SAHPRA update Portfolio Committee - PowerPoint Presentation

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SAHPRA

update Portfolio Committee

Dr B Semete-Makokotlela

SAHPRA CEO

21 July

2021

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Contents

COVID-19 vaccines updates

Vaccines authorization process

Ivermectin update

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COVID-19 vaccines updates

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Pre-Submission Meetings between SAHPRA and Applicants

Vaccine

Applicant

Date

Outcome

J&J

Ad-26

Janssen

4/11/ 2020

Submission of a rolling review application(Rolling review Part 1)AZ/ RPharmRPharm/AZ15/12/2020Rpharm-Russian ManufacturerRPharm18/01/2020Establish Rpharm local Intend for S21 and rolling submissionAZ/SII-ChadOXNDoH31/12/2020Section 21 NDoH granted 22 Jan 2021Pfizer/BioNtec ComirnatymRNAPfizer7/01/202103/02/2021Submission for Reliance review application Section 21 application 04/02/2021Sputnik VAd-26 and Ad-5 Lamar Pharmaceuticals11/02/202118/02/2021Applicant to provide details of vaccine and available data, Applicant to submit Section 21 and rolling review for registration 23/02/2021Sinovac CoronaVac(Vera-cell)Numulox/Curanto Pharma18/02/2021Intend to submit Section 21

ModernaTautomer (Pty) Ltd 22/06/2021Intention for booster - No stock of Moderna for 2021

Sputnik VAd-26 and Ad-5 Mbabala Biotech11/06/2021Contract with RDIF requested

Sputnik V

Ad-26 and Ad-5

Dr Reddy (Pty) Ltd

2021/04/08

Proceed

with submission of application

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Pre-Submission meetings

cont

…

Coronavac

(Vera-cell)

Solace

16/04/2021

Applicant not licensed for Pharmaceuticals and will apply for SAHPRA license. Applicant required

to gain more knowledge and information of their product

VaccineApplicantDateOutcomeSputnik VDr Reddy’s08/04/2021A submission to be made as rolling review submissionUB-612Multitope Peptide-Based Vaccine (MPV) Against COVID-19Vaxxinity16/04/2021Will establish local presence of Vaxxinity. Data up to phase II available; phase 3 India commenced in March 2021. Intend for EUL WHO mid 2021Coronavac (Vera-cell)Solace16/04/2021Applicant not licensed for Pharmaceuticals and will apply for SAHPRA license. Applicant required to gain more knowledge and information of their productCovaxint Bharat Biotech Limited ( Usembe Healthcare )05/05/2021A submission to me made for a rolling reviewSinopharmLHC Pharmaceutical11/06/2021Submitted application subsequently

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COVID-19 Vaccine Applications and approvals

Section 21 for

Applicant

Application Date

Status

AZ/SII

ChadOx

NDoH

7/01/2021

Section 21 Authorisation Issued 22/01/2021Pfizer/BiontechComirnatyPfizer03/02/2021Section 21 Authorisation issued 10/03/2021J&J Ad-26Janssen4/11/ 2020Conditional Market authorization on 30/03/2021Sinovac CoronavacCuranto pharma10/03/2021Section 21 Authorisation issued 2/07/2021Sputnik VLamar pharmaceuticalsDr Reddys23/02/202130/04/2021In review. SinopharmLHCMCpharma22/06/202108/07/2021In review

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Vaccines authorization process

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Key steps of COVID-19 vaccine assessment

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Assessment of cGMP

Compliance of Good Manufacturing Practice

Sites producing drug substance (DS), drug product(DP), filling, packing, testing

Inspections performed at sites that are not

GMP

certified must be executed by an authority

SAHPRA

aligns with

NOTE

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Assessment of CMC

CHEMISTRY | MANUFACTURING | CONTROL

Sites producing drug substance (DS), drug product(DP), filling, packing, testing

MANUFACTURED

CHARACTERIZED

IMPURITIES ARE CONTROLLED

CONTROL TESTS AND LIMITS ARE JUSTIFIED

TEST METHODS ARE USED

TESTS ARE VALIDATED

STANDARDS ARE REFERENCED AND USEDPACKAGED – PACKING MATERIALS AND STABILITYFOCUS ON HOW DS AND DP ARE

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CLINICAL STUDIES ASSESSMENT

ASSESSMENT OF SAFETY DATA

Sites producing drug substance (DS), drug product(DP), filling, packing, testing

ASSESSMENT OF EFFICACY DATA

ASSESSMENT OF RISK MANAGEMENT PLAN

Requires an adequate number of vaccine recipients and monitoring for a sufficiently long time

