The Pharmacy and Poisons Board has cleared the AstraZeneca Covid-19 vaccine for use in the country, paving the way for its rollout in the coming weeks.
Samples of the dossier submitted to the board have been evaluated and registered as fit for use in Kenya.
The vaccine will be supplied by Serum Institute of India (SII), manufacturer of the the vaccine under license from AstraZeneca. In Kenya, the institute has an agreement with Sai Pharmaceuticals as its local agent.
Countries are required to give a national authorisation for any vaccine before it is used on its citizens, according to the World Health Organisation.
Kenya is one of the countries; including the UK, South Africa and Brazil, that is currently conducting a clinical trial on the vaccine at the Kenya Medical Research Institute Wellcome Trust.
South Africa last week paused the distribution of the vaccine in the country following a small clinical trial that showed it offered minimal protection against mild to moderate illness from the 501Y.V2 Covid-19 variant dominant in the country.
Despite the hiccups, Kenya has reported that it will go ahead with procurement of the vaccine.
Nairobi is expecting 24 million doses of the vaccine sometime next week, according to Dr Mercy Mwangangi, the Health Ministry chief administrative secretary.
“We are going on as planned with the purchase of the vaccine,” she said.
The vaccination programme, which will begin early next month, will cover 40 per cent of the population and will be conducted in three phases.
The first phase will involve 1.2 million frontline workers including the health care workers, security officers and teachers which will be done for six months.
The second phase will target 5.1 million Kenyans who are over the age of 50 years while the third phase will focus on 5.2 million with chronic illnesses.
The WHO has issued a statement encouraging countries to continue procuring the vaccine following South Africa’s rejection.
The WHO has given a mandatory condition that all countries procuring the Covid-19 vaccines from any manufacturer must sign an agreement indemnifying the manufacturer of any blame should those who get the jabs react negatively.
Procurement is only finalised after signing of the agreement.
Should the government sign the agreement, it means that it would be liable for any rare side effects and would foot the compensation bill if any member of the public wins legal action against the drug company.
This requirement is not entirely new to Kenya or the Covid-19 vaccine, governments have in the past provided some indemnity to pharmaceutical companies that make vaccines against smallpox and influenza.
The governments of other countries including those of the United Kingdom, United States of America, the European Union, Japan, Germany, Canada, Vietnam, France, South Korea, Austria, Italy and New Zealand have agreed to indemnify Covid-19 vaccine manufacturers.
Indemnity is a contractual agreement between two parties. In this arrangement, one party agrees to pay for potential losses or damages caused by another party as long as WHO standards are adhered to in the manufacturing process.
“All countries must sign the agreements with any manufacturer they are procuring from before the doses are received through Covax,” WHO said in a statement.
Kenya was to receive 4,176,000 doses of the AstraZeneca/Oxford vaccine according to the first distribution list published by WHO and Covax initiative last week, with additional doses expected later.
The Ministry of Health, at the same time, reported that it was expecting 24 million doses from Covax facility estimating that the delivery of the first batch of the vaccine was mid-February, which has since passed.
Kenya will procure Covid-19 vaccine candidates at Sh770 per dose through the Gavi Covax facility. Gavi will supply Covid-19 vaccines to 92 developing countries, including Kenya, through the Covax facility.
The cheapest in all the viable Covid-19 candidates so far is the AstraZeneca jab, which is best suited for African health systems and fits within most countries' cold chain supply system.
“The Oxford University-Astrazeneca candidate is ideal for Kenya because it fits within our cold chain supply system. We are currently testing it and we already have the systems in place for it,” said Dr Patrick Amoth, Director General, Ministry of Health.
Through an MoU between Gavi and AstraZeneca, Gavi has secured “hundreds of millions of doses” and contracted the Serum Institute of India as the manufacturer.
Dr Mercy Mwangangi, Chief Administrative Secretary, Health ministry said through the Gavi facility, the country has already secured Sh19.7 billion while the remaining Sh23 billion will be secured to a World Bank Credit line as well as exchequer financing to be able to cover 40 per cent of Kenya’s population.
The country, she said, will use at least two mechanisms in the vaccination programme to secure Covid-19 vaccines, the Africa CDC and the Covax initiative, which both seek to help African countries to get the vaccines. Kenya is a member of both.
Dr Mwangangi clarified that the country has not yet received the jabs due to supply chain issues.
“If we can get 40 per cent of Kenyans vaccinated, then we should be near herd immunity in the country,” she said.