Subject: RE: A New Human Papilomavirus Vaccine-- Cecolin will be available through UNICEF for Georgia
From: Maia Nikoleishvili
To: "[email-masked]" <[email-masked]>
Cc: Marina Latsabidze </o=ExchOrganization/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=7d0b704ee21b4503af22624da479a448-Marina>
Date: Tue, 30 Jun 2020 14:50:00 +0000

Dear Mr. Jean Zhao,

With reference to your correspondence I would like to kindly address you from the Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs of Georgia.

First of all, please accept our sincere gratitude for the proposed collaboration regarding the purchasing Human Papillomavirus (HPV 16/18) vaccines Cecolin®.  We highly appreciate your commitment to initiate partnership in this direction, however it should be mentioned that the state has already purchased significant amount of HPV vaccine and at this stage there is no shortage of the vaccine.

Thank you once again for the proposed partnership.

Best regards,

Maia Nikoleishvili MPA

Acting Head of International Relations and Protocol Division of Administration

Ministry of IDPs from the Occupied Territories, Labour, Health and Social Affairs of Georgia

Address: 144 Tsereteli ave., 0159 Tbilisi, Georgia

Tel.: +995 32 2510034 (0803)

Cell phone: +995 577272713

E-mail: [email-masked]

From: [email-masked] <[email-masked]>
Sent: Friday, May 29, 2020 10:40 AM
To: info <[email-masked]>
Cc: 赵警芳 <[email-masked]>
Subject: A New Human Papilomavirus Vaccine-- Cecolin will be available through UNICEF for Georgia

Dear Sir or Madam,

Following the call from the WHO Director General in 2018, a Strategy for the Elimination of Cervical Cancer will be submitted for the World Health Assembly’s approval in May 2020 (https://www.who.int/activities/a-global-strategy-for-elimination-of-cervical-cancer). This strategy calls for 90% coverage of HPV vaccination of girls (by 15y of age) by 2030.  Yet today, many countries cannot provide HPV vaccination to all of its girls due to the global shortage of WHO Prequalified HPV vaccines.

My name is Jean Zhao(Mrs), I work for Xiamen Innovax Biotech Company as the international business manager. We are excited to inform you that we have developed a safe, effective, and low-cost Human Papillomavirus (HPV 16/18) vaccine - Cecolin®, that will be WHO Pre-qualified and available to Gavi countries in mid-2021. Our product is officially listed on the Gavi Detailed Product Profile. (see below link) :https://www.gavi.org/our-alliance/market-shaping/product-information-vaccines-cold-chain-equipment.

We believe that our HPV vaccine offers many advantages to the HPV program relative to Merck’s and GSK’s vaccine for the following reasons:

1.     Immediately Available Supply by Mid-2021: We will have significant quantities of vaccine immediately available once we receive WHO PQ certification in 2021. This will enable you to accelerate its timeline for HPV routine immunization AND multi-cohort campaigns. In contrast, Merck and GSK HPV vaccines are expected to be heavily supply constrained until at least 2024 as detailed in the below UNICEF and WHO Vaccine Market Reports.

a.      UNICEF HPV market report: https://www.unicef.org/supply/reports/human-papillomavirus-hpv-vaccine-supply-and-demand-update

b.     WHO HPV market report:https://www.who.int/immunization/programmes_systems/procurement/mi4a/platform/module2/WHO_HPV_market_study_public_summary_Dec2019.pdf?ua=1

Based on IMHE cervical cancer mortality data, we estimate that introducing in 2021 with our vaccine versus hypothetically waiting for available competitor supply in 2024 (and missing immunization opportunities for 3 cohorts of girls) could prevent an additional cervical cancer deaths. We will have enough supply to support multi-age cohort, catch-up campaigns in your country starting in 2021, which will further enhance the health impact that our vaccine could have in your country.

2.     Cecolin® is at least >45% cheaper than the cost of competitor HPV vaccines: A full, 2-dose course of Cecolin® costs about 50% less than Merck/GSK vaccines per course. We estimate that the net direct savings to Ministry of Health, after accounting for Gavi co-financing to be quite remarkable over the 5-year period 2021-2026. As your country approaches Gavi transition, these savings could greatly improve the financial sustainability of your immunization program.

3.     Equivalent Protection and Safety:  The protective efficacy and safety of Cecolin was demonstrated in a five-year multicenter, randomized, double blind placebo control clinical trial (J Natl Cancer Inst (2020) 112: 1-9.).  The efficacies for preventing high grade genital lesion and persistent infection(≧6 month duration) were 100% and 97.3% respectively.  Most AEs were were mild; no vaccine-related serious adverse events were noted.

We strongly believe that our HPV vaccine, Cecolin®, is a strong match for your country’s immunization needs and goals. We welcome your feedback and inquiries, and please feel free to reach out to me for further information. You may also contact your Gavi Senior Country Manager to verify the information included in this email.

Sincerely yours,

Jean Zhao

Manager, Int’l Business Dept.

XIAMEN INNOVAX BIOTECH LTD

Tel：    +86-592-653 6555 ext 8330

Fax：    +86-592-653 6567

Skype:   jeanny.zhao

Web：   www.innovax.cn

This e-mail and any attachments are confidential. It is intended for the recipient only. If you have received this e-mail in error, please immediately notify the sender by replying to this e-mail and delete the e-mail from your computer. Although the sender and INNOVAX have taken every reasonable precaution, the e-mail and attachments may have some errors or omissions and may contain viruses. We cannot accept liability for any damage that you sustain as a result of that.

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About Innovax: Innovax is a leading company in the field of developing, manufacturing and marketing innovative vaccines with its headquarters and manufacture based in Xiamen, China. Innovax has established its unique Escherichia coli-based recombinant vaccine system for vaccine industrialization, and is dedicated to provide high-quantity and affordable vaccines for people in need to combat infectious disease. As of now, Innovax, has 2 vaccines, more are in clinical trials and development.  Our HPV Cecolin received official licensure from the National Medical Products Administration, China on December 30th, 2019. Innovax submitted its WHO Prequalification (PQ) application in January 2020 and is now undergoing the PQ review process.

More information is available on our website http://www.innovax.cn/en/index.aspx

Maia Nikoleishvili MPA

Acting Head of International Relations and Protocol Division of Administration

Ministry of IDPs from the Occupied Territories, Labour, Health and Social Affairs of Georgia

Address: 144 Tsereteli ave., 0159 Tbilisi, Georgia

Tel.: +995 32 2510034 (0803)

Cell phone: +995 577272713

E-mail: [email-masked]