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SAHPRA COVID-19 Vaccines Update Portfolio Committee on Health

SAHPRA provided updates on the most advanced vaccines in development, pre-meetings held on COVID-19 vaccines, vaccine applications for registration, and Section 21 COVID-19 vaccine applications. The rigorous review process involved SAHPRA experts and collaboration with other regulatory authorities and the WHO.

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SAHPRA COVID-19 Vaccines Update Portfolio Committee on Health

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  1. SAHPRA Covid-19 vaccines update Portfolio Committee on Health 17 March 2021

  2. Contents • Summary of the most advanced vaccines in development • Summary of Pre-meetings on Covid-19 Vaccines • Covid-19 vaccine applications for registration • Section 21 Covid- 19 vaccine applications

  3. Summary of the most advanced vaccines in development

  4. Pre-Submission Meetings Vaccine Applicant Date Outcome J&J Ad-26 Janssen 4/11/ 2020 Submission of a rolling review application (Rolling review Part 1) AZ/ RPharm RPharm/AZ 15/12/2020 Rpharm-Russian Manufacturer RPharm 18/01/2020 Establish Rpharm local Intend for S21 and rolling submission AZ/SII-ChadOX NDoH 31/12/2020 Section 21 NDoH granted 22 Jan 2021 Pfizer/Biontec Comirnaty mRNA Pfizer 7/01/2021 03/02/2021 Submission for Reliance review application Section 21 application 04/02/2021 Sputnik V Ad-26 and Ad-5 Lamar Pharmaceuticals 11/02/2021 18/02/2021 Applicant to provide details of vaccine and available data, Applicant to submit Section 21 and rolling review for registration 23/02/2021 Sinovac CoronaVac (Vera-cell) Numalox/Curanto Pharma 18/02/2021 Intend to submit Section 21

  5. Submissions for Registration Date of Submission Status Name Comments J&J Ad-26 11/12/2021-Part1 of Rolling review Recommendation 7/02/2021 issued Inspectorate Approval Response awaited for rolling review 1 08/02/2021 Part 2 of Rolling review In Evaluation of rolling review 2 This is a second part of anticipated 4 part rolling review. Anticipated submission of last part by end March beginning April 2021. 03/03/2021 Rolling review pack 3 submitted Under review . Outstanding documents as submitted to EMA to be submitted to SAHPRA on 17/03/2021 Pfizer/Biontec Comirnaty 08/01/2021 Verification review Verification Review not possible - EUA not equivalent to registration. - SAHPRA commenced full review Under review Inspectorate Approval Queries raised-report of Pfizer scheduled for March 2021 Sputnik V (Lamar Pharma) 23/02/2021 (rolling) Inspectorate response awaited from the applicant Under review Sinovac-Coronavac (CurantoPharma) 10/03/2021 Submission to SAHPRA Under review

  6. Section 21 Covid Vaccine Application Section 21 for Applicant Date Status AZ/SII ChadOx NDoH Applied 7/01/2021 Issued 22/01/2021 Pfizer/Biontech Comirnaty Pfizer 03/02/2021 (application received) Query list sent 09/02/2021 16/02/2021- meeting on deficiencies 17/02/2021 deficiencies query issued- Section 21 Authorisation issued 10/03/2021 Sputnik V Lamar 23/02/2021 Under review Response awaited from the applicant Sinovac Coronavac Curanto 10/03/2021 Under review

  7. Conclusions • A rigorous review process was implemented by SAHPRA • SAHPRA experts with extensive knowledge and expertise were part of the review committee • Extensive collaboration with other regulatory authorities that SAHPRA aligns itself with as well as the WHO is on-going

  8. Thank you

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