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Protests over NMRA’s decision to grant waiver to Sinopharm
The waiver granted by the National Medicines Regulatory Authority (NMRA) to allow the import of the Sinopharm vaccine from China on March 19 drew much fire, with the Vaccine and Infectious Diseases Forum of Sri Lanka urging the Health Ministry to “strictly” follow the unanimous decision of the NMRA’s independent Panel of Experts.
The eight-member Panel of Experts on candidate vaccines in its report submitted on March 17 states categorically that it recommends not to use the vaccine until more information is made available and evaluated.
The controversy surrounds the SARS-CoV2 vaccine (vero cell) inactivated, manufactured by the Beijing Institute of Biological Products under the China National Pharmaceutical Group – Sinopharm vaccine.
Echoing serious concerns in the health sector over reports that the NMRA’s Acting Chairman has approved the Sinopharm vaccine, the Vaccine and Infectious Diseases Forum points out that the Panel of Experts had met on March 17 and studied the information provided by the manufacturer up to March 15.
“They were of the unanimous opinion that the data submitted were not sufficient to decide on immunogenicity, safety and efficacy of this vaccine at present and therefore recommends ‘not to use the vaccine’ until more information is made available and evaluated,” stated the Vaccine and Infectious Disease Forum.
The Sunday Times on March 21, in an article headlined ‘Crisis-ridden NMRA gives waiver of registration for import of China’s Sinopharm vaccine’ reported how the Sinopharm vaccine was granted a ‘waiver of registration’ by Sri Lanka’s ‘new’ drug regulator on the night of March 19.
The NMRA’s Acting Chairman, Prof. Sisira Siribaddana, said the waiver was granted under Section 109 of the NMRA Act which deals with ‘Emergency and other special circumstances’ and it was with specific regard to a donation of around 600,000 doses of Sinopharm vaccines. He was not sure to whom these vaccines would be administered.
This week, the March 17, 2021 dated Review report No. 4 of the NMRA’s Panel of Experts on the Sinopharm vaccine was circulating in the public domain. Of 11 questions posed by the Panel of Experts, according to the document, the Panel has indicated “Not answered” to nine.
In the report, the Expert Panel points out that the questions to which answers have not been provided include:
Interim analysis of phase 3 data presented until October 31. No data after that. Can the follow up data be provided?
Vaccine efficacy is claimed to be 76.06% and 78.01%. Were participants only followed up for an average period of 22 days after the 2nd dose?
Efficacy data in >60-year-old age group. The sample size inadequate to draw conclusions.
Were anyone with co-morbidities included in the trial?
Phase 3 safety data. What were the side-effects observed?
In conclusion, the Expert Panel states that “with data submitted to the NMRA on 01.03.2021 and 15.03.2021 by the vaccine manufacturer, the Expert Panel is of the opinion that the data submitted are not sufficient to decide on immunogenicity, safety and efficacy of the vaccine at present”.
Meanwhile, in a letter dated March 19 to the Controller General of Import and Export, the NMRA’s Director-General/Chief Executive Officer, Dr. Kamal Jayasinghe, states that as per the board (NMRA’s Board Members), the NMRA grants Waiver of Registration for emergency use of the vaccine in terms of Section 109.
Many stressed that Sinopharm has not received emergency-use listing (EUL) by the World Health Organisation (WHO) or a stringent regulatory body such as the Food and Drug Administration (FDA) of America, the United Kingdom’s (UK’s) Medicines and Healthcare products Regulatory Agency (MHRA) or the European Medicines Agency (EMA).
Others pointed out that it is not the NMRA Board’s decision whether or not to grant EUL but the decision of the Technical Evaluation Committee, which, in this case, is the Panel of Experts.
Looking around the world, sources also said that in the United Arab Emirates (UAE), a small number was being given the third jab of Sinopharm as they had not developed a sufficient immune response from two doses.
Sri Lanka, so far, based on the expert panel’s recommendation, 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.
In the past few weeks, the NMRA has been plagued by crises, firstly by the lightning sacking of four members of “eminence” of its board by a State Minister, followed by its Chairman Prof. Asita de Silva submitting his resignation.
Prof. Siribaddana and three others had been appointed as NMRA Board Members by State Minister Channa Jayasumana soon after he sacked the four who were in service.
The sacked members were well-known health expert Dr. Palitha Abeykoon, management expert Dr. Kapila Ranasinghe, accountancy expert M.K. Harshana Karunaratne and lawyer Chamindika Herath. In their place were appointed Prof. Sisira Siribaddana (Management), Raja Goonaratne (Law), Dr. Udayasri Kariyawasam (Accountancy) and Dr. R.I. Wijewantha (Health).
With much opposition to a suggestion that Dr. R.I. Wijewantha who has still not returned from his post-graduate training abroad should be appointed Chairperson, Prof. Siribaddana had been made Acting Chairperson temporarily.
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, Prof. Sudheera Jayasinghe from the Department of Pharmacology, Faculty of Medicine, Ruhuna University had been appointed in his place.