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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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Toxic coconut oil scare trigger public wave of fear over aflatoxins in foodstuffs

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People now wary of buying certain products

By Suresh Perera

In the backdrop of a top official of Sri Lanka’s key standards body coming under heavy flak over her controversial claim that several other consumer commodities also contain toxic substances, public apprehension has shifted to many other products in the market following a wave of fear triggered over cancer-causing free radicals in foodstuffs, industry players said.

The Trade Ministry has already initiated a disciplinary inquiry into the assertion by Dr. Siddhika Senaratne, the Director-General of the Sri Lanka Standards Institution (SLSI), that aflatoxins are also found in certain other food items sold to the public.

Aflatoxins are a family of toxins produced by certain fungi found on agricultural crops.

As the SLSI scientist’s remarks during a television talk show ignited an uproar following the seizure of imported stocks of contaminated coconut oil, industry officials said that customers are now wary of purchasing certain food products as the social media, rightly or wrongly, painted a frightening picture, they said.

A committee will be appointed to examine Dr. Senaratne’s statement to ascertain the validity or otherwise of her claim of the presence of aflatoxins in some food products in the marketplace, authoritative sources said.

Though the Director-General didn’t identify any of the “toxic products” she claimed were being sold to consumers, her statement unleashed a cycle of fear and uncertainty as consumers, influenced largely by social media reports and hearsay, viewed many brands with suspicion, the sources noted.

However, there has been no credible scientific evidence so far to prove that products identified on social media contain carcinogenic properties, they said.

Dr. Senaratne’s contention was that identifying products with toxic substances could lead to the collapse of some local industries. The Consumer Affairs Authority (CAA) has been informed to take up the issue with the relevant manufacturers for remedial action, she said.

It is no secret that many mills use copra with fungus to extract coconut oil. The perishable copra is dried outdoors but there is no proper cleaning of the fungi, which are common under tropical and sub-tropical conditions, before the oil is extracted, industry officials said.

Has it been established whether the shiny wax coating used on apples as an oxygen barrier to preserve freshness, particularly in consignments imported from China, belong to the safe food grade material?, they asked.

In the case of apples imported to Sri Lanka from the USA, the whole process of orchard to point of landing take many weeks. It is true that fruits are stored in cold rooms to preserve quality and slow the aging process by regulating oxygen and carbon dioxide levels. However, the question arises whether there are accredited processes to monitor the agro chemical and other toxic levels in imported apples and other varieties of fruits before permitting the stocks to be released to the local market, they noted.

Hoppers are a staple of Sri Lankan cuisine, but it’s common knowledge that many wayside eateries introduce plaster of paris (a quick-setting gypsum plaster consisting of a fine white powder known as calcium sulfate hemihydrate) to the batter to keep them fresh and crispy, the officials asserted.

“This is because customers insist on freshly baked hoppers and as a result, those that have gone flat cannot be sold”, they said.

Cleanliness of eateries is being monitored to some extent, but are there any quality checks for toxicity on the food served to customers?, they queried.

After the contaminated coconut oil scandal surfaced, people are reluctant to even buy traditional oil-based sweetmeats from the marketplace, they further said.

Unlike earlier years, there is a slump in sweetmeat sales, a supermarket official said. “Customers are wary about toxic coconut oil in the market”.

 

 

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Ceyleon Solutions launch Sparetime App to turn spare time into income

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Ceyleon Solutions, a leading mobile app solution provider, launched Sparetime (www.sparetime.lk), a special mobile app to make easy money using one’s spare time. This app helps to search for people providing domestic, official or personal services or earn an extra income by providing a wide range of services.

Services such as masonry, plumbing, computer related services, wholesale, distribution, medical & healthcare, teaching, legal, beauticians, cleaning, helping, babysitting and car wash can be either searched or provided using this app as it creates an online platform for such service providers and those who seek their services.

There are two apps compatible to android and apple phones, ‘Sparetime Provider’ for those who provide services and ‘Sparetime User’ for those who seek such services.

“This is an ideal option for those who find it difficult to make ends meet with their salaries. Using this app, they can make use of their spare time effectively to earn extra money. This creates a comprehensive service hub. For an example, a vegetable farmer can find both a whole seller and a transport service provider to transport his goods with just a click. Even students can find part time work for their financial needs”, said Chaminda De Silva, creator and owner of the Sparetime app.

