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Crisis-ridden NMRA gives waiver of registration for import of China’s Sinopharm vaccine
China’s Sinopharm vaccine was on Friday night granted a ‘waiver of registration’ by Sri Lanka’s newly appointed drug regulator.
The waiver of registration was granted under Section 109 of the National Medicines Regulatory Authority (NMRA) Act which deals with ‘Emergency and other special circumstances’, confirmed NMRA’s Acting Chairman Prof. Sisira Siribaddana, stressing that it was with specific regard to a donation of Sinopharm vaccines.
He said he believed that it would be a donation of around 600,000 doses but was unsure when they would arrive in the country and to whom these vaccines would be administered.
Asked whether the “full” dossier including the vaccine’s Phase 3 clinical trial data had been submitted to the NMRA, he said the “complete” dossier had been sent.
With regard to concerns over a lack of data, Prof. Siribaddana said the Lancet’s ‘Infectious Diseases’ journal had published data indicating that the vaccine was “fairly safe” and had good immunogenicity. On the numbers on whom the data were published, he explained that they were the numbers required for Phase 1 and 2 clinical trials, while pointing out that it was difficult to compare different vaccines.
He added that information on animal studies of the Sinopharm vaccine published in the prestigious ‘Cell’ journal was good and the NMRA would also seek the views of experts before granting registration while awaiting emergency-use listing (EUL) for this vaccine by the World Health Organisation (WHO).
The NMRA Chief Executive Officer, Dr. Kamal Jayasinghe, who concludes his term on March 24 (Wednesday), said the waiver of registration was granted for Sinopharm by the NMRA so that a government-to-government donation could be imported and cleared. The EUL for Sinopharm might be granted in time to come.
Asked what Sri Lanka was hoping to do with the Sinopharm vaccine as it had no EUL to administer it to the people and how many doses were expected in the donation, he requested that the Sunday Times contact the Health Ministry and the State Pharmaceutical Corporation (SPC).
The Sunday Times understands that the ‘new’ NMRA (with several recently appointed Board Members), which has been dogged by controversy recently, held two exhaustive emergency Zoom meetings on Friday, in the afternoon and night, to decide on whether or not to grant EUL to the vaccine produced by Sinopharm, the China National Pharmaceutical Group Corporation, a Chinese state-owned enterprise. They had not been able to reach consensus.
The thinking behind the registration-waiver had been that, as requested by the Chinese government, some of the vaccine doses could be used on 30,000-odd Chinese workers in Sri Lanka, it is learnt.
The issue around the Sinopharm vaccine is that insufficient data have been released with regard to the Phase 3 clinical trials, it is understood. The vaccine has also not secured EUL, either from the WHO or a stringent regulatory authority such as the Food and Drug Administration (FDA) of the United States, the United Kingdom’s (UK’s) Medicines and Healthcare Products Regulatory Agency (MHRA) or the European Medicines Agency (EMA).
Friday’s NMRA meetings had been to fast-track the grant of EUL to Sinopharm on the basis of WHO advice to South Asian drug regulators on giving expedited market authorisation to government-to-government donations. However, there had been no consensus on the matter. Some sources said the full dossier on the vaccine had not been received from Sinopharm as yet.
The Sunday Times understands that it is also not the NMRA’s Board Members who should grant EUL to a vaccine but the NMRA’s independent advisory Panel of Experts on vaccines. So far, based on the expert panel’s recommendation, the NMRA has granted EUL to AstraZeneca’s COVISHIELD vaccine produced by the Serum Institute of India and the Sputnik V vaccine produced by the Gamaleya Research Institute in Russia.
Prof. Siribaddana who guided Friday’s meetings has taken the place of Prof. Asita de Silva who submitted his resignation on Monday (March 15) as Head of the crisis-hit NMRA. His resignation followed hot on the heels of the lightning sacking of four members of its board by a State Minister, the previous week.
On Wednesday, at a meeting summoned by Health Minister Pavithra Wanniarachchi with the participation of Pharmaceuticals State Minister Channa Jayasumana, a suggestion to appoint a just-qualified Consultant Anaesthetist, Dr. R.I. Wijewantha who has still not returned from his post-graduate training abroad, had generated much discussion, with the culmination being the appointment of Prof. Siribaddana as the Acting Chairperson for a month, it is understood.
Prof. Siribaddana and three others had been appointed as NMRA Board Members by State Minister Jayasumana soon after he sacked the four who were in service. The legality of these moves by the State Minister is under question, the Sunday Times understands as the appointing authority for NMRA members is the Health Minister, based on recommendations with regard to ‘people of eminence’.
Even though Prof. Asita de Silva had resigned only from the post of NMRA Chairperson but not as the Board Member representing the field of pharmacology, in his place, Prof. Sudheera Jayasinghe from the Department of Pharmacology, Faculty of Medicine, Ruhuna University has been appointed. Prof. de Silva has not been issued a letter of termination of service.
The four NMRA Board Members who were sacked the previous week were well-known health expert Dr. Palitha Abeykoon, management expert Dr. Kapila Ranasinghe, accountancy expert M.K. Harshana Karunaratne and lawyer Chamindika Herath.
Those appointed in their place were Prof. Sisira Siribaddana (Management), Raja Goonaratne (Law), Dr. Udayasri Kariyawasam (Accountancy) and Dr. R.I. Wijewantha (Health).