From: Volkan Cetinkaya <vcetinkaya@worldbank.org>
Sent: 3 February, 2021 19:13
To: Nino Kvernadze <ninokvernadze@moh.gov.ge>
Cc: Ekaterine Tikaradze <etikaradze@moh.gov.ge>; Tamar Gabunia <tgabunia@moh.gov.ge>; Tamar Tsenteradze <ttsenteradze@worldbank.org>; Nino Ramishvili <nramishvili@worldbank.org>; Jelena Lukic <jlukic@worldbank.org>; Damir Leljak <dleljak@worldbank.org>; Maddalena Honorati <mhonorati@worldbank.org>; Natalie Godziashvili <ngodziashvili@moh.gov.ge>; Lia Tavadze <ltavadze@moh.gov.ge>; Nino Gvenetadze <ngvenetadze@moh.gov.ge>; Nino V. Moroshkina <nmoroshkina@worldbank.org>; Beka Jakeli <bjakeli@moh.gov.ge>; Maia Nikoleishvili <mnikoleishvili@moh.gov.ge>
Subject: RE: No-objection request

From: Nino Kvernadze <ninokvernadze@moh.gov.ge>
Sent: Monday, February 01, 2021 11:14 AM
To: Volkan Cetinkaya <vcetinkaya@worldbank.org>
Cc: Ekaterine Tikaradze <etikaradze@moh.gov.ge>; tgabunia@moh.gov.ge; Tamar Tsenteradze <ttsenteradze@worldbank.org>; Nino Ramishvili <nramishvili@worldbank.org>; Jelena Lukic <jlukic@worldbank.org>; Damir Leljak <dleljak@worldbank.org>; Maddalena Honorati <mhonorati@worldbank.org>; Natalie Godziashvili <ngodziashvili@moh.gov.ge>; Lia Tavadze <ltavadze@moh.gov.ge>; ngvenetadze@moh.gov.ge; Nino V. Moroshkina <nmoroshkina@worldbank.org>; Beka Jakeli <bjakeli@moh.gov.ge>; Maia Nikoleishvili <mnikoleishvili@moh.gov.ge>
Subject: RE: No-objection request

Dear Volkan,

Dear Team,

 

Following our communication previously, on COVAX facility, which the GoG has prioritized as a main platform to support Georgia’s commitment to provide COVID-19 Vaccination to priority populations, we would like to return to this important matter with some overview of the background, and current dynamics and evolving needs to directly procure AD syringes,  considered to be supported under the PIU further.

 

At a current stage, as Pfizer-BioNTech COVID-19 Vaccine (https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/downloads/standing-orders.pdf ) obtained wide recognition through WHO and US FDA / CDC listings, and following GAVI Alliance Director’s special message (https://www.gavi.org/vaccineswork/gavi-covax-amc-explained ) explaining opportunities for AMC (Advance Market Commitment) countries, Georgia could be part of “first wave’ distribution for limited number of target populations. 

 

Namely, based on assessment regarding adequate preparedness for the vaccine deployment, the country would be eligible to receive the vaccine for front line health personnel (within established 0,25% of the total population per AMC country).

Within the frame above, and according to recommendations for the vaccine administration, the Ministry is intending to urgently procure the 0,3ml volume AD syringes, directly from one of WHO prequalified manufacturers - Hindustan Syringes & Medical Devices Ltd. – relevant email communication enclosed.

 

Notably,  the NCDC&PH point person has also been in contact with another WHO prequalified manufacturer of needed syringes in China, but they work mostly with bigger packages of orders and no agreement has been possible to achieve at this stage. Only mentioned two companies have WHO’s prequalifications so far ( Hindustan Syringes & Medical Devices Ltd.and Wuxi Yushou Medical Appliances Co., Ltd)

WHO link:   https://apps.who.int/immunization_standards/vaccine_quality/pqs_catalogue/categorypage.aspx?id_cat=37

 

Neither UNICEF country office will be able to broker the needed deal via the Agency’s relevant global mechanism, due to the long waiting list of standing orders already placed from other countries.

 

With this email, the Ministry through the PIU, requests the WB, to consider this urgent procurement of 50 000 pcs of 0,3ml AD syringes needed to be stocked in advance to guarantee preparedness for administering the Pfizer-BioNTech COVID-19 Vaccine to front-line health personnel playing paramount role in the COVID-19 emergency response in Georgia. The total price would be approximately 4000 US (please find  invoice attached).  The budget line for this activity would be diagnostic and supplies of the PP.

