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As reported in the Daily Mirror yesterday (03), the new chairman of the National Medicines Regulatory Authority (NMRA) had stated that approval for the Sinopharm vaccine will be granted only after the World Health Organisation (WHO) grants approval to the Sinopharm vaccine and therefore it is understood that this is the policy of the Government and the NMRA of which I am no longer an official, Senior Consultant Pediatrician and the President of the Association of Medical Specialists of Sri Lanka Dr. LakKumar Fernando said.

Pointing out that China has manufactured great vaccines in the past such as the Japanese Encephalitis vaccine currently used in Sri Lanka, he said that he has no personal reason to oppose the Chinese vaccine when China has excelled in the fields of medicine and technology.

Dr. Fernando made these observations in response to allegations levelled by certain websites which had stated that he had prevented by various means the administration of the Sinopharm vaccine in Sri Lanka.

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He vehemently denied exerting any influence on any person, at any moment in time, against the approval of this vaccine. Responding to these allegations further, Dr. LakKumar Fernando said that;

lakkumraIt was plausibly reported in two news websites, lankacnews.com 02. 05. 2021 and lankaleadnews.com dated 03. 05. 2021 respectively, that I, the President of the Association of Medical Specialists Sri Lanka had prevented by various means the administration of the Sinopharm vaccine when we as a nation are struggling to procure adequate Covid-19 vaccinations.

In the earlier item by lankaCnews.com, it was broadcast that the Acting Chairman of the National Medicines Regulatory Authority (NMRA) Professor Sisira Siribaddana had posted a related account in his Facebook page.

I write this message to disprove these spurious defamatory allegations.

The procedure adhered to by the NMRA when a vaccine has been presented for approval was to submit its related information and documents to an expert advisory panel who would go through the data provided and offer their recommendations to the NMRA who would then evaluate and authorize its use in Sri Lanka (based upon the knowledge we possess of infectious disease Dr. Ananda Wijewickrama and I have been members of this expert panel since 2017).  

This independent expert panel would comparatively examine the side effects and its risks versus its benefits. An essential mandatory requirement of this assessment is the complete data of the Phase-3 clinical trials. If a vaccine was to be approved in the absence of such data, the other means of doing so is the World Health Organization (WHO) to approve it or for it to be approved in a country whose National Regulatory Authority has been designated as a “Stringent Regulatory Authority (SRA)” by the WHO.

At present only the Covishield and Sputnik vaccines have been approved for use against Covid-19 in Sri Lanka. The manufacturers of both these vaccines had submitted all data of Phase-3 clinical trials to the NMRA.

In addition to this, approval granted for the Covishield vaccine by Great Britain's MHRA which is listed under SRA facilitated this.

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Furthermore, Sputnik vaccine, the second vaccine to be approved, submitted all data of Phase-3 clinical trials while the data was published in a respected Peer reviewed journal the lancet as well.

Further clarification for questions was obtained by Sputnik manufacturers via two Zoom interviews.

We approved both these vaccines before the WHO granted its approval for these two vaccines. We did so as we were keen to initiate the covid vaccination in our country. Even after approval it has taken a long time to receive Sputnik with the global demand.

We embarked on the approval of the Sinopharm vaccine which was applied for approval in February 2021 even before the Sputnik vaccine and despite repeated requests to submit all Phase-3 clinical trial data we were not given the data. An online Zoom meeting was not possible with them either. Instead of giving the data, they insisted that it is being used in several countries. These countries which use it have received it as donations.

sinopharm vaccine

Sinopharm vaccine’s application for WHO approval was submitted several months earlier. Even though approval was expected to be granted by the WHO in early March and then late April, approval has not been granted to date.

Since the side effects and risks versus benefits of the Sinopharm vaccine could not be comparatively assessed in the absence of all Phase-3 data, the independent expert advisory panel consisting of eight members submitted their unanimous decision of inability to approve this vaccine till all necessary data is made available, in an official report to the NMRA on March 17th 2021.

It is not correct at all to state that I alone did not approve the Sinopharm vaccine. Together with me this expert panel consisting of Professor Neelika Malavige, Dr. Ananda Wijewickrama, Dr. Rajiva de Silva, Professor Channa Ranasinghe, Professor Pathmeswaran, Dr. Hasitha Tissera and Dr. Kanthi Nanayakkara arrived at this unanimous decision.

No matter that the recommendations of these expert advisory panels are, the NMRA retains the authority to consider or reject these recommendations and approve a vaccine.

Dr. Ananda Wijewickrama and I were on the Director board of the NMRA too at this time.

DrThe Sinopharm vaccine was discussed on the 19th of March when a meeting was convened by the then acting Chairman of NMRA Professor Sisira Siribaddana. Out of the 13 members, Dr. Ananda Wijewickrama and I mentioned that the expert advisory panel has reported that the Sinopharm vaccine cannot be recommended. As such, both of us were not willing to agree with its approval.

However, 6 of these members were appointed anew by the government a week ago while 3 were in their ex-officio capacity which included the Director General of Health Services.

In spite of suggesting to the acting chairman at the time, Professor Sisira Siribaddana, that a vote could be called for to arrive at a decision, he avoided being responsible for granting approval until and only if everyone agreed to approve this vaccine.

Finally this vaccine was brought to Sri Lanka to administer only to Chinese citizens living in Sri Lanka without being registered under the NMRA.

sinopharm vaccine to LankaPresident Gotabaya Rajapaksa attends the handover ceremony of Sinopharm COVID-19 vaccines at the Bandaranaike International Airport in Colombo, Sri Lanka, March 31, 2021

 

After the 17th of March, the acting chairman decided to remove activities related to Sinopharm vaccine approval from the existing advisory panel and a new advisory committee selected by him was appointed for the purpose. Even if I was not a member of this newly appointed expert panel, they too did not recommend approving this vaccine.

Removed from NMRA director board

On the 1st of April, I was terminated from the NMRA director board. Even though about 10 out of the 13 board members in the NMRA could have easily agreed to the acting chairman’s request and approve the Sinopharm vaccine, during the one and half months from the 17th of March, the NMRA has still not approved this vaccine.

This approval does not require a unanimous approval. I wish to state my condemnation and detestation of these malevolent attempts to make me the scapegoat, when the Sinopharm vaccine could be approved even today.

I do not have vested interests in any political party or its members. I vehemently deny that I forced or influenced any person, at any moment in time, against the approval of this vaccine. Furthermore I have never threatened to sue any persons in relation to the approval of this vaccine.

China has manufactured great vaccines in the past such as the Japanese Encephalitis vaccine currently used in Sri Lanka. When China has excelled in the fields of medicine and technology I have no personal reason to oppose the vaccines manufactured by China.

It saddens me that these websites have acted plausibly and irresponsibly to publish slanderous tales.

I saw reported in the Daily Mirror yesterday (the 3rd of May 2021), that the new Chairman, Dr Wijewantha of the NMRA had stated that approval for the Sinopharm vaccine will be granted only after the WHO grants approval to the Sinopharm vaccine.

Through this statement, I would like to point out that it is understood that this is the policy of the Government and the NMRA (of which I am no longer an official).

Dr. LakKumar Fernando
MBBS, DCH, MD(Paed), MRCP(UK), MRCPCH(UK), FRCP(London), FSLCP
Senior Consultant Paediatrician
President- Association of Medical Specialists Sri Lanka