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Sinopharm and Sputnik V vaccines: Approved, but clinical tests continue  

28 Mar 2021

  • Yet to finalise administering to Sri Lankans 

  • Second dose to proceed as planned 

  Concerns have been raised over the two Covid-19 vaccines recently approved by the National Medicines Regulatory Authority (NMRA) for usage in “emergency and other special circumstances”, while it is still being tested at clinical levels, The Sunday Morning learnt.  It is learnt that the two Russian and Chinese vaccines are yet to receive approval from the World Health Organisation (WHO).  According to international statistics, the efficacy rate of Russia's Sputnik V is said to be at 91.6% and the vaccine made by Chinese firm Sinopharm’s Wuhan subsidiary has a 72.5% efficacy rate. The efficacy rate of other vaccines such as Pfizer, Moderna, and Oxford-AstraZeneca are said to be at 95%, 94.5%, and 81.3%, respectively.  Approval granted for Sputnik V and Sinopharm for emergency usage in Sri Lanka was confirmed by the NMRA. Its CEO Dr. Kamal Jayasinghe told The Sunday Morning that the two vaccines were given a “waiver of registration” while the clinical tests were being conducted for other usages within the country.  Further, State Minister of Primary Healthcare, Epidemics, and Covid Disease Control Dr. Sudarshini Fernandopulle confirmed the approval given by the authority for the Sputnik V vaccine for emergency usages. But when queried about the Sinopharm vaccine, the State Minister said: “The NMRA is under the purview of State Minister Prof. Channa Jayasumana and he is the one who knows about the approval of the Sinopharm vaccine for emergency usage.”  Approval of the Sinopharm vaccine for emergency usage was revealed by Pharmaceuticals Production, Supply, and Regulation State Minister Prof. Channa Jayasumana a week ago and it was re-confirmed by NMRA’s Dr. Jayasinghe, who said: “The waiver of registration was given for the Sinopharm vaccine for government-to-government donations and the waiver is for the usage for emergency purposes.”  Dr. Jayasinghe reiterated: “Clinical tests are being conducted for both Sputnik V and Sinopharm.”  In such a backdrop, the Cabinet of Ministers has granted approval for a proposal submitted by the Health Ministry to purchase seven million doses of Russia’s Sputnik V at a cost of $ 69.65 million to vaccinate 14 million Sri Lankans against the Covid-19 virus.  In the meantime, State Minister Jayasumana confirmed the availability of Chinese Sinopharm, as he reiterated that the importation of the vaccine was approved by the NMRA and as a result, Sri Lanka will receive 600,000 doses of the vaccine within a week as a gift.  Even though the health authorities have no clue about the distribution of the Sinopharm vaccine within the country once it has been received from China, Co-Cabinet Spokesman and Minister of Mass Media Keheliya Rambukwella said around 750,000 persons from the Central Province would be vaccinated with the Sputnik V vaccine to be received from Russia.  However, State Minister Dr. Fernandopulle had stated that the Chinese Embassy had requested the Government to prioritise the Chinese nationals in Sri Lanka when giving the Sinopharm Covid-19 vaccine. It was reported that the management of the Colombo Port City had forwarded a request to the Ministry of Health to provide the Sinopharm vaccine to Chinese nationals in Sri Lanka.  The Russian vaccine is yet to be approved for widespread use in Western countries, despite Moscow's insistence that it is safe and effective, and the slow rollouts of vaccination campaigns in Europe.  However, last week, the media reported that the European Medicines Agency (EMA) is still inspecting facilities in Russia that are producing the Sputnik V Covid-19 vaccine before approving the vaccine for use in the European Union (EU).  The media reports also highlighted that China’s lack of transparency in its clinical trials has hurt public confidence despite China’s coronavirus vaccine makers Sinovac and Sinopharm being among the earliest in the world to begin clinical trials last year.  It remains unclear why Sinopharm still has not published the data from the studies; even after dozens of governments have greenlit their vaccines for emergency use.  Accordingly, around 17 countries including Pakistan, Indonesia, Jordan, Ukraine, Algeria, the Philippines, and Turkey have purchased Covid-19 vaccines developed by Chinese developers including Sinovac, Sinopharm, and Cansino.  In total, over 50 countries worldwide placed orders for Sputnik V from Russia. As of January 2021, the vaccine was used for vaccination in Russia, Belarus, and Serbia. In October 2020, Russia applied for prequalification of Sputnik V at the WHO to speed up its availability worldwide.  Accordingly, it is reported that Russia has already sold 100 million doses of the Covid-19 vaccine Sputnik V to India, which was also among the countries that agreed to produce it on its territory. Indian companies planned to produce 752 million doses of Sputnik V in 2021.  