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

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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.



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Parliament rejected two anti-corruption proposals

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Ex-COPE Chairman makes another revelation:

By Shamindra Ferdinando

Parliament has blocked two specific proposals made by MP Prof. Charitha Herath in his capacity as the Chairman of the Committee on Public Enterprises (COPE) to enable the Parliamentary Watchdog Committee to engage the Attorney General in high profile corruption cases, directly.

SLPP National List MP Herath lost the COPE Chairmanship with the prorogation of the Parliament on 28 July by President Ranil Wickremesinghe. The prorogation results in suspension of all business before the House and quashed all proceedings pending at the time, except impeachments.

Prof. Herath told The Island yesterday (25) that in consultation with Auditor General W. P. C. Wickremaratne, he had requested for the modification of Standing Orders 120, several months back, to permit the COPE to call for Attorney General’s interventions as and when necessary. If that was not acceptable, Parliament should approve specific requests made by him on behalf of the COPE, he suggested.

Prof. Herath said that the alternative, too, has been rejected. Responding to another query, he said that he had submitted the proposals to the Parliamentary Committee on Standing Orders. The Committee consists of nine members, including the Speaker, the Deputy Speaker and the Deputy Chairman of Committees.

Appearing before the Parliamentary Committee on Standing Orders, Prof. Herath also suggested that if proposals submitted in writing weren’t acceptable then at least a representative of the Attorney General should be allowed to participate in the COPE proceedings. That proposal too was turned down.

Prof. Herath said that the rejection of specific measures to address corruption accusations should be examined against the backdrop of the economic fallout of waste, corruption, irregularities and mismanagement of the national economy as well as the unprecedented recommendation by the United Nations Human Rights Council (UNHRC) to investigate economic crimes that impact on human rights and the tracing and recovery of stolen assets.

Prof. Herath alleged that the Parliament should be seriously concerned over the Geneva intervention especially because the country was seeking immediate assistance from the International Monetary Fund (IMF). Asserting that the situation was so grave that even USD 2.9 bn loan facility spread over a period of four years couldn’t revive the national economy, Prof. Herath emphasised that streamlining of public sector enterprises was a prerequisite for the economic recovery process. Therefore, corruption had to be curtailed by taking tangible measures, he said.

Prof. Herath said that though the particular Standing Order had been amended it didn’t meet their aspirations. What has been approved by the Parliament was inadequate to meet the growing threat posed by influential racketeers, the outspoken MP said. Prof. Herath has closed ranks with the dissident SLPP group, led by Party Chairman Prof. G.L. Peiris, and Dullas Alahapperuma. Other members of the group are Prof. Channa Jayasumana, Dr. Nalaka Godahewa, Dilan Perera, Dr. Upali Galappatti, Dr. Thilak Rajapaksa, Lalith Ellawala, K.P. S. Kumarasiri, Wasantha Yapa Bandara, Gunapala Ratnasekera and Udayana Kiridigoda.

Prof. Herath said that as the SLPP declined to allocate time for members of the rebel group, he was compelled to obtain five minutes from the Opposition to take up the issue in Parliament.Appreciating Opposition Leader Sajith Premadasa and Chief Opposition Whip Lakshman Kiriella for giving him the opportunity, Prof. Herath pointed out how a carefully prepared set of proposals to strengthen the COPE had been rejected.

Prof. Herath stressed that the intervention of the COPE was required as the Secretaries to the Ministries often failed to proceed with the instructions issued to them. The MP found fault with section 3 and 4 of Standing Orders 120. Declaring that though the Parliament was routinely blamed for its failure to arrest corruption, MP Herath said that Members of Parliament weren’t aware of what was going on. He also called for the strengthening of Standing Orders 119, 120 and 121 that dealt with the Committee on Public Accounts (COPA), COPE and the Committee on Public Finance (COPF), respectively.

MP Herath declared in Parliament that the crux of the matter was that those appointed members of the Cabinet represented the interests of the Executive and thereby undermined the very basis of the responsibilities of the House. The undeniable truth was that the Cabinet ministers didn’t represent the interests of the Parliament. “In other words, they worked against the collective responsibility as members of Parliament to ensure financial discipline,” MP Herath said, pointing out that in some countries the lawmakers were not entrusted with the task of decision-making.

Referring to Executive Sub-Committees to be established, Prof. Herath emphasized the pivotal importance of recognizing their responsibilities. If they were answerable to the Executive there would be serious consequences pertaining to the parliamentary system. Executive Sub-Committees shouldn’t be at the expense of the Parliament, the MP said, underscoring the responsibility of the part of all political parties represented in Parliament to take immediate remedial measures.

The rejection of the COPE proposals meant that the Parliament,as an institution hadn’t been sensitive to the recent public upheaval that forced Gotabaya Rajapaksa, elected with a staggering 6.9 mn votes to give up the presidency and literally flee for his life.

