Dear Colleagues,

 

Thank you for the call today, as promised please find the information we discussed over the ZOOM.

 

The EUL approval for Synovac and Synopharm is expected – earliest April 2021 - https://extranet.who.int/pqweb/sites/default/files/documents/Status_COVID_VAX_23March2021_0.pdf

 

Attached you can find the Confidentiality Disclosure Agreement (CDA) to be filled in and signed and sent to EUL colleagues. As soon as they will grant emergency use listing the GEO focal point will have access to the dossier, reports, RMP, etc. through the secured platform. We suggest to NRA’s to ask for access to all the vaccines in the list and those to be approved shortly, so we get access instant without losing precious time. In case there are any questions or you need any help with the CDA, please do not hesitate to contact me.

 

On the other hand, we also discussed the information available from the Hungarian Medicines Agency  – OGYEI - https://www.ogyei.gov.hu/

 

Please find HERE the national registry where I could find the vaccine as authorized, however, on their website you can find some extra in for regarding the leaflet, SmPC, etc. please note that in all the below documents published it is mention that the Sinopharm vaccine is subject of emergency approval.

 

All the published information on the COVID-19 vaccines are published  - https://www.ogyei.gov.hu/koronavirus

All the info published on the ‘SINOPHARM’ vaccines have this disclaimer – CNBG BIO COVID-19 vaccine (Vero Cell), inactivated - This product is used under emergency approval.

 

Please read the following carefully PROSPECTUS - https://www.ogyei.gov.hu/dynamic/sinopharm_taj_oltottak_reszere.pdf

SUMMARY OF PRODUCT CHARACTERISTICS - (in line with European rules) - https://www.ogyei.gov.hu/dynamic/sinopharm_vakcina_taj_szakembereknek.pdf

PACKAGE LEAFLET - https://www.ogyei.gov.hu/dynamic/sinopharm_taj_oltottak_reszere.pdf

 

Unfortunately, I could find more info about the emergency use procedure…

In case you have any questions please do not hesitate to contact us.

 

 

 

Dear Dorina,

 

Just got confirmation from the MoH to have a meeting at 11:00 CPH (14:00 Tbilisi) time.

 

First DM may also join to the meeting.

 

If this still ok for you, please send zoom link.

 

Thank you very much in advance.

 

Best regards,

Giorgi

 

 

Dear Tamar,

 

Regarding the below e-mail please kindly let me know if it is possible for us to organse a call tomorrow, Wednesday 24 March 2021 at 10:00 am CPH time or Thursday 25 March 2021 from 9:00 am to 12pm

 

Please advise what time works better with you and I will send you a ZOOM link.

 

Thank you

 

 

 

Dear Giorgi,

 

Thank you for your e-mail.

 

Sinovac and Sinopharm are in the pipeline to get an emergency use listing from WHO. At the moment we are still awaiting the final information to be received from the manufacturer. As soon as the info will be received we will inform you and the NRA focal point for the EUL will have access to the dossier.

 

I will schedule a meeting with the NRA tomorrow to discuss in detail how to request access in advance (meaning to sign the CDA) so GEO will get access as soon as the products are listed.

 

On the question related to AEFI, detailed information will be provided when the vaccine will get emergency approval by WHO.

 

Thank you

 

 

 

Dear Dorina,

 

As we just discussed with Oleg, dossiers of Sinopharm and Sinovac vaccines might be accessible for country NRAs. Could you please kindly let us know if this is the case? And if so, is it possible to help get such access for GEO NRA?

 

Country may receive Sinopharm by bilateral agreement and Sinovac also might be donated, so this information is critically important for country to have detailed information about vaccine safety and efficacy in advance. If process of granting access takes some time, it would be good to initiate it now.

 

Main question is regarding so many “very frequent” AEFIs for AZ among vaccinated individuals – how such AEFIs are expected in inactivated vaccines, like Sinopharm and Sinovac. If you also have provide some information on that, it would be most welcomed 😊

 

Thank you very much in advance!

 

Best regards,

Giorgi

 

--

Giorgi Kurtsikashvili, M.D.

National Officer

WHO Country Office in Georgia

 

Office location: 81 Vasil Barnov Street, 0179 Tbilisi, Georgia

Mailing address: UN House, 9 Rapiel Eristavi Street, 0179 Tbilisi, Georgia

GPN.: 74214

Tel.: + 995 32 299 80 73

Mobile: +995 599 76 44 43                          mailto:kurtsikashvilig@who.int