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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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Trade, Investment and Tourism Cooperation Forum strengthens economic ties between Sri Lanka and Vietnam

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Marking a significant milestone in strengthening bilateral relations between Sri Lanka and Vietnam, the Sri Lanka– Vietnam Trade, Investment and Tourism Cooperation Forum was successfully held on Friday (08) at the Hilton Colombo.

The Forum, jointly organised by the Vietnam Chamber of Commerce and Industry and the Sri Lanka Export Development Board, was held in parallel with the State Visit of President Tô Lâm of the Socialist Republic of Vietnam and General Secretary of the Central Committee of the Communist Party of Vietnam. The event was attended by President Tô Lâm and Prime Minister Dr. Harini Amarasuriya.

The Forum underscored the importance of the longstanding bilateral relationship between the two countries and reflected the shared commitment to expanding economic cooperation.

The primary objective of the Forum was to further strengthen bilateral economic ties by focusing on key priorities including the expansion of trade, promotion of investment and enhancement of tourism cooperation. The event also provided an opportunity to explore new avenues of collaboration, strengthen business-to-business engagement and facilitate greater market access by bringing together senior government officials, entrepreneurs and industry leaders from both countries on a common platform.

During the Forum, direct air connectivity between Colombo and Ho Chi Minh City was officially launched. The new services, operated by Vietnam Airlines and VietJet Air, are expected to further strengthen relations between the two nations and their people.

Six Memoranda of Understanding covering key areas of cooperation were also signed during the Forum. In addition, a notable development was the establishment of the Sri Lanka–Vietnam Business Council under the Ceylon Chamber of Commerce.

Alongside the Forum, the Sri Lanka Export Development Board organised a business networking session, providing Sri Lankan and Vietnamese entrepreneurs with the opportunity to engage directly with one another. The event received strong participation from the private sectors of both countries, with businesses expressing keen interest in expanding trade and establishing resilient supply chains.

Representing Sri Lanka at the event were Minister of Industry and Entrepreneurship Development, Sunil Handunnetti, Minister of Environment , Dr. Dhammika Patabendi, Deputy Minister of Industry and Entrepreneurship Development ,Chathuranga Abeysinghe, Deputy Minister of Ports and Civil Aviation, Janitha Ruwan Kodithuwakku, Deputy Minister of Tourism Ruwan Ranasinghe, Secretary to the Ministry of Industry and Entrepreneurship Development, Thilaka Jayasundara, Secretary to the Ministry of Trade, Commerce, Food Security and Cooperative Development, K.A.Vimalenthirarajah, Chairman of the Export Development Board Mangala Wijesinghe along with several other dignitaries and officials.

Representing Vietnam were Politburo Member, Secretary of the Party Central Committee and Chairman of the Central Organisation Commission , Nguyen Duy Ngoc, Politburo Member, Secretary of the Party Central Committee and Chairman of the Central Commission for Policies and Strategies , Nguyen Thanh Nghi, Politburo Member, Deputy Prime Minister and Minister of National Defence, Phan Van Giang, Politburo Member and Minister of Public Security, Luong Tam Quang and Politburo Member and Minister of Foreign Affairs, Le Hoai Trung, among others.

(PMD)

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Accelerate projects related to resolving the public’s drinking water issues – President Instructs Officials

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President Anura Kumara Dissanayake has instructed officials to promptly identify and commence the projects required to resolve the drinking water issues that have become a major concern for the public.

The President also instructed officials to formulate plans with close attention to the current needs of the people, pointing out that the inability to ensure an adequate supply of drinking water has given rise to numerous problems affecting the public.

President Anura Kumara Dissanayake made these remarks during a discussion held on Friday  (08) afternoon  at the Presidential Secretariat with relevant officials to review the current status of national drinking water, community water supply and wastewater management projects, the progress and requirements of budget allocations, as well as future plans.

The President further instructed officials to submit a report indicating the projects that could be identified and commenced immediately, the required allocations and the expected completion dates. He stressed that financial constraints should not be treated as an obstacle and directed officials to prepare project plans and submit the necessary funding requests accordingly.