Furthermore, Mexico was to import 7.4 million doses between February and April 2021, with more doses to be delivered in May. Sputnik V was authorised in 49 countries worldwide as of 11 March 2021. Russia applied for the vaccine approval in the EU in January, while several EU countries approved its use earlier, such as Hungary and Slovakia.  Nevertheless, health experts are alleging that the Government was struggling to secure the Chinese Sinopharm vaccine as well while keeping world-recognised vaccines such as Moderna and Pfizer away.  They stressed that the NMRA has not yet given its approval for the Moderna and Pfizer vaccines, which have received wide recognition all over the world and also, they denied the claims made by the health authorities that the country did not have the required cooling facilities to store these two vaccines.  As highlighted by them, the Central Blood Bank has a cooling capacity for one million vaccines at once and the vaccines can be delivered to any hospital around the country in the cooling boxes at the blood bank.  Speaking to The Sunday Morning, Sri Lanka Association of Government Medical Laboratory Technologists (SLAGMLT) President Ravi Kumudesh alleged that the Government, through the NMRA, was attempting to register the Chinese vaccine Sinopharm which has not even completed the third stage of its clinical trials. “If we bring down the Sinopharm vaccine, we will only be giving them the chance to complete their third stage of clinical trials, as it cannot still be considered a proper vaccine,” he said, alleging that Sri Lanka has now become a “pawn” of commercial dispute between China and India and that was the reason behind the Government’s struggle to import Sinopharm by even changing the higher-ranking officers of the NMRA.  Commenting on the Russian Sputnik V vaccine, Kumudesh said: “The Russian vaccine is yet to receive approval from the WHO but it can be considered a proper vaccine that Sri Lanka can use. The Russian vaccine has some sort of similarities and matches the vaccines used in Sri Lanka. But we need to bring down recognised vaccines such as Moderna and Pfizer to have vaccine variation in the country.”  Meanwhile, concerns have also been raised over the ability of the country to supply a continuation of vaccination stocks for local usage, especially for those who have already administered the first dose of the vaccine.  State Minister Dr. Fernandopulle assured a continued supply of vaccines and the continuation of the programme, despite the delay of receiving India’s AstraZeneca vaccine doses.  “The vaccination programme would be continued without any interruption,” she told The Sunday Morning.  Commenting further, she said the Government is focusing on high-risk areas, especially areas in the Western Province, where the highest number of Covid-19 cases were recorded within the last two weeks.  In the meantime, State Minister Prof. Jayasumana also assured that those who received the first dose will be able to receive the second vaccine on time, as India’s decision to temporarily hold exports of the AstraZeneca Covishield vaccine will not affect Sri Lanka adversely, as the country has enough doses for the vaccination drive till the end of May.  Accordingly, the roll-out of the second dose of the AstraZeneca Covishield vaccine in Sri Lanka is scheduled to begin on 10 April.  Currently, India has reportedly put a temporary hold on all major exports of the vaccine made by the Serum Institute of India (SII), the world’s largest vaccine manufacturer, to meet the domestic demand, as infections have increased there.  Prof. Jayasumana noted there will not be any issue regarding the administration of the second dose, due to the remaining Covid vaccines and the consignment expected to arrive in the island.  “We will be able to administer the second dose till May this year using the doses remaining in our stores. Therefore, there will be no problem until May end. Also, we are in discussion with India and have been unofficially informed that steps will be taken to provide another 500,000 doses of the AstraZeneca vaccines to Sri Lanka. Therefore, those who have already received the first dose of the vaccine will have no problem getting the second one,” he added.  As of now, Sri Lanka has received a total of 1.46 million doses of the Oxford-AstraZeneca vaccine. The first 500,000 doses were received as a grant from the Government of India under its Vaccine Maitri programme. The second consignment of 500,000 doses was purchased by the Government of Sri Lanka. The country received another 264,000 doses under the WHO COVAX facility.     At present, around 856,000 individuals have been inoculated with the first dose of the vaccine and 400,000 doses of vaccines remain in stores, according to Health Ministry statistics.    Sri Lanka is expecting another consignment of 500,000 doses of vaccines, which has already been ordered from India.   


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