Talk:Cervarix

Merge?

I think Ceravarix deserves its own article. Just the section "Social issues" should be merged into HPV vaccine. —Remember the dot (t) 18:40, 26 January 2007 (UTC)

Since no one has replied, I went ahead and merged the "Social issues" section into HPV vaccine#Controversy and removed the proposed merge tag. —Remember the dot (t) 04:40, 5 February 2007 (UTC)

Cancer Vaccine Indication: not just for young women

I think it is incorrect to say: "This means that a woman who is already infected with HPV will not benefit from this treatment."

I think this is too generic, as there is more than one strain of HPV. If a woman is infected with one strain of HPV, she may still benefit from the vaccination, as it may protect against the strains she is not infected with.

202.129.81.153 01:21, 26 April 2007 (UTC)

Also, the vaccines do help women who are already infected get rid of the infection. It is right and proper that the phrase be removed. Darkfrog24 21:35, 11 May 2007 (UTC)

There is no evidence that Cervarix or Gardasil are beneficial in protecting from or helping clear previous infections with the HPV types covered by the vaccine. They may protect against future infections with other covered types. Thus, Vaccinating women who are already infected with covered types is less effective and less cost-effective than vaccinating those who have not been infected. Zodon (talk) 01:36, 31 October 2008 (UTC)

Basis of UK selection of Cervarix over Gardasil

At this point the claim that UK based their selection of Cervarix over Gardasil on relative duration of protection appears to be speculation. It contradicts the one source that covers this topic in the article. Please provide sources to support the claim if you want to add it. (Evidence is lacking both that Cervarix provides longer protection, and the claim that in this specific case that was a consideration). Thanks. Zodon (talk) 01:30, 31 October 2008 (UTC)

Controversial?

This reference has been removed from the main text, where it was placed inside the first passage of the article. "controversial ".

The reference does not qualify the characterisation that the vaccine is controversial. The vaccine has been introduced in many countries with highly developed health care systems. It can a subject of discussion whether or not the vaccine is controversial, but I find it hard to believe that this should be highlighted in the first passage in the article. Lipothymia (talk) 12:20, 29 September 2009 (UTC)

In the light of the death of a 14 year old girl shortly after vaccination with Cervarix this (re-) ignited the debate about whether Cervarix or Gardasil should be prescribed in the United Kingdom. There was a note already in the article that said "by whom" when the article stated that there was some controversy about the use of Cervarix. There has been considerable discussion in the UK media about the difference whereby Cervarix protects against HPV types 16 and 18 and Gardasil protects against these variants and also variants 8 and 11 one the one side and that it cost more per dose on the other. This appears to be the controversy as at this time. Soarhead77 (talk) 13:13, 29 September 2009 (UTC)

References

Cancer jab girl 'died of tumour'

A girl who was vaccinated against cervical cancer died from a malignant tumour and not from a reaction to the jab, it has been revealed. (http://news.bbc.co.uk/2/hi/health/8284517.stm) 60.49.111.200 (talk) 10:55, 1 October 2009 (UTC)

Because kids fall over dead all the time from undiagnosed chest tumors. I have a bridge to sell you. 98.192.200.202 (talk) 04:17, 5 October 2009 (UTC)

No, kids don't fall over dead all the time from undiagnosed chest tumors, but a lot of kids get vaccines, and at least one of them had an undiagnosed chest tumor.Keepstherainoff (talk) 16:06, 26 July 2010 (UTC)

Section "Lead researcher comes out against vaccines"

This section is clearly not neutral, and barely related to Cervarix. I say take it out. --Apoc2400 (talk) 16:51, 12 January 2010 (UTC)

I won't get into this but I point this interview.--Nutriveg (talk) 18:23, 12 January 2010 (UTC)

Huffington Post isn't normally very reliable. --Apoc2400 (talk) 18:41, 12 January 2010 (UTC)

I don't see much they could change from that statement. Anyway, similar content, from a different source.--Nutriveg (talk) 19:17, 12 January 2010 (UTC)

I don't know who Dr. Diane Harper is, but as you can see from the redlink, she's apparently not notable enough to have a Wikipedia bio. In my view, it's reasonable to conclude that quoting her in this article violates WP:UNDUE. --Steven J. Anderson (talk) 01:45, 22 January 2010 (UTC)

Also, please see this link where Harper disavows negative comments about Cervarix attributed to her. --Steven J. Anderson (talk) 02:10, 22 January 2010 (UTC)