“This app works as a platform for social workers to get together and mobilize people for tasks that they wish to perform. This is a very user friendly app. However, operating instructions can be obtained by calling our hotline 0706355450 or 0706355452. An instructor will come to help you if necessary”, he noted.

Regardless of being a service provider or a user, this app will be ideal. It will also pave the way to gradually reduce the unemployment rate in Sri Lanka and will subsequently contribute to the gross domestic product accelerating economic growth of Sri Lanka.

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“Zahran Hashim and his group were not Muslims; they hijacked the name of Islam to commit these crimes’

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Rishad Bathiudeen tells Parliament

The Muslims never called for separatism. The Muslims have been on the side of the nation for over 1,000 years in Sri Lanka as documented in the book of Dr. Lorna Devaraja titled, ‘The Muslims of Sri Lanka – One Thousand Years of Ethnic Harmony’. Even when the Muslims were threatened with eviction or death from the North, they risked their lives and the lives of their loved ones to be on the side of the State, Rishad Bathiudeen, MP, said.

Speaking in English during the fifth day of the debate on the report of the Commission of Inquiry on the Easter Attacks in Parliament on April 7, he said: “Zahran Hashim and his group were not Muslims. They hijacked the name of Islam to commit these crimes. The report in Page 94 confirms that Zahran wanted to build tensions between the Sinhalese and Muslim Communities of Sri Lanka”.

The MP’s speech contained many points and references to matters in the report and events that transpired thereafter.

Some of the points raised by the MP were:

* The State is antagonizing the Muslim community in the manner that Zahran had wanted them to act. The State should not play to the tunes of Zahran. The State should not act in a way that would jeopardize national security. The State has already commenced the process of State sponsored oppression by prohibiting the import of Muslim books and are making plans to ban Niqabs/Burkas and Madrasas.

* The PCoI has exonerated Rishad Bathiudeen from all charges in connection with the Easter attacks. Only two charges remain to be investigated. First one is in relation to the phone call placed by Bathiudeen to then Army Commander General Mahesh Senanayake, concerning Ihsan Moinudeen. Secondly, the sale of scrap metal by the Industrial Development Board to Colossus (Pvt) Ltd. Rishad Bathiudeen visited the Bribery Commission on 8th of April, 2021 to request them to investigate the allegation in the report.

 

* The weight placed on the phone call made by Rishad Bathiudeen to General Mahesh Senanayake, was given far higher significance in the report in comparison to the actions of Dayasiri Jayasekara who released six persons from the Hettipola Police Station who were involved in torching and destroying Muslim owned shops and Muslim places of worship. The Commission Report had recommended investigation into the phone call but had not charged Dayasiri on any matter.

 

* The Government cannot have a law banning the Niqab and Burka without also banning medical masks, helmets, sunglasses, etc.

* Restriction of Islamic books being brought into the country is a violation of the Constitution.

* Bathiudeen quoted Page 331 of the Report:‘Reciprocal radicalization is the cycle of radicalization which promotes each other’s radicalized ideologies’. If the Government can keep politicians like Wimal Weerawansa in check, the de-radicalization program will be half completed. He also said that inciting racism will only provoke and radicalize more Muslims.

 * Killing of Fouzul Ameer Mohamed Salley in Kottramulla before his children in the aftermath of the Easter Attacks, was Genocide under Article 2 of the Genocide Convention, and all persons who were inciting racism could be charged for incitement to genocide. Subsequent charges of oppression too can have a detrimental effect on Sri Lanka. Sri Lanka must be careful as Sri Lanka is now a party to the Rome Statute and can be held accountable by the International Criminal Court.

 

* It was Azath Salley who indicated during a press conference concerning the criminal activities of Zahran Hashim in 2017, but he is alleged to have connections to the Easter Attacks. This is not fair. The Government is politically victimizing Muslims who are speaking up against the oppressive tactics of the Government.

* The One Country One Law Policy does not mean that Muslim Personal Laws alone should be targeted. Most people believe that Customary Laws should be removed. However, that logic would require the Government to abolish Provincial legislation too, as Provincial legislation is also territorially implemented and not countrywide. Several laws will have to be struck down. However, the right way of interpreting the One Country One Law policy would be to maintain all laws that are consistent with the Constitution of Sri Lanka.

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