fair.png
Thursday May 6th, 2021 11:53AM

EU regulators start review of China's Sinovac vaccine

By The Associated Press
Related Articles
  Contact Editor

THE HAGUE, Netherlands (AP) — The European Union’s drug regulator announced Tuesday that it 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 bloc.

The European Medicines Agency said Tuesday that its decision to start the review is based on preliminary results from laboratory studies 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.

The EMA, which so far has approved four coronavirus vaccines, added that no application seeking marketing authorization for the Sinovac vaccine has been submitted yet. The agency also is conducting rolling reviews of three other vaccines: the one developed by German biotech company CureVac, the American-developed Novavax and Russia's Sputnik V.

The agency said its experts will “evaluate data as they become available to decide if the benefits outweigh the risks” of the vaccine. The rolling review will continue until “enough evidence