He also instructed that, rather than depending on foreign loans, greater attention should be given to completing projects as far as possible using domestic funds. In addition, he directed that staff required for project planning be recruited on contract basis.

The President also emphasised the importance of utilising capital expenditure allocations within the same year for the relevant projects. He pointed out that failure to do so would result in adverse consequences such as additional project costs, the loss of benefits from the funds already spent and the need to allocate capital provisions again in the following year for the same projects.

During the discussion, the President separately reviewed the projects being implemented and planned to resolve drinking water issues faced by people in the districts of Colombo, Gampaha, Kalutara, Galle, Matara, Monaragala, Kandy, Gampola, Anuradhapura, Vavuniya, Jaffna, Ampara, Batticaloa and Polonnaruwa, along with the progress achieved and the issues that had arisen in implementing them.

Officials also informed the President that deteriorating main water pipelines had resulted in insufficient water capacity being supplied to residents in the Colombo District. They further presented plans to address these issues, while the President highlighted the need for close coordination and systematic planning between the Road Development Authority and the National Water Supply and Drainage Board in carrying out these activities.

The President also instructed officials to take steps to commence the Weli Oya Reservoir Project next year in order to support flood control and meet drinking water requirements in the Colombo District.

Attention was also drawn to the North Central Main Canal and North Western Canal projects. Reviewing the progress of projects being implemented to address the severe drinking water shortage faced by people in the areas of Welikanda, Medirigiriya and Lankapura, the President instructed officials to expedite the completion of projects that would not incur significant costs by using domestic funds.

The President further pointed out the importance of implementing all projects in a highly systematic and organised manner and ensuring that their benefits are delivered to the public. Although certain projects had been suspended midway due to priority being given to essential projects, he stressed that all projects were aimed at addressing the needs of the people and should therefore be carried out in a planned and methodical manner.

Minister of Housing, Construction and Water Supply Dr Susil Ranasinghe, Deputy Minister of Transport and Highways Prasanna Gunasena, Deputy Minister of Housing, Construction and Water Supply T.B. Sarath, Deputy Minister of Cooperative Development, Upali Samarasinghe, Members of Parliament including Samantha Ranasinghe, Nishantha Samaraweera, Sunil Biyanwila, Manjula Suraweera Arachchi, Shantha Padmakumara Subasinghe, Wasantha Piyathissa, Roshan Akmeemana, Ilan Kumaran, M. Jegadeeswaran, and S. Thilakanadan and Kandasamy Prabhu, Secretary to the President Dr Nandika Sanath Kumanayake, Secretary to the Ministry of Housing, Construction and Water Supply L.B. Kumudulal, Director General of the Department of National Budget Jude Nilukshan, Chairman of the National Water Supply and Drainage Board Engineer A.M.P.C.P. Bandara, Chairman of the Water Resources Board R.M.S. Bandara, Director General of the Mahaweli Authority of Sri Lanka H.M.J.K. Herath and several other state officials were also present at the occasion.

(PMD)

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President of Vietnam and delegation departs Sri Lanka

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Tô Lâm, President of the Socialist Republic of Vietnam and General Secretary of the Central Committee of the Communist Party of Vietnam and his delegation departed Sri Lanka on Friday (08) night from the Bandaranaike International Airport, Katunayake, successfully concluding the State visit undertaken at the invitation of President Anura Kumara Dissanayake.

The visit by the Vietnamese President and the accompanying delegation further strengthened the longstanding friendship and cooperation between Vietnam and Sri Lanka, while paving the way for numerous mutual benefits for the peoples of both countries.

This marked the first visit to Sri Lanka by a Vietnamese President in 15 years. The visit also comes at a significant moment as Sri Lanka continues its forward journey towards economic stability under the present Government.

Minister of Industry and Entrepreneurship Development, Sunil Handunnetti, was present at the airport to bid farewell to the Vietnamese President and the delegation.

President’s Media Division (PMD)

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