Connect with us

news

Many questions raised by medical experts on Sinopharm unanswered by its manufacturer

Published

on

by Suresh Perera

The report of the advisory panel of medical experts, seen by The Sunday Island, raised some critical questions on the “safety, efficacy and immunogenicity” of the Sinopharm vaccine.

The report says there was no response from the Chinese manufacturer on how the vaccine induces antibodies (neutralizing antibodies and IgG antibodies to the SARS-CoV2) compared to the responses following natural infection. i.e. antibody responses induced by the vaccine in comparison to antibodies convalescent serum following natural infection. The manufacturer only provided seroconversion rates of the two vaccine arm.

The panel was of the view that it was important to find out if the immune responses elicited by the vaccine are adequate. All other vaccines showed a higher or an equal antibody response compared to natural infection.

There was also no answer provided to neutralizing antibody levels in those over 60 years of age in comparison to younger individuals. The manufacturer only provided Seroconversion rates of 18-59 and 60 but not the neutralizing antibody levels. It was vital to elicit a response to this to determine the immunogenicity of this vaccine in older individuals, the report said.

The following were the questions raised by the experts and the response given (or not given, as in some cases) by the manufacturer:

Q:

The lack of detectable SARS-CoV2 IgG antibodies 14 days after the first dose and also very minimal at 28 days (when they received the 2nd dose).

Answer

by the manufacturer: Higher titres of antibodies were induced following the second dose than the first.

(The panel observed that SARS-CoV2 inactivated vaccine produced by a different manufacturer, high levels of antibodies were seen at 28 days following a single dose. A good antibody response has been observed with the inactivated vaccines. inactivated polio vaccine after one dose, which is boosted by the second and third doses. The levels of antibodies following inactivated vaccines is lower but the levels are still detectable after a single dose).

Q:

Interim analysis of phase 3 data presented until October 31. There was no data after that. Can the follow up data be provided?

(Not answered)

(The panel noted that as the participants would have been followed after October 31, 2020, it would be important to have more safety and efficacy data. Such follow up data related to other vaccines have been made available through phase III clinical trials reports published in peer-reviewed journals).

Q:

Vaccine efficacy is claimed to be 76.06% and 78.01%. Were participants only followed up for an average period of 22 days after the second dose?

(Not answered)

Observation by Panel: Period of follow up is insufficient.

Q:

Efficacy data in 60 year old age group. The sample size inadequate to draw conclusions.

(Not answered)

Observation by Panel: Since this is the most vulnerable group for COVID-19 infection as well as severe disease, this data is required.

Q:

Was anyone with comorbidities included in the trial?

(Not answered)

Observation by Panel: Data required to determine efficacy and safety in those with comorbidities. In the exclusion criteria of the trial, it appears that all those with comorbidities have been excluded from study.

Q:

Phase 3 safety data. What were the side effects observed? Only the percentage of AE given and no breakdown of the type of side effects seen with the two vaccines. What are the type of grade 3 and 4 side effects observed and the proportion who experienced each side effect?

(Not answered)

Observation by Panel: Detailed information on types AEs is important to make an assessment on safety of the vaccine. The safety data should be available in an age-specific manner.

Q:

Some people had itching. Did anyone develop allergies or anaphylaxis? Rashes with itching? What are the ingredients of the vaccine? Does it have BSA or FBS? Since vero cells are known to be grown in FBS if there is contamination that might cause issues in those with beef allergy.

(Not answered).

Observation by Panel: As above.

Q:

How many were included in the analysis of immunogenicity? How many from all age groups? When reporting the GMTs of neutralizing Abs and binding antibodies, only median/mean have been reported. No idea about the range, IQR or SD.

(Not answered).

Observation by Panel: This information is critical to make an assessment of immunogenicity of the vaccine. The number of individuals in whom immunogenicity was evaluated is also important.

Q:

T cell studies. To show whether vaccine activates a TH1 response, rather than a TH2.

Manufacturer has noted that relevant studies have not been conducted.

Observation by Panel: In previous clinical trials on inactivated vaccines for measles and RSV, and also animal studies on SARS, a TH2 response caused organ pathology, including deaths, after infection with wild-type virus. This was attributed to a TH2 response, rather than the ideal TH1.



Continue Reading
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

news

Litro Gas grappling with billions of rupees in losses as govt. still undecided on LPG price hike

Published

on

by Suresh Perera

With staggering losses running into Rs. 3.8 billion (Rs. 3,800 million) over the past three months, Sri Lanka’s biggest importer and supplier of Liquid Petroleum Gas (LPG) is in the throes of a grave financial crisis as the government continues to dilly-dally on the demand for a substantial increase in the price of cooking gas.

