The Pharmacy and Poisons Board (PPB) that granted Emergency Use Approval of Sputnik V vaccine to the private pharmacy in Kenya is now at loggerheads with the Ministry of Health.
The Ministry of Health as per now declares that the Russian-made vaccine has not met regulatory approvals for use in the country.
CAS of health Dr Mercy Mwangangi spoke to the media yesterday during a coronavirus update and 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 pointed out.
The PBB yesterday gave the vaccine, which has a 92 per cent efficacy rate the go-ahead for administering by a private pharmacy in the country.
The board took it to Twitter saying, ‘‘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.”
The board put it across that, before a vaccine is approved, sufficient scientific and clinical evidence has to be gathered for a demonstration of safety, efficacy and suitability in terms of quality.
However, drug giant AstraZeneca yesterday updated its data on how well its vaccine works. The company as of now proposes that the vaccine is 76 rather than 79 per cent effective at preventing any kind of symptomatic coronavirus disease.
Despite the low percentage, they proposed that the vaccine is 100% efficient against the need for hospitalization hence making it remain 100 per cent effective against severe COVID-19.
The vaccine was 85% effective in preventing symptoms in volunteers 65 and older, the company added.
The new figure is based on a trial study on 190 people who fell sick among 32,449 trial participants, two-thirds of whom received the vaccine while the rest received a placebo. The earlier figure was based on 141 cases in mid-February.
In contrast, the price for the two mandatory doses of the vaccine which will be administered 21 days apart remains high. Individuals who need to acquire the vaccine will have to pay Ksh. 11,000. The vaccine now makes it to the ranks of proven vaccines along with Pfizer BionTech, Oxford’s AstraZeneca, Moderna and Janssen.
By Everlyne Bosibori