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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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Current El Niño Status in Sri Lanka

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At present, El Niño conditions have developed and are classified as being at a weak level. Forecasts indicate a 63% probability of a very strong El Niño event developing during the period from November 2026 to January 2027. According to the National Oceanic and Atmospheric Administration (NOAA), there is approximately a one-third probability that El Niño will remain below a very strong intensity.

Typical Climatic Conditions Associated with El Niño
Based on analyses of past El Niño events that occurred between 1950 and 2025:
• Rainfall during July and August may be below normal, particularly in the dry zone areas.
• From October onward, rainfall is generally expected to be above normal.
• If a positive Indian Ocean Dipole (IOD) develops, enhanced rainfall conditions may continue until December.

Sectors Requiring Attention
• Appropriate measures should be taken for water resource management during July and August.
• Increased rainfall expected from October onward may lead to floods and landslides, requiring preparedness and close monitoring. The forecasts are important for sectors such as, Agriculture /Water management /Livestock /Health /Energy /Other climate-sensitive sectors
• Attention should be paid to official information issued by the Department of Meteorology.

Actions by the Department of Meteorology
The Department of Meteorology continuously monitors the evolving situation and issues:
• Weekly and monthly seasonal forecasts and Monthly analyses of rainfall data to monitor meteorological drought conditions.
As weather conditions are influenced not only by El Niño but also by other climatic factors, updated forecasts and advisories are regularly shared with relevant stakeholder organizations (Irrigation/ Water Management Committee /Department of Agriculture/National Building Research Institute/Disaster Management Centre (DMC)/Ministry of Health /Sri Lanka Land Development Corporation…etc). The Department also provides technical support to the committee established through a Cabinet decision to address climate-related impacts. The Department’s monthly rainfall outlook for July to September 2026 is attached

Monthly Rainfall Forecasts for July, August and September 2026
Month Rainfall forecast
July 2026

During July 2026, there is a higher probability of having near normal rainfall across most parts of the Western and Southern Provinces. The remainder of the country is expected to experience below normal rainfall.

August 2026

There is a higher probability of having below normal rainfall across most parts of the country during month of August 2026.

September 2026

There is a possibility of above-normal rainfall across most parts of the Western and Southern Provinces, while near-normal rainfall is expected in the Sabaragamuwa Province. Below-normal rainfall is likely in the remaining areas during September 2026.

Note: These long-range forecasts may change due to strong day-to-day atmospheric variability associated with the movement of weather systems such as atmospheric disturbances, low-pressure areas, and depressions, as well as intra-seasonal oscillations such as the Madden–Julian Oscillation (MJO). Therefore, in addition to the weekly and monthly forecasts, it is important to pay attention to the Department’s official announcements, weather advisories and warnings, as well as the daily weather forecasts issued by the Department of Meteorology.

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Govt. move to extend retirement ages of top judges: Opp. complains to UN

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Prof. Peiris addresses the media outside the UN compound in Colombo on Thursday on the controversial government move to extend the retirement ages of Superior Court judges, while former MPs Thalatha Atukorale, Dr Suren Raghavan and Premanath C. Dolawatta look on.

Former External Affairs Minister Prof. G. L. Peiris yesterday (15) briefed the UN Resident Coordinator in Colombo, Marc-André Franche, on President Anura Kumara Dissanayake’s move to extend the retirement ages of the superior court judges and the delay in filling the vacancies in the Supreme Court and the Court of Appeal.

Prof. Peiris, the convenor of the People’s Joint Opposition, led the delegation that included UNP General Secretary and former Minister Thalatha Atukorale, former UPFA National List parliamentarian Suren Raghavan and ex- SLPP MP Premnath C. Dolawatta.

Having met the top official here, Prof. Peiris briefed the media on their decision to bring the developing situation to the notice of the UN.

Referring to the opposition of the legal fraternity to the NPP government’s plan, Prof. Peiris emphasised that the civil society, too, had opposed the politically motivated initiative.

Prof. Peiris said that instead of addressing the burning issues affecting the public, the government was creating new problems.

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Dengue surge pushes hospitals to the brink as cases near 70,000

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A week-long crackdown to begin in 11 districts

Hospitals are coming under mounting pressure as the country’s dengue epidemic gathers pace, with nearly 70,000 infections and 48 deaths reported so far this year, prompting health authorities to launch an intensive week-long mosquito control campaign in 11 districts.

The National Dengue Control Unit (NDCU) said 69,951 dengue cases had been reported by July 13, with 14,572 new infections recorded during the first 13 days of July alone. June saw the highest monthly caseload of the year, underlining the rapid spread of the mosquito-borne disease during the southwest monsoon.

Acting Director of the NDCU, Dr. Kapila Kannangara, warned that the hospital system was facing severe congestion due to the unprecedented influx of dengue patients.

“We are seeing an alarming increase in admissions. Hospitals are under tremendous pressure, and public cooperation is essential to bring the outbreak under control,” he said, announcing that a special one-week dengue control programme would be implemented across 11 high-risk districts.

Health authorities have identified 175 Medical Officer of Health (MOH) divisions as high-risk dengue zones. Public Health Inspectors will conduct inspections, eliminate mosquito breeding sites and initiate legal action against those maintaining mosquito-infested premises.

The Western Province continues to account for the largest share of infections, with Gampaha and Colombo among the worst-affected districts. Several hospitals are already operating beyond capacity as the number of admissions continues to climb.

Health officials attributed the surge to intermittent rains, poor waste disposal, stagnant water collections and inadequate community participation in vector control programmes.

The Ministry of Health has appealed to local authorities, schools, workplaces, religious institutions and households to inspect their premises regularly, clear blocked drains and roof gutters, cover water storage containers and remove discarded tyres, cans, bottles and other containers capable of collecting rainwater.

Medical experts urged the public not to ignore symptoms such as persistent fever, severe headache, pain behind the eyes, vomiting, abdominal pain and bleeding manifestations, stressing that early medical treatment is critical in preventing severe dengue and deaths.

Officials emphasised that eliminating mosquito breeding sites remains the single most effective way of controlling dengue, warning that unless communities actively participate, the outbreak could worsen during the ongoing rainy season.

With daily case numbers continuing to rise and hospitals struggling to cope, health authorities said the coming weeks would be crucial in determining whether the country can curb one of its worst dengue outbreaks in recent years.

By Ifham Nizam

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