 

We hereby request WB’s no-objection to proceed with direct procurement of 50 000 pcs AD syringes, from the Indian company Hindustan Syringes & Medical Devices Ltd.

 

For more clarity, please find below some basic background information on COVAX platform and Georgia’s membership below:

 

On 24 April 2020, the World Health Organization (WHO) hosted the launch of the Access to COVID-19 Tools (ACT) Accelerator, a new global collaboration to accelerate development, production, and equitable access to COVID-19 diagnostics, therapeutics, and vaccines (https://www.who.int/initiatives/act-accelerator ). - The COVAX (https://www.who.int/initiatives/act-accelerator/covax#:~:text=COVAX%20is%20co%2Dled%20by,every%20country%20in%20the%20world ), the act-accelerator vaccines pillar, is co-led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI) and WHO. Its COVAX Facility (https://www.gavi.org/covid19/covax-facility ) aim is to accelerate the development and manufacture of COVID-19 vaccines, and to guarantee fair and equitable access for every country in the world.

 

Through supporting financially the world’s prominent manufacturers’ active portfolios of front-runner candidate vaccines, the COVAX Facility ensures participant countries’ equal access to essential doses of vaccine(s);

 

On 31st August the MoILHSA of Georgia signed the standard affiliation / commitment letter with the COVAX Facility, which is also providing for selecting purchase model from the 2 available mechanisms under the Facility. – Optional Purchase model has been selected for its flexibilities applied. Under the same commitment, at least 20% of the country’s population will be covered, and with 2-dose series of vaccination 1,484,400 doses (“total participant doses”) of the vaccine will be a target to allocate. 

 

On 18 September 2020 duly signed Agreement between GAVI and the Ministry on behalf of the GoG was presented to the Facility, and following the signing of the Agreement, the committed “Upfront Payment” to the Facility: ($3.10 per dose) US$4,601,640 was covered from the Georgia State Budget, plus the “Risk Sharing Guarantee Amount” US$593,760 also paid in advance.

 

(Full cost of “Total Participant Doses” meaning 1,484,400 number of doses of “Approved Vaccine”, sufficient to vaccinate 20% of the Participant’s Population, ($10.55 per single dose) makes $15,660,420 total.

The COVAX Facility also leaves it at the country’s full discretion to define the financial sources to participate in the Facility, whether it is state budget, contributions from international financial institutions, or other investment instruments.)

 

 

We hereby ask your immediate attention to this matter, since the notice period for the Ministry to COVAX, whether Georgia is able to get AD syringes, is January 18.

 

Kind regards,

 

 

ნინო კვერნაძე

პროექტის მენეჯერი,

მსოფლიო ბანკის COVID-19-ის წინააღმდეგ სწრაფი რეაგირების

პროექტის განმახორციელებელი ჯგუფი (PIU), 

საქართველოს ოკუპირებული ტერიტორიებიდან დევნილთა, შრომის, ჯანმრთელობისა და სოციალური დაცვის სამინისტრო 

www.moh.gov.ge  

 

Nino Kvernadze

Project Manager, PIU – World Bank

Emergency COVID-19 Response Project Implementation Unit

Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs of Georgia

www.moh.gov.ge 

 

Email: ninokvernadze@moh.gov.ge

Cell: +995 599 18 46 44; office: +995322510011/0506

 

 

 

 

 

Dear Volkan,

With this email PIU team is sharing with you the basic information on COVAX facility, which we think will be very helpful to proceed further. Please find information below:

On 24 April 2020, the World Health Organization (WHO) hosted the launch of the Access to COVID-19 Tools (ACT) Accelerator, a new global collaboration to accelerate development, production, and equitable access to COVID-19 diagnostics, therapeutics, and vaccines (https://www.who.int/initiatives/act-accelerator ).

COVAX (https://www.who.int/initiatives/act-accelerator/covax#:~:text=COVAX%20is%20co%2Dled%20by,every%20country%20in%20the%20world ), the act-accelerator vaccines pillar, is co-led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI) and WHO.

Its COVAX Facility (https://www.gavi.org/covid19/covax-facility ) aim is to accelerate the development and manufacture of COVID-19 vaccines, and to guarantee fair and equitable access for every country in the world.

