Attempt to bring COVID-19 vaccines from China without reliable data

An attempt is being made to bring COVID-19 vaccines from China without reliable data, a newspaper claimed today.

The Sunday Times reported that the lightning sacking of four respected members of the country’s drug regulator has thrown it into disarray, with the health sector being rocked by serious allegations that this is an attempt to bring in COVID-19 vaccines without reliable data.

The National Medicines Regulatory Authority’s (NMRA) four board members who are serving on an honorary basis are well-known health expert Dr. Palitha Abeykoon, management expert Dr. Kapila Ranasinghe, accountancy expert M.K. Harshana Karunaratne and lawyer Chamindika Herath.

The ‘letters of termination’ of appointment dated March 8 (Monday) signed by State Minister Channa Jayasumana states: “By virtue of the powers conferred to me as the State Minister of Production, Supply & Regulation of Pharmaceuticals under the extraordinary gazette No. 2187/27 of Sunday, August 09, 2020 and further to His Excellency the President’s communication, according to Section 9 (2) of the NMRA Act No. 05 of 2015, I have decided to reform and increase the efficiency at NMRA by appointing fresh members to the Board of the NMRA. Hence, your appointment as a Board Member of the NMRA will terminate with effect from March 8, 2021.”

In a similar letter sent out the same day (March 8) to NMRA Chairperson Prof. Asita de Silva, but with the change “…..with His Excellency the President’s concurrence per the letter dated 17th February 2021”, the State Minister has appointed Prof. Sisira Siribaddana (Management), Raja Goonaratne (Law), Dr. Udayasri Kariyawasam (Accountancy) and Dr. R.I. Wijewantha (Health) in place of the sacked members.

The Sunday Times understands that as a sop to Cerberus, Dr. Palitha Abeykoon has been “appointed” as a Member of the MMRA’s National Advisory Committee which has not been convened for three years. There was no confirmation whether Dr. Abeykoon has accepted or declined the offer.

These letters had followed an emergency meeting on Monday (March 8) that the NMRA’s independent advisory Panel of Experts on vaccines had held with Health Minister Pavithra Wanniarachchi, State Minister  Jayasumana and State Minister of Primary Health Care, Epidemics and COVID Disease Control Dr. Sudharshini Fernandopulle to explain the reasons why the Chinese vaccine Sinopharm has not yet been granted emergency-use listing (EUL) by the NMRA.

The Panel of Experts had pointed out that Sinopharm has not been given World Health Organisation (WHO) EUL, neither has it got EUL from a stringent regulatory authority. No data on efficacy and safety had also been submitted to the NMRA with regard to the required Clinical Trial studies.

A source said that no data on safety and efficacy had been submitted for Sinopharm, even though the NMRA had made many requests for such data.

This was as China’s food and drug regulator’s former chief Bi Jingquan, as reported in the South China Morning Post, urged vaccine manufacturers in his country to give more details about Clinical Trial data. “Publish all your data, it’s good for strengthening everybody’s trust,” he has said.

Sri Lanka’s NMRA has so far given EUL for AstraZeneca’s COVISHIELD vaccine produced by the Serum Institute of India and the Sputnik V vaccine produced by the Gamaleya Research Institute in Russia.

Minister Wanniarachchi, after listening to the vital need for vaccine EUL to be granted only based on science and proper data on safety and efficacy, as otherwise it would pose a serious danger to the people of the country, had at Monday’s meeting requested that the NMRA organise a Zoom meeting with the Chinese vaccine manufacturer.

With regard to the sacking of the four members, the Sunday Times also heard views that such action cannot be carried out by a State Minister as the appointing authority for NMRA members is the Health Minister, based on recommendations with regard to ‘people of eminence’.

In early January, Dr. Palitha Abeykoon was one of six handpicked as Special Envoys by WHO Head Dr. Tedros Adhanom Ghebreyesus to coordinate the global response to COVID-19. He represents the South East Asia Region and works in close collaboration with the WHO DG’s Office, the WHO Regional Directors and the country offices.

Meanwhile, the Sunday Times understands that with regard to the four NMRA Board Members who are nominated by the Colleges of Physicians, Paediatricians, Surgeons and Obstetricians & Gynaecologists, the State Minister has in an unprecedented move requested some of the colleges to submit three names each for just one seat respectively.