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BY JOAN WANJIKU,NAIROBI,24TH MARCH,2021-The Ministry of Health now says the Russian-made Sputnik V vaccine has not met all the necessary regulatory approvals for use in the country.
The latest comes just hours after the Pharmacy and Poisons Board (PPB) granted Emergency Use Approval to a private pharmacy in Kenya.
Speaking to the media on Wednesday during an update of the coronavirus situation in the country, Ministry of Health CAS Dr. Mercy Mwangangi warned against the marketing of the vaccine in the country.
“We have already made it clear that we are ready to accept any vaccines and not just the Astrazeneca which is currently in use, but this must follow all the laid down rules for approval both locally and globally. Any vaccine distributed in the country must have Emergency Use Authorization from a Stringent Regulatory Agency including WHO,” she said.
The Ministry noted that despite the approval by PBB, all the parties involved in the distribution are 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. No vaccines are available for sale in the country as none has received market authorization,” she added.
She continued:” We also intend to partner with the private sector but stringently regulate them. Eventually all vaccines that meet our regulatory requirements will be in use in Kenya,”
On Wednesday, the PBB gave the vaccine, which has a 92 percent efficacy rate the go-ahead for administering by a private pharmacy in the country.
A statement posted on Twitter by the PPB on Wednesday said: ” PBB Kenya has given Emergency Use Authorization to AstraZeneca vaccine and the Sputnik V vaccine after a successful evaluation process. This is not a registration.”
According to the PBB, before a vaccine is considered for approval, sufficient scientific and clinical evidence must be collected to show that it is safe, efficacious and of suitable quality.
The Board said that in reviewing the Sputnik V vaccine, it had considered all aspects of quality, safety and efficacy and arrived at conclusion that it is wholesomely safe.
Those interested in getting the vaccine will have to part with Ksh. 11,000 for the requisite two doses which will be administered 21 days apart.
The vaccine which was initially met with scepticism now joins the ranks of proven vaccines alongside Pfizer BionTech, Oxford’s AstraZeneca, Moderna and Janssen.