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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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Promoting Local Industries is a key priority of the Government – PM

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Prime Minister Dr. Harini Amarasuriya stated that promoting the local industrial sector is one of the key priorities of the Government.

The Prime Minister made these remarks while attending the official opening ceremony of the INCO 2026 Industrial Exhibition on 13 th of March, which is being held for the 20th consecutive year at the BMICH Exhibition Center.

The INCO 2026 Industrial Exhibition, organized by the Institution of Incorporated Engineers, Sri Lanka (IIESL), will be held from March 13 to 15.

Addressing at the event, Prime Minister  stated:

“The engineering sector is a key driving force in addressing practical challenges faced by a country while enhancing efficiency and safety. In particular, the contribution extended by exhibitions of this nature encourages the student community to engage in innovation.

The Government has implemented several measures to accelerate the country’s industrial development. Notably, the National Industry Information System (NIIS) has established a centralized digital platform to collect data related to the country’s economic and industrial activities. The Government is also taking steps to provide necessary financial support to industrialists through Revolving Funds.

It is also noteworthy that this year’s exhibition has attracted international participation, creating opportunities for local entrepreneurs to explore new markets and gain exposure to international technologies. With the participation of engineers, students, and entrepreneurs, this exhibition marks an important step toward the country’s industrial future”.

The event was attended by the Chairman of the Export Development Board Mangala Wijesinghe, Chairman of the National Paper Company Limited  Upali Rathnayake, President of the Institution of Incorporated Engineers, Sri Lanka Engineer Ananda Gunawardena, along with local and foreign investors, entrepreneurs, and industrialists.

(Prime Minister’s Media Division)

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Crypto loopholes funnel Lankan funds abroad

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Chief Magistrate draws CB attention to massive drain in foreign exchange through cryptocurrency deals

Colombo Chief Magistrate Asanga S. Bodaragama yesterday observed that loopholes in actions carried out by State financial institutions, under the Foreign Exchange Act, had enabled funds in Sri Lanka to be transferred overseas, through cryptocurrency transactions.

The Magistrate said immediate steps should be taken to curb such activities and to educate the public, and directed that the matter be brought to the attention of the Central Bank of Sri Lanka.

He noted that cryptocurrency transactions carried out, using modern technology without approval from the Central Bank, had taken place without adequate public awareness, adding that incidents of the nature were increasingly being reported before courts.

The Magistrate observed that investigations into such incidents appeared to be confined to court proceedings alone and emphasised that the Central Bank, as the country’s principal financial regulator, together with other relevant institutions, should take appropriate measures and raise public awareness in the interest of the public and the country.

He also said the Criminal Investigation Department and the Central Bank should take steps to educate the public on such financial frauds and introduce a proper mechanism to address the issue.

The court further observed that many individuals had exploited loopholes in the Foreign Exchange Act and related procedures to commit financial fraud, and stressed that the Central Bank should take necessary action upon being apprised of such matters.

The Magistrate made these observations when a case relating to an alleged Rs. 290 million fraud at a well-known private bank was taken up before court yesterday. The suspects are alleged to have fraudulently obtained public funds through cryptocurrency transactions using accounts on Binance.

The Magistrate also directed the Criminal Investigation Department to expedite investigations into the disappearance of Rs. 290 million and report progress to court.Observing that the incident was not an ordinary case, the Magistrate instructed the CID to take prompt action to prevent similar frauds carried out through Binance platforms.

Making further observations, the Magistrate noted that the suspects had been produced before court, over the past three months, in connection with the incident, and stressed that investigations should be completed promptly by gathering all relevant information.

He earlier observed that the case did not involve a minor offence, such as ordinary theft, but a serious matter concerning the fraudulent misappropriation of public funds, through Binance accounts, and emphasised the need for swift action to prevent such crimes.

Nineteen suspects, connected to the incident, had earlier been remanded and subsequently released on bail.

The case was fixed to be called again on 15 May .

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SLCERT urges Lankans not to get gypped by internet scams in run-up to festive period

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The Sri Lanka Computer Emergency Readiness Team (SLCERT) has issued a public advisory urging internet users to exercise caution when engaging with online advertisements in the run-up to the festive season.

Senior Information Security Engineer at SLCERT, Charuka Damunupola, said that several incidents of online scams had already been reported to the organisation during the first two months of this year.

He warned that with the approaching Sinhala and Tamil New Year, the risk of fraudulent advertisements and malicious links, appearing online, was likely to increase, often disguised as discount offers, cash prizes, or special promotional deals.

Damunupola noted that such links frequently redirect users to fraudulent websites designed to harvest personal information and other sensitive data.

He further cautioned that during the Vesak and Poson festive periods, scammers may attempt to collect user data through deceptive schemes promoted under various guises, including campaigns such as ‘Poson Maha Data Dansala.’

SLCERT has, therefore, urged the public to remain vigilant and exercise caution when clicking on unsolicited links or advertisements encountered online.

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