Rigorous examination for Covid-19 vaccines

14 Feb, 2021 - 01:02 0 Views
Rigorous examination for Covid-19 vaccines

The Sunday Mail

Emmanuel Kafe and Debra Matabvu

The first batch of Covid-19 vaccines, which arrive in the country early tomorrow morning, will undergo rigorous examination by a team of local multidisciplinary experts over the next 48 hours  to ascertain their authenticity before deployment to vaccination centres countrywide.

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 has granted Emergency Use Authorisation (EUA) for the vaccines, after months of examining data on different vaccine candidates, including the Sinopharm jab, which had been identified by the 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 and 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 The Sunday Mail 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,” said Mr Gwatidzo.

“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 the Ministry of Health and these have been deemed to have a favourable benefit-risk balance.”

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 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 and 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.”

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,” said Dr Mudyiradima.

“We are still working on that and other issues and we will let the public know when we have finalised everything.”

According to the vaccination rollout schedule released last week, front-line health workers, ports of entry officials and funeral parlour workers will be among the first to be vaccinated.

Immunisation of the chronically ill, the elderly, prisoners and those living in refugee camps, and staff at all schools will follow soon after.

Training of health care workers who will administer the vaccines is ongoing.

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.

The inoculation will take three phases which are the  demographic data collection, blood test for antibodies and swab- a sample will be required to determine the potency and the vaccination, the delicate process is being done to monitor and track any side effects.

The jabs will be administered at fixed facilities and mobile outreaches.

Clinical trials have shown that the Sinopharm vaccine has efficacy levels ranging between 76 to 86 percent.

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