“There’s no option other than to absorb the mounting losses as no price revision has been granted so far”, says Anil Koswatte, Chairman/CEO of Litro Gas Lanka.

“We are facing an uphill task in continuing operations amidst the financial difficulties”, he noted.

LPG prices zoomed in the global market over the past quarter with a ton selling at a new high of US$ 600.

“There’s a ray of hope now that international prices will reduce further”, Koswatte said, referring to the marginal dip over the past week with pricing per tonnage settling at US$ 539.

Litro Gas has sought a Rs. 700 increase per domestic cylinder in a desperate bid to at least cover procurement costs, but the government go-ahead has still not been forthcoming, a senior official said.

“The more people buy cooking gas, the more the losses we suffer as 700 rupees are lost on every cylinder purchased”, he explained.

Litro’s biggest marketing segment is the domestic household market, which translates into 83% of total sales.

Asked whether a government bailout has been sought as, with billions of rupees in accumulated losses, Litro Gas was being pushed towards a cash crunch, the Chairman said that as a company, Litro Gas cannot expect a subsidy from the Treasury.

“Anyway, we are trying to work out some relief and a meeting has been scheduled to examine the possibility of tiding over the situation”, Koswatte noted.

In terms of the law, Litro Gas, though a private company, cannot increase the price of domestic LPG cylinders without the approval of the Consumer Affairs Authority (CAA). However, industrial LPG cylinders are excluded from the price control mechanism.

There’s still no word from the government on the price revision on domestic gas cylinders that was sought about two months ago, a senior official said.

“Even if a price increase is finally granted, we won’t be able to recoup our losses”, he pointed out.

It is true that at a time the government has come under fire over the spiraling cost of living, increasing the price of cooking gas will make a bad situation worse, he admitted.

However, there should be a level playing field for companies also to remain viable to continue their uninterrupted services to the public, he reasoned.

Sri Lanka Insurance Corporation (SLIC) is the primary shareholder of Litro Gas Lanka Limited with 99.94% shareholding.

The impact of a LPG price hike will reflect across the board with low and middle income groups having to bear the brunt of it as a range of food items, from the ordinary man’s buth packet to flour-based products such as stringhoppers, roti, pittu and hoppers going up in price.

As even wayside eateries now depend on cooking gas, a price revision of food items will be inevitable, industry players said.

Continue Reading

news

Senior banker K. B. Rajapakse appointed APB President

Published

on

Senior banking professional, K. B. Rajapakse of the People’s Bank, was unanimously appointed President of the Association of Professional Bankers (APB) for 2021/2022 at its 32nd Annual General Meeting (AGM) held recently.

Established in 1988, the APB has been the most representative organization of banking professionals in the country and has functioned as a forum that brings together leading personalities in business administration and intellectual discussion in the contemporary banking scene.

The AGM of the Association was held on March 25 at Bougainvillea Ballroom, Galadari Hotel on a hybrid basis, where a large number of APB members attended the meeting physically in keeping with recommended health and social distancing guidelines, while another group of members attended the meeting virtually.

Addressing the gathering after his appointment, Rajapakse said that APB would be in a strong position to contribute to the banking fraternity and to achieve the national development goals of the country.

He emphasized on the need for each member to take up the challenge to think out of box and be creative thinkers in order to make necessary changes, which will be vital not only to survive, but to succeed as well.

“All of us are professional bankers shouldering responsibility in our respective offices, committed to make profits, improve the bottom line and further develop our banking institutions. As a professional body, you and I know that banking comes with strict regulations. So the real challenge is to achieve our objectives which include retaining sufficient flexibility to satisfy our customers within the regulatory boundaries under the ‘new normalcy’ with new systems, new products, new management styles and digitalization”, he stressed.

Rajapakse has 33 years plus experience at People’s Bank, of which over 12 years was in corporate and executive management. He is at present the Senior Deputy General Manager of Payment and Digitalization.

He is a Fellow member of the Institute of Bankers of Sri Lanka and an Attorney. He holds a Diploma from the Institute of Credit Management of Sri Lanka.

The following were elected APB office bearers and council members for 2021/22 and also to the Fund Management Committee:

President: K. B. Rajapakse, Senior Vice President: Jeremy De Zilva, Vice Presidents: Halin Hettigoda & B. A. H. S. Preena, Treasurer: Indika Kudagamage, Secretary-General: Anton Arumugam, Assistant Secretary: Mahesha Amarasuriya.

