South African National Department of Health Minister, Dr Zweli Mkhize

South African Health Products Regulatory Authority Chairperson, Professor Helen Rees
Pharma-Ethics Independent Research Ethics Committee Chairperson, Dr C.S.J Duvenage
Tygerberg Hospital CEO, Dr D Erasmus
TASK Applied Science Founder & CEO, Professor Andreas Diacon
TASK Applied Science Investigator, Caryn Upton
TASK Applied Science Investigator, Naadira Vanker
TASK Applied Science Investigator, Reinout van Crevel, Netherlands
TASK Applied Science Investigator, Coenie Koegelenberg Stellenbosch University
Western Cape MEC for Health, Dr Nomafrench Mbombo
South African National AIDS Council Interim CEO, Coceka Nogoduka

Friday 12th June 2020

CALL FOR THE IMMEDIATE SUSPENSION OF THE TASK BCG CORONA VACCINE
TRIAL.

We, the undersigned, hereby call for the immediate suspension of the operations of the TASK BCG
Corona Vaccine Trial. This statement refers to the trial whose full title is: “Reducing morbidity and
mortality in health care workers exposed to SARS-CoV-2 by enhancing non-specific immune
responses through Bacillus Calmette-Guérin vaccination, a randomized controlled trial” and whose
protocol number is TASK-008-BCG-CORONA.

The labour unions represented by the South African National AIDS Council Labour Sector (COSATU,
FEDUSA, NACTU) and the Health Care Worker movements listed below would like to state that, based
on a critical lack of information sharing, engagement by or accountability of this trial, we are unable
to guarantee the safety of our members who choose to participate in this trial.

We, therefore, call for all Health Care Workers to refrain from engaging in and supporting this trial until
the research institution is open to engagement with a broad range of interested stakeholders and
communities.

Additionally, as community and advocacy groups who have an interest in ensuring ethical and
accountable vaccine research and other trials that are truly community-owned, we are deeply
concerned about this trial and its leadership. Attempts to engage with the trial indicate a failure by the
researchers to broadly engage and consider the input of critical national structures of people living
with and survivors of TB and the communities where the trial is taking place. There has not been
sufficient evidence that practices recommended by Good Participatory Practice guidelines for trials of
emerging (and re-emerging) pathogens (GPP-EP) have been taken into consideration before and
during this trial. The researchers have been unwilling to provide basic accountability information to
civil society related to its operations to date.

The undersigned groups released a joint statement and cover note on the 5th June 2020 raising
additional concerns related to the non-provision of personal protective equipment to the trial’s Health
Care Worker participants as a standard of care.
We are further concerned that the appointed civil society representative on the structures of this trial,
TB Proof, has failed to be accountable to broader civil society on key issues that have formed the
basis of and become the standard of ethical research over the last decades. The questions raised to
this organisation have largely gone unanswered and deferred to the organisation running this trial,
TASK Applied Science.

The questions submitted to TB Proof and the leadership of this trial can be viewed here and the
responses to those questions can be viewed here. Despite reaching out to TASK requesting additional
information, on a public call held on Thursday 11th June 2020 with concerned civil society groups, TB
Proof stated that the TASK trial leadership had requested them, as the civil society representative on
the trial, to not engage further with civil society groupings following our joint statement raising
concerns about this trial.

We are in full support of all research that is ethical, truly community-owned and accountable to the
communities it purports to be in service to. Each day that this trial is allowed to proceed without these
critical checks and balances sets the broader accountable research agenda backwards and
compromises the goodwill, the trust and the confidence that trial participants have in research not only
for this trial but for trials to come.

Until the TASK trial leadership shows an understanding and appreciation of accountability, the critical
need for meaningful community engagement in research and a contextual understanding of the
standard of care, we demand its immediate suspension and urgent review. This review should be
carried out by the South African Health Products Regulatory Authority (SAHPRA), the Pharma-Ethics
Independent Research Ethics Committee (National Health Research Ethics Council Registration
number: REC-220508-008) who provided approval to this trial, in partnership with the undersigned
organisations. We must ensure that, should this trial go ahead after review, it can truly be called ethical,
accountable and community-owned and shaped by a comprehensive consultative process that is led
by the community that the trial purports to serve; Health Care Workers.

Signed:
Vaccine Advocacy Resource Group, Community Constituency COVID-19 Front1, SANAC Labour
Sector (COSATU, FEDUSA, NACTU), SANAC Civil Society Forum Tuberculosis TASK Team, Show
Me Your Number, Treatment Action Campaign, STOP TB Partnership – Kenya, APHA, WACI Health,
NHVMAS.

Queries: Tian Johnson, tian@africanalliance.org.za, +27734324069

1 Representing 131,978 organisations and that operate at National, Provincial, District and Local levels including the SANAC Civil
Society Forum (CSF) with membership of 6012 organisations from 18 sectors, South African National Co-Operatives Organisations
(SANACO), South African Youth Council (SAYC), Women in Informal Employment: Globalizing and Organizing (WIEGO),
Women’s National Coalition (WNC), Alliance of NPO Networks, Patient User Network, Financial Sector Co-Coalition Campaign
(FSCC), Disabled People South Africa (DPSA) and the South African National Civic Organisation (SANCO).