Connect with us

News

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

Published

on

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.



News

Israel resumes attacks as Iran vows to avenge supreme leader’s death

Published

on

An explosion caused by an Iranian missile in Tel Aviv

* Iran begins 40-day mourning after Khamenei killed in US-Israeli attack

* President Pezeshkian condemns killing as ‘a great crime’

Iran has begun 40 days of mourning after Supreme Leader Ayatollah Ali Khamenei was killed in ongoing attacks by the United States and Israel, according to Iranian state media.

Top security officials were also killed in Saturday’s strikes, along with Khamenei’s daughter, son-in-law and grandson. The killings mark one of the most significant blows to Iran’s leadership since the 1979 Islamic revolution Al Jazeera has reported.

Iranian President Masoud Pezeshkian condemned the killing as “a great crime”, according to a statement from his office. He also declared seven days of public holidays in addition to the 40-day mourning period.

Reporting from Tehran, Al Jazeera’s Tohid Asadi said people were pouring into the streets of the capital following the news of Khamenei’s killing.

“There will be expected ceremonies,” he said, noting they would likely take place amid continuing bombardment across the country.

Protests denouncing Khamenei’s killing were also reported elsewhere, including Shiraz, Yasuj and Lorestan.

“There will be expected ceremonies,” he said, noting they would likely take place amid continuing bombardment across the country.

Footage aired by Iranian state media showed supporters mourning at the shrine of Imam Reza in Mashhad, with several people seen crying and collapsing in grief, according to Al Jazeera.

The killing also led to protests in neighbouring Iraq, which declared three days of public mourning. In Baghdad, protesters confronted security forces in the heavily fortified Green Zone, which houses Iraqi government buildings and foreign embassies.

Videos verified by Al Jazeera showed demonstrators waving flags and shouting slogans, with witnesses saying some were attempting to mobilise towards the US Embassy. Footage also showed protesters blocking vehicles at a roundabout near one of the entrances to the area.

There was also a protest in the Pakistani city of Karachi, where footage, verified by Al Jazeera, showed people setting fire to and smashing the windows of the US consulate.

However, there have also been reports of celebrations in Iran, with the Reuters news agency quoting witnesses as saying some people had taken to the streets in Tehran, the nearby city of Karaj and the central city of Isfahan.

Meanwhile, the official IRNA news agency reported that a three-person council, consisting of the country’s president, the chief of the judiciary, and one of the jurists of the Guardian Council, will temporarily assume all leadership duties in the country. The body will temporarily oversee the country until a new supreme leader is elected.

Ali Larijani, the head of Iran’s Supreme National Security Council, accused the US and Israel of trying to plunder Iran, in an interview aired on state TV.

He also called on Iranians to unite. “Groups seeking to divide Iran should know that we will not tolerate it,” he added.

Smoke rises over central Tehran following ongoing U.S.–Israeli strikes on Iran yesterday.[EPA]

Khamenei assumed leadership of Iran in 1989 following the death of Ayatollah Ruhollah Khomeini, who had led the Islamic revolution a decade earlier.

While Khomeini was regarded as the ideological force behind the revolution that ended the Pahlavi monarchy, Khamenei went on to shape Iran’s military and paramilitary apparatus, strengthening both its domestic control and its regional influence.

Meanwhile, the Islamic Revolutionary Guard Corps (IRGC) pledged revenge and said it had launched strikes on 27 bases hosting US troops in the region, as well as Israeli military facilities in Tel Aviv.

Explosions have continued to be reported in Qatar and the United Arab Emirates, while security alerts are in place in several countries across the region.

US President Donald Trump, in a social media post on Sunday, warned Iran that it would be hit “with a force that has ?never been seen before” if it retaliated.

Iran’s retaliatory attacks since Saturday have targeted Israel and US assets across multiple Middle East countries, including Qatar, the UAE, Kuwait, Bahrain, Jordan, Saudi Arabia and Iraq.

Harlan Ullman, chairman of the strategic advisory firm Killowen Group and an adviser to the Atlantic Council in Washington, DC, said the US may have made a “big mistake” by killing Khamenei.

“Decapitation only works when you get all the leaders, and I don’t think that we got all the leaders,” Ullman said, adding that the US should not expect Iran’s leadership to enter negotiations in the immediate aftermath.

Iranian state media reported on Saturday at least 201 people have been killed in the joint US-Israeli attacks across 24 provinces, citing the Red Crescent. In southern Iran, at least 148 people were killed and 95 wounded in a strike on an elementary girls’ school in Minab on Saturday, with the toll continuing to rise, according to state media.

