Sri Lankans have just finished a week long break for the Sinhala and Hindu New Year. Scenes of people thronging streets and shopping malls shoulder to shoulder as they prepared to celebrate the New Year drew frowns and predictions of the inevitable which now look set to become a reality. Why the authoritiesallowed a free for all during this time will be known only to them. With the number of positive cases on the rise, especially outsideColombo, the Advisory Committee on Communicable Diseases which met on Monday wasted no time asking the government to ban May Day rallies and to recommend a roll out of the second dose of the Covid–19 vaccination starting May 1.
Matters have been made worse because the country’s Covid –19 vaccination program is in limbo because of the vaccine being in short supply. There are at least 15 million people who have to be vaccinated in the country and as at the 14th of April only 925, 242 had beenvaccinated, which is just a fraction of thepopulation that has to be immunized.
So far, Sri Lanka has received under 1. 5 million vaccines for its population. The first consignment of 500000 Oxford AstraZeneca Covishield vaccines was a donation from India from where Sri Lanka had also placed an order to purchased 1. 5 million vaccines. Only 500000 of these vaccines have been received so far and one million vaccines are still pending. A further 264, 000 vaccines were received through the COVAX facility. The vaccines which remain from these stocks will be prioritised to immunize frontline health workers with their second dose but will clearly not suffice to cover all those who will become eligible for the second round. While immunity from the first dose will decrease over time if it is not topped up there is still insufficient data to determine how long the efficacy of one dose will be for.
Health officials here are accusing the Ministry of Health of not being proactive and ordering the vaccine when there was a window to do so around November and December last year. The lapse could be a costly one. ‘The government instead was promoting the Dhammika paniya and was trying to export it.’ The government’s plans went awry and it had to eat humble pie after many people who had taken the crude concoction which was produced by a local man contracted Covid. None less than the country’s health minister, who also drank the concoction to demonstrate its efficacy at fighting the virus, succumbed to it.
The Covid– 19 pandemic has killed millions and countries have been jockeying to get the vaccine. There are reportedly more than 200 vaccines being trailed to join the race.
Countries queued up at the doorstep of multiple potential vaccine producers in the hope that at least one door would open and lead them to the vaccine. Canada for instance pre ordered nine times more than what had been needed to vaccinate its population. The Pfizer-BioNtechvaccine which costs around US$ 6.7 for instance could have been pre ordered by paying anadvance of US$ 1.
According to sources the government is negotiating for the vaccine with India which is having a bottleneck with vaccine production while having to cope with an exponential surge in recent cases which has left victims without hospital beds and oxygen. ‘The Indian government will become unpopular with its own people if India gives vaccines to other countries when their own situation is bad’, pointed out the source. Sri Lanka is also reportedly negotiating for the Pfizer vaccine.
Meanwhile the Sinopharm vaccine, the saga of which rocked the foundation of the National Medicines Regulatory Authority (NMRA) which is the country’s apex medicinesregulatory body, is still pending approval from both it and the WHO which was expected to greenlight its use back in March.
The 13– member NMRA is the country’s watchdog which provides quality assurance fordrugs and vaccines. Its website describes itself as ‘playing a leading role in protecting and improving public health by ensuring medicinal products available in the country meet applicable standards of safety, quality andefficacy’. The composition of the NMRA board includes a representative each from the four major professional colleges of Medicine, Obstetrics and Gynaecology, Surgery and Pediatrics. These representatives are nominated by their respective Colleges and appointed by the Minister of Health. The NMRA board also has a management specialist, an accountant, a lawyer and a person of medical eminence who are appointed by the Minister of Health. The others on the Board have to be a professor of pharmacology and the appointee normally is the most senior in the country, a professor in pharmacy, and three ex officio members who are the Director General of Health Services, a representative of the Treasury and the CEO of the NMRA, a post which is advertised and filled.
At the beginning of this year, the local agent for Sinopharm applied to the NMRA to register the vaccine to bring it to the country through the State Pharmaceuticals Corporation. If a vaccine is to be given to an entire community for use inan emergency, the NMRA can appoint an Independent Expert Panel to review applications. The same Panel that was constituted in 2017 to review applications for the dengue vaccine produced in France continued to carry out this function for the Covid vaccine as well. The Panel did not approve the submission for Sinopharm because the data that was provided of the vaccines phase three trials was incomplete and could not vouch for the safety and efficacy of the vaccine. These two elements are key for the approval of a vaccine.
It is not unusual for the NMRA to ask for data where it is incomplete, or to give a conditional approval for a vaccine or for there to be a rolling review where the applicant keeps sending the data and the parties remain engaged with the process which generally is a long and cumbersome one. In the case of the Sputnik vaccine which has also been approved for use in Sri Lanka in addition to Covishield, all the data which the NMRA requested was provided. Instead, the health ministry and the NMRA locked horns after the ministry tried to circumvent established procedures in its rush to obtain approval for the Sinopharm vaccine and the NMRA board resisted it. It resulted in the sacking of the four ministerial appointees on the NMRA board among whom were Sri Lanka’s WHO representative Dr Palitha Abeykoon and Professor Asitha De Silva, and two others including the representative of the College of Pediatricians Dr Lak Kumar Fernando. The replacements which took place subsequently were also flawed with for instance a junior pharmacologist being appointed instead of the country’s most senior professional in that area of speciality. An alternative specialist Committee which was appointed to get the vaccine passed also did not greenlight it.
Sources point out that had the NMRA succumbed to pressure and approved the vaccine which did not have the Panel’s approval, it would have set a dangerous precedent.
Reactions to Sinopharm, which is about US$ 62 and therefore nearly ten times more expensive than the Pfizer vaccine, have been mixed. The global North has not been receptive to the vaccine. An article in the New York times in February explains how both the ‘Chinese and Russian vaccines were initially dismissed in the West because of the perception that they are inferior to those vaccines produced by Modena, Pfizer- BioNtech or AstraZeneca and that this perception partly stems from China and Russia being authoritarian states’. The article goes on to state that ‘evidence has been accumulating for a while that the vaccines from these countries also work well’ and could be the answer to the vaccination woes of many countries. The Maldives which got about 10, 000 does of the vaccine put it on their backburner until the WHO approved it but have reportedly started using it. Meanwhile the vaccine has been used widely in the UAE and Brazil where its phase three trials are likely to have been conducted because China had the epidemic under control during the vaccine’s phase three trials and had to carry them out on populations in countries such as the UAE and Brazil which have not been efficient in sending the data.
While registration of the vaccine for Sri Lanka’s general population is still pending, six hundred thousand doses of the Sinopharm vaccine weresubsequently brought into the country by means of a waiver of registration to be administered exclusively to the Chinese community in Sri Lanka. According to the Epidemiology Unit’s immunization breakdown, as at 14th April 2469 Chinese nationals had taken the vaccine. But sources point out that the Chinese community in Sri Lanka at around 30, 000 is much bigger and query why the take up has been so low.
