#Chinese regulators have approved the country’s first homegrown coronavirus vaccine, developed by state-owned pharmaceutical giant #Sinopharm, officials announced #Thursday.
The approval comes a day after #Sinopharm said its vaccine is 79.34 per cent effective, citing interim analysis of #Phase 3 clinical trials.
#China has drastically scaled up its vaccine emergency use program in recent weeks.
#Since #December 15, it has administered more than three million vaccine doses on “key groups” in the population, #Zeng #Yixin, vice-minister of #China’s #National #Health #Commission, said at a news conference #Thursday.
#That’s on top of the 1.5 million doses administered on “high-risk groups” by the end of #November, #Zeng added.
#Side effects of #Sinopharm’s COVID vaccine
#Among those inoculated, fewer than 0.1 per cent developed a light fever, and about two people per million developed “relative serious adverse reactions” such as allergies, according to #Zeng.
#Beijing #Biological #Products #Institute #Co., a #Sinopharm subsidiary, said interim results show the #Sinopharm vaccine is safe and people who received two doses produced high-level antibodies.
#But the statement gave no details on the data, such as the trial size, the number of infections in the trial and side effects.
#Coronavirus vaccines developed by #Sinopharm have already been administered to hundreds of thousands of people under a controversial emergency use program approved by the #Chinese government.
#By #November, nearly 1 million people had received a #Sinopharm vaccine, according to the company’s chairman, though he didn’t specify which of the company’s two vaccines they had received.
#Few details
#Though few details were provided, the statement said the vaccine met the standards of the #World #Health #Organisation and #China’s own regulator, the #National #Medical #Products #Administration.
The #Sinopharm vaccine is less effective than those developed by #Pfizer-BioNTech and #Moderna, which have an efficacy rate of about 95 per cent.
#Russia says its #Sputnik V vaccine is 91 per cent effective.
#And the vaccine’s efficacy rate of 79 per cent is lower than the 86% announced by the #United #Arab #Emirates for the same vaccine on #December 9.
The UAE based its results on an interim analysis of late-stage clinical trials conducted there from #July.
#It has since approved the vaccine for public use.
The #Sinopharm vaccine has a higher efficacy rate than the one developed by the UK’s #Oxford #University and #AstraZeneca, which averaged 70 per cent.
#On #Wednesday, the UK became the first country to approve that vaccine for public distribution.
#Closer to massive rollout
#Sinopharm’s results were announced weeks after its global competitors.
#And with a lack of details, it remains unclear whether the information provided will be enough to dispel scepticism over the quality of #Chinese vaccines.
#Nevertheless, the announcement could still pave the way for the vaccine’s large-scale rollout both within #China and globally.
The country is aiming to inoculate 50 million people with homegrown COVID-19 vaccines ahead of #February’s #Lunar #New #Year celebrations.
#China is ready to send hundreds of millions of doses to countries that have conducted last-stage trials for its leading vaccine candidates.
#Chinese leaders have also promised a growing list of developing countries priority access.
#Beijing is using the global campaign as a soft power tool, analysts say, to try to repair any damage to its image from its early mishandling of the coronavirus pandemic.
#Other vaccine candidates
#Aside from the approved #Sinopharm vaccine, #China has four coronavirus candidates which have reached #Phase 3 clinical trials, the last and most important step of testing before regulatory approval is sought.
#Having largely eliminated the spread of coronavirus inside its borders, #Chinese drugmakers had to look abroad for places to test the efficacy of their vaccines.
#Together, they have rolled out #Phase 3 trials in at least 16 countries.
#Sinopharm’s two vaccine candidates, including the one approved in #China, have rolled out #Phase 3 trials in 10 countries, mostly in the #Middle #East and #South #America.
#Sinopharm chairman #Liu #Jingzhen said dozens of countries have requested to buy the company’s vaccines.
#He did not name the countries or elaborate on the number of doses they proposed, but he said CNBG was capable of producing more than a billion doses in 2021.
#Compared with #Pfizer and #Moderna, #Sinopharm’s vaccines do not require freezing temperatures for storage, making transport and distribution much easier – especially in developing countries that lack cold storage capacities.
[ source link ]
https://7news.com.au/travel/china/china-approves-its-first-homegrown-coronavirus-vaccine-developed-by-sinopharm-c-1868427
##Sinopharm #COVID #vaccine #approved ##China