I will also point out that whoever titled the section "Lead researcher comes out against vaccines" was (how do I put this?) not being truthful. At no point did Dr. Harper "come out against" either Gardasil or Cervarix. She simply expressed a disagreement about the way one of them (Gardasil) was being marketed and promoted, and believes that more stringent warnings should be attached to it. --Steven J. Anderson (talk) 02:18, 22 January 2010 (UTC)

I am now deleting the entire section since Dr. Harper has been clear about the fact that her criticisms are directed at the marketing of Gardisil only, not Cervarix. As far as I can tell, she's never said anything about Cervarix apart from disavowing the Express story to the Guardian. --Steven J. Anderson (talk) 02:27, 22 January 2010 (UTC)

Wikipedia doesn't retain all the knowledge of the world and shouldn't be used as a self-reference. She is widely cited and wasn't hired by those two companies for nothing. I don't care very much about this to propose a change, but she did criticize HPV vaccines as a whole.

Harper, D. (2009). "Current prophylactic HPV vaccines and gynecologic premalignancies" (pdf). Current opinion in obstetrics & gynecology. 21 (6): 457–464. doi:10.1097/GCO.0b013e328332c910. PMID 19923989.

Nutriveg (talk) 11:46, 22 January 2010 (UTC)

As you can see from reading my previous comments, I never suggested that Wikipedia should be used as a self-reference. If you will look at the link I posted, you'll see that Harper specifically, categorically disavowed the comments about Cervarix attributed to her. And as for the study you just linked to, here's the summary:

The benefits and risks of vaccination must be weighed with the benefits and risks of screening to reduce cervical cancer in a cost-effective manner.

Mercy, what a brutal attack. --Steven J. Anderson (talk) 12:56, 22 January 2010 (UTC)

The link you posted is a newspaper, the one I posted is a scientific review.

It's "criticism". The article is not a primary source so we don't need to restrict just to its conclusions. Did you actually read the article and think these phrases are well represented in the current text?

"Without continued screening the number of cancers preventable by vaccination alone is less than the number of cancers prevented by regular screening alone.""No efficacy trials for children under 15 have been performed.""Duration of vaccine efficacy is not yet answered by rigorous methodologic trials. Cervarix efficacy is proven for 7.4 years with published data through 6.4 years.""Age of vaccination is less important than the duration of efficacy".

Where they are particular to Gardasil?--Nutriveg (talk) 16:07, 22 January 2010 (UTC)

Actually, selecting quotes and using them to come to a different conclusion than the source is explicitly defined as original research: "Do not... imply a conclusion not explicitly stated by any of the sources." Novangelis (talk) 19:47, 22 January 2010 (UTC)

(edit conflict)Did you read the article? The article is a review, most of these quotes are in fact citations of primary sources. I'm not reaching a different conclusion I'm just exposing the negative points.--Nutriveg (talk) 20:03, 22 January 2010 (UTC)

The study is a primary source. The newspaper article is a secondary source. Secondary sources are preferred on Wikipedia because, among other things, they contextualize primary sources. Harper has never said that either of the vaccines should not be used. She has never said that either should be pulled from the market. She has never said that either is ineffective. She has never said that either is dangerous. She has never said that Cervarix is overmarketed. The statements you quote from her paper are fairly typical, pedestrian caveats of the kind that can be applied to any medication, including vaccines. Do you have anything to say about how this article can be improved? --Steven J. Anderson (talk) 20:01, 22 January 2010 (UTC)

The review I posted is a secondary source. Newspaper articles are usually less preferred in Medical articles. Her (study) did criticize vaccines as a hole, bringing negative points that are not taken in account, like it being less efficient than screening, age of administration. These critics are not specific to Gardasil, that's what I said. I will edit the article to point this facts.--Nutriveg (talk) 20:24, 22 January 2010 (UTC)

I have no substantial objections to your most recent edit. --Steven J. Anderson (talk) 20:56, 22 January 2010 (UTC)

Propose new section in Cervarix Article for Important Safety Information

{{Request edit}} Not done: --ANowlin: talk 21:20, 31 July 2010 (UTC)

Not done for now: This request has been sitting for quite a while now, but that is beside the point. If this information could be included, a source would be needed, and not just a message on a talk page. --ANowlin: talk 13:39, 28 July 2010 (UTC)

Hi, the source for the information below is from the Cervarix prescribing information and is released with a Creative Commons license per below. Does this help? Thanks.Maitri Shah, PharmD, GSK (talk) 15:06, 28 July 2010 (UTC)

Not done for now: Unfortunately, that is a first-party source, which could result in a conflict of interest. Is there a reliable third-party source (or sources) that includes that information, such as a medical journal article, or other publication? Possibly FDA documentation that is publicly available? --ANowlin: talk 01:34, 30 July 2010 (UTC)

