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Registering Covid-19 vaccine suppliers: NMRA awaits Govt.’s decision

29 Dec 2020

The National Medicines Regulatory Authority (NMRA) is awaiting the Government’s decision on picking countries that Covid-19 vaccinations could be imported from, to open registrations for suppliers, it is learnt.  Speaking to The Morning, NMRA Chief Executive Officer (CEO) Dr. Kamal Jayasinghe said: “The Ministry of Health is currently in discussion with several countries, and is consulting the World Health Organisation (WHO), about bringing down the most compatible vaccination for Sri Lanka. Once the Government decides which countries the vaccination would be brought down from, then we will allow suppliers from the corresponding countries to register their product with us.”  State Minister of Pharmaceuticals Production, Supply, and Regulation Prof. Channa Jayasumana is expected to discuss importing Russia’s Sputnik V Covid-19 vaccine with Russian Ambassador to Sri Lanka and the Maldives Yury Materiy.  The Russian Direct Investment Fund (RDIF), in a media communiqué in November, announced that the cost of one dose of the Sputnik V vaccine for international markets will be less than $ 10. The RDIF added that it continues to expand existing agreements with international manufacturing partners to produce the vaccine for more than 500 million people in 2021. A person that wants to be vaccinated will have to take two inoculations. The RDIF also assured that Sputnik V will be cheaper than mRNA vaccines with similar efficacy levels.  RDIF and partners have launched production of the lyophilised (dry) form of the vaccine, which is stored at a temperature of +2 to +8 degrees Celsius. Such a regime enables the distribution of the vaccine in international markets, as well as expanding its use in hard-to-reach regions, including areas with tropical climates.  The first international deliveries of the Russian Sputnik V vaccine are expected to reach customers in January 2021, based on the existing partnerships with foreign manufacturers. For those who have recently submitted their requests, the vaccine’s first batches would be dispatched from March 2021, RDIF stated. The second interim analysis of clinical trial data was said to have shown a 91.4% efficacy for the Sputnik V vaccine on day 28 after the first dose, while vaccine efficacy is over 95% 42 days after the first dose.

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