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Chinese Sinopharm jab under fire over ‘safety and efficacy’ concerns

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Expert panel warns against using the unproven vaccine in SL

by Suresh Perera`

In the backdrop of an independent panel of medical experts cautioning against administering the controversial Chinese manufactured Covid-19 Sinopharm jab over “safety and efficacy” concerns, a key body of eminent medical specialists last week warned of the adverse fallout of using an unproven vaccine in Sri Lanka.

In what was described as a “strong warning”, the Association of Medical Specialists (AMS) drove home the point that adopting the roll out of any vaccine that’s unproven could reflect adversely on the fight against the pandemic.

“As the expert medical panel concluded there was insufficient data provided to make a determination on the safety, efficacy and immunogenicity of the Sinopharm vaccine, it was accordingly concluded that this vaccine should not be used in Sri Lanka under the present circumstances”, Dr. Lalantha Ranasinghe, the president of the prestigious body of medical professionals, said.

“Scientific evidence by experts should form the basis of any move to curb the pandemic”, the powerful Government Medical Officers’ Association (GMOA) stressed.

Despite this clear recommendation of a properly-constituted independent expert advisory panel, we are concerned about reports that a newly reconstituted Board of the NMRA appears to have taken an unprecedented step to disregard the expert panel opinion and allowed the import of the vaccine to be used in Sri Lankans”, Dr. Ranasinghe said.

The independent advisory panel appointed by the National Medicines Regulatory Authority (NMRA) on candidate vaccines for use in Sri Lanka, comprised Dr. Rajiva de Silva, Prof. Neelika Malavige, Prof. Arunasalam Pathmeswaran, Dr. Ananda Wijewickrema, Dr. Kanthi Nanayakkara, Prof. Channa Ranasinhe, Dr. Hasitha Tissera and Dr. LakKumar Fernando.

In its ‘conclusion’ in relation to Sinopharm based on data forwarded to the NMRA on 01.03.2021 and 15.03.2021 by the vaccine manufacturer, the expert panel was of the opinion that the data submitted was 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.

The panel submitted the review report titled “SARS-CoV2 vaccine (vero cell) inactivated manufactured by Beijing Institute of Biological Products” to Dr. Kamal Jayasinghe, NMRA’s Chief Executive Officer on March 17, 2021.

The panel found clarifications provided with regard to regulatory and administrative information to be satisfactory. However, important clinical information that has not yet been provided and their significance for easy reference, the report said.

Saying that it is deeply perturbed over conflicting statements by government sources, the NMRA and the media regarding the Chinese manufactured Sinopharm vaccine, the AMS noted that the panel, after reviewing all the data made available by the manufacturer of Sinopharm, concluded that there is insufficient data provided to make a determination on the safety, efficacy and immunogenicity of the vaccine.

It was accordingly concluded that the Sinopharm vaccine should not be used in Sri Lanka under the present circumstances, the AMS said in a statement.

“We also note with great anxiety and dismay of certain arbitrary appointments and removals being made to the NMRA Board. We strongly believe such moves as an attempt to undermine the scientific basis of vaccine approval and hence it’s safety, efficacy and acceptance by the general public”, it noted.

“As specialists doctors working in the frontline, we do understand the pressing need for safe and effective vaccine against Covid-19 However, we do recognize that any decision on the suitability of a Covid-19 vaccine must be taken on sound scientific evidence in line with practices of stringent regulatory authorities and the World Health Organization”, it stressed.

With Sri Lanka having an enviable record in the uptake of immunization, one should be mindful of any action deleteriously impact the confidence and acceptance of vaccines, the professional body of specialists further said.

The AMS is a strong advocate for a careful, timely and transparent review of candidate vaccines by the NMRA with the support of relevant experts. The first step towards this is to ensure the independence of the National Medicines Regulator is maintained, it added.

“Any decision on controlling, mitigating or eradicating a public health emergency should be taken on a scientific, evidence based methodology by experts”, says Dr. Sumith Ananda, GMOA spokesman.

Adopting a vaccine, whether it’s Chinese, Indian or from whatever country, should not be based on political or commercial interests as it’s a health-related issue. Experts should determine the outcome, not laymen, he noted.

Apart from evaluating a manufacturer’s guidelines, it’s imperative to ascertain whether a vaccine has been approved by the WHO and evidence of its use locally and internationally, he explained.

“We should look at the pandemic not from a Sri Lankan viewpoint but from a global perspective”, he added.

Asked for comment, an official knowledgeable on the developments, said the opinion of NMRA’s Advisory Committee on Communicable Diseases was not to administer the jab as the data provided was insufficient.

None of the eleven stringent regulatory authorities recommended by the WHO has given the green light to use the vaccine. Neither has the WHO itself approved it, the official, who asked not be named, asserted.

“It is no secret that there’s geopolitics and vaccine diplomacy involved in these matters. However, as it stands the Sinopharm jab cannot be used in Sri Lanka due to critical safety and efficacy concerns”, the official explained.

The panel of experts looked at evidence, but there was no adequate data received for an indepth scientific evaluation to give the go ahead for the jab, he said.

Chinese nationals living in Sri Lanka will be given priority for the Sinopharm vaccine donated by Beijing last week.



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Japan-funded anti-corruption project launched again

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Anura

‘NPP taking credit for what was started during previous govt.’

The National Anti-Corruption Action Plan (NACAP) 2025-2029, ceremonially launched by President Anura Kumara Dissanayake on 09 April, 2025, had actually got underway during former President Ranil Wickremesinghe’s tenure, sources said.

According to a joint media release issued by the interested parties, following the launch, also attended by Chief Justice Murdu Fernando, PC, the Commission to Investigate Allegations of Bribery and Corruption (CIABOC)-led project received the financial backing of Japan and the technical expertise of the UNDP.