Hi Anowlin. This information is also available on fda.gov. I have included this reference as part of the proposed new section below. Thank you. Maitri Shah, PharmD, GSK (talk) 14:03, 30 July 2010 (UTC)

Not done: I'm sorry. I looked over this again, and it just doesn't appear to be something that would be generally included in Wikipedia. I'm not familiar with medical articles, so I'm not 100% sure if this is the case, but I've not found any other article so far that include a section like that. You might want to take this up with WikiProject: Medicine, and discuss this with them. Again, I'm sorry. --ANowlin: talk 21:20, 31 July 2010 (UTC)

Hi Anowlin, I have taken a new approach, please see bottom of this posting. Maitri Shah, PharmD, GSK (talk) 18:03, 2 August 2010 (UTC)

Done That works. I guess I wasn't looking for something like that. --ANowlin: talk 01:47, 3 August 2010 (UTC)

Thank you Anowlin. I went in and made a minor modification to move the adverse events and contraindications into their own sections and changed minor typos (non-controversial edits). Maitri Shah, PharmD, GSK (talk) 18:18, 3 August 2010 (UTC)

My name is Maitri Shah, PharmD, and I work for GlaxoSmithKline Pharmaceuticals (GSK) in the United States as a Medical Information Scientist. My intent is to provide information to the editors of Wikipedia for their use in Cervarix related articles to help ensure that healthcare professionals in the United States receive accurate and balanced scientific information.

Please visit my User Page for information regarding my intentions for engagement on Wikipedia in alignment with the Wikipedia Conflict of Interest Principle. Any potential side effects of Cervarix or other GSK prescription drugs should be reported to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

I would like to propose that a new section be added to the Cervarix article that includes the important safety information for Cervarix. Below I have included important safety information, which has been summarized from the US prescribing information:

Proposed New Section: Important Safety Information

Cervarix is contraindicated in patients with severe allergic reactions to any component of the vaccine. Safety has not been established in pregnant women. Register women who receive Cervarix while pregnant in the pregnancy registry by calling 1-888-452-9622. Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with Cervarix. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position. The tip cap and the rubber plunger of the needleless prefilled syringes contain dry natural latex rubber that may cause allergic reactions in latex-sensitive individuals. Alternative is the single dose vial, in which the vial stopper does not contain latex. The most common local adverse reactions and general adverse events in ≥20% of patients were pain, redness, and swelling at the injection site, fatigue, headache, myalgia, gastrointestinal symptoms, and arthralgia. Vaccination with Cervarix may not result in protection in all vaccine recipients.

End of Proposed New Section

The Important Safety Information for Cervarix above is available for modification and reuse under the terms of the Creative Commons Attribution-Sharealike 3.0 Unported License and the GNU Free Documentation License (unversioned, with no invariant sections, front-cover texts, or back-cover texts). Maitri Shah, PharmD, GSK (talk) 16:18, 28 June 2010 (UTC)

Note to the Editors: Please note that the following statement from the introductory section of the article is not part of the U.S. FDA-approved package insert, also described as the “labeling”.

Cervarix is also formulated with AS04 (Adjuvant System 04), a proprietary adjuvant, that has been found to boost the immune system response for a longer period of time. Maitri Shah, PharmD, GSK (talk) 19:59, 16 June 2010 (UTC)

Also, I would like to note that the only HPV type that demonstrated statistical significance in the analysis of the 12 other oncogenic types in the Phase III clinical trial was HPV type 31. Maitri Shah, PharmD, GSK (talk) 19:31, 28 September 2010 (UTC)

Hi Maitri, we don't provide advice here or are a textbook so it's unlikely your suggestion will be included that way, but maybe some user (I don't edit this article much) will someday take a look in your points and complement the current Wikipedia article if he think any of these points aren't already well represented. Thank you.--Nutriveg (talk) 02:54, 16 June 2010 (UTC)

The one issue with the above text is that its copyright is not clear. Is the above text released into the CC? Doc James (talk · contribs · email) 16:57, 16 June 2010 (UTC)

Hi Nutriveg, thank you for responding. I think that it is important to add important safety information to ensure that the reader receives a balanced view of Cervarix. All of the pharmaceutical product articles that I have read on Wikipedia with ratings of “B and GA” (e.g. Atorvastatin and Warfarin) in the WikiProject Medicine Quality scale include safety related information. Doc James, thank you - the content that I have provided is from the US Cervarix Prescribing Information. Maitri Shah, PharmD, GSK (talk) 19:59, 16 June 2010 (UTC)

