By Aazam Ameen The Independent Vaccine Advisory Expert Committee which has been tasked with approving Vaccines for use in Sri Lanka has seen a number of resignations over the past few weeks with the most recent being the resignation of Prof. Neelika Malavige and Prof. A. Pathmeswaran. The Morning’s investigative desk looked into the matter and based on information received from high level health sources, it appears that the Committee was allegedly pressured by the National Medicines Regulatory Authority (NMRA) on numerous occasions, which undermined the Committee’s independence. The Morning learnt that the NMRA submits documents related to the vaccine for which approval is sought from all members of the committee individually. Following this, the committee studies these documents before presenting their findings to the NMRA along with their approval or disapproval of the relevant vaccine. It was revealed that since its inception, the committee consisted of Prof. Pathmeswaran, Prof. Neelika Malavige, Dr. Ananda Wijewickrama, Dr. Rajiva de Silva, Dr. Kanthi Nanayakkara, Prof. Channa Ranasinghe, Dr. LakKumar Fernando and Dr. Hasitha Tissera. The Morning received information which allegedly highlighted that when the NMRA produced the documents relating to the Sinopharm vaccine, seeking approval from the committee, data relating to the Phase 3 studies of the vaccine were not presented. Accordingly, the independent panel had not given their approval for the vaccine due to the lack of data. In the Committee’s report which was given to the NMRA on 17 March which requested for the provision of Phase 3 data in order to approve the Sinopharm vaccine, sources alleged that the then acting NMRA Chairman Prof. Sisira Siribaddana decided to appoint a new panel only for the purpose of Sinopharm vaccine evaluation. However, it is learnt that this proved to be futile as the second committee also refused to approve the vaccine. Following this, the new panel, consisting of Dr Pushpa Punchihewa and others is reported to have been allegedly dropped. Meanwhile, the initial expert committee was asked to evaluate vaccines from other manufacturers. Our source further stated that on 06 May, Phase 3 data relating to the Sinopharm vaccine was submitted to the initial committee which then approved it on 08 May. However, prior to this, Prof. Saroj Jayasinghe, Dr Mahen Kothalawa and Dr Rohitha Muthugala were added to the committee. It is learnt that with the onset of the third wave of Covid-19, the Committee was partly blamed for this by numerous parties which allegedly stated that they should have given approvals for the Sinopharm vaccine earlier, even though the essential Phase 3 data was not available to them at the time. On the 19th of this month, the NMRA is reported to have submitted documents pertaining to the Sinovac vaccine to the committee for approval. However, it was confirmed that Dr. LakKumar Fernando did not receive the same documents, excluding him from the evaluation process. When The Morning contacted Dr Fernando for his comments on this matter, he stated the reasons for his exclusion are not known to him. Speculations are rife that even though the recent resignations of Prof. Malavige and Prof. Pathmeswaran were attributed to personal reasons, the actual reason could be due to the fact that the committee has been asked to approve the controversial Sinovac vaccine which has been widely criticised. “What happens is that if these professionals evaluate such vaccines and do not green light them, they will be criticised and attacked. Just the same way if they approve these vaccines and then something goes wrong, their professional integrity will be at stake again,” our sources said. Further, it is learnt that some alleged that the picture which is painted based on the actions of the NMRA shows that the NMRA only seeks an approval from the committee, and not their professional advice. “If they (NMRA) really wanted a professional insight to benefit the people of this country, why would they scramble to appoint different committees when one does not approve of a vaccine? All they want to do is produce documentation and have it approved,” our sources expressed This new controversy surrounding the NMRA comes after the recent appointment of a new Chairman who replaced Dr Palitha Abeykoon. Individuals from the country’s medical fraternity are of the view that the new Chairman is not of medical eminence as they alleged that he has not obtained board certification. “The new chairman is an Anesthesia Trainee who has just returned to the country after completing his overseas training. He is also the son of a former SLFP Minister from the Southern Provincial Council,” The Morning learnt from our medical sources. When The Morning contacted NMRA Chairman Dr. Rasitha Wijewantha for his comments on the reason why the NMRA chooses to submit vaccine related documents to the committee on an individual basis, he stated that it was a matter of convenience for the experts. “The experts need to give their assessment of the vaccine concerned after going through the data provided by us. We hand it to them individually so that they can go through it during their free time,” he explained. Further, when queried about Dr. LakKumar Fernando’s exclusion from the Sinovac vaccine approval process, Dr. Wijewantha stated that following Board approval, Dr. LakKumar was removed from Sinovac evaluations. “This is not a fixed committee, there is no hard and fast rule that we have to include all members of the expert committee in evaluations. The Board can decide to add or remove persons,” he stated. In terms of the reason behind the Removal of Dr. LakKumar, Dr. Wijewantha said, “If we decide that his services are no longer required, we can remove him,” With regard to the alleged appointment of another committee specially tasked with approving the Sinopharm vaccine once it was rejected by the initial committee, while this took place before the tenure of Dr. Wijewantha, he stated that he did get to know that there was a lack of data when the documents were initially given to the committee. Further, he denied the appointment of any second committee tasked with approving the Sinopharm vaccine. “There was no such separate panel. All panel members are approved by the Board,” he said.