In response to The Island query regarding the recipients of the funding, exact amounts provided to them and the duration of the project, sources said that the 18-month-long project, implemented by the UNDP, had been launched in March 2024. According to sources, the project was launched with Yen 137 mn made available through the Japanese Supplementary Budget (approximately 931,000 USD) six months before the last presidential election.

New Japanese Ambassador in Colombo Akio Isomata, and UNDP Resident Representative Ms. Azusa Kubota, were among those present at the 09 April launch.

Isomata’s predecessor Mizukoshi Hideaki finalised the agreement with Ms Kubota on 12 February, 2024, to pave the way for the new project, titled ‘The Project for Promoting Economic Governance through Anti-corruption Policy Support.’

Assistance from Japan and UNDP was in line with their efforts to enable Sri Lanka struggling to resolve the economic crisis.

The Japanese Embassy said on 12 February, 2024, that the project sought to (1) strengthen legal and policy frameworks; (2) improve coordination among key institutions combating financial and tax crimes; and (3) enhance strategic institutional and individual skills and capacities around combating anti-corruption through strategic action.

By Shamindra Ferdinando

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Ranil makes statement to CIABOC

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Former President Ranil Wickremesinghe leaving the Commission to Investigate Allegations of Bribery or Corruption (CIABOC) yesterday after making a statement related to ongoing investigation into former State Minister Chamara Sampath Dassanayake. Dassanayake is in remand custody pending investigations into an alleged misappropriation of funds during his tenure as the Uva Province Chief Minister.

(Pic by Nishan S. Priyantha)

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Nearly 500 kilos of heroin destroyed under court supervision

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Sujith Gunawardena, Director, INSEE Ecocycle and Acting Inspector General of Police (IGP) in Sri Lanka, Priyantha Weerasooriya.

The police and court officials yesterday (28) supervised the destruction of nearly 500 kilos of heroin at the INSEE Cement Plant located in Puttalam.

The following is the text of statement issued by the INSEE Ecocycle Lanka (Private) Limited in this regard: ” Building on a consistent track record of supporting national anti-narcotics initiatives and eradicating a national menace, INSEE Ecocycle Lanka (Private) Limited, the leading professional waste management solutions provider, collaborated once more with the Sri Lanka Police Narcotics Bureau (PNB) and the National Dangerous Drugs Control Board (NDDCB) to responsibly dispose of 494.048 kgs of confiscated heroin via co-processing technology.

This marks the fourth collaboration between INSEE Ecocycle and law enforcement authorities for the destruction of such substances, following successful disposals carried out in 2018, 2019, and 2023 totalling approximately 1804 kgs of dangerous drugs.

The disposal, which ensured environmentally safe and secure destruction of the narcotics, was conducted on 28 April at the INSEE Cement Plant located in Puttalam, under the strict supervision of PNB officials and court-appointed representatives.

Prior to disposal, the confiscated heroin, seized during national anti-narcotics operations, was rigorously verified by the Government Analyst Department (GAD), NDDCB, and judicial authorities to ensure compliance with legal and safety protocols.

INSEE Cement Sri Lanka Chairman/CEO Nandana Ekanayake explained: “INSEE Cement is the only fully integrated cement manufacturing facility in the country with the required capability to provide this solution. We proudly support the national cause and contribute to building a drug-free nation. Sri Lanka’s only operational Cement Kiln Co-processing facility is in our Puttalam Cement Plant. INSEE Cement has always focused on the Health and Safety of all our stakeholders. As a responsible corporate citizen, we are proud and honoured to extend our support and ensure the safe disposal of harmful substances with utmost care and professionalism.”

Emphasizing the significance of the initiative, Sujith Gunawardena, Director, INSEE Ecocycle, said, “As Sri Lanka’s sole provider of co-processing technology, we are proud to collaborate with the authorities and support this critical effort. We successfully disposed of the confiscated narcotics in an environmentally friendly and sustainable manner, complying with all the regulations. Co-processing offers a complete destruction solution for hazardous waste at extremely high temperatures, eliminating it without harmful emissions or residual byproducts. It is a cleaner and more sustainable solution than traditional incineration. It is globally accepted as the superior waste management method, significantly reducing greenhouse gas emissions and aligning with global best practices for sustainable waste management.”

INSEE Ecocycle played a critical role in the technical evaluation of the feeding mechanism and pre-processing activities, collaborating closely with PNB and NDDCB to guarantee the safe disposal of the hazardous substance. The comprehensive technical evaluation comprised thorough risk assessments and mitigation action plans, addressing environmental, social, health, and safety concerns for the entire pre-processing and co-processing value chain.

Throughout the confiscated heroin disposal process, experts from PNB and NDDCB provided guidance on critical components, including laboratory analyses and procedural adherence, culminating in the secure and transparent destruction of the narcotic substance. The disposal took place using cement kiln co-processing technology, also known as thermal destruction, at temperatures of 1800- 2000 °C with a 4-6 sec residence time and under fully controlled process parameters.

INSEE’s co-processing facility satisfies all regulatory requirements and technical standards and is globally adopted for waste management. The facility offers a complete solution with zero harmful emissions to the environment. It has also obtained all required licenses, such as the Environmental Protection License and Scheduled Waste Management License from the Central Environmental Authority and the Provincial Environmental Authority, and certifications including ISO 9001, ISO 14001, ISO 17025, ISO 39001, and ISO 45001.

With a proud legacy of over two decades, INSEE Ecocycle has managed more than 1.3 million metric tons of industrial waste in collaboration with over 1,000 customers, including multinationals, local conglomerates, corporations, government authorities at central and regional levels, and recycling partners. The partnership demonstrates the company’s commitment to advancing Sri Lanka’s circular economy and environmental stewardship.”

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