Yes I agree. If you rewrite the above in your own words here on the talk page I will review it and add it if there are no concerns. I cannot cut and past the above as the copyright is held by GSK and not in the creative commons. Doc James (talk · contribs · email) 20:27, 16 June 2010 (UTC)

Hi, I have sent an email to the Wikipedia email response team granting permission for the Important Safety Information above to be published on Wikipedia and licensed under Creative Commons Atribution-Sharealike license. Per the process that was outlined in the related articles, I have placed OTRS PENDING at the end of the content that I would like to include in the article. Link the referenced article: http://en.wikipedia.org/wiki/Wikipedia:Declaration_of_consent_for_all_enquiries Thanks. Maitri Shah, PharmD, GSK (talk) 19:44, 25 June 2010 (UTC)

Per ticket #2010062510035681, the above document is released "under the free license "Creative Commons Attribution-ShareAlike 3.0" (unported) and GNU Free Documentation License (unversioned, with no invariant sections, front-cover texts, or back-cover texts)". Sincerely, Blurpeace 21:55, 26 June 2010 (UTC)

Thank you - you have wisely been very clear in setting out the COI issues and approached this in the correct manner. Most of the safety details belongs by regulation in the Patient Information Leaflet and product licencing details, but does not make for an encyclopaedia which sumarises details on the topic for a general reader (rather than for doctors or patients). So cautions over observing after vaccination should apply to all vaccines, likewise care if known allergy to any component. Details on pregnancy database apply to USA only, whereas the article has scope for all English speakers across the world. The only points that I find noteworthy are:

• That the tip cap and the rubber plunger contain latex rubber - I might have assumed these were all plastic these days - so is this true all prefilled vaccinations, or just this one product ?
• The article should not be a textbook list of all possible side effects but information on ≥20% of patients getting mild sypmtoms (localised inflammatory reaction as well as mild systemic symptoms of fatigue, headache, mulse & joint pains and gastrointestinal symptoms) is probably higher than most people might guess - but again is this atypical of vaccines in general ? David Ruben ^Talk 18:45, 26 July 2010 (UTC)

David, Thank you for your response. There are other vaccines currently on the market that have latex in the packaging. I have included a link to the list posted by the Centers for Disease Control and Prevention in May 2010. Regarding your comment on side effects, the most common type of vaccine adverse reactions are local reactions, such as pain, swelling, and redness at the site of injection. Local reactions may occur with up to 80% of vaccine doses, depending on the type of vaccine. Local reactions are most common with inactivated vaccines, particularly those that contain an adjuvant. I have included another CDC link that references this.

GSK’s intent through our engagement on Wikipedia is to improve the quality of articles on Wikipedia for our products. We offer our suggestions to add safety information to help enable Wikipedians receive a balanced view of the vaccine, as there is currently no information regarding side effects included in the article. We researched articles for pharmaceutical products grade B and higher on the WikiProject Medicine scale and noted that they typically contained safety information – for example Atorvastatin, Warfarin and Simvastatin.

We have a number of other suggestions to improve the quality of the Cervarix article. In the next section we have posted proposed corrections to erroneous data under the Clinical Trials section of the article. Maitri Shah, PharmD, GSK (talk) 13:00, 28 July 2010 (UTC)

Hello, I have reviewed other highly rated pharmaceutical product articles to see what format was used to include safety information. Many articles including Atorvastatin and Warfarin included safety information in sections of the article (e.g. Contraindications, Adverse Effects). Therefore if the above Important Safety Information is not appropriate for the Cervarix article, I propose the following three new sections and content be added to the article after the Clinical Trials section:

New Section: Contraindications

• Severe allergic reactions to any component of Cervarix.

New Section: Adverse Effects

• The most common local adverse reactions and general adverse events in ≥20% of patients were pain, redness, and swelling at the injection site, fatigue, headache, myalgia, gastrointestinal symptoms, and arthralgia.
• Most common general adverse events in ≥20% of subjects were fatigue, headache, myalgia, gastrointestinal symptoms, and arthralgia.

New Section: Warnings and Precautions

• Syncope: Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with Cervarix. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position.
• Latex: The tip cap and the rubber plunger of the needleless prefilled syringes contain dry natural latex rubber that may cause allergic reactions in latex sensitive individuals. The vial stopper does not contain latex.
• Preventing and Managing Allergic Vaccine Reactions: Prior to administration, the healthcare provider should review the immunization history for possible vaccine hypersensitivity and previous vaccination-related adverse reactions to allow an assessment of benefits and risks. Appropriate medical treatment and supervision should be readily available in case of anaphylactic reactions following administration of Cervarix.

