EMA starts rolling review of CoronaVac, WHO approves Sinopharm vaccine for emergency use
May 11, 2021 Category Health, Weekly
The European Medicines Agency (EMA) has started a rolling review of China’s Sinovac coronavirus vaccine to assess its effectiveness and safety, a first step toward possible approval for use in the 27-nation European Union (EU). Separately the World Health Organization (WHO) has approved a vaccine made by Sinopharm Beijing for emergency use and inclusion in the Covax facility to provide vaccines to developing countries. WHO approval of the CoronaVac vaccine of Sinovac is expected this week.
EMA’s decision to start the review is based on preliminary results from laboratory and clinical studies. “These studies suggest that the vaccine triggers the production of antibodies” that fight the coronavirus “and may help protect against the disease,” the Agency said in a statement. Rolling reviews are aimed at speeding up the approval process by allowing researchers to submit findings in real-time before final trial data is available. Sources at Sinovac told the Global Times that since there are many Covid-19 vaccines awaiting EMA approval, the process is not expected to be completed soon. The previous four vaccines took two to three months to be approved after rolling reviews began.
The EMA, which so far has approved four coronavirus vaccines (Pfizer/BioNtech, Oxford/AstraZeneca, Moderna and Johnson & Johnson), added that no application seeking marketing authorization for the Sinovac vaccine has been submitted yet. The Agency is also conducting rolling reviews of three other vaccines: CureVac (Germany), Novavax (U.S.) and Sputnik V (Russia). The rolling review will continue until “enough evidence is available for a formal application for marketing authorization,” the EMA said.
The Sinopharm vaccine – now approved by the WHO for emergency use – has been authorized by 45 countries and jurisdictions for use in adults over 18, and more than 65 million doses have been administered through emergency use programs, while the Sinovac vaccine has been authorized by 32 countries and 260 million doses of the vaccine have been distributed to the public in domestic and overseas markets.
The EU’s 27 member states also began discussing a proposal to ease coronavirus travel restrictions in an effort to resuscitate the tourism sector and broader economy. The EU is preparing to again welcome vaccinated visitors and those from countries where Covid-19 is under control. But if virus variants emerge, the EU could still use an emergency brake mechanism and quickly reimpose travel restrictions. Visitors would have to proof that they have had the “last recommended dose of an EU-authorized vaccine” approved by the European Medicines Agency (EMA) at least 14 days prior to arrival in the EU. The European Commission hopes the member states would adopt the proposal at the end of the month. Vaccine certificates would not exempt travelers from requirements such as presenting a negative test result or undergoing a quarantine that individual EU member states regard as necessary in their own national health policies. The European Commission has so far only proposed lifting restrictions on non-essential travel to travelers coming from Australia, New Zealand, Rwanda, Singapore, South Korea and Thailand. Chinese travelers will also be allowed in if China reciprocates by allowing EU citizens to enter China.
This overview is based on reporting by the China Daily, Shanghai Daily and Global Times.
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