck and Sanofi that sells Gardasil in Europe, also got into the act: ”We see no clinical relevance in the results of this study … and we don’t see the point of doing such a comparison,” Bennett Lee, medical director, told the wire service. “If you want to compare vaccines, you compare clinical efficacy.”

Nonetheless, it’s something of a coup for Glaxo, which was betting the farm on Cervarix when it chose to pit its HPV shot against Merck’s. Now if only Glaxo can get Cervarix past the FDA, then it will really have a fight with Merck on its hands.

©2012 An Inconvenient Woman. All Rights Reserved.

Issued: Friday 8 May 2009, London, UK & Malmö, Sweden

Key results from three important studies of the cervical cancer vaccine, Cervarix®, will be available as of today at the 25th International Papillomavirus Conference (IPV) in Malmö, Sweden.

Comparative trial of Cervarix® and Gardasil® (Study 010)
Results from the first, large-scale comparative trial between licensed human papillomavirus (HPV) vaccines show that Cervarix® generated a significantly higher immune response compared to Gardasil® .1 The comparative study looked at two key measures of immune response, neutralising antibodies and memory B cells. Although the post-vaccination immune correlates of protection for cervical cancer are still unknown, neutralising antibodies and B cells are believed to play an important role in protecting women from HPV infection and subsequent cervical cancer over the long term.2-7 Across all ages studied (women 18 – 45 years), neutralising antibody levels for Cervarix ® were more than two times higher than those for Gardasil ® for HPV type 16, and more than six times higher for HPV type 18. These results were highly statistically significant  (p<0.0001).1 In addition, the proportion of women with detectable levels of neutralising antibodies in cervical secretions was higher in the group that received Cervarix® .1 Compared toGardasil® , GSK’s vaccine also produced nearly three (2.7) times more memory B cells for HPV types 16 and 18.1

Compliance with the full vaccination course was high and comparable for both vaccines8 which indicates that both were well tolerated. Rates of solicited symptoms were higher for Cervarix® with injection site reactions being most common.8 However, in both groups solicited symptoms tended to be of short duration. It is expected that the full results from this comparative study will be published in a peer reviewed journal.

Thomas Breuer, Head of Global Clinical R&D and Chief Medical Officer of GSK Biologicals commented: “The presence of neutralising antibodies at the location of the infection (the cervix) appears to be an important part of vaccine-induced protection against HPV. This study offers the first evidence that these two vaccines do not generate the same immune response against HPV types 16 and 18, the two most common cancer-causing virus types. We are confident that these results, along with new results from additional key studies being presented this week, demonstrate the potential of Cervarix® .”

Phase III efficacy trial (Study 008)
Results from the final analysis of the Phase III study (HPV-008) will be presented for the first time at the conference, showing that Cervarix® provided a high and statistically significant level of efficacy against pre-cancerous lesions associated with each of the HPV types included in the vaccine (HPV 16 and HPV 18).9  In addition,the data demonstrated that the vaccine also provided type-specific protection against pre-cancerous lesions associated with some additional common cancer-causing HPV types other than HPV 16 and HPV 18.10 In women without evidence of prior cancer-causing HPV infection the overall efficacy demonstrated against any lesion, regardless of HPV type, was much greater than would be expected for a vaccine targeting only HPV types 16 and 18.11

Rates of serious adverse events and medically significant conditions were similar between study and control groups.9 These data have been submitted to regulatory authorities including the US FDA and publication is expected in a peer reviewed journal.

Long term follow up study (Study 023)
Results from a third study to be presented in Malmö show that GSK`s cervical cancer vaccine provided high and sustained antibody levels against HPV 16 and HPV 18 through the 7.3 years of follow up after vaccination. This is the longest follow up reported to date for any licensed HPV vaccine.12

Jean Stéphenne, President and General Manager of GlaxoSmithKline Biologicals said, “Preventing cervical cancer is a public health priority in both developed and developing countries. We are pleased with these findings and how they can further the understanding of the role of Cervarix ® in helping to protect women against cervical cancer.”

Notes to editors

About HPV 008
The efficacy and safety results from the interim analysis of the HPV 008 study were previously published in The Lancet.13 The data presented at the 25th International Papillomavirus Conference (IPV) are from the final event driven analysis. Further follow up results will be forthcoming from the end of study analysis in due course.

About the HPV vaccines
Cervarix ® provides protection against the most common cancer-causing virus types – HPV 16 and 18.9 Gardasil ® provides protection against HPV 6, 11, 16 and 18.

