What Ails Sinopharm and Who Exerted Pressure to Approve It?
By Sulochana Ramiah Mohan
China is locking horns with the Health Ministry officials over not starting the Sinopharm jab on Sri Lankans, although it arrived in the country several weeks ago. The seven persons who stood in the way of the vaccine being approved for locals were from the National Medicines Regulatory Authority (NMRA), who said China had not produced the data of the vaccine. However, they were sacked by the Health Ministry for being an obstacle.
The Chinese diplomatic circles are lambasting the NMRA for being biased over Sputnik V approval, which is not yet approved by the WHO. Those sacked during a zoom meeting had raised pertinent questions from the Chinese for which there were no answers, they said.
They also said Russia’s ‘Sputnik V’ had given sufficient reasons that were acceptable.
China has been inquiring about accepting their vaccine Sinopharm and the delay was making the Chinese Embassy uneasy. There were calls after calls to the local authorities including the Foreign Ministry urging them to approve the Chinese vaccine.
China’s vaccine diplomacy
It’s a stoic example how China gets about when things go wrong in Sri Lanka for them. The immediate reaction when the vaccine is put under the scrutiny by the NMRA team, the government reacts.
Only the Chinese workers based in Sri Lanka are now receiving the jab.
China’s diplomatic circle said the Chinese government announced to gift 300,000 doses of BBIBP-CorV COVID-19 vaccine manufactured by Sinopharm to Sri Lanka on January 16, 2021 and then increased the amount to 600,000 on February 26.
On 27th February, upon the request of NMRA and the instruction of President Gotabaya Rajapaksa, Sinopharm made a special arrangement and provided most detailed documents about its BBIBP-CorV COVID-19 vaccine to the medicine regulator, including seven pages of Vaccine Introduction and 54 pages of International Summary Report of the Phase III Clinical Trial.
A top Chinese diplomat told Ceylon Today that “As an inactivated vaccine using most traditional and reliable technology, the BBIBP-CorV is proven to be safe and effective. Within the 54 pages of Phase III Trial Report submitted to Sri Lankan NMRA, about 10 pages are on the Data and Safety Monitoring Board (DSMB) with a study population of 45,000 plus. In summary, in the healthy population aged above 18 years old, the vaccine is safe.
One of the doctors who were sacked from the NMRA Board said he was sacked because State Minister of Production, Supply and Regulation of Pharmaceuticals, Prof/ Channa Jayasumana felt he was an obstacle to get the Sinopharm approved in a hurry. “It's his initiative. Minister of Health Pavithra Wanniarchchi just needed to send me the letter as she only has the power to do it. She was asked to do so by chief of Treasury P.B. Jayasundera on the request of Minister Jayasumana,” he added.
Sinopharm under review – WHO
But when Ceylon Today inquired from the World Health Organisation (WHO) Colombo office, as to what ails Sinopharm, the official reply from WHO was that, the dossiers are being reviewed for the Moderna, Gamaleya, Sinopharm, Sinovac, and others are in discussions with the WHO prequalification team for data submission to WHO.
This is exactly what the NMRA team had required from the Sinopharm Company and told the local authorities unless there is clearance and the data is obtained, they cannot approve the jab for Sri Lankans.
It’s before data submission to the WHO and to the NMRA, that the government has invited the Chinese to bring the vaccine to the country.
The WHO has already proclaimed that each country is sovereign and has the right to choose the tools and products it considers to be best suited for its population. This choice must be guided by the highest standards of science and ethics.
WHO has guidance around the exceptional authorisation of vaccines, and other products in the context of emergencies. Therefore, even with emergency use listing WHO Emergency Use Listing Procedure (EUL), all vaccines need to be approved and registered by regional or national regulatory authorities before use.
The WHO EUL procedure assesses the suitability of novel health products during public health emergencies. The objective is to make medicines, vaccines, and diagnostics available as quickly as possible to address an emergency while adhering to stringent criteria of safety, efficacy, and quality. The assessment weighs the threat posed by the health emergency and the benefits of the proposed product against any potential risks.
The EUL pathway involves a rigorous assessment of late phase II and phase III clinical trial data and substantial additional data on safety, efficacy, quality, and risk management. The data is reviewed by independent experts, not by WHO authorities.