Thanks Maitri Shah, PharmD, GSK (talk) 18:03, 2 August 2010 (UTC)

I've had a major reorgnaistion to the article [1]. The sections (content, headers naming and sequence) seems out of keeping with WP:MEDMOS suggested layout. Merely trying to style the article to reflect patient information sheets does not make for good encyclopaedic articles. Remember, wikipedia is NOT written for the benefit of patients (WP:NOTMANUAL), but general readers. ASO4 components covered thrice over and the L1 protein production twice...

I rearranged the information, and in so doing removed the duplications. Following more closely the outline of sections from WP:MEDMOS allowed for a better (IMHO) flow of the article. Together with coverting a list to prose, some copyediting of blank lines, and cutting back on the excessive number of section headers (16 to 10) leads to a shorter running article which looses none of the original pertinant points (safe adminstration of vaccines and first aid of syncope are distracting side issues to this specific vaccine article). David Ruben ^Talk 01:19, 11 August 2010 (UTC)

References

Propose corrections to erroneous data under Clinical Trials Section

{{Request edit}} Not done for now: Edit looks like it can be done once source is confirmed. Once my question below is cleared up, I will make the edit, and tag as done if the source checks out. --ANowlin: talk 23:01, 28 July 2010 (UTC)

Done --ANowlin: talk 03:01, 30 July 2010 (UTC)

Done --ANowlin: talk 01:45, 3 August 2010 (UTC)

I would like to propose the following corrections to the Clinical Trials section (highlighted proposed deletes with strike through and adds in green):

Phase II trials demonstrated 100% protection of the vaccine against types 16 and 18 HPV, including among 1100 women from North America and Brazil. Phase III trials included over 660 18,000 women from Germany and Poland 14 countries in Asia Pacific, Europe, Latin America and North America (reference: Paavonen J et al. Lancet 2009;374:301-314). Company officials are now conducting a clinical trial to determine whether Cervarix is more effective than rival Merck's HPV vaccine Gardasil. a trial that compares the immunogenecity and safety of Cervarix with Gardasil (reference: Einstein MH et al. Human Vaccines 2009;5:1–15)

Below is the proposed update without markup:

Phase II trials demonstrated 100% protection of the vaccine against types 16 and 18 HPV, including among 1100 women from North America and Brazil. A Phase III trials included over 18,000 women from 14 countries in Asia Pacific, Europe, Latin America and North America. Company officials are now conducting a trial that compares the immunogenecity and safety of Cervarix with Gardasil. Maitri Shah, PharmD, GSK (talk) 13:49, 28 July 2010 (UTC)

Can you get me a full link to the new source, or is it in the new edit shown without the markup? --ANowlin: talk 23:00, 28 July 2010 (UTC)

Hi, I have fixed the references in the edit above shown without markup. Thank you. Maitri Shah, PharmD, GSK (talk) 14:36, 29 July 2010 (UTC)

Done Thank you! I'm going to make the changes here shortly. --ANowlin: talk 03:01, 30 July 2010 (UTC)

Thank you Anowlin. I noticed that the proposed correction to the last sentence (below) was not included, and the original is also no longer there:

"Company officials are now conducting a trial that compares the immunogenecity and safety of Cervarix with Gardasil. " Maitri Shah, PharmD, GSK (talk) 14:02, 30 July 2010 (UTC)

DoneWooooooooops! I guess I inadvertently deleted it while I was working with the content. Sorry! --ANowlin: talk 21:10, 31 July 2010 (UTC)

Hi, it is still not quite right, a typo I think - rather than this (changes highlighted in bold):

" The manufacturer is now conducting trials and tests to compare the effectiveness and safety and safety of Cervarix with Gardasil."

it should say this:

"Company officials are now conducting a trial that compares the immunogenecity and safety of Cervarix with Gardasil. "

Thank you! Maitri Shah, PharmD, GSK (talk) 13:16, 2 August 2010 (UTC)

Done Sorry. Was copyediting, and forgot what I had there. I thought I was right, but guess not. Done. For future reference: this is an edit you could have done yourself, as it's a typo-fix. COI Edit requests should be used for addition, removal, or large changes. --ANowlin: talk 01:45, 3 August 2010 (UTC)

Proposed updates to "Indications" section

{{request edit}} Done --ANowlin: talk 03:41, 6 August 2010 (UTC) Hello, in the spirit of completeness for the Cervarix article, I would like to propose the following additions to the "Indications" section. Currently, this section does not actually contain indications for Cervarix, so I have proposed this below, as well as the Limitations of Use and Effectiveness and Administration information which should also be included as part of "Indications".