Cervarix ® was specifically designed with a novel adjuvant, AS04, to deliver high and sustained levels of antibodies aimed at providing long-term protection against the most common and aggressive HPV types.14 It has been shown to be generally well tolerated. The most common symptoms after vaccination included pain, redness and swelling at the injection site.15

To date, GlaxoSmithKline’s HPV- vaccine, Cervarix ® has been approved in 95 countries around the world, including the 27 member states of the European Union (EU), Australia, Brazil, South Korea, Mexico and Taiwan. Licensing applications have been submitted in more than 20 additional countries including Japan and the United States. GSK also submitted the vaccine to the World Health Organization (WHO) for prequalification in September 2007.

About HPV and cervical cancer
Women are at risk of HPV infection throughout their sexually active lives.16 Approximately 100 types of human papillomavirus have been identified to date17 and, of these, approximately 15 virus types are known to cause cervical cancer.18 HPV types 16 and 18 are responsible for approximately 70 percent of cervical cancers globally, with types 45, 31 and 33 among the next most common cancer-causing HPV strains.19,20 Persistent infection with cancer-causing HPV types can lead to abnormal Pap smears, cervical pre-cancer and cervical cancer. Worldwide, more than 500,000 women will be newly diagnosed with cervical cancer21 and 280,000 women will die from it each year.21

GlaxoSmithKline Biologicals - GSK Biologicals, GlaxoSmithKline’s vaccines business, is one of the world’s leading vaccine companies and a leader in innovation. The company is active in the fields of vaccine research, development and production with over 30 vaccines approved for marketing and 20 more in development. Headquartered in Belgium, GSK Biologicals has 13 manufacturing sites strategically positioned around the globe. In 2008 GSK Biologicals distributed 1.1 billion doses of vaccines to 176 countries in both the developed and the developing world – an average of 3 million doses a day.

Through its accomplished and dedicated workforce, GSK Biologicals applies its expertise to discover innovative vaccines that contribute to the health and well-being of people of all generations around the world.

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com

Cervarix ® is a registered trademark of the GlaxoSmithKline group of companies.

Gardasil ® is a registered trademark of Merck & Co., Inc.

©2012 An Inconvenient Woman. All Rights Reserved.

As Glaxo is forced to wait for FDA’s approval for its own HPV vaccine, Cervarix, will the company use its time on the sidelines to absorb lessons learned from Merck’s missteps? There is a building backlash against Merck’s ‘BIG-FOOT’, political lobbing strategy that aggressively pushes politicians to mandate its vaccine. Merck has pushed through from one political firestorm to the next. An increasing resentful public is feeling like Atlanta to Merck’s Sherman-like march to market share.

Preparing for its FDA review, Glaxo tested the Cervarix vaccine on nearly 30,000 girls and women, ranging in age from 10 to 55 years old. An effectiveness trial involved 18,000 girls and women between 15 and 25 years old.

Independent medical researchers and financial analysts believe Glaxo’s Cervarix will have a slight edge over the Gardasil product. However, given how Merck has muddied the waters with political controversy and been accused of predatory marketing, the Cervarix HPV-vaccine will draw more scrutiny.

Once Cervarix wins FDA approval, the real question is; Will Glaxo be tempted to follow the Merck marketing model? Or will the Glaxo rollout team let the product’s efficacy speak for itself?

©2012 An Inconvenient Woman. All Rights Reserved.

Cervarix won out over Merck’s Gardasil in the Netherlands, but has yet to be approved in the United States. That makes European market penetration vital for Glaxo.

“We are delighted with this decision and the fact that since Cervarix received European approval it has been selected as the cervical cancer vaccine for more than half of eligible tenders across Europe,” said Eddie Gray, president of Pharmaceuticals Europe for GSK. “We look forward to working with the Netherlands Vaccine Institute.” Globally, cervical cancer is the second leading cause of cancer death among women.

- check out GSK’s release

©2012 An Inconvenient Woman. All Rights Reserved.

GlaxoSmithKline’s (GSK) cervical cancer vaccine, Cervarix TM, was today confirmed by the Netherlands Vaccine Institute (NVI) as the cervical cancer vaccine for the Dutch National Immunisation Programme (NIP). GSK will supply Cervarixfor the programme, which aims to vaccinate all 12 year old girls.   A catch-up programme for all girls aged 13 to 16 will also start within the first half of 2009, with the aim of reducing the risk of HPV infection and cervical cancer for a broader group of Dutch girls.  The National programme for girls aged between 12 and 13 will commence in September 2009. It is estimated that more than 350,000 girls in total will be vaccinated with Cervarix in the first year.