Sinopharm was welcomed by many countries that were looking for ways to halt the spread of the COVID-19 and it came under an emergency mission. But that sort of hurriedness is never seen in Sri Lanka due to the highly controlled system that is in place.
Nevertheless, the game played out on Sri Lankan soil is, India and China are in a race trying to vie for Sri Lanka approval and to choose one over the other. However, given the fact that India’s AstraZeneca was approved by the WHO, the government invited India’s jab over the Chinese doses and 500mn vaccine was donated by India in a ceremony where the President Gotabaya Rajapaksa accepted the packages from the Indian High Commissioner in Colombo Gopal Bagley. China felt, they were letdown in this course of action by the government of Sri Lanka.
Senior Consultant Paediatrician Dr. Lak Kumar Fernando writes…
Over the sacking of NMRA Board member, Dr. Senior Consultant Paediatrician Lak Kumar Fernando wrote to his circle of medical experts who asked him to explain why he was sacked. He also explains why Sputnik was chosen. Below is an extract:
“In the past few weeks a major shake-up of National Medicines Regulatory Authority (NMRA) board took place. Out of the first four board members removed included our fellow Sri Lankan Dr. Palitha Abhayakoon, the regional representative for the whole Asian region for Covid-19 to the World Health Organization. Professor Asita de Silva was one of the next two professionals to go. The seventh to be expelled was me, being appointed to the NMRA to represent the Sri Lanka College of Paediatricians. The total number of members in the NMRA Board is 13 out of whom there are three officials who are in the board as ex-officio capacity that included the Director General of Health Services, Chief Executive Officer and a Treasury representative.
It is my belief that this recent shake up took place due to the fact that the Chinese Sinopharm vaccine was not approved by the NMRA as promptly as expected. After the appointment of six new officials to the NMRA on the 18th of March 2021, the newly appointed acting chair of the NMRA convened two urgent meetings to approve the Sinopharm vaccine. However Dr. Ananda Wijewickrama and I, had voiced our concerns based on expert panel's recommendation. Though there was a WHO guided shorter faster pathway for such approval when it's a donation from a country to country that still needs at least minimally the safety and efficacy data. The expert panel has clearly said that the submissions received so far lacks that data.
Scientifically and technologically China is a foremost country in the present world. They have developed highly efficacious vaccines out of which the Japanese Encephalitis vaccine currently being used in Sri Lanka is a good example. Despite the ongoing corona pandemic originating in China, China managed to successfully curb its spread while the virus spread rampantly in the rest of the world. This was not as a result of a vaccine but owing to stringent hygienic practices which prevented the spread of the virus.
While the pandemic took its toll many countries and companies began to competitively develop vaccines against the virus. China too was amongst these.
Sri Lanka was able to begin vaccinating since the end of January 2021. The first vaccine received by our country was the Covishield vaccine donated to us from India, manufactured in India together with the Oxford AstraZeneca Company.
All vaccines imported to Sri Lanka including the Covishield vaccine are approved by the NMRA for which there is a procedure and a protocol to follow. During an urgent instance such as this, the procedure is to present the scientific data given by the vaccine manufacturer to an impartial expert committee who will examine the data and give their recommendations to the NMRA. This expert committee was first appointed in 2017 when French manufacturer Sanofi applied for the registration of their dengue vaccine. Dr. Ananda Wijewickrama and I have been on this expert committee from that moment up to now.
Oxford Astra Zeneca manufactured Covishield vaccine and the Russian manufactured Sputnik vaccine was also approved in Sri Lanka adhering to this process. There are several important factors to consider during such approval. This process is simple and straightforward if it is already approved by the WHO or one of the eleven world renowned stringent authorities (eg. FDA) If not approved by such authorities, all data related to its Phase 3 clinical trials must be submitted to our NMRA. If these phase 3 trials have been published in a peer reviewed medical journal that too would favour this process.
The Sri Lankan representatives of this Sinopharm vaccine requested approval to administer it to the Sri Lankan population from the NMRA more than two months ago. However the information needed to be submitted together with the application were not received. No matter how much the impartial expert committee appointed by the NMRA requested the data, they have not been submitted even to this date.
If approval is granted without scrutinising such required data it will be a detrimental precedent. This will not be the last vaccine to be approved by the NMRA. Every vaccine presented for approval must be approved only by adhering to the proper methodology in place for its approval and this procedure should be the same for any medicine presented for approval for use in Sri Lanka. We are unaware as to why it is taking so long to produce the necessary data until now. A possible reason for this delay maybe that a large population is required to test the efficacy of a vaccine and by the time phase 3 trials began, in China it had controlled the spread of the disease significantly and they may not have had a sufficient number of patients. This phase 3 trial was mostly conducted in countries like UAE and Brazil. The data from these countries may not have been gathered efficiently. *Even if approval for this vaccine was requested from the WHO since January 2021 they too have not approved it yet. It is believed that this delay in providing necessary data lead to the WHO delaying this vaccine’s approval from its initial timeline of early March to the end of April 2021.
However much it is believed that this vaccine is good and safe to be used and all other items manufactured by China are proven to be fine; the expert committee or the NMRA board cannot approve this vaccine without the required data.
At certain times there was pressure by certain persons to have the approval as soon as possible even without the data. When this was not forthcoming they thought re-constitutions of the NMRA board would be the best answer and I believe the head rolling happened as a result.
A vaccine is administered to healthy disease free people. As such it is essential to approve a vaccine only after carefully evaluating its side effects and life threatening effects. In spite of my belief that the Sinopharm vaccine maybe efficient and safe, considering the other vaccines manufactured by China to date; as a board member of NMRA and a member of the expert committee for vaccine approval, I could only contribute by arriving at a conclusion based on the scientific data.
The time it will take is only the time it will take for them to provide the necessary data. The members of this expert committee burnt the midnight oil consistently to assimilate data related to vaccines. I did not claim any monetary benefits for the membership of these committees. I attended all related expert committee meetings in Colombo at my own expense travelling from Negombo. This was the norm over the past years when I attended the NMRA meetings too. I have not accepted any payments of the NMRA to this date.
After the expulsion of the former Chair of the NMRA, Professor Asita de Silva, a big of effort was taken to get this vaccine approved by the newly appointed acting Chairman. I was in the NMRA representing the Sri Lanka College of Paediatricians and never as a political appointee.
Together with Dr. Ananda Wijewickrama, I had to scientifically explain to the new board, how unsafe and inappropriate it is to approve a vaccine without the needed data. I had to tell the board about the Dengvaxia dengue vaccine story in Philippines, where the regulators ended up getting jail sentences years later for approving a vaccine in 2017. (the NMRA did not approve this vaccine in 2017 because the expert committee did not recommend it even though there was pressure exerted to approve this vaccine by the then government).
If they so wished the thirteen members of the NMRA panel of directors could have held a vote in favour of approving this vaccine. However, I had to express that it is inappropriateness of such disregarding the recommendations of the expert committee. In conclusion it was unanimously decided that even if the vaccine is imported to Sri Lanka, it should be used only on Chinese citizens living in Sri Lanka as a medicine under Waiver of Registration for issuing on named patient basis, until the necessary data is received or an authority like the WHO approves it.
It is paramount that the NMRA remains a fully independent authority for the health and wellbeing of the citizens of Sri Lanka. It could be stated that its independence was safeguarded up to now even from the influence of the relevant ministers. The harm generated by this action will not be limited to this one vaccine.
The right of the people of Sri Lanka to receive quality and safe medicines in future is under some threat. I believe and wish that once the required data is received the WHO will speedily approve Sinopharm. I wish that the related officials and political leadership would realise that as a policy, it is important to await such approvals patiently, at least in the future. It should be realised by all of us that not maintaining a constant unswerving policy in matters such as this could give rise to many more problems.
We have been protected by many existing diseases in the world by the safe and strong vaccines developed against such diseases. Our belief in vaccines must be further strengthened. Many decades ago in 1997, while I was an official of the Government Medical Officers’ Association when an epidemic occurred following the administration of a Triple vaccine which was not approved by the WHO, I too joined hands with others to protest against its use. Following this, the government decided to only accept vaccines which were approved by the WHO for the national immunization programmes”.
Nevertheless, People’s Movement for Rights of Patients has already filed a FR petition at the Supreme Court to prevent the jab for Sri Lankans until the NMRA approves it. The government needs to keep away from the independent bodies that work for the betterment of the people of the country as is explained well in this confusing state of affairs.