CDC Africa had warned Kenya against Sputnik V vaccine

This revelation that CDC warned Africa begs the question: who was behind the importation of the vaccine in Kenya and why did they defy expert advice?

The Pharmacy and Poisons Board approved the emergency authorisation use of the vaccine, a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current Covid-19 pandemic.

Read: Russian vaccine only authorised for emergency use, State says

Africa CDC deputy director, Dr Ahmed Ogwell Ouma, told the Sunday Nation that the involvement of the private sector in importation of Covid vaccines presents a myriad of challenges, adding that the entry of Sputnik V in Kenya violated the standard method of transporting vaccines.

Importing vaccines

"Our standard method of importing vaccines is by air, not sea. They are perishable goods and we need a cold supply chain system that must accommodate all their conditions and to remain safe for the users,” he said.

Dr Ogwell clarified that the African Union has not granted emergency use authorisation (EUA) of the Russian vaccine, as it is still studying the data.

"Emergency use means someone has to take liability, when you give it to the private sector, who is taking liability?” he posed, adding that EUA is granted through an open process and the moment there is doubt in the process, this does more harm in the country's national vaccination roll out exercise.

Africa CDC's third principle is that governments must facilitate vaccination and this means that it should be free.

"We do not have a problem with Sputnik V and in fact we are engaging Gamaleya and asking questions, the problem is engaging the private sector in vaccine acquisition, importation and distribution. It is a problem we uniquely seem to have in Kenya and nowhere else," the deputy director said.

While the MoH disowned the authorisation, according to a source privy to the matter, the ministry was aware of the whole process and no single step was skipped during approval.

“The ministry kept asking how many companies had applied, what stage the approval was and what was pending. We were giving briefs at every step,” says the official.

When asked why they approved a vaccine that was not on the World Health Organisation list, the officer wondered why the issue of the WHO list only arose with regard to the Covid vaccine when there were medicines used in the country that are not it.

Breach of due process

“This is politics,” our source said.

Announcing the ban of commercial vaccines, Mr Kagwe said the government is keen on buying only those that are prequalified for emergency use by the WHO and Sputnik V is not yet one of them, although it is already in use across the globe.

“Vaccines being used in Kenya must be cleared by WHO and PPB. If a vaccine has not been cleared by WHO, it will not be used in Kenya, whether it is being used in other countries or not,” Mr Kagwe said.

Just recently, the minister told the Senate Health Committee that Dinlars Pharm, the importer of the vaccine, had followed due process and was approved by the PPB and was free to roll out the vaccine. Then on Friday, he revoked their licence citing breach of due process.

But PPB officers told the Sunday Nation that had the ministry communicated this before the approvals, then the application could have been rejected.

What does it take for a country to approve a vaccine for emergency use? If a vaccine is on the WHO list, approval takes seven days.

“Since everything, including safety, efficacy has been confirmed, we only look at the documents presented for certification and whether they conform with the initial ones presented to the WHO. If they do, then we approve, if not we reject. This is what happened with AstraZeneca,” said an official who requested anonymity.

Once a vaccine has been listed for emergency use, the WHO engages its regional regulatory networks and partners to inform national health authorities on the vaccine and its anticipated benefits based on data from clinical studies to date. Each country undertakes a policy process to decide whether and who to use the vaccine, with prioritisation specified for the earliest use. Countries also undertake a vaccine readiness assessment, which informs the deployment and introduction plan for the implementation of the vaccine.

Safety

For those not yet prequalified by the WHO, it takes at most 30 days checking on the qualification of the documents presented.

 “Do you want to tell me that for the 30 days that we were doing approval, we were not briefing the Ministry?” the official wonders.

For the government to allow at least 200 people to get the jabs, it means it acknowledges the safety and efficacy of the vaccine.

Mr Kagwe says only the government is authorised to carry out the vaccination in the country until further notice.

 “We do not have the infrastructure to create transparency for a streamlined way of accounting for paid for and free vaccines,” said Mr Kagwe.  The CDC says that countries should consider pricing and equity since it is not the time for profiteering.

"When it comes from the hands of the private sector there is an issue with safety and efficacy unlike when it comes from government where we can be able to vouch and as a member of the public you want to have confidence in both the vaccine and the information from government, if we lose trust we are putting ourselves up for failure,” said Dr Ouma.

He said governments can only engage private sector at the vaccination point, but the jabs should be free.

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