The vaccines arrive at 3am tomorrow at the Robert Gabriel
Mugabe International Airport, where a Government delegation led by
Vice-President and Health and Child Care Minister Dr Constantino Chiwenga will
receive the consignment of 200 000 inoculation doses. An additional 600 000
doses, procured from Chinese pharmaceutical giant Sinopharm, are due to arrive
early next month.
The Medicines Control Authority of Zimbabwe (MCAZ) has
granted Emergency Use Authorisation (EUA) for the vaccines, after months
examining data on different vaccine candidates, including the Sinopharm jab,
which had been identified by Ministry of Health. The authorisation allows for
the use of medicines that would have undergone Phase I and II clinical trials
and have started Phase III studies but are already showing favourable safety,
efficacy levels.
On arrival, experts will physically inspect the shipment
and its accompanying certificates before they are ferried off to storage where
further examinations will be conducted. This comes as Government is finalising
distribution modalities of the vaccines ahead of commencement of the first phase
of the largest immunisation programme in the country’s history.
MCAZ projects and public relations manager Mr Shingai
Gwatidzo told our Harare Bureau that the medicines regulator had quickly put in
place EUA protocols of Covid-19 vaccines in line with international standards.
“MCAZ and other stakeholders were involved in the planning
of vaccine deployment plan for the Covid-19 vaccines by the Ministry of Health
and Child Care from the beginning. In view of the global pandemic, MCAZ, like
most regulatory authorities, established a system for Emergency Use
Authorisation (EUA) of Covid-19 vaccines. This route allows regulatory agencies
to conduct benefit-risk assessment of vaccines that have undergone Phase I and
II clinical trials and have started Phase III studies but are already showing
favourable safety, efficacy in preventing Covid-19.
MCAZ conducted EUA assessment of the vaccines identified by
Ministry of Health and these have been deemed to have a favourable benefit-risk
balance,” said Mr Gwatidzo.
He said physical inspection of the shipment would ensure
that the right vaccines have been imported.
“When the product arrives we do not anticipate any further
delays emanating from MCAZ regulatory processes since the authority has been
issued EUA already. The only remaining step will be to physically verify the
imported stock and its accompanying certificates.
“In addition, MCAZ will be working with the Ministry of
Health and Child Care monitoring any adverse events following immunisation
(AEFI) to ensure that products maintain a favourable benefit-risk balance as
they are used on the Zimbabwe population.”
He said under normal circumstances, review of a vaccine’s
development dossier takes between 12-16 months.
“However, in view of the public health emergency, through
use of the EUA guidelines, MCAZ aims to assess these vaccines within 48 hours,
thereafter the report is submitted to members of the Evaluations and
Registration Committee for review and approval. Overall a target timeline of 5
days has been set.
The authority prioritised Covid-19 vaccines over any other
assessments and it employed the ‘all hands on deck’ approach whereby a
multidisciplinary team of over 10 senior regulatory experts have devoted their
time to focus on the urgent need for review of the vaccines needed by the
Ministry of Health and Child Care.”
Vice-President Constantino Chiwenga will tomorrow receive
the first batch of Sinopharm vaccines from China, as the country prepares for
Covid-19 vaccination programme. Acting Health secretary, Dr Robert Mudyiradima
said the Government was finalising the vaccines distribution modalities.
“The vaccines are arriving on Monday and they will be
distributed across the country however, we have some issues we are still
finalising such as the date when vaccination will begin. We are still working
on that and other issues and we will let the public know when we have finalised
everything.”
On arrival the jabs will be taken to central vaccine stores
where they will follow the distribution chain to 10 provincial vaccine stores,
63 district vaccine stores and more than 1 800 service delivery health
facilities such as clinic vaccine stores as well as rural health centres. Sunday News
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