Cervarix is indicated for the prevention of the following diseases caused by oncogenic HPV types 16 and 18: cervical cancer, cervical intraepithelial neoplasia (CIN) grade 2 or worse and adenocarcinoma in situ, and CIN grade 1. Cervarix is approved for use in females 10 through 25 years of age.

Limitations of Use and Effectiveness

• Cervarix does not provide protection against disease due to all HPV types.
• Cervarix has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a woman has previously been exposed through sexual activity.
• Females should continue to adhere to recommended cervical cancer screening procedures.
• Vaccination with Cervarix may not result in protection in all vaccine recipients.

Administration

Immunization with Cervarix consists of 3 doses of 0.5-mL each, by intramuscular injection according to the following schedule: 0, 1, and 6 months. The preferred site of administration is the deltoid region of the upper arm. Cervarix is available in 0.5-mL single-dose vials and prefilled TIP-LOK syringes.

Thank you. Maitri Shah, PharmD, GSK (talk)

Done Thank you for your contributions to Wikipedia! --ANowlin: talk 03:41, 6 August 2010 (UTC)

Thank you! I made a minor edit to move the content to indications vs. contraindications. Maitri Shah, PharmD, GSK (talk) 20:04, 6 August 2010 (UTC)

References

Propose additions to Clinical Trials section

{{request edit}}

Hi, I recommend that the following additions be made to the Clinical Trials section (highlighted in green, with full source link displayed):

Clinical Trials

Phase II trials demonstrated 100% protection of the vaccine against types 16 and 18 HPV, including among 1100 women from North America and Brazil.[10] A Phase III trials included over 18,000 women from 14 countries in Asia Pacific, Australia, Europe, Latin America and North America. In this study, Cervarix was 93% effective against precancerous lesions caused by HPV types 16 and 18 in the according to protocol population. In a population of women not previously exposed to HPV, Cervarix was 98% effective against precancerous lesions caused by HPV types 16 and 18. In addition, Cervarix was 37% effective against precancerous lesions caused by 12 HPV types (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) not included in the vaccine. (Reference: http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM186981.pdf)

The minimum HPV antibody level that confers protective efficacy has not been determined. The duration of immunity following a complete schedule of vaccination with Cervarix has not been established. However, vaccination with Cervarix has been shown to offer protection for at least 6.4 years. In the clinical trials, women were given three doses over a six-month span—at 0 month, 1 month, and 6 months. The technology used in this vaccine was licensed from the University of Rochester.

No efficacy trials for children under 15 have been performed. This is because detection of clinical endpoints would require performing gynecological exams in this age groups. Immunogenecity trials did show that the immune response in girls 10 through 14 years of age was non-inferior to that seen in women 15 through 25 years of age. (Reference: http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM186981.pdf)

The manufacturer is now conducting a trial to compare the immunogenecity and safety of Cervarix with Gardasil.

Updated section without markup with source link included in bottom references:

Clinical Trials

Phase II trials demonstrated 100% protection of the vaccine against types 16 and 18 HPV, including among 1100 women from North America and Brazil. A Phase III trials included over 18,000 women from 14 countries in Asia Pacific, Australia, Europe, Latin America and North America. In this study, Cervarix was 93% effective against precancerous lesions caused by HPV types 16 and 18 in the according to protocol population. In a population of women not previously exposed to HPV, Cervarix was 98% effective against precancerous lesions caused by HPV types 16 and 18. In addition, Cervarix was 37% effective against precancerous lesions caused by 12 HPV types (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) not included in the vaccine.

The minimum HPV antibody level that confers protective efficacy has not been determined. The duration of immunity following a complete schedule of vaccination with Cervarix has not been established. However, vaccination with Cervarix has been shown to offer protection for at least 6.4 years. In the clinical trials, women were given three doses over a six-month span—at 0 month, 1 month, and 6 months. The technology used in this vaccine was licensed from the University of Rochester.

No efficacy trials for children under 15 have been performed. This is because detection of clinical endpoints would require performing gynecological exams in this age groups. Immunogenecity trials did show that the immune response in girls 10 through 14 years of age was non-inferior to that seen in women 15 through 25 years of age.

The manufacturer is now conducting a trial to compare the immunogenecity and safety of Cervarix with Gardasil.

Thank you. Maitri Shah, PharmD, GSK (talk) 15:53, 9 August 2010 (UTC)

Please no, and protect us from this verbositry :-) The general target audience level is variously proposed as above high school to undergraduate or just beyond. "detection of clinical endpoints" and "Immunogenecity trials did show that the immune response in girls 10 through 14 years of age was non-inferior to that seen in women 15 through 25 years of age" might be fine in a product summary report for doctors, but is jargon loaded poor English - even I had to read the sentances twice to hack my way through the obscurifaction. That penultimate paragraph, for example, might be better phrased as:

Children under the age of 15 years have not been directly studied because of the intimate gynecological examations that this would require. Blood tests have though shown similar levels of produced antibodies in girls aged between 10 - 14 years as women aged between 15 - 25 years.

