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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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US pledges unwavering support for Sri Lanka’s Anti-Corruption Drive

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The U.S. Assistant Secretary of State for South and Central Asian Affairs, Mr. Donald Lu expressed the United States government’s commitment to supporting Sri Lanka’s on-going anti-corruption initiatives as needed during a meeting with President Anura Kumara Dissanayake at the Presidential Secretariat today (07).

Mr. Lu stated that the US is prepared to provide financial and technical assistance to strengthen Sri Lanka’s security and economy. He also emphasized the US government’s willingness to offer technical expertise to help recover funds that were illegally taken out of the country, as part of Sri Lanka’s anti-corruption program.

The discussion highlighted the US government’s appreciation for the new administration’s prioritization of key political, economic, and social challenges. Mr. Lu reaffirmed US support for safeguarding Sri Lanka’s sovereignty and territorial integrity.

President Anura Kumara Dissanayake, speaking at the event, highlighted that Sri Lanka’s political culture significantly influences corruption and waste. He emphasized that efforts are underway to reduce these issues by fostering a new and improved political culture.

The President also spoke about initiatives to uplift rural living standards through improvements to the rural economy and efforts to establish a modern civil service by enhancing the quality of public services.

The meeting was attended by Minister of Labour and Deputy Minister of Economic Development Anil Jayantha Fernando, Secretary to the President Dr. Nandika Sanath Kumanayake, Additional Secretary to the President Roshan Gamage, U.S. Ambassador to Sri Lanka, Ms. Julie Chung, USAID Deputy Assistant Administrator for Asia Ms. Anjali Kaur, Deputy Assistant Secretary for Asia and the Pacific at the U.S. Department of Treasury Mr. Robert Kaproth, USAID Mission Director Gabriel Grau and Counsellor for Political and Economic Affairs Ms. Shawn Gray, among others.

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Atkinson hat-trick, Bethell 96 highlight England’s day of dominance

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Jacob Bethell gets a pat on the back after being dismissed for 96 (Cricinfo)

England have not won a Test series in New Zealand since 2007-08 but they are surely within sight of breaking that drought after a day of utter dominance at Basin Reserve. It was littered with landmarks and milestones: Gus Atkinson’s hat-trick, Jacob Bethell’s  highest first-class score, Joe Root reaching 50 in a Test innings for the 100th time. With three days left in the game, New Zealand already face being set a record fourth-innings chase.

Having wrestled their way into the ascendency on a topsy-turvy opening day, they pinned New Zealand to the canvas from the outset. Atkinson and Brydon Carse utilised what juice remained in the pitch to blow through the last five New Zealand wickets, securing a 155-run lead on first innings. Bethell and Ben Duckett then thrashed 187 runs in partnership to put England in a seemingly impregnable position just five sessions into the Test.

Bethell’s contribution was bittersweet, as he fell four runs short of a first hundred in any format. He nevertheless confirmed the range of his talent, in his second Test and batting at No. 3 for only the fourth time. He drove the scoreboard on after Zak Crawley had fallen in the second over – dismissed by Matt Henry for the fourth innings in succession – and outscored his partner during a free-flowing stand that went at more than 5 an over.

Nathan Smith bore the brunt of their initial onslaught, Bethell twice hooking him into the crowd and also proving strong on the drive. He survived when slashing Smith between keeper and slip, with Daryl Mitchell stood wide, on the way to a 52-ball half-century, and was not afraid to chance his arm as the second-wicket pair cemented England’s position.

Only on entering the 90s for the second time in his first-class career, and having copped a blow from a Will O’Rourke short ball the over before, did Bethell betray signs of nerves. A skied pull off Tim Southee landed in no-man’s land, before he nearly chopped on next ball. Four dabbed through third took him within range of a memorable Test century only to be caught behind aiming an expansive drive.

England’s lead was already past 350 and although Duckett, who was dropped by Tom Blundell down the leg side on 22, also failed to convert after a busy innings ended with a deflection on to his stumps off Southee, there was no let up for the home side after tea as Root and Harry Brook added 95 in untroubled fashion. Brook brought up his sixth 50-plus score in seven Test innings against New Zealand, before holing out off the bowling of Glenn Phillips, while Root also bobbed along to another half-century and into ratified company.

After Ollie Pope fell cheaply, Ben Stokes strode out and threw the bat for another fifty partnership from just 39 balls, suggesting that a declaration may not be far away. While New Zealand have achieved some great escapes in recent memory, not least when the man who now coaches England, Brendon McCullum, helped them to amass 680 for 8 against India at this ground a decade ago, and their pitches have a habit of flattening out, there’s no doubt they were deep in the hole.

One measure of how the day had gone for New Zealand was that their five-man attack managed to bowl zero maidens. Another was that none of their remaining batters faced more than Phillips’ 16 balls as they were steamrollered during the morning session.

Atkinson took the plaudits, having become the first man to take a Test hat-trick at Basin Reserve. It was the latest accolade in a stunning start to the 26-year-old’s Test career, less than six months on from claiming a 12-wicket haul on debut. It made him the seventh player to record a ten-for, a hundred (achieved against Sri Lanka, in fifth appearance) and a hat-trick, and in only his 10th Test – well ahead of the next-quickest, Irfan Pathan (26 matches).

Both Atkinson and Carse claimed four-fors as New Zealand collapsed inside 45 minutes of the morning session. After Kane Williamson’s 37 on day one, no other New Zealand batter made it to 20.

Brief scores:

England 280 and 378 for 5 (Joe Root 73*, Ben Stokes 35*) lead New Zealand 125 (Gus Atkinson 4-31, Brydon Carse 4-46) by 533 runs

(Cricinfo)

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The government’s aim is to bring about a new transformation in the country, grounded in research, evidence, and data. – Prime Minister Dr. Harini Amarasuriya

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Prime Minister Dr. Harini Amarasuriya emphasized the government’s commitment to reshaping the nation’s trajectory during her address at the Digital Library Conference 2024, organized by the National Science Foundation and held on Friday [6th of December] at the Colombo Medical College.

While addressing the audience the Prime Minister stated “We believe that investment in research and development is critical for the government’s development agenda. Our aim is to redirect the country onto a new path, one based on research, evidence, and data, rather than continuing in the same direction as the past 75 years.

One of the greatest challenges we’ve faced in recent years is that, particularly at the highest levels of decision-making, choices are often not informed by science, evidence, or data. This must change. Moving forward, it is essential that decision-makers and the research community collaborate more closely to ensure informed and effective governance, prime minister further added.

The event was attended by the Chairman of the National Science Foundation, Professor Saman Seneweera, Director General Dr. Sepalika Sudasinghe, Head of the National Science Library Resource Center, Manjula Karunaratne, and a group of researchers, librarians and scholars.

[Prime Minister’s Media Division]

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