Ranil Wickremesinghe, who had been elected by Parliament to complete the remainder of the five-year term secured by Gotabaya Rajapaksa, and the SLPP, hadn’t realised the need to introduce urgent reforms, the MP alleged.Prof. Herath also questioned the rationale behind setting up of the National Council when the powers that be deprived the existing mechanisms required power to achieve their objectives.

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AHP asks President RW to be wise gazette-wise

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The Academy of Health Professionals (AHP) has called on President Ranil Wickremesinghe to learn from the mistakes of his predecessor and refrain from issuing gazettes, one after the other, and then reverse them in order to prevent worsening of the crisis situation prevailing in the country’s health sector.

AHP President Ravi Kumudesh, has, in a letter to President Ranil Wickremesinghe, said that the country’s health sector is in the present situation as the former President and the Health Minister allowed themselves to be manipulated by a coterie of officials. “We call on the President not to become another ruler who reverses gazettes and to assess the practicality of the proposals put forward by his advisors before gazzetting them. One such cause for the downfall of the health sector was former Health Ministers playing with the retirement age. As a result, there are many senior officials holding top offices of the health sector despite the fact that all of them are above the age of 60 years. If any official is given a service extension for an office in a health sector position, then it should be given only for a six-month period with the specific objective of training one of his qualified subordinates for that particular position.

 During that period, the official who is given the service extension should not be sent abroad for training or further education. Many officials, who are over 60 years of age, had been given service extensions and were found given foreign trips for capacity building. The irresponsible human resource management in the public sector is one of the main concerns that has been raised by the International Monetary Fund when assisting this country,” Kumudesh has said in his letter.

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BASL contemplates legal action against HSZ gazette

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The Bar Association of Sri Lanka (BASL) has threatened legal action against President Ranil Wickremesinghe’s reintroduction of war-time high security zones (HSZs).

“The BASL will be carefully studying the provisions of the said order and take appropriate legal action to ensure that the Fundamental Rights of the people are secured,” the BASL has said in a statement.

The BASL has said it is concerned that the purported order of the President also seeks to create offences under the said order which are not found in the Principal Act.

Full text of the statement: The Bar Association of Sri Lanka (BASL) is deeply concerned at the declaration of certain areas in Colombo as High Security Zones under Section 2 of the Official Secrets Act No. 32 of 1955 by President and Minister of Defence Ranil Wickremesinghe.The said order appears to cover several areas in the Colombo District including the areas in Colombo ordinarily used by the members of the public. It also covers several areas in Hulftsdorp in the vicinity of the Court premises.

The said order by the President purports to prohibit public gatherings or processions whatsoever on a road, ground, shore, or other open area situated within such High Security Zones without the permission of the Inspector General of Police or a Senior Deputy Inspector General. It also prohibits the parking of vehicles within the zone unless reserved for parking by the Competent Authority or under a permit issued by him, such Competent Authority being the Secretary to the Ministry of Defence.The scope of the Official Secrets Act is clearly set out in Section 2 of the said Act which can be read at: https://www.lawnet.gov.lk/official-secrets.4/

What Section 2 of the Official Secrets Act enables the Minister, is to declare any land, building, ship, or aircraft as a prohibited place. The Act does not empower the Minister to declare large areas as High Security Zones.The objective of making an order under Section 2 of the Official Secrets Act is to better safeguard information relating to the defences of Sri Lanka and to the equipment, establishments, organisations, and institutions intended to be or capable of being used for the purposes of defence. Orders under Section 2 cannot be made for any other purpose.

The BASL is concerned that the purported order of the President also seeks to create offences under the said order which are not found in the Principal Act. It is also of utmost concern that the purported order imposes stringent provisions in respect of bail by stating that a person taken into custody in connection with an offence under the said orders shall not be granted bail except by a High Court. The Official Secrets Act contains no such provisions, and in fact Section 22 of the Act empowers a Magistrate to release a suspect on Bail. As such the purported order seeks to significantly curtail the liberty of the citizen, without any reasonable or legal basis.

The BASL is deeply concerned that under the cover of the purported order under Section 2 of the Official Secrets Act that there is the imposition of draconian provisions for the detention of persons who violate such orders thus violating the freedom of expression, the freedom of peaceful assembly and the freedom of movement all of which are important aspects of the right of the people to dissent in Sri Lanka

The BASL will be carefully studying the provisions of the said Order and take appropriate legal action to ensure that the Fundamental Rights of the people are secured.We continue to remind the authorities including the President of the wisdom found in the Judgment of the Supreme Court in the ‘Jana Ghosha’ case of Amaratunge v Sirimal and others (1993) 1 SLR 264 which states as follows:

“Stifling the peaceful expression of legitimate dissent today can only result, inexorably, in the catastrophic explosion of violence some other day.”

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