Through supporting financially the world’s prominent manufacturers’ active portfolios of front-runner candidate vaccines, the COVAX Facility ensures participant countries’ equal access to essential doses of vaccine(s); - this is expected that by end of 2021, 2 bln. doses of new developed vaccine(s) will be available to purchase for all participants of the Facility.  - Importantly, it’s calculated that $11.3 B is needed urgently to cover needed investments within the next 6 months. This includes almost $2 B in immediate funding for advance market commitments to secure doses for LMICs.

At a current stage, unprecedented race for development of COVID-19 vaccine is still under way, with over 300 proposals and only 9 candidate vaccines among them actively supported by the facility. From these, 7 are at the stage of clinical trials.

On 31^st August the MoILHSA of Georgia signed the standard affiliation / commitment letter with the COVAX Facility, which is also providing for selecting purchase model from the 2 available mechanisms under the Facility. – Optional Purchase model has been selected for its flexibilities applied. Under the same commitment, probable coverage rate of the vaccination has been defined: at least 20% of the country’s population will be covered, and if 2-dose series of vaccination adopted then 1,484,400 doses (“total participant doses”) of the vaccine will be essential to allocate. 

By participating in the COVAX Facility, the Participant will have access to doses of vaccine candidates as a result of the advance purchase commitments that Gavi will conclude with vaccine manufacturers. As doses from successful candidates become available, a Participant will be given the opportunity to purchase Approved Vaccines from manufacturers. (excerpt from guiding documents)

Importantly, the Optional Purchase model also provides for possibility of rejecting a vaccine offered, as the country will have a discretion on choosing among possible available options (“purchase opportunities”), the same time, securing full amount of assigned doses, but accepting certain delays if concrete opportunity was rejected. - This is paramount, as the participant countries stay conscious of the realistic expectation that only 1 or 2 vaccines can be available at initial stages, in a limited amount of doses.

In case of rejecting concrete “purchase opportunity”, the participant country receives prepaid doses of acceptable vaccine. Also importantly, if all assigned doses are not purchased under the facility, the “risk sharing guarantee” payment is retained, as irrevocable.  – For all terms and definitions, see please the annexed Commitment Agreement / Optional Purchase Arrangement, received from GAVI on 8^th September 2020 via email communication, compliant with the terms and conditions outlined in the letter confirming engagement of Georgia with the Facility, signed by the Ministry on 31^st August 2020.

18 September 2020 is a deadline of presenting a duly signed Agreement between GAVI and the Ministry on behalf of the GoG to the Facility.

After the signing the Agreement, 9 October is a deadline to cover the committed advance payments to the Facility, outlined in the Agreement:

“Upfront Payment” ($3.10 per dose) which means US$4,601,640,

(Full cost of “Total Participant Doses” meaning 1,484,400 number of doses of “Approved Vaccine”, sufficient to vaccinate 20% of the Participant’s Population, ($10.55 per single dose) makes $15,660,420 total.)

The “Risk Sharing Guarantee Amount”, which means US$593,760, must be also paid in advance.

The COVAX Facility also leaves it at the country’s full discretion to define the financial sources to participate in the Facility, whether it is state budget, contributions from international financial institutions, or other investment instruments.

Therefore, the MoILHSA intends to mobilize the funds from the Georgia Emergency COVID-19 Emergency Project, supported by the World Bank Group, to accommodate the upfront and guarantee payments to the Facility, - $5,195,400 totally.

Through the PIU, the First Deputy Minister of MoILHSA conveys the Ministry’s great appreciation to the World Bank Group, for considering inclusion of such payment of paramount importance to the COVID-19 emergency response within the priority procurement plan of the Project.

Kind regards,

 

ნინო კვერნაძე

პროექტის მენეჯერი,

მსოფლიო ბანკის COVID-19-ის წინააღმდეგ სწრაფი რეაგირების

პროექტის განმახორციელებელი ჯგუფი (PIU), 

საქართველოს ოკუპირებული ტერიტორიებიდან დევნილთა, შრომის, ჯანმრთელობისა და სოციალური დაცვის სამინისტრო 

www.moh.gov.ge  

 

Nino Kvernadze

Project Manager, PIU – World Bank

Emergency COVID-19 Response Project Implementation Unit

Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs of Georgia

www.moh.gov.ge 

 

Email: ninokvernadze@moh.gov.ge

Cell: +995 599 18 46 44