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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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Facilities for infected pregnant women inadequate – SLCOG

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By Rathindra Kuruwita

The distribution and availability of high-flow oxygen machines to treat Covid-19 infected pregnant women were not adequate, President of the Sri Lanka College of Obstetricians & Gynaecologists (SLCOG,) Dr. Pradeep de Silva said yesterday.

Dr. de Silva said that while they had not yet faced any lack of oxygen in treating Covid-19 infected pregnant mothers, things could change rapidly given the limited availability of equipment. “Having an adequate supply of oxygen alone is not enough. You need high flow oxygen machines, and 50 litres of oxygen per minute is needed to operate a high flow oxygen machine. I do not know how many machines we have in this country but where I work, Castle Street Maternity Hospital has about four. We need to estimate the number of these machines we require and how much oxygen we want. From my understanding, the distribution and availability of high flow oxygen machines to treat Covid-19 infected pregnant mothers is not adequate.”

Dr de Silva said that Sri Lanka needed about 50–200 high-dependency unit (HDU) beds per district, based on the population, 10–50 high flow oxygen machines per district, four for ten ICU beds and two dedicated Extracorporeal Membrane Oxygenation (ECMO) machines.

“If we get this, we will be able to deal with pregnant women who develop complications from COVID-19 for the next four to five years,” he said.

Dr de Silva said that currently one pregnant woman who has been infected with COVID-19 is receiving ECMO treatment. There is also a shortage of beds at the Mulleriyawa Base Hospital, which has the largest ward dedicated to COVID-19 infected pregnant women. On Thursday, Obstetrician & Gynaecologist, Dr Mayuramana Dewolage, who heads the ward that treats COVID-19 infected pregnant women at the Mulleriyawa Base Hospital, said that they only had 37 beds were dedicated to pregnant women with COVID-19. They didn’t have any HDU or ICU beds dedicated for their use, he said.

“We share HDU and ICU beds with other patients at Mulleriyawa Base Hospital,” Dr Dewolage said.

The President of the SLCOG also urged all hospitals to find a separate space for pregnant women who were receiving treatment at their institutions. When COVID-19 pandemic started, the Health Ministry instructed all hospitals to do so but it was now obvious that those instructions had not been followed, he said.

“When the second wave started people got ready but later, they just stopped getting ready and now we are unprepared to meet the challenges of the third wave. We need to find a way to manage this. If the Ministry of Health has not prepared a plan, we are ready to help formulate one,” the President of the SLCOG said.

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Those who had AstraZeneca first jab, should take Sputnik V with adenovirus 26 – Specialist

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By Rathindra Kuruwita

If those who have taken the first dose of AstraZeneca are to receive a second jab of Sputnik V, they should take the first Sputnik V vaccine with adenovirus 26 (Ad26), Consultant Immunologist and head of the department of Immunology-MRI, Dr Nihan Rajiva de Silva says.

Dr. de Silva said that the first dose of Sputnik had Ad 26 and the second had adenovirus-5. “Adenovirus-5 is common. We may have been exposed to that and we may have developed antibodies. Adenovirus-26 is rarer and we will better respond to that. That is why the vaccine-maker has used adenovirus-26 in the first vaccine. So, if you had a first jab of AstraZeneca and you are to get the second dose from Sputnik-V remember to get the first jab,” Dr. de Silva said.

He added that any vaccine has the chance of reducing the severity of the virus and that the general public should get vaccinated when the opportunity is available.

Dr. de Silva said that there was a shortage of AstraZeneca vaccines because the Serum Institute of India could not deliver shipments as promised.

“However, we are now getting Sputnik V vaccines and we are looking at mixing them. There is a study in Russia about the efficiency of mixing Sputnik V with AstraZeneca and the results should be out soon. I can say that theoretically mixing the two vaccines should work,” he said.

Dr. de Silva added that the AstraZeneca vaccine should work against the new variant spreading in the country.

Consultant Cardiologist at the National Hospital of Sri Lanka, Dr. Gotabaya Ranasinghe said that those with heart issues, non-communicable diseases and were obese must get vaccinated to minimise the complications of Covid-19.

Dr. Ranasinghe said that those in the above-mentioned categories were at risk of contracting, getting complications and dying of COVID-19 and research had proven that vaccination would reduce the chance of such eventualities.

“If you worry about getting vaccinated, talk to your doctor. Don’t seek advice from friends and family,” he said.

Dr. Ranasinghe added that they had limited the number of heart surgeries they do due to COVID-19. ICU beds used for heart patients too were being now allocated for COVID-19 patients. “We only do the most pressing cases. But this means that the waiting list keeps on growing. Now, the waiting list is over eight months. If we limit the surgeries more and keep taking away ICU beds available for those who have had heart surgeries, the waiting list will grow further,” he said.

The Consultant Cardiologist also advised the public to eat healthy food and engage in moderate exercises, at least five days a week. This will reduce the mental stress as well as boost the immune system. ‘We recommend moderate exercises like jogging and brisk walking, for 30 minutes, five days a week. Being healthy is as important as wearing masks or adhering to physical distancing,” he said.

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STF raids narcotics distribution centre close to Bloemendhal police station

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Acting on information received from the Organised Crime Fighting Unit of the elite Special Task Force (STF), police commandos, on Thursday (6), arrested a person running a narcotic distributing network, 1.5 km away from the Bloemendhal police station.

The STF identified the suspect as Thawasidevan Pradeep Kumar, 21, a key associate of one Suresh with links to a criminal outfit run by Kimbulaele Guna, now absconding in India.

DIG (Legal) Ajith Rohana said that the raiding party had recovered 2 kg, 22 g and 88mg of ‘ICE,’ with a street value of Rs 25 mn in addition to 4kg, 2 g and 527 mg of substance known as ‘hash,’ as well as Rs 400,000 in cash and a mobile phone.

Kimbulaele Guna is believed to have sought refuge following an LTTE attempt to assassinate President Chandrika Bandaranaike Kumaratunga at the final PA presidential election rally at the Town Hall in December 1999.

DIG Rohana said that Guna’s brother Suresh was a major heroin distributor in Colombo. The STF later handed over the suspect, along with contraband and locally made ‘hash,’ and his phone to the Police Narcotics Bureau (PNB). The raid on the heroin distribution centre situated in Aluth Mawatha, Colombo 15, followed specific information received as regards the ‘operation’ conducted with impunity (SF)

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