“We are delighted with this decision and the fact that since Cervarix received European approval it has been selected as the cervical cancer vaccine for more than half of eligible tenders across Europe,” said Eddie Gray, President of Pharmaceuticals Europe for GSK.  “We look forward to working with the Netherlands Vaccine Institute to support the successful implementation of the Public Health vaccination programme so that girls in the Netherlands will benefit from the effective and sustained protection against cervical cancer which Cervarix offers.”

Cervarix has been designed specifically to protect against cervical cancer and has demonstrated high protection against HPV 16 and 18, which are responsible for approximately 70% of cervical cancers1 worldwide. With clinical data from over 6 years of follow-up, Cervarix has the longest duration of protection reported for any HPV vaccine to date.

In the Netherlands, the cervical cancer NIP has been added to the existing National Screening Programme that recommends women of 30 years and over have a PAP-smear test every five years in order to combat cervical cancer.  It is estimated that nationally, up to 700 women are diagnosed with cervical cancer and more than 200 die from the disease each year, making it the second biggest killer of women after breast cancer.2 Cervical cancer is the second leading cause of cancer death among women globally, killing one woman every two minutes.3,4 As well as the deaths associated with the disease, cervical cancer and pre-cancerous lesions are also a significant cause of emotional and physical distress in women.5Alongside screening and a healthy lifestyle, vaccination is expected to significantly reduce the lifetime risk of cervical cancer.6

Notes to Editors

About the Dutch National Immunisation Programme

From 2009, cervical cancer vaccination will be routinely recommended for all girls between 12 and 13 years of age (first year of secondary education). There will also be a catch-up programme in the first half of the year where girls aged 13 to 16 years will be offered the vaccine. Cervarix TM was selected as the cervical cancer vaccine for the Dutch National Immunisation Programme.

About cervical cancer and its progression

Approximately 100 types of HPV have been identified to date7 and, of these, approximately 15 virus types are known to cause cervical cancer.1 Virus types 16 and 18 are responsible for approximately 70% of cervical cancers.1 Persistent infection with cancer-causing virus types can lead to the formation of abnormal cells in the cervix, which, over time, may become precancerous or cancerous.8 Throughout their sexually active lifetime, women may be exposed to cancer-causing virus types. The majority of women will clear an infection spontaneously.  However, if the infection persists it can lead to precancerous lesions or cervical cancer.9

Experts believe that neutralising antibodies – so-called because they have the ability to neutralise cancer-causing virus types and prevent them from infecting cells in the cervix – are essential for cervical cancer protection, post-vaccination.10-12 The World Health Organization (WHO) states that neutralising antibodies are the likely mediatorof vaccine-induced protection from infection.11,12

Worldwide, more than 500,000 women will be newly diagnosed with cervical cancer and over 280,000 women will die from it each year.4

About the GSK Cervical Cancer Vaccine

CervarixTM has been specifically designed by GSK to provide women with protection against cervical cancer, targeting the two human HPV types, 16 and 18, that are responsible for over 70% of cervical cancer.1

To-date, GSK’s cervical cancer vaccine has been approved in more than 80 countries around the world including the 27 member countries of the European Union, Mexico, Australia, Singapore and the Philippines. Licensing applications have been submitted in more than 30 additional countries including Japan. In September 2007, GSK submitted CervarixTM to the WHO for prequalification, towards distribution across the developing world via the United Nations and the GAVI Alliance. GSK also submitted a Biologics Licence Application (BLA) to the U.S. Food and Drug Administration (FDA) for CervarixTM in March 2007.

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com

GSK Biologicals (GSK Bio) -  is a global vaccine company which has shown itself to be a leader in innovation. The company is active in the fields of vaccine research, development and production with over 30 vaccines approved for marketing and 20 more in development. Headquartered in Belgium, GSK Bio has 14 manufacturing sites strategically positioned around the globe. GSK Bio employs over 9,000 people worldwide including more than 1,600 passionate scientists engaged in research aimed at developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems worldwide. In 2007, GSK Bio distributed 1.1 billion doses of vaccines to 169 countries in both developed and the developing world – an average of 3 million doses a day. Of those vaccine doses, more than one in every ten doses delivered were combination vaccines intended to prevent up to six diseases in one vaccine.

CervarixTM is a trademark of the GlaxoSmithKline group of companies.

©2012 An Inconvenient Woman. All Rights Reserved.

Issued – Monday 30 June 2008, London, UK & Philadelphia, US

GlaxoSmithKline today provided the following update regarding its application to the U.S. Food and Drug Administration (FDA) for approval of Cervarix^®, its vaccine to prevent cervical cancer.