David Ruben ^Talk 01:41, 11 August 2010 (UTC)

Procedural: As there is an objection to this edit, I have cancelled the {{request edit}} for now; please discuss; and if there is consensus to change, use another {{request edit}}. Thanks,  Chzz  ►  02:57, 11 August 2010 (UTC)

Hi David Ruben. It is helpful to get guidance from the Wikipedia community as I go through the learning process. I agree with your concerns around the readability of the language proposed. It’s important that what I as a GSK employee propose for posting be consistent with the product prescribing information, but I am happy to work with the Wikipedians to include important information in the appropriate style. —Preceding unsigned comment added by Maitri Shah, PharmD, GSK (talk • contribs) 15:28, 8 September 2010 (UTC)

Thank you for your suggestion above. I have attempted to simplify the section below, and have linked to existing Wikipedia articles where possible (existing text from the article or your proposal in black, my proposals in green):

Clinical Trials

Phase II trials demonstrated 100% protection of the vaccine against types 16 and 18 HPV, including among 1100 women from North America and Brazil. A Phase III trial included over 18,000 women from 14 countries in Asia Pacific, Australia, Europe, Latin America and North America. This study resulted in the following  :

• Cervarix prevented 93% of the cervical lesions caused by the HPV types included in the vaccine (HPV 16 and 18)
• In addition, there are other HPV types not included in the vaccine that may cause lesions. Cervarix prevented 37% of the cervical lesions caused by 12 HPV types not included in the vaccine.

Trials have demonstrated that vaccination with Cervarix offers protection for at least 6.4 years. However, the minimum amount of HPV antibodies needed for protection and the duration of protection with Cervarix is not known.

Children under the age of 15 years have not been directly studied because of the gynecological examinations that this would require. Blood tests have though shown similar levels or higher levels of produced antibodies in girls aged between 10 - 14 years as women aged between 15 - 25 years.

The manufacturer is now conducting a trial to compare the immunogenicity and safety of Cervarix with Gardasil. In this study at seven months, Cervarix generated higher antibodies levels than Gardasil, the other commercially available HPV vaccine, with twice the level for HPV type 16 and six times for HPV type 18. In addition Cervarix induced twice as many memory B cells than Gardasil for both these HPV types.

Proposed updates without markup:

Clinical Trials

Phase II trials demonstrated 100% protection of the vaccine against types 16 and 18 HPV, including among 1100 women from North America and Brazil. A Phase III trial included over 18,000 women from 14 countries in Asia Pacific, Australia, Europe, Latin America and North America. This study resulted in the following:

• Cervarix prevented 93% of the cervical [lesions] caused by the HPV types included in the vaccine (HPV 16 and 18)
• In addition, there are other HPV types not included in the vaccine that may cause lesions. Cervarix prevented 37% of the cervical lesions caused by 12 HPV types not included in the vaccine.

Trials have demonstrated that vaccination with Cervarix offers protection for at least 6.4 years. However, the minimum amount of HPV antibodies needed for protection and the duration of protection with Cervarix is not known.

Children under the age of 15 years have not been directly studied because of the gynecological examinations that this would require. Blood tests have though shown similar levels or higher levels of produced antibodies in girls aged between 10 - 14 years as women aged between 15 - 25 years.

The manufacturer is now conducting a trial to compare the immunogenicity and safety of Cervarix with Gardasil. In this study at seven months, Cervarix generated higher antibodies levels than [Gardasil], the other commercially available HPV vaccine, with twice the level for HPV type 16 and six times for HPV type 18. In addition Cervarix induced twice as many memory B cells than Gardasil for both these HPV types.

Thank you, Maitri Shah, PharmD, GSK (talk) 15:21, 8 September 2010 (UTC)

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<showing links so we can see the sources>David Ruben ^Talk 00:53, 16 September 2010 (UTC)

---

This needs redrafting. In essence, IMHO, it is inappropriate material for the article, remembering that articles are not written for doctors or patients as their target. Details of phase studies are rarely of any great interest to the general readership, bore the pants of me a family doctor, and need be considered (from copyediting stand) as relative weak material per WP:MEDRS – it is primary research, and stringing these together risks being original interpretation. A single good secondary review source will eventually summarise far more succinctly. Research development studies are frankly irrelevant once a drug proceeds to the next level, so a phase II study is interesting but is of little importance once the subsequent phase III study is reported. Likewise, once a drug is in real world usage, I think phase III studies are of historical interest only - the vaccine might well give 100% protection in research conditions, but in real world of being left out of fridges a little too long, variable quality injection administration techniques, and booster doses being given a little outside of recommended optimum intervals, who knows quite what precise impact will be...? An independent study done 5 years down the line will be the more impressive value to be used. Ok, I've done my rant against some paragraphs which sound like marketing spiel :-)

I failed to match the references to some of the statements.

