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Sinopharm vaccine given to Chinese, bypassing ‘Lot Release’ certificate
The Chinese Sinopharm vaccine against COVID-19 is being administered to Chinese workers in the country without the mandatory ‘Lot Release’ certificate, a requirement for all vaccines, the Sunday Times understands.
These Chinese citizens work largely on development project sites in Colombo, Puttalam, Kandy and Hambantota. They were inoculated with the vaccine this week.
The vaccine programme comes in the backdrop of the sacking of many board members of the NMRA (National Medicines Regulatory Authority) who refused to authorise the use of the vaccine in Sri Lanka for emergency-use.
‘Lot Release’ is the process of evaluating each ‘individual lot’ of a licensed product before the granting of approval for its release into the market, it is learnt.
The usual practice involves the review of a manufacturer’s production data and quality control test results (product summary protocol) by the country’s regulator, the NMRA and the National Control Laboratory (NCL) of the Medical Research Institute (MRI).
The Sunday Times learns that the ‘Lot Release’ cannot be issued for the Sinopharm vaccine because it does not have eligibility under the ‘minimum requirements’ set by law in an emergency situation. The Sinopharm vaccine has no registration from the NMRA, neither does it have emergency-use listing (EUL) by the World Health Organisation (WHO). The vial labelling and product information are in Chinese and not in English and the labelling does not match the artwork given with the dossier submitted to the NMRA.
The matter has been brought to the notice of the Chief Epidemiologist, it is understood, but attempts to contact him failed.
At a media briefing on Thursday, several high level health officials assured that the Sinopharm vaccine would not be administered to Sri Lankans until the WHO granted this vaccine EUL and local experts gave the nod after receiving the data on safety and efficacy.
According to the WHO, the ‘Lot Release’ certificate – after review of a summary protocol and access to a laboratory – is essential for a national drug regulator to assure the quality of a vaccine.
The scientific process of ‘Lot Release’ is mandated by law for all vaccines in Sri Lanka. They include Gazette No. 2149/25 issued on November 14, 2019 (Gazetted regulations for Vaccine Lot Release in Sri Lanka) and the NMRA Act.
‘Lot Release’ is also a mechanism that provides the national drug regulator with a real-time system to continuously monitor product quality on document review, it is learnt.
Earlier, the NMRA, in a much-criticised move, granted a ‘waiver of registration’ for the importation of a donation of 600,000 doses of Sinopharm after the original members were removed from the Board and then Chairman Dr. Asita de Silva resigned.
The last Board Member to be shown the door was the nominee of the Sri Lanka College of Paediatricians (SLCP), Dr. LakKumar Fernando who told the Sunday Times that he “only asked for safety and efficacy data of Phase 3 clinical trials” as he did not want a bad precedent set in the country. He also did not want the people to be used as guinea pigs.
The SLCP has urged the Health Minister to revoke the sacking, while seeking an urgent meeting her.