GSK has submitted its response to questions raised by the FDA in their Complete Response Letter, received in December, 2007.  In addition, given that final data from GSK’s Phase III pivotal efficacy study, HPV-008, are expected to be available later this year, GSK has decided to augment its application for approval with these data to ensure they are included in the U.S. label. GSK anticipates submitting these data in the first half of 2009. The timing depends on reaching a certain number of cases in order to conduct the final analysis. An FDA action on the application is expected to take up to six months following this submission. Interim data from this study were filed in the original application for the vaccine in March, 2007. The company does not expect that new clinical studies will be required for approval.

“Study 008 is a key study that will be completing later this year, and we expect the final results will strengthen the U.S. label for Cervarix,” said Barbara Howe, M.D., Vice President and Director, North American Vaccine Development, GlaxoSmithKline. “We continue to have positive and productive discussions with the FDA and remain confident in the vaccine’s safety and efficacy profile. We look forward to bringing this important new cervical cancer vaccine to girls and women in the U.S.”

To date, GSK’s cervical cancer vaccine has been approved in 67 countries around the world including the 27 member countries of the European Union, Mexico, Australia, Singapore and the Philippines. Licensing applications have been submitted in more than 35 additional countries including Japan. GSK also submitted the vaccine to the World Health Organization (WHO) for prequalification in September 2007.

Notes to editors

Burden of cervical cancer
Worldwide, more than 500,000 women will be newly diagnosed with cervical cancer and over 280,000 women will die from it each year.¹ In the United States, after breast cancer, cervical cancer is the second leading cause of cancer death in women ages 20 to 39.²

About GlaxoSmithKline
GlaxoSmithKline—one of the world’s leading research-based pharmaceutical and healthcare companies—is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, please visit www.gsk.com/media.

GlaxoSmithKline Biologicals (GSK Biologicals) is a leading global vaccine manufacturer committed to preventing disease in people of all ages with innovative vaccines and delivery systems. The division, headquartered in Belgium, is active in vaccine research, development and production with more than 30 vaccines currently available globally and 20 more in development. In 2007 GSK Biologicals distributed 1.1 billion doses of vaccines – an average of 3 million doses a day.

Cervarix^® is a registered trademark of the GlaxoSmithKline group of companies.

GSK cautionary statement regarding forward-looking statements
Under the safe harbour provisions of the U.S. Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this Announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group’s operations are described under ‘Risk Factors’ in the ‘Business Review’ in the company’s Annual Report on Form 20-F for 2007.

References:

1.       World Health Organization. Initiative for Vaccine Research.  Accessed on May 2, 2007.

2.       Jemal A, Murray T, Ward E, Sammuels A et al. Cancer Statistics, 2005. Cancer Journal for Clinicians 2005; 55; 10-30

This press release is intended for business journalists and analysts/investors. Please note that this release may not have been issued in every market in which GSK operates.

©2012 An Inconvenient Woman. All Rights Reserved.

Glaxo, still struggling to overcome the Avandia diabetes pill controversy and subsequent lost revenue, has been dealt another blow by the FDA. The agency has issued a “complete response letter” to Glaxo for its Cervarix vaccine. It is unclear whether the FDA will require additional clinical trials for Cervarix.  The unexpected delay in approval could last as little as six-months or as long as two-years.

“We have already started addressing the questions and will be engaged in discussions with the FDA to finalize our responses,” says Barbara Howe, VP and Director for Glaxo’s North American vaccine development, says in a statement. “Our discussions with the agency continue to be positive and constructive, and we are working diligently to resolve any outstanding questions to bring CERVARIX the U.S. market.

Cervarix is one of Glaxo’s biggest new meds and is already approved in 45 countries, including the European Union. The US market remains its most important battleground, where the drugmaker already trails Merck and its Gardasil vaccine for the human papillomavirus that leads to cervical cancer. Gardasil targets four strains of HPV – including two causing cancer and two causing genital warts, while Cervarix targets only the two cancer strains.

What we don’t want, is the FDA saying. we want to see new data because that would  potentially add in one to two years, Navid Malik, an analyst at Collins Stewart in London, tells Bloomberg News.  It would be disappointing if the delay was substantial, but it could be something like a six-month delay if the FDA only wants relatively minor information.

©2012 An Inconvenient Woman. All Rights Reserved.

The FDA’s approval for the ‘other’ HPV-vaccine, Cervarix is still delayed. GlaxoSmithKline, the world’s second-largest drugmaker, requested a ‘priority’ review, potentially prompting an approval decision and sale of the Cervarix vaccine by the end of 2007, said James Tursi, Glaxo’s director of medical affairs for cervical cancer vaccines, at a medical meeting in San Diego.