Nominated council members: K. Raveendran, M. R. N. Rohana Kumara, Theekshana Pandithasekara, Hasrath Munasinghe, Anjali Gunathilake, Christine Jesudian, Vijitha Kumarasiri, Asitha Pinnaduwa and Isuru Jayaweera.

Fund Management Committee members: Hennanayake Bandara, Aravinda Perera, Sunil De Silva & Ms. Shashi Kandambi Jassim.

Continue Reading

news

Inciting ethno-religious animosity has become a means of survival for parts of Sri Lanka’s political elite

Published

on

What is behind the anti-Muslim measures in Sri Lanka?

Farzana Haniffa

Head of the Department of Sociology at the University of Colombo

On March 13, Sarath Weerasekara, Sri Lanka’s minister of public security, announced that the government will ban wearing of the burqa and close more than 1,000 Islamic schools in the country. The minister was quoted as saying that “the burqa” was a “sign of religious extremism” and has a “direct impact on national security”.

The news was picked up internationally and resulted in several statements by human rights organisations and the UN special rapporteur on freedom of religion or belief, Ahmed Shaheed, as well as from Pakistan’s ambassador to Sri Lanka. Three days later the government stepped back from Weerasekera’s statement. Cabinet spokesman Keheliya Rambukwella announced that the decision “requires time” and a consultative process.

The burqa ban announcement caused a stir among Muslims, who saw it as yet another attack on their community. In the past few months, the government has undertaken a number of controversial measures under the banner of fighting extremism, which have increasingly intimidated the Muslim population and disregarded rule of law principles.

The anti-Muslim movement

Since it gained independence from the British in 1948, Sri Lanka has witnessed tumultuous relations between the Sinhala Buddhist majority, which makes up about 70 percent of the population and the Hindu and Christian Tamil minority, which accounts for roughly 12 percent. During the war between the military forces and the Liberation Tigers of Tamil Eelam (LTTE), other minorities, like the Muslims, who make up around nine percent of the population, were targeted less frequently by ultra-nationalist Sinhalese groups.

After the end of the civil war in 2009, an anti-Muslim movement initiated by the Bodu Bala Sena (BBS), with the monk Galaboda Aththe Gnanasara at the helm, began to emerge. The BBS is an activist group led by Buddhist monks which mobilised around what they described as the threat posed by the “social separatism” of “extremist Muslims”. Their definition of extremism, however, seems to encompass the majority of Muslims’ everyday practices.

The BBS’s large public rallies and their strident social media campaigns normalised hate speech and everyday low-intensity harassment of Muslims across the country. Incitement by the BBS and the cultivation of anti-Muslim sentiment over the post-war years also led to violent attacks against small Muslim communities in 2014, 2017 and 2018. The BBS also aligned itself with similar groups in Myanmar.

Following these incidents, the local authorities did not take serious action against BBS and other similar groups and in some cases blamed Muslims for the violence.

In 2019, anti-Muslim hatred escalated further after eight suicide bombers pledging allegiance to the Islamic State detonated themselves at churches, hotels and other locations across the country on Easter Sunday. There was evidence of the failure to pursue available intelligence by the security establishment and negligence on the part of the political leadership. However, the media coverage of the event and government policy discussion in the aftermath primarily targeted the country’s Muslim population.

Experts rarely referenced the role of the anti-Muslim movement in radicalising local Muslims. In May, there were violent retaliatory attacks against Muslim communities in the northwest.

The government response to the attack was to embrace the anti-Muslim language of the BBS and initiate sweeping arrests of suspected followers of the group responsible for the bombings.

Since then, several prominent Muslims have also been arbitrarily targeted by the government, with little or no evidence produced of their wrongdoing. In April 2020, the police arrested Hejaaz Hisbullah, an activist lawyer, on suspicion of aiding the attackers. Then in May 2020, Ahnaf Jazeem, a young Muslim poet, was also detained under the same pretext. Recently, the former leader of the Jamati Islami, Hajjul Akbar was arrested and detained for a second time, again without charges being filed.

In the aftermath of the Easter Sunday attacks, a parliamentary sectoral oversight committee on national security was set up to put together proposals for terrorism prevention measures. It has made recommendations in 14 areas, many of which curb the religious rights of the Muslim minority.

