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
Advertisement
Click to comment

Leave a Reply

Your email address will not be published.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

News

Elders’ home devastated by fire was a ‘house of horror’: Witnesses

Published

on

Death toll rises to 12: Director remanded

Some residents were allegedly chained

Police have come under public pressure to investigate allegations of inhumane treatmenf the residents at an elders’ home in Batagoda, which was also reportedly used as a care centre for persons with special needs, following a devastating fire that has so far claimed 12 lives.

Eyewitnesses who were among the first responders told the media that several residents had been chained inside rooms at the Senehase Kedella Elders’ Home when the fire broke out on Wednesday. They claimed that rescue efforts were hindered as iron chains could not be removed, and that some residents died while being restrained.

Authorities have not yet verified these claims, and Police said investigations are continuing.

Police spokesman ASP F.U. Wootler, contacted for comment, said there were rumours to that effect, but the Police were not in a position to verify the claims until a report from the Government Analyst was received. He said eight survivors with burn injuries were being treated in hospital.

Meanwhile, the Director of the facility had been arrested and was due to be produced before the Horana Magistrate’s Court, Police said adding that he was remanded till June 11.

The death toll from the fire has risen to 12 as of Thursday morning following the recovery of additional charred remains during ongoing forensic examinations at the site. Six others sustained serious injuries and are being treated at the Horana Base Hospital.

Police said 72 residents were inside the facility at the time of the blaze. Of them, 10 died inside the building, seven were injured and hospitalised, while 51 were rescued and relocated.

Survivors were initially housed at Batagoda Junior School before being transferred with Army assistance to another branch of the same care network in Galpatha.

A magisterial inquiry was conducted on Thursday morning. Horana Magistrate Lakmini Vidanagamage visited the scene. The burnt remains were examined and removed under judicial supervision.

Separately, allegations have emerged that residents were required to pay an admission fee of Rs. 75,000, along with a monthly charge of Rs. 35,000 to the centre. Police have not commented on these claims.

The director was taken to the scene as part of ongoing investigations, while forensic experts continue examinations to determine the cause of the fire, which remains undetermined.Anguruwatota Police are conducting investigations.

 By Norman Palihawadane and Nishan S Priyantha

Continue Reading

News

CERT : AI-generated videos depicting Prez, PM lure public into financial scams

Published

on

Sri Lanka CERT has issued a public warning over the circulation of artificial intelligence (AI)-generated videos falsely depicting President Anura Kumara Dissanayake, Prime Minister Harini Amarasuriya and several other prominent personalities to promote fraudulent investment schemes online.

According to complaints received by the national cyber security agency, the videos have been created using deepfake technology and are being used as part of attempts to defraud members of the public through financial scams.

The images of famous sports personalities and other public figures have also been misused in the deceptive content.

The agency has warned that similar AI-generated material has been used to spread false information relating to investment opportunities, employment offers, as well as matters concerning the country’s economy and tax policies.

According to Sri Lanka CERT, the videos are being widely shared across online platforms and frequently contain links urging viewers to make investments in return for purported profits.The agency has cautioned that these links may redirect users to fraudulent websites designed to steal personal information, financial data and money from unsuspecting victims.

Sri Lanka CERT has urged the public to exercise extreme caution when encountering such content online and advised against clicking on suspicious links or sharing personal information through unverified websites.

“The public should remain vigilant and avoid becoming victims of false information and online fraud schemes,” the agency said.

Sri Lanka CERT has also encouraged internet users to verify information through official sources before acting on any investment, employment or financial offers circulated via social media or other online platforms.

Continue Reading

News

New tax law comes into force

Published

on

Speaker Dr Jagath Wickramaratne endorsing the certificate on a Bill (File)

Speaker Dr Jagath Wickramaratne on Wednesday endorsed the certificate on the Inland Revenue (Amendment) Bill, bringing the legislation into force as the Inland Revenue (Amendment) Act, No. 11 of 2026, Parliament sources said.

The Bill, which amends the Inland Revenue Act, No. 24 of 2017, was passed by Parliament on May 19.

The new law introduces a series of reforms aimed at modernising tax administration procedures, improving compliance and enforcement mechanisms, enhancing the accuracy of tax calculations and deductions, and strengthening transparency within the tax system.

The amendments also support broader economic policy objectives and include measures designed to reinforce anti-money laundering safeguards.Among the key provisions of the Act is the mandatory use of Taxpayer Identification Number (TIN) certificates for specified high-value financial transactions.

The legislation also introduces revisions to the calculation of taxable income, clarifies tax exemptions applicable to certain projects and business entities, and expands the scope for information disclosure to relevant authorities.

The amendments are expected to improve the efficiency of tax administration while facilitating greater accountability and regulatory oversight.With the Speaker’s endorsement of the certificate, the Inland Revenue (Amendment) Bill has now become law as the Inland Revenue (Amendment) Act, No. 11 of 2026.

Continue Reading

Trending