Continue Reading

News

CPC has enough fuel stocks

Published

on

There would be no delay in fuel shipments scheduled for April and May, the Ceylon Petroleum Corporation (CPC) assured yesterday.

Addressing a media briefing in Colombo, CPC Chairman D.J. Rajakaruna said Sri Lanka’s fuel supplies did not originate from the present conflict zone in West Asia and, therefore, supplies to the Corporation would not be disrupted.

He noted that the relevant consignments were due to arrive from India and Singapore as planned.

“We are making this statement responsibly. There is no need for the public to queue up for fuel. Distribution was not originally scheduled for Sunday (01), but due to increased demand, we have deployed all distribution staff to continue fuel issuance. Although Monday (02) is a Poya Day, fuel supplies will continue without interruption,” he said.

The Chairman added that all filling stations had been instructed not to dispense fuel into cans or barrels, warning that legal action would be taken against those attempting to purchase fuel in bulk containers for resale.

Continue Reading

News

Lanka, Pakistan strengthen ties at 13th JEC

Published

on

Wasantha Samarasinghe, Minister of Trade, Commerce, Food Security and Cooperative Development and Haroon Akhtar Khan, Special Assistant to the Prime Minister of Pakistan for Industries and Production at the 13th Session of the Sri Lanka–Pakistan Joint Economic Commission in Colombo.

The 13th Session of the Sri Lanka–Pakistan Joint Economic Commission (JEC) was successfully held recently in Colombo, reinforcing the strong and longstanding economic and diplomatic ties between the two countries.

The Sri Lankan delegation was led by Wasantha Samarasinghe, Minister of Trade, Commerce, Food Security and Cooperative Development, while the Pakistani delegation was headed by Haroon Akhtar Khan, Special Assistant to the Prime Minister of Pakistan for Industries and Production. The session concluded with the signing of the Agreed Minutes by both Co-Chairs, formalising cooperation across multiple sectors.

The Pakistan High Commission in Colombo said that in the IT and digital economy, both sides agreed in principle to establish a Joint Working Group on IT and telecommunications, promote collaboration in emerging technologies, and support each other in international digital forums.

Industrial cooperation was a key focus, with discussions on expanding trade in chemicals, polymers, engineering goods, glassware, surgical instruments, and pharmaceuticals. Sri Lanka invited Pakistani pharmaceutical companies to explore investment opportunities in designated pharmaceutical zones. Both countries also agreed to strengthen collaboration in Export Processing Zones and enhance support for small and medium enterprises through their respective development agencies.

Significant progress was made in agriculture and livestock, including cooperation on meat exports, livestock farming, seed certification, sanitary and phytosanitary harmonisation, pest risk analysis, and capacity building. Procedures for the export of Sri Lankan pineapples and avocados to Pakistan were advanced. Both sides explored electronic phytosanitary certification (ePhyto), blockchain-based seed traceability systems, and increased trade in agro-commodities such as rice, sesame, and onions.

In education, the JEC emphasised academic and research cooperation, faculty and student exchanges, accreditation and quality assurance, and promoting Pakistan as a higher education destination for Sri Lankan students. A Joint Working Group on Education and Science was proposed, alongside renewal of several institutional Memoranda of Understanding.

Cooperation in science, technology, and innovation will continue under existing bilateral frameworks, with plans for joint research in advanced materials, biotechnology, climate change mitigation, and emerging technologies. Collaborative research projects, student exchanges, and co-authored publications were highlighted as key initiatives.

Health sector collaboration will focus on joint research, academic exchanges, regulatory cooperation on therapeutic goods, capacity building, fast-track registration of essential medicines, public-private partnerships, epidemiological surveillance, and coordinated responses to disease outbreaks.

Maritime cooperation was also discussed, with Pakistan offering technical expertise, training, and industrial collaboration through its shipbuilding institutions. Both sides explored enhanced maritime connectivity, including transshipment, port cooperation at Karachi and Gwadar, direct shipping routes, logistics integration, and maritime training programs.

Commerce secretary-level talks reviewed the progress of the Pakistan–Sri Lanka Free Trade Agreement (PSFTA), assessing current implementation and identifying measures to further enhance bilateral trade and economic cooperation.

On the sidelines, Special Assistant Haroon Akhtar Khan held discussions with Sri Lankan Cabinet members on collaboration in industry, labor and foreign employment, and health sectors.

Both delegations expressed satisfaction with the outcomes of the 13th JEC and reaffirmed their commitment to regular engagement and effective implementation of agreed initiatives. It was mutually agreed that the 14th session will be held in Islamabad, with dates to be confirmed through diplomatic channels.

Continue Reading

Trending