The burqa ban and the closing of Islamic schools stem from these recommendations, as do several other measures recently taken. In early March, the government declared that all Islamic books imported into the country will need defence ministry approval. Several days later, it gazetted a set of regulations ominously sub-titled “Deradicalisation from holding violent extremist religious ideology” under the Prevention of Terrorism Act. The regulations give it powers to arrest and forward persons to a rehabilitation centre to be “deradicalised” for one year on suspicion without requiring any additional process.

Apart from the above, the government has sought other ways to intimidate the country’s Muslims. When the COVID-19 pandemic spread to Sri Lanka in the spring of 2020, it imposed a mandatory cremation policy for the COVID-19 dead and refused to allow Muslims to bury their dead, in accordance with their religion.

Muslims’ call for the burial option on religious grounds was written and talked about as “tribal” and “backward” and as reprehensible behaviour in the middle of a public health emergency. Despite condemnations at home and abroad and guidelines by the World Health Organization emphasising the safety of burials, the government maintained its position for nearly a year. Burial was permitted only recently under international pressure.

 

Demonising Muslims as a political strategy

Political elites in Sri Lanka have consistently demonised minorities and incited ethno-religious animosity to win elections. After the end of the war in 2009, when victory over the Tamil Tigers was glorified by the government, enmity against all other minorities and especially the Muslims was cultivated with renewed vigour.

The Rajapaksa family, which has dominated the political scene in Sri Lanka since 2005, was complicit in this cultivation until their electoral defeat in the 2015 elections. During their political campaigning after 2015, the Rajapaksas’ new party, the Sri Lanka Podujana Peramuna (SLPP), took on a Sinhala supremacist position, accommodating activist monks and anti-Muslim movement stalwarts.

Rhetoric regarding Muslim business prowess as challenging the ascendence of Sinhala entrepreneurs, Muslims conspiring to upend the majority status of Sinhalese or constituting a terrorist threat was widely used.

In October 2018, the Rajapaksas suffered a significant setback. Former president and then MP Mahinda Rajapaksa, in collusion with President Maithripala Sirisena staged a coup to take control of the government. They were defeated when the Supreme Court threw out their claim to legitimacy and the Rajapaksa brand suffered some damage as a result.

The 2019 bombings energised the Rajapaksas’ familial politics and helped them overcome the momentary unpopularity they were struggling with.  The Rajapaksas attempted to leverage the bombings to their political advantage in the immediate aftermath.  They accused the ruling regime of concentrating on reconciliation with minorities and neglecting security. When several months later, Gotabaya Rajapaksa, the brother of Mahinda Rajapaksa, was nominated as the SLPP’s presidential candidate, he declared in his platform: “My main task would be to ensure that our motherland which is once again under threat from terrorist and extremist elements is safe and protected.”

Using anti-minority and pro-security rhetoric in his campaign, Rajapaksa won the presidential election by a high percentage of Sinhala Buddhist votes and appointed his brother, Mahinda, the former president as prime minister. Since then, at every opportunity, the president has reiterated his commitment to this majority and outlined his actions to combat Islamic extremism, and the government has pressed forward with anti-Muslim policies.

In this context, the recent flurry of anti-Muslim government activity, including the burqa ban, serve not only to mitigate the fallout from the shift in position on COVID-19 burials, but also to distract from the Rajapaksa administration’s ongoing failures. The cabinet is facing anger over a vast tax scam, mounting opposition to its permission of deforestation, and growing public anxiety over the economic downturn. It is likely that anti-Muslim activities will increase if their popularity continues to decline.

But the anti-Muslim policies of the government may be backfiring. In March, it suffered a defeat at the UN Human Rights Council (UNHRC), which passed a resolution empowering the UN High Commissioner for Human Rights to collect and preserve information and evidence of war crimes committed during the civil war. The motion went through mainly because of the loss of support for the government from some Muslim-majority countries, who abstained from voting. The resolution included reference to the government’s treatment of Muslims in its COVID-19 response and the continued marginalisation of minorities.

The current government’s inability to mobilise its constituency around anything other than ethno-religious animosity is a legacy of Sri Lanka’s post-independence politics that looks set to continue in the long term. The UNHRC resolution was a welcome development. However, the future outlook for minorities in the country remains bleak. Ten years after a devastating war the Sri Lankan polity shows little evidence of having learnt from its past. (Al Jazeera)

The views expressed in this article are the author’s own and do not necessarily reflect Al Jazeera’s editorial stance.

(Farzana Haniffa is Professor and Head of the Department of Sociology at the University of Colombo. She has published on the social and political history of Muslims, gender politics and the anti-Muslim movement in Sri Lanka)

Continue Reading

Trending