Iran 29 January 2021
Dear Honorable Minister of Health, We are very pleased to share with you information about the COVID-19 vaccine(s) you can expect to receive over the coming few weeks. These are the first of the assigned doses to satisfy COVAX’s agreement with you. As you know from previous communication, the COVAX Facility has managed to secure significant doses of vaccines from various manufacturers. In addition, these are authorised or very close to being authorised by WHO Emergency Use Listing (EUL). We can now provide more visibility for your planning purposes, and would like to call your attention to the key next steps to be taken to ensure timely procurement and delivery. Pfizer/BioNTech On 6th January, we offered the opportunity to all COVAX participants to express their interest in having access to an initial limited volume of an ultra-cold chain vaccine from Pfizer/BioNTech. By 18th January, we had received 72 submissions (36 Advance Market Commitment participants and 36 Self-Financing participants). Six Regional Review Committees (composed of staff from WHO, UNICEF, Gavi and members of Gavi’s Independent Review Committee) undertook a technical assessment of the applications to make readiness recommendations. The Participant you represent chose not to apply for this first wave of Pfizer vaccines, and we have now moved forward with a small set of selected Participants. AstraZeneca We are pleased to inform you that Iran can expect to be distributed doses of the AstraZeneca AZD1222 vaccine, as indicated in the table below. Because EUL has yet to be granted by WHO in respect of this vaccine, we have for now only provided an indicative number of doses, covering the next two quarters. Furthermore, given the global supply constraints currently experienced by manufacturers, we expect the distributed doses in H1 to be reduced from the initial contracted number of doses. The indicative doses reflected below takes these supply constraints into account, based on our latest understanding. We would like to underscore that the indicative distribution is based on current communication of estimated availability from manufacturers. In this regard, it is likely the distribution may need to be adjusted in light of circumstances that are difficult to anticipate and variables that constantly evolve. Therefore, please keep this in mind when considering the estimated indicative allocated quantities. Please also note that due to this vaccine being supplied from two different manufacturers, namely Serum Institute of India (SII) and SK Bioscience (SKBio), additional registration or waiver requirements may transpire. Furthermore, the timing of the delivery of doses is subject to UNICEF SD/PAHO establishing supply agreements with the manufacturers. Details surrounding the indicative distribution can be found in Annex Z. See the below table for Iran’s indicative distributions of AstraZeneca vaccines, including anticipated supply schedules: Vaccine AstraZeneca SKBio
Doses / 4,216,800 - 5,628,000 indicative doses
Estimated Supply Schedule • Delivery as of mid/late February, subject to WHO EUL and completion of next steps below • Indicates H1 supply, with 25-35% available in Q1 and 65-75% available in Q2
• Lower end of range reflects the expected distribution due to supply constraints, based on our latest understanding, while the high end reflects the contracted number of doses
The final allocation of the AstraZeneca vaccine(s) will be announced following the WHO fair and equitable allocation mechanism once it receives the EUL, and subject to the validation of the Independent Allocation of Vaccine Group (IAVG). Next steps • •
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Have the necessary indemnity and liability frameworks, including the required legislative framework, in place in order to complete an agreement directly with AstraZeneca Initiate contact with the COVAX Facility Procurement Coordinator (procurement_coordinator@unicef.org; copied on this exchange) and proceed with next steps required to obtain doses from your economy. Execute and provide documentation of: a) national regulatory approval or proof of recognition or reliance on another type of regulatory approval b) import license and c) signed indemnity and liability agreement The Procurement Coordinator will issue a cost-estimate. Participants will transfer funds to UNICEF or PAHO, share documentation listed above, and a Purchase Order will be placed.
Summary We hope that this information will assist you in making the necessary arrangements to ensure a successful introduction of a COVID-19 vaccine in the coming weeks. We encourage you to take the required next steps as promptly as possible, and not later than the end of February, to avoid idle doses and potential delays in receiving these vaccines through the Facility. Should you not be ready to do so within the set timeframe, please inform us as soon as possible so that we may re-distribute these doses to another Participant. We will be regularly communicating updates on expected doses and remain confident that we will be able to meet our commitment to you by the end of 2021. Should you have any further questions, please do not hesitate to reach out to your Senior Country Manager or your COVAX Facility focal point or contact us through COVAX@gavi.org. Please do keep WHO and UNICEF colleagues in copy.
Sincerely,
Aurélia Nguyen Managing Director Office of the COVAX Facility