PHARMACY BOARD CLEARED IT

Do not take Russian vaccine just yet, Kenyans told

Health CAS Mwangangi says they cannot guarantee safety, but doctors support the jab

In Summary

• Dinlas Pharmaceuticals, the distributor, said Sputnik is in Kenya and Ministry of Health officials are aware.

• Leading Kenyan pathologist Dr Ahmed Kalebi gave the Sputnik vaccine a thumbs up, saying it is highly effective in preventing severe  Covid-19 disease and deaths, just like other approved vaccines.

A nurse at KNH is vaccinated against Covid-19 on March 5, 2021.
A nurse at KNH is vaccinated against Covid-19 on March 5, 2021.
Image: File

The Ministry of Health has asked Kenyans not to take Russia’s Sputnik V vaccine just yet.

The ministry said it cannot yet vouch for the vaccine's safety or efficacy although it has been granted emergency use authorisation in Kenya.

The vaccine is already being used in 36 countries but is facing a pushback from European countries mainly due to business rivalry.

Health CAS Mercy Mwangangi said the manufacturer, the Gamaleya Institute in Moscow, is yet to furnish Kenya’s Pharmacy and Poisons Board with all required information for full licensing.

“A technical agreement stipulating the responsibilities of all the parties involved in the distribution is yet to be submitted to the Pharmacy and Poisons Board. What this means is that the vaccine has therefore not received all the necessary regulatory approvals for use in the country,” she said.

Mwangangi claimed the Sputnik V vaccine is not even available in Kenya yet.

However, Syokimau-based importer Dinlas Pharmaceuticals said Sputnik is in Kenya and Ministry of Health officials know this.

Nishant Mishra, an official of Dinlas, told a local newspaper they have yet to begin distributing it to hospitals, awaiting final clearance from PPB.

“We used Freight in Time Ltd as our clearing agent," he said.

Mwangangi said full market authorisation comes with a set of stringent measures that include tracking of batches of the commodity and reporting of the pharmaco-vigilance.

Interim results published in the Lancet last month indicate that the vaccine is 91.6 per cent effective, based on its ability to prevent symptomatic infection.

No serious adverse events were detected during trials since last year. Most adverse effects were mild, with just over half experiencing pain at the injection site.

Leading Kenyan pathologist Dr Ahmed Kalebi gave Sputnik vaccine a thumbs up, saying it is highly effective in preventing severe Covid-19 disease and deaths, just like other approved vaccines.

“It’s very good and is top three in the world in terms of efficacy,” he told the Star.

The top two are Pfizer and Moderna at 95 per cent, while from fourth position are Novovax (90 per cent), Sinopharm (79 per cent), AstraZeneca (76 per cent) and Johnson and Johnson (72 per cent).

PPB on Wednesday admitted authorising the vaccine. 

"The Pharmacy and Poisons Board in reviewing the Sputnik V considered all aspects of quality, safety and efficacy. It is wholesomely safe,” the board said in a statement.

“It is the duty of the ministry as guided by the national vaccine and immunisation programme to determine what vaccines to buy based on factors such as the cost and cold chain considerations."

Doubts were seeded when President Vladmir Putin surprised the world by announcing Russian approval for emergency use of Sputnik V as early as August 2020, before phase I or II data had been published and before the phase III trial had begun.

Putin was vaccinated with the vaccine last Wednesday, boosting confidence in the jab.

Approximately 3.5 million Russians had received both doses of Sputnik V as of March 15. The mass vaccination in the country started on January 18, 2021 for all adults and no other vaccine is approved in the country.

On Wednesday, a German official at the European Commission asked the EC to launch a joint purchase of Sputnik V for the EU.

“We have asked the commission to launch a procurement procedure for Sputnik,” the official told reporters at a briefing in Berlin, adding that “we are seeing now that the commission is in the process of launching this procedure.”

However, the head of the EU's medicines regulator said the agency would visit the Sputnik V production and clinical facilities as it decides whether to authorise the vaccine for the bloc.

  (edited by o. owino)