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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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Facilities for infected pregnant women inadequate – SLCOG

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By Rathindra Kuruwita

The distribution and availability of high-flow oxygen machines to treat Covid-19 infected pregnant women were not adequate, President of the Sri Lanka College of Obstetricians & Gynaecologists (SLCOG,) Dr. Pradeep de Silva said yesterday.

Dr. de Silva said that while they had not yet faced any lack of oxygen in treating Covid-19 infected pregnant mothers, things could change rapidly given the limited availability of equipment. “Having an adequate supply of oxygen alone is not enough. You need high flow oxygen machines, and 50 litres of oxygen per minute is needed to operate a high flow oxygen machine. I do not know how many machines we have in this country but where I work, Castle Street Maternity Hospital has about four. We need to estimate the number of these machines we require and how much oxygen we want. From my understanding, the distribution and availability of high flow oxygen machines to treat Covid-19 infected pregnant mothers is not adequate.”

Dr de Silva said that Sri Lanka needed about 50–200 high-dependency unit (HDU) beds per district, based on the population, 10–50 high flow oxygen machines per district, four for ten ICU beds and two dedicated Extracorporeal Membrane Oxygenation (ECMO) machines.

“If we get this, we will be able to deal with pregnant women who develop complications from COVID-19 for the next four to five years,” he said.

Dr de Silva said that currently one pregnant woman who has been infected with COVID-19 is receiving ECMO treatment. There is also a shortage of beds at the Mulleriyawa Base Hospital, which has the largest ward dedicated to COVID-19 infected pregnant women. On Thursday, Obstetrician & Gynaecologist, Dr Mayuramana Dewolage, who heads the ward that treats COVID-19 infected pregnant women at the Mulleriyawa Base Hospital, said that they only had 37 beds were dedicated to pregnant women with COVID-19. They didn’t have any HDU or ICU beds dedicated for their use, he said.

“We share HDU and ICU beds with other patients at Mulleriyawa Base Hospital,” Dr Dewolage said.

The President of the SLCOG also urged all hospitals to find a separate space for pregnant women who were receiving treatment at their institutions. When COVID-19 pandemic started, the Health Ministry instructed all hospitals to do so but it was now obvious that those instructions had not been followed, he said.

“When the second wave started people got ready but later, they just stopped getting ready and now we are unprepared to meet the challenges of the third wave. We need to find a way to manage this. If the Ministry of Health has not prepared a plan, we are ready to help formulate one,” the President of the SLCOG said.

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Those who had AstraZeneca first jab, should take Sputnik V with adenovirus 26 – Specialist

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By Rathindra Kuruwita

If those who have taken the first dose of AstraZeneca are to receive a second jab of Sputnik V, they should take the first Sputnik V vaccine with adenovirus 26 (Ad26), Consultant Immunologist and head of the department of Immunology-MRI, Dr Nihan Rajiva de Silva says.

Dr. de Silva said that the first dose of Sputnik had Ad 26 and the second had adenovirus-5. “Adenovirus-5 is common. We may have been exposed to that and we may have developed antibodies. Adenovirus-26 is rarer and we will better respond to that. That is why the vaccine-maker has used adenovirus-26 in the first vaccine. So, if you had a first jab of AstraZeneca and you are to get the second dose from Sputnik-V remember to get the first jab,” Dr. de Silva said.

He added that any vaccine has the chance of reducing the severity of the virus and that the general public should get vaccinated when the opportunity is available.

Dr. de Silva said that there was a shortage of AstraZeneca vaccines because the Serum Institute of India could not deliver shipments as promised.

“However, we are now getting Sputnik V vaccines and we are looking at mixing them. There is a study in Russia about the efficiency of mixing Sputnik V with AstraZeneca and the results should be out soon. I can say that theoretically mixing the two vaccines should work,” he said.

Dr. de Silva added that the AstraZeneca vaccine should work against the new variant spreading in the country.

Consultant Cardiologist at the National Hospital of Sri Lanka, Dr. Gotabaya Ranasinghe said that those with heart issues, non-communicable diseases and were obese must get vaccinated to minimise the complications of Covid-19.

Dr. Ranasinghe said that those in the above-mentioned categories were at risk of contracting, getting complications and dying of COVID-19 and research had proven that vaccination would reduce the chance of such eventualities.

“If you worry about getting vaccinated, talk to your doctor. Don’t seek advice from friends and family,” he said.

Dr. Ranasinghe added that they had limited the number of heart surgeries they do due to COVID-19. ICU beds used for heart patients too were being now allocated for COVID-19 patients. “We only do the most pressing cases. But this means that the waiting list keeps on growing. Now, the waiting list is over eight months. If we limit the surgeries more and keep taking away ICU beds available for those who have had heart surgeries, the waiting list will grow further,” he said.

The Consultant Cardiologist also advised the public to eat healthy food and engage in moderate exercises, at least five days a week. This will reduce the mental stress as well as boost the immune system. ‘We recommend moderate exercises like jogging and brisk walking, for 30 minutes, five days a week. Being healthy is as important as wearing masks or adhering to physical distancing,” he said.

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STF raids narcotics distribution centre close to Bloemendhal police station

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Acting on information received from the Organised Crime Fighting Unit of the elite Special Task Force (STF), police commandos, on Thursday (6), arrested a person running a narcotic distributing network, 1.5 km away from the Bloemendhal police station.

The STF identified the suspect as Thawasidevan Pradeep Kumar, 21, a key associate of one Suresh with links to a criminal outfit run by Kimbulaele Guna, now absconding in India.

DIG (Legal) Ajith Rohana said that the raiding party had recovered 2 kg, 22 g and 88mg of ‘ICE,’ with a street value of Rs 25 mn in addition to 4kg, 2 g and 527 mg of substance known as ‘hash,’ as well as Rs 400,000 in cash and a mobile phone.

Kimbulaele Guna is believed to have sought refuge following an LTTE attempt to assassinate President Chandrika Bandaranaike Kumaratunga at the final PA presidential election rally at the Town Hall in December 1999.

DIG Rohana said that Guna’s brother Suresh was a major heroin distributor in Colombo. The STF later handed over the suspect, along with contraband and locally made ‘hash,’ and his phone to the Police Narcotics Bureau (PNB). The raid on the heroin distribution centre situated in Aluth Mawatha, Colombo 15, followed specific information received as regards the ‘operation’ conducted with impunity (SF)

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