Chinese manufacturer left queries unanswered

CEYLON TODAY | Published: 2:00 AM Apr 17 2021

By Sulochana Ramiah Mohan

Several pertinent questions posed by the National Medicines Regulatory Authority (NMRA) experts’ panel, to the Beijing Institute of Biological Products, that manufactured the Sinopharm vaccine, were not answered, the final review report of the independent experts’ panel on the vaccine stated.

The independent experts’ panel comprising Dr. Rajiva de Silva, Prof. Neelika Malewige, Prof. Arunasalam Pathmeswaran, Dr. Ananda Wijewickrema, Dr. Kanthi Nanayakkara, Prof. Channa Ranasinhe, 

Dr. Hasitha Tissera and Dr. Lak Kumar Fernando, in the report dated 17 March 2021, said the NMRA requested data on both 1 March and 15 March. 

However, the data provided by the manufacturer was not sufficient to decide on immunogenicity, safety and efficacy of the vaccine and therefore, they recommend not using the vaccine until more information was made available and evaluated, the experts’ panel said.

However, the Health Ministry sacked seven of the NMRA Board members over ‘not approving’ the vaccine.  They were Dr. Palitha Abeykoon (Chairman of NMRA), Chamindika Herath (Lawyer), Harshana Karunaratna (Accountant), Dr. Kapila Ranasinghe (PhD Management), Dr. Asita de Silva, Dr. Nethushi Samarasinghe, Dr. Lak Kumar Fernando and they were replaced by a team led by a medical practitioner and not one of medical eminence, as required based on the NMRA Act. 

The termination letter issued to all seven members had no specific reason given but that the ‘Health Ministry has decided to reform the NMRA and appoint new members to the Board and that the team was terminated’.

Out of the 11 questions posed to Sinopharm by the experts’ panel, seven (7) were left unanswered by the Chinese company.

Questions such as efficacy data in the 60-year-old age group, the sample size inadequate to draw conclusions, whether anyone with comorbidities had been included in the trial, safety data of phase three of the vaccine, side effects observed, whether anyone developed allergies or anaphylaxis, ingredients in the vaccine,  whether it has BSA or FBS since vero cells are known to be grown in FBS, the number of persons included in the analysis of immunogenicity, number of persons from all age groups were not given answered by the manufacturer. 

Furthermore, the manufacturer has not provided follow up data after the interim analysis of phase 3 data presented until 31 October 2020. 

The answer to the question “Neutralising antibody levels in those below 60 years of age in comparison to younger individuals,” the manufacturer had not responded other than ‘Seroconversion rates of 18-59 and below 60 provided but not the neutralising antibody levels,” the review report said. 

Lack of answers from the Sinhopharm companies led the expert panel to halt the use of the vaccine. 

One of the terminated members said, “I was removed because State Minister of Production, Supply and Regulation of Pharmaceuticals Channa Jayasumana thought I am an obstacle to get the Sinopharm approved in a hurry. It is his initiative. Health Minister Pavithra Wanniarachchi just had to send me the letter as she only has the power to do it. She was asked to do so by Secretary to the President P. B. Jayasundera on the request by of State Minister Jayasumana.

In the meantime the Chinese diplomatic circle has questioned the NMRA for delaying the Sinopharm jab that is only administered to the Chinese workers living in Sri Lanka currently. 

They said Sinopharm made a special arrangement and provided most detailed documents about its BBIBP-CorV COVID-19 vaccine to the medicine regulator, including seven pages of Vaccine Introduction and 54 pages of International Summary Report of the Phase 3 Clinical Trial.

They also told Ceylon Today until Thursday (15), the population vaccinated in Chinese Mainland has passed 175.6 million.

They also claimed that on 31 March, the Strategic Advisory Group of Experts (SAGE) of the WHO said that Sinopharm and Sinovac have presented data on their COVID-19 vaccines indicating levels of efficacy and safety compatible with those required by the World Health Organization.

But the WHO in Colombo said that the dossiers are being reviewed for the Moderna, Gamaleya, Sinopharm, Sinovac, and others are in discussions with the WHO prequalification team for data submission to the WHO.

CEYLON TODAY | Published: 2:00 AM Apr 17 2021

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