I would critiscise the proposed overall suggested wording for the following points:

• "A Phase III trial... resulted in... Cervarix prevented 93% of the cervical [lesions] caused by the HPV types included in the vaccine (HPV 16 and 18)" clearly contradicts the initial opening "Phase II trials demonstrated 100% protection of the vaccine against types 16 and 18 HPV" - the phase II trials therefore demonstrated nothing and merely suggested a 100%, disproved as a null hypothesis by the subsequent phase III trial showing 93% level. Therefore cut out mention of the Phase II trial entirely.
• The FDA reference given does not mention "93%", so where is the source for that ?
• There is no need to list where studies were undertaken - it reads as WP:PEACOCKing. The interested reader can follow the reference links. So cut out the "including among 1100 women from North America and Brazil"
• As for last paragraph, biomarkers are poor substitute for clinical effectiveness. As the abstract concedes "Although the importance of differences in magnitude of immune response between these vaccines is unknown", and if the importance of the different in antibody levels is unknown, then why bother mentioning information which is of unknown importance ?
  • As an aside the studies abstract (PMID 19684472) of "Geometric mean titers of serum neutralizing antibodies ranged from 2.3-4.8-fold higher" is an extraordinary tortology of mathematical ideas: multiplication (geometric), averaging (mean), negative (neutralising of antibodies – but what else are protective antibodies going to do), a further multiplication (fold higher). Best of all, what starts out implying an average result is about to be stated, instead ends up giving a range of values ! Others might skip happily through the turgid wording, but someone should slap researchers wrists for such abysmal writing and journal editors should be ashamed of themselves, WP:MEDRS is right to prefer secondary sources to interpret the significance of primary studies for us mere mortals.

So upon trimming by half, may I suggest the following as a more readable redraft:

Clinical Trials

A Phase III trial suggested Cervarix may prevent 93% of the cervical lesions caused by the HPV 16 and 18 strains included in the vaccine. It also provided 37% protection against 12 strains not included in the vaccine. The duration of protection afforded is unknown, but is at least 6 years.

Children under the age of 15 years have not been directly studied because of the gynecological examinations that this would require. Blood tests have though shown similar levels or higher levels of produced antibodies in girls aged between 10 - 14 years as women aged between 15 - 25 years.

The manufacturer is now comparing the greater immune response seen with Cervarix compared to Gardasil, but the importance of this difference is currently unknown.

David Ruben ^Talk 02:45, 16 September 2010 (UTC)

Usually review articles are needed before notability of studies is established.Doc James (talk · contribs · email) 21:56, 16 September 2010 (UTC)

David Ruben, thank you for creating a readable draft. I have proposed some minor modifications and added citations where needed below:

A Phase III trial showed that Cervarix prevented 93% of the high grade cervical lesions caused by the HPV 16 and 18 types included in the vaccine. The duration of protection afforded is unknown, but is at least 6 years. Girls under the age of 15 years have not been directly studied because of the gynecological examinations that this would require. Blood tests have shown that levels of produced antibodies in girls aged between 10 - 14 years were similar or higher than in women between 15 - 25 years. Maitri Shah, PharmD, GSK (talk) 14:43, 14 October 2010 (UTC)

Please could you clarify what the consensus is here, and exactly what you'd like editing, and then use another {{request edit}}. Thanks,  Chzz  ►  20:29, 24 December 2010 (UTC)

Rearranged sections

I rearranged the sections of the article to make them more closely match WP:MEDMOS in September 2010. I am not sure whether the best place for the licensing section is down at the end (as the legal section in MEDMOS), or whether it was better up in the history. (Since most of it is history of when it was licensed where). Opinions? Zodon (talk) 06:54, 19 September 2010 (UTC)

Efficacy

to be effective 7.3 years the section is mislabeled. efficacy should be telling us "the reduction in the incidence of a disease among people who have received a vaccine compared to the incidence in unvaccinated people." instead what is written is telling us about long those effects last which is not efficacy. Note the CDC has some actual efficacy info:

§TE — Preceding unsigned comment added by 66.234.216.147 (talk) 23:06, 9 July 2014 (UTC)

References

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