Requires robust evidence of the vaccine's ability to prevent COVID-19 infection from well-conducted phase 3 clinical trials in humans

Applicant ability to record and report side effects. Assessment of efficacy against variants of concerns is critical

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Vaccine effectiveness

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Monitoring of AEFIs and AESIs

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Monitoring of AEFIs and AESIs

(Since the Sisonke Phase 3B open label study up to 07/07/2021)

Cumulative summary

Vaccine

# of ICSRs

# of AEFIs

# of AESIs

Fatalities

Death Rates per ICSRs received

All reportsComirnaty J&J Vaccine1 494564 (66% female; 30% male)930 (77%female; 17% male) 3730 1243 2487 279 155 1242824 4 1.8% 4.2% 0.4%ICRS: Individual Case Safety ReportsAEFI: Adverse Events Following Immunisation

AESI: Adverse Events of Special Interest

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Common AESIs reported on

Comirnaty

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Common AESIs reported with J&J Vaccine

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Update on ivermectin

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Ivermectin for Treatment and/or Prevention of COVID-19

> 80 on-going trials globally as at May 2021

Current evidence:

No pivotal RCT study for regulatory consideration. Only small studies with different design strengths and weaknesses

Alternative evidence:

Systematic reviews and meta-analyses of a selection of comparable small studies (1;2;3)

Meta-analytic study selection criteria:

Comparable study end-points, comparators, and study baseline characteristics

1. Ivermectin and COVID-19: Research Review and Meta-Analysis | Updated May 2021 (Accessed on 23 June 2021 from

https://www.onedaymd.com/2021/01/ivermectin-and-covid-19-review-updated.html)2. Siemieniuk RAC, Bartoszko J, Ge L, et al. Drug treatments for covid-19: living systematic review and network meta-analysis. BMJ 2020;370:m2980 (http://dx.doi.org/10.1136/bmj.m2980)3. IVERMECTIN FOR TREATMENT OF COVID-19: EVIDENCE REVIEW OF CLINICAL BENEFITS AND HARMS. South African National Department of Health Rapid Review Report: COVID-19 Component (Published on 18 June 2021)

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Ivermectin for Treatment and/or Prevention of COVID-19

Current findings

Current evidence from pooled studies is still not conclusive whether ivermectin confers any clinical benefits in COVID-19

No evidence that ivermectin increases viral clearance, reduces hospital admissions, disease complications or mortality

Ivermectin should not be used routinely in the management of any stage of COVID-19, except in the context of a sufficiently powered Randomised Clinical Trials (RCTs) with well-defined study endpoints intended for regulatory marketing authorization.

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Ivermectin for Treatment and/or Prevention of COVID-19

NEMLC Recommendation (18 June 2021):

Currently there is insufficient evidence to recommend ivermectin use in COVID-19.

Much of the RCT evidence consists of trials of low methodological quality for the most part, with small samples sizes and disparate interventions and controls, limiting the confidence in any conclusions with respect to ivermectin.

No evidence of clinical or virological benefits

Ivermectin should not be used routinely in the management of COVID-19, except in the context of a clinical trial.

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Section 21 ivermectin controlled compassionate use program

(Since implementation on 28 January 2021 up to 09 July 2021 )

*The reason for rejections - requests for ivermectin products from unapproved GMP non-compliant suppliers

Approved

Rejected*

Pending

Duplicate

Tier 3: Section 22C(1)(b) Licence Holder

8

310Tier 2: Health Facility2693904Tier 3: Named-patient3551801TOTALS632601

5

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Applications for registration

Currently, there is no application for registration of ivermectin for the treatment of COVID-19 infection.

SAHPRA has registered an ivermectin cream formulation (

Soolantra

10mg/g cream) for human use which is indicated for the

topical treatment of moderate to severe inflammatory lesions of papulopustular rosacea

in adult patients

SAHPRA has also recently received an application for ivermectin

tablet formulation

for registration for use for tropical diseases. This application is currently under review

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Thank you