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Private companies to import Covid-19 vaccines

The Health Ministry will allow some private pharmaceutical companies to import coronavirus vaccines to compliment government efforts.

According to the ministry, discussions are underway with the Pharmacy and Poisons Board (PPB) to issue the companies a conditional market authorisation in a bid to bridge access gap and increase the number of doses in the country.

Speaking at a virtual meeting hosted by the Kenya Medical Association (KMA), Covid-19 vaccine advisory taskforce Chairman Willis Akhwale said the government will monitor the prices and regulate the entire process.

The world has been using vaccines licensed through an emergency use authorisation (EUA), a mechanism that facilitates the availability and use of medical commodities like vaccines during public health emergencies such as the current Covid-19 pandemic. This authorisation opens the door for countries to expedite their own regulatory approval processes to import and administer the vaccine.

During a global health crisis like the ongoing pandemic, the government has a responsibility to keep things under control. However, by opening the market for vaccines through conditional market authorisation, the potential threat of substandard or counterfeit vaccines could enter the market because this decision is not far-fetched.

Emergency use authorisation tends to restrict the purchase, import, and distribution to government.

With Kenya likely to start vaccination for healthcare workers as well as essential workers in March, the expert group on vaccines is in the process of finalising the details for this phase.

“For the public, it will be free. We are working with the private sector to standardise the cost. Say, they only charge Sh200 to administer the vaccine,” Dr Akhwale told the doctors’ meeting.

But for Dr Simon Kigondu, secretary-general of the Kenya Medical Association, price control is probably not an issue because Covid-19 vaccines are in use on emergency authorisation, meaning that they have not been ‘commercialised’ like other vaccines.

“What is important is the ability of the government to make it available to the majority of Kenyans who need it but cannot afford it. It is also their ability to monitor efficacy,” said Dr Kigondu. “Put another way, suppose a private entity starts selling the vaccine at a ‘high’ price and the vaccine is then declared ‘ineffective’,” he added.

Dr Akhwale also said that final touches have been put in place to ship the first four million Covid-19 doses before the end of the month. The doses will be stored at the Ministry’s central vaccine depot in Kitengela, which can store up to 20 million vials of vaccines. From there, the shots will be distributed to the eight regional storage centres across the country.

Upon arrival of the vaccines, the head of the taskforce said the vaccination exercise will take off in two weeks.

The head of the vaccine task force noted that a conversation held with Gavi’s Covid-19 Vaccines Global Access (Covax) gave the ministry three conditions to meet before they can dispatch the vaccines.

“The first is that we needed to have local registration, import licence, and indemnification of companies,” noted Dr Akhwale.

While the first two conditions are easy to meet according to Dr Akhwale, he explained that the government needed to sign indemnification or “no fault” agreements, which absolve companies from liability in case of unexpected adverse effects arising from the emergency use of vaccines.

“We are in communication with Treasury, the Attorney General, and manufacturers before our orders are shipped,” explained Dr Akhwale.