Glaxo filed for U.S. clearance for Cervarix in March, nine months after Merck won approval for Gardasil, which generated $365 million in sales in first quarter 2007. Gardasil, which protects against the Human Papillomavirus, Or HPV, is one of Merck’s most important new products as it seeks to offset $800 million in lost sales from its cholesterol pill Zocor, which lost patent protection in 2006.

“Gardasil and Cervarix are both nearly 100 percent effective against the two types of HPV that cause the majority of cervical cancer cases,” said Kevin Ault, an obstetrician and gynecologist at Emory University in Atlanta who has worked as a consultant for both companies. “Based on the data we have right now, I would say much of the choice could come down to price.”

Shares of Glaxo, based in London, fell 43 cents to $57.39 at 4 p.m. in New York Stock Exchange composite trading. The stock of Merck, based in Whitehouse Station, New Jersey, fell 19 cents to $52.05.

Both vaccines protect against forms of HPV that can cause 70 percent of cervical cancer cases.

Vaccine Costs

Gardasil, given in a series of three shots, costs $120 per injection. Glaxo hasn’t disclosed how much it will charge for Cervarix. The vaccines may compete for as much as $8 billion in annual revenue by 2010, analyst Navid Malik of Collins Stewart in London said in a research note in March.

Generally, the FDA grants priority review to products that serve unmet medical needs. Regulators take about six months to review drugs granted priority designation, compared with at least 10 months for products under standard review.

Glaxo discussed selected test results for Cervarix yesterday at a meeting of the American College of Obstetricians and Gynecologists. The data were first reported last week at a medical meeting in Portugal.

In women aged 15 to 55, Cervarix protected against the two HPV types that are most responsible for cervical cancer for at least 18 months at the site of infection on the cervix, Glaxo said today.

10 Years of Immunity

“We estimate, based what we know now about how the vaccine works, that it can provide immunity for 10 years,” said Tino Schwarz, study author and head of the Central Laboratory at the Stiftung Juliusspital, Academic Teaching Hospital of the University of Wuerzburg in Germany.

The vaccine was 100 percent effective for as much as 5.5 years against types 16 and 18 of the human papillomavirus that causes cervical cancer and maintained an immune response at least 11 times natural levels, Glaxo reported in April.

Cervarix protected against HPV types 45 and 31 for the same duration, was 68 percent effective against pre-cancerous lesions and was 38 percent effective against abnormal Pap smears, Glaxo said. The four strains cause 80 percent of cervical cancers.

Cervical cancer is the second-most common cancer among women and kills 250,000 women a year, according to the World Health Organization. HPV, which causes cervical cancer, is a sexually transmitted virus, so the goal is to vaccinate girls before they become sexually active.

500,000 Cases

About 500,000 cases of the disease are reported every year, 80 percent of them in developing countries, the Geneva-based agency said. About 10,000 women were diagnosed with cervical cancer in the U.S. in 2006 and nearly 4,000 died from the disease, according to the American Cancer Society.

While the two vaccines are similar, there some differences. Gardasil is also designed to work against two strains of HPV that cause genital warts. Cervarix uses a booster that may make it last longer.

Both products use vaccine boosters called adjuvants, a substance which enhances the ability of an antigen to stimulate the immune system. Antigens are foreign substances in the body that cause the immune system to form an antibody that responds only to that particular antigen.

Merck’s Gardasil uses a traditional aluminum adjuvant. Glaxo’s Cervarix uses a proprietary adjuvant known as AS04, which the company is seeking to prove makes its vaccine better.

Stronger Immune Response

A study published in the journal Vaccine last year found the immune response to Glaxo’s vaccine was stronger and more sustained when made with AS04 than when made with the conventional adjuvant.

Glaxo will present more detailed data on Cervarix next month at a meeting of the American Society of Clinical Oncology.

Gardasil has drawn some controversy since the Merck drug was approved. Groups, including the conservative political organization Focus on the Family, have opposed making the vaccine mandatory because HPV isn’t spread by casual contact like the germs that cause measles or polio. The American Academy of Pediatrics also said there wasn’t enough funding to pay for the $360 vaccine or public acceptance to make it a requirement.

Among growing criticism, Merck said in February it would stop lobbying state officials to require that girls receive the company’s cervical cancer vaccine before they can attend school

Source: Bloomberg News

©2012 An Inconvenient Woman. All Rights Reserved.