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
Click to comment

Leave a Reply

Your email address will not be published.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

Latest News

Abandon selfishness and embrace a life of sacrifice and harmony to achieve spiritual and worldly success – President

Published

on

By

President Ranil Wickremesinghe, in his Hajj message emphasizes that to achieve spiritual and worldly success, individuals must abandon selfishness and embrace a life of sacrifice and harmony. It is with this noble aim in mind that Muslims celebrate the Hajj festival each year.

On this occasion, Muslims from around the globe gather at a single place of worship, united in purpose, to pray for communal values that embody the hope of humanity. The Hajj celebration fosters feelings of equality and brotherhood among all people, delivering a profound message for world peace.

I extend my heartfelt wishes to the entire Muslim community in Sri Lanka and around the world for a meaningful Hajj celebration, where everyone comes together to fulfill the aspirations of humanity.

Continue Reading

News

Justice Minister goes ahead with SLFP election campaign

Published

on

… attends Karandeniya meeting with MS

by Shamindra Ferdinando

Justice Minister Dr. Wijeyadasa Rajapakshe, who calls himself the SLFP’s presidential candidate, launched the SLFP’s election campaign yesterday (16) in spite of restraining orders the Colombo District Court has issued against him and former SLFP Chairman Maithripala Sirisena.

Minister Rajapakshe attended the SLFP meeting at Karandeniya, the main meeting of the Galle District. Former President Sirisena was also present at the meeting organised by former monitoring MP of the Foreign Ministry Sajin de Vas Gunawardena.

Restrictions imposed on Sirisena and Rajapakshe are effective until June 19 and June 25, respectively.

The Election Commission on May 09 announced by virtue of the powers vested in the Commission to fix the date for the Presidential Election, it will hold the Presidential Election between 17 September and 16 October 2024.

The group headed by Sirisena decided to go ahead with the campaign, especially in the wake of the other section forming an alliance with a group of SLPP rebels to back Ranil Wickremesinghe’s candidature at the forthcoming Presidential Poll. However, Sirisena and Minister Rajapakshe, both elected to Parliament on the SLPP ticket, couldn’t represent the party, in any capacity, sources say.

Meanwhile, Chief Government Whip Urban Development and Housing Minister Prasanna Ranatunga yesterday (16) disclosed that the ruling SLPP wouldn’t field a candidate of its own and would throw its weight behind a candidate in the fray instead.

When he was asked, after a meeting in Minuwangoda, whether the SLPP would field a presidential candidate, Minister Ranatunga said it would support a candidate in the fray. Minister Ranatunga reiterated that the incumbent President was the best to lead the country therefore he believed he should be supported. The Minister said that the support would grow for Wickremesinghe after he officially declared his candidature.

Minister Ranatunga said that though he didn’t like Wickremesinghe the current crisis had compelled him to back him.

Another Minister Pavitradevi Wanniarachchci, widely believed to be a staunch Rajapaksa loyalist, declared on Saturday (15) though the SLPP and President Wickremesinghe differed on policy for the sake of the country such differences had to be sunk. Wanniarachchi said so in Embilipitiya.

Continue Reading

News

NMSJ calls for proper use of IMF funds

Published

on

Karu Jayasuriya

Former Speaker and the National Movement of Social Justice (NMSJ) Chairperson Karu Jayasuriya, yesterday stressed the critical importance of effectively utilising the third tranche of the International Monetary Fund (IMF) bailout package.

Jayasuriya has, in a media statement, said steps must be taken to ensure proper use of the funds. The IMF released the third tranche of $ 336 million from its $ 2.9 billion bailout package.

Full text of the statement: “We believe that the release of the third tranche by the International Monetary Fund (IMF) is crucial for Sri Lanka’s restructuring programme and is in the nation’s best interest. It is our national responsibility to allocate and manage these funds towards the country’s development. Given the current economic challenges and the significant sacrifices made by the people, it is imperative that every penny received is used responsibly and effectively.

“Our foremost concern is the urgent need to combat waste and corruption, consistently highlighted by the IMF.

“Additionally, rehabilitating neglected ancient tanks, totaling approximately 15,000, for modern agricultural use is essential. This initiative can be supported by international funds, friendly nations, the private sector, and the military, promising transformative outcomes.

“Another major task is to immediately accelerate the export sector. In the 1990s, a significant programme under the theme “Export or Perish” was launched, including the highly successful international trade fair “Expo 92,” which attracted 5,600 foreign buyers. The concept of Export Villages was successfully implemented, resulting in high incomes for people in selected villages. Given the current situation, we can establish special export villages by leveraging the support of the supermarket chains that are currently operating successfully.

“The Export Development Board (EDB) should be given the necessary resources and powers to strengthen its capabilities. With advanced communication technology, Sri Lanka can be promoted as a country with rapidly increasing exports, even without the need for traditional exhibitions.

“At the same time, it is crucial to support the development of small and medium-scale entrepreneurs (SMEs). This can be achieved by providing subsidized interest rates and basic infrastructure facilities. We should take inspiration from the former Indian Prime Minister Manmohan Singh, who created new opportunities for India’s youth through the development of the IT/BPO sector. This concept can be easily popularized in Sri Lanka, offering similar benefits.

“The National Movement for Social Justice (NMSJ) urges immediate action on these fronts, expecting responsible leadership to address these pressing issues.”

Continue Reading

Trending