WHAT’S WITH THE SINOPHARM VACCINE?

by Sanjeewa Jayaweera

In the last month or so, the government’s attention and the public have been on Geneva, the purported sugar scam, illegal deforestation, and now contaminated coconut oil. The concern over Covid-19 and the faltering vaccination programme has taken a back seat. It might be because of the decline in the daily positive cases. Some have, however, attributed the decline more to reduced testing and tracing than getting on top of the virus.

Most countries have not been able to get on top of the pandemic other than for a very few. Till recently, India was lauded for having brought the virus under control. There was even talk of India having achieved herd immunity. However, in the last two weeks, there has been a sharp increase in the number of positive cases, and it looks as if India is facing its third wave.

Europe is also in the midst of a third wave, and in the USA., despite a vigorous vaccination programme, the daily numbers are once again increasing. The numbers coming out of Brazil regarding both positive cases and deaths are a damning indictment of a President who has mismanaged the fight against this dreaded illness by disregarding basic public health precautions that most other countries have embraced.

In Sri Lanka, we have done better. In a recent TV talk show, a member of the ruling party said that it is only because the government is on top of the pandemic that opposition politicians concentrate on sugar scams, illegal deforestation, and contaminated coconut oil when elsewhere the main topic is about Covid-19. In a perverse way, he is correct!

However, Sri Lanka can certainly do better, and the current comedy surrounding the approval of the Sinopharm vaccine from China is a case in point. On March 20, the Pharmaceuticals Production State Minister Prof. Channa Jayasumana said that The National Medicines Regulatory Authority (NMRA) of Sri Lanka had approved the use of the COVID-19 vaccine ‘Sinopharm’ manufactured by China.

A couple of days later, it was announced that NMRA had only approved the vaccine’s receipt as a donation and not for use! A few days later, it was announced that only Chinese nationals residing in Sri Lanka could receive the vaccine. I am confused because if the vaccine is not safe for use in Sri Lankan arms, how is it safe for Chinese nationals living here? Are we to assume that Lankan lives are more important than Chinese lives? Is the Government of Sri Lanka not responsible for the lives of Chinese nationals living in Sri Lanka?

A couple of days ago, the cabinet spokesman, who I believe was also a medical practitioner, said that the phase four trials information on the Sinopharm vaccine is only in Chinese and need to be translated to English before the NMRA can decide. In any case, we need to wait until the World Health Organisation (WHO) approves the vaccine.

This is the first time that I have heard of phase 4 trial data for a vaccine. For all other vaccines, the data from phase 3 has been the basis for approval. So, I am not sure whether the cabinet spokesman has got his wires mixed? The comment about the information being available in only Chinese seems a bit stretched.

The rationale for awaiting WHO approval is a bit puzzling, although some others have said the same. Most of the countries that have approved the use of various vaccines have not waited for WHO approval. They have been approved by their own approving authority. Why Sri Lanka needs to await WHO clearance is puzzling and seems to be a bit like passing the buck.

WHO has not endeared itself to many during the pandemic. Many feel that its inaction at the beginning of the pandemic contributed to the spread. As I recall, the WHO was critical of countries closing their borders and banning overseas arrivals at the pandemic’s inception in February 2020. They were also slow on recommending the mandatory wearing of masks and initially questioned its efficiency. They have, of course, subsequently gone back. The only aspect of what Donald Trump uttered during the pandemic that made sense to me was his call for the WHO to be investigated for their actions during the pandemic’s initial stages.

Some have accused the government of reconstituting the NMRA to replace some eminent personnel because they were preventing the approval of the Sinopharm vaccine. If this is indeed true, then it is regrettable because such organizations need to be independent and free of government interference.

Medical professionals also need to exercise a degree of flexibility in dealing with the pandemic. I know that most medical and engineering professionals have a great affinity towards what is manufactured in the West (the USA. and Europe). I suppose this is due to us being ruled for many centuries by the British, Dutch and Portuguese. We tend to accept whatever comes from the West but derides those produced in China and India. I remember in the 1970’s we used to laugh about the lack of quality of Japanese cars. The belief was that if you are involved in a severe accident driving a Japanese car, then your chances of survival were minimal. Today the story is very different, although a colleague did say that even now in Colombo, if you drive a European vehicle, your social status is much higher!

Sinopharm is approved for general use in China, UAE, and Bahrain. It has been approved for emergency use in 16 countries and limited use in two countries. UAE. granted emergency approval for the use of the vaccine on health care workers in September 2020 and, on December 9, 2020, granted general approval for the use of the vaccine.

The phase 3 trials of the Sinophram vaccine were conducted in the UAE, Morocco, Argentina, Peru and several other countries with over 60,000 participants. The UAE. authorities announced that the vaccine has a 86% efficacy against COVID-19, whilst Sinopharm said that the efficacy was 79.34%. According to the company, the discrepancy was the result of differences in how the trials were run. In January 2021, Hungary authorized the vaccine making the country the first European nation to use a Chinese vaccine. Sinopharm plans to raise the annual output of its vaccine to three billion doses a year. It appears that the Oxford-AstraZeneca vaccine, known as Covishield manufactured by the Serum Institute India, is going to be in short supply with India ramping up their vaccination programme in the face of a third wave. Most of the poorer nations are banking on this vaccine, and the demand is massive. As to where Sri Lanka will fit in the priority list of countries to receive their orders may well depend on the generosity of the Indian government.

Having not endeared ourselves to the Indian government due to the unprofessional manner in which GOSL unilaterally cancelled the East container Terminal agreement, the country’s options in procuring an effective vaccine are limited. In light of that, the comedy of errors blighting the approval of the Sinopharm vaccine to be used in Sri Lanka in the public’s full gaze is both unprofessional and unnecessary.