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COVID-19 vaccine update

VPI/DCD
10 January 2021

Personal photo
Regulatory timeline of key phase lll vaccine candidates

By end of 2020

By end of Feb 2021

From Mar ‘21/No info

Medicines & Healthcare products Regulatory Agency (UK)

11/01/2021 | Title of the presentation 2

COVID-19 vaccine deployment in EMR: Countries that
started vaccination and those with bilateral agreement,
8 Jan 2021

Vaccination started

Bilateral agreement exists

3
 COVID-19 vaccine deployment in EMR:
Date of initiation and number of persons vaccinated

Start date Total vaccination

UAE 05-Jan 1,020,349 (as of 9 Jan)

Saudi Arabia 06-Jan 130,000 (as of 7 Jan)
Bahrain 23-Dec 84,157 (as of 9 Jan)
Oman 29-Dec 14,980 (as of 9 Jan)
Kuwait 28-Dec 2,500 (as of 29 Dec)
Qatar NA NA
Source: Coronavirus (COVID-19) Vaccinations - Statistics and Research - Our World in Data

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 COVID-19 vaccine deployment in EMR: Vaccination doses
administered per 100 population, 9 Jan 2021

UAE 9.5

Bahrain 5,67

Saudi Arabia 0.38

Oman 0.36

Kuwait 0.05

0 1 2 3 4 5 6 7 8 9 10
Vaccination dose per 100 population

Source: Coronavirus (COVID-19) Vaccinations - Statistics and Research - Our World in Data
Vaccines in COVAX facility portfolio

170 million doses

500 million doses

200 million doses

1100 million doses

Total: 1.97 billion doses secured

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Open invitation sent by GAVI CEO on 6 Jan 2021 to all COVAX
facility participants for potential early rollout of limited
quantities of Pfizer BioNTech vaccine as 1st wave

• Limited number of doses made available through dose sharing from

the European Union (Pfizer BioNtech not yet part of COVAX)

Objectives:

• Maximize public health impact with limited doses

(e.g., target centralized HCWs)

• Ensure continuity for countries (e.g., subsequent deliveries of

same vaccines, in meaningful volumes within a reasonable
timeframe)

• Gain critical learnings for full-scale up

• Ensure no doses go idle, with timely delivery

Early 1st wave of Pfizer BioNTech vaccine
Requirements
✓ Express an interest in mRNA vaccines
✓ Plan to vaccinate before May 2021
✓ Willingness to use more than 1 type of vaccine in the national response1
✓ Agree to use standard labels2 and rely on WHO EUL or EUA3 to grant national regulatory authorization
✓ Have necessary indemnity & liability frameworks in place, including agreement with Pfizer

Minister of Health or other authorizing authority need to confirm that:

✓ The above conditions for using the Pfizer vaccine can be fully met in January 2021
✓ Essential elements of an early rollout plan are in place

Timeline
❑ 18 Jan 2021: Participants to confirm interest to COVAX facility with minimum criteria met
❑ 29 Jan 2021: Final selection and notification of country names

1. through the Vaccine Request Form (VRF) for AMC participants, the VIF for self-financing participants, or a subsequent communication
2. Without additional inserts or a language other than Spanish, French, Arabic, English, Chinese or Russian
3. or equivalent by a Stringent Regulatory Authority
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WHO interim recommendation for the use of mRNA
BNT162b2 (Pfizer-BioNTech) (1/2)
SAGE meeting, 5 Jan 2021

• BNT162b2 (Pfizer vaccine) has an efficacy of 95% against symptomatic

SARS-CoV-2 infection
• No data on impact on transmission or viral shedding
• Vaccination recommended for persons aged 16 years and above
• Two doses given intramuscularly with an interval of 21–28 days
• Need for flexibility in the schedule
• Current data support an extension up to 42 days (6 weeks)
• The same product should be used for both doses.
• No studies on interchangeability with other vaccines against COVID-19

https://apps.who.int/iris/bitstream/handle/10665/338484/WHO-2019-nCoV-vaccines-SAGE_recommendation-BNT162b2-2021.1-eng.pdf
WHO interim recommendation for the use of
mRNA BNT162b2 (Pfizer-BioNTech) (2/2)
Vaccination of specific populations

• BNT162b2 is not a live vaccine, the mRNA does not enter the nucleus and is rapidly degraded
• Animal studies show no toxicity to the fetus, but no data on safety in pregnant women exist
• SAGE recommends not to use BNT162b2 in pregnancy until more data are available, except
where the benefit outweighs risks, such as health workers at high risk of exposure or women with
significant comorbidities
• Vaccination can be offered to breastfeeding women if part of risk group, and WHO does not
recommend discontinuation of breastfeeding after vaccination
• Vaccination can be offered to people living with HIV in accordance to the prioritization roadmap
Summary
Vaccine roll out started, more to come soon…..

• COVID-19 vaccine becoming available in the region, mostly through bilateral agreements
• Some countries of the region provided emergency authorizations for Sinopharm vaccine ahead of WHO and
stringent NRAs
• COVAX facility secured almost 2 billion doses as initially targeted and more are under negotiation
• COVAX facility is exploring interest and readiness for early rollout with Pfizer vaccine as 1st wave
• More vaccine expected to be gradually available by the 2nd half of 2021
• WHO approved Pfizer-BioNTech vaccine under EUL and made interim recommendations for use of this
vaccine
• More vaccines are under review of WHO – recommendations will be made soon the product is approved
under EUL

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COVID-19 vaccine use in EMR,
5 Jan 2021

COVID-19 vaccine Vaccination started Bilateral agreement signed but Probable bilateral
vaccination not started agreement/donation
Pfizer BioNTech Bahrain, Kuwait, Egypt (20 million doses) Lebanon (MoH statement through
Oman, Qatar, Saudi Tunisia (2 million doses) media)
Arabia, UAE Jordan (procuring UCC equipment)
AstraZeneca Egypt (30 million doses)
Morocco*
Sinopharm UAE Morocco* Egypt (donation from UAE)

*Morocco is procuring total 65 million doses of vaccine from two manufacturers (AstraZeneca and Sinopharm)

UCC: Ultra cold chain for mRNA vaccine

Approval of COVID-19 vaccines by National
Regulatory Authorities (NRAs) and WHO
(Emergency Use Listing, EUL) – 5 Jan 2021
COVID-19 Regulatory approval in EMR countries Approved by other NRAs WHO EUL
vaccine Emergency Emergency use Conditional
approval/Tempora authorization (EUA) approval
ry authorization
Pfizer Iraq Bahrain, Jordan, Saudi Arabia UK MHRA, US FDA Yes
BioNTech Kuwait, Oman, Health Canada
Qatar, UAE TGA-Australia
Moderna US FDA Under review
Health Canada
AstraZeneca Morocco UK MHRA, India Under review
Sinopharm Egypt Bahrain, UAE, China
Jordan*
Sputnik V Russia Under review
*Jordan- Sinopharm vaccine dossier is submitted and under review for EUA
COVAX Facility: Co-convened by CEPI, GAVI and WHO

• The Coalition for Epidemic Preparedness Innovations (CEPI)

• Supporting vaccine research and development from the lab to the production
facility

• Pulling procurement and incentivizing manufacturing expansion to secure rapid

supply of safe and efficacious vaccines for countries and territories

• Providing normative guidance on vaccine policies, safety, regulation, and

allocation

Goal: Ending the acute phase of the global pandemic by the end of 2021, through fair
and equitable allocation of safe and effective doses of vaccines
Aim: 2 billion doses of COVID vaccine fairly and equitably distributed by end 2021
The path to COVID-19 vaccine delivery from COVAX facility

Approve
candidates
based on SRA,
WHO PQ / EUL

CONFIRMATION OF REGULATORY ALLOCATION VACCINE DISPATCH

PARTICIPATION AUTHORIZATION VACCINES
DELIVERED

Dec 2020 – Jan 2021 Jan 2021

Sign Terms and Conditions
Complete Vaccine Request and
express preferences on vaccines
Request TA & CCE support and
cost-sharing
• Monitor readiness using
VIRAT/VRAF 2.0
Countries develop National Feb - Mar 2021
•
Vaccine Deployment Plan Feb 2021 • Country regulatory approval
• NDVP reviewed by regional • Indemnification and liability
review committee agreement

COUNTRY PREPARATION FOR VACCINE

FINANCING READINESS READINESS

CHECK CHECK

Speed, Scale, Access 15