Firm runs into trouble trying to re-export Sputnik vaccine
The company that imported Russian Covid-19 vaccine Sputnik V, whose sale, distribution and administration has been banned in Kenya, has run into another hurdle in trying to re-export over 74,000 doses.
The regulator, Pharmacy and Poisons Board (PPB), says that an application has to be made by the local agents to return the consignment to the Export Processing Zone warehouse before they can be moved out of the country.
Dinlas Pharma EPZ Ltd imported 75,000 doses of Sputnik V, of which 228 were administered locally. They were first warehoused at their warehouse at the EPZ before being moved to the Jomo Kenyatta International Airport, from where they would be distributed to hospitals. For local distribution, Dinlas had to use a local distributor, so they contracted Harvey Ltd.
But then no sooner had they started selling it than the Ministry of Health revoked their licence. The firm has since requested to be allowed to re-export the remaining doses to either Lebanon or Pakistan.
Harvey Ltd, therefore, needs to apply for a new permit to remove the vaccines from the JKIA back to the EPZ for Dinlas to ship them out.
The application has to be done online. A senior PPB official yesterday told the Saturday Nation that when the vaccines came in and were taken to EPZ, they were not considered to be in the country. Harvey Ltd had to apply for another permit to allow them be warehoused at the airport.
“Now, after the ban, for them to be re-exported, the reverse has to happen,” the official said.
In a letter dated April 6 addressed to Health PS Susan Mochache and copied to CS Mutahi Kagwe, Dinlas Pharma EPZ Ltd requested approvals and permission to ship out the doses.
Dinlas cited huge storage costs for the urgency to export the vaccine.
“We are writing this letter with reference to the ban by the government on importation, distribution and administration of Covid-19 vaccine by the private sector,” the letter says. “We are incurring heavy costs for storage and due to the ban. We would like to immediately export the doses to either Lebanon or Pakistan. We request the Ministry of Health to give us necessary approvals... to export the vaccines by April 8, 2021.”
But by yesterday, the PPB source said they had not applied for re-export. “When they apply, we will clear them because we are not holding the consignment for any safety reasons and they were not recalled. We are just waiting for application and this will take a working day to be cleared,” the official said.
In a resolution announced by Mr Kagwe, who chairs the National Emergency Response Committee (NERC), the government said the country would only acquire vaccines through the Covax facility, the Africa CDC platform or bilateral arrangements.
According to the committee, Kenya will only buy vaccines that have been pre-qualified for emergency use by the World Health Organization.
It added that Sputnik V is not yet one of the vaccines though it is in use in several countries.
“Our focus as a country has been to go for vaccines in the WHO list. This is because all the works, including safety and efficacy, have been done for us and the global community.
“Vaccines being used in Kenya must be cleared by WHO and the Pharmacy and Poisons Board,” Mr Kagwe said.
The minister said it is only the government that is authorised to carry out Covid-19 vaccinations “until further notice”.
“The government is closing the window of private sector importation, distribution and administration of vaccines until such a time it is confident there is greater transparency and accountability in the entire process in the interest of public health safety,” he said. The decision, according to the committee, would ensure transparency and accountability in the vaccination campaign.
The government also says private companies and hospitals lack the capacity to meet the vaccine storage requirements.
“We do not have the infrastructure to ensure transparency, or a streamlined way of accounting for paid for vaccines and free ones,” Mr Kagwe said.
Private firms have been accused of going against emergency use authorisation guidelines where they are not supposed to advertise their vaccines.
However, that happened even after the PPB reviewed Sputnik V and considered all aspects of quality, safety and efficacy. The government found the vaccine to be safe.
The board says Sputnik V is in Kenya legally and that only one hospital, Bliss Westlands, was accredited to administer it.
The efficacy of the vaccine is rated at 91.6 per cent, according to data published in the Lancet, one of the world’s most trusted medical journals.
Sputnik V is one of the three vaccines on the planet with an efficacy rate of more than 90 per cent.
Meanwhile, the blame game between the ministry and the PPB over the controversial authorisation of the importation of Sputnik V continued this week, with health acting director-general Dr Patrick Amoth telling the Senate Standing Committee on Health that the regulator hurriedly made the approvals.
“The regulator made a decision without looking at the authorisation process, that’s why we had to come in to ban the administration of the vaccine since there were several mishaps in the process,” Dr Amoth said.
The senators accused Mr Kagwe of shifting positions on the emergency authorisation, importation and distribution of the Russian vaccine.
On March 18, Mr Kagwe appeared before the same committee and said that there was no private company that had been approved to import vaccines in the country.
By then, the firm had 75,000 doses at the Mombasa port.
On March 29, the CS told the members that Dinlas Pharma EPZ Ltd had been approved to bring the vaccine and they had followed the due process and were free to roll out the vaccine.
On April 2, the minister banned the vaccine. Chief Administrative Secretary, Dr Rashid Aman, who represented Mr Kagwe told the committee that the importers ran ahead of the ministry and imported the vaccine before proper frameworks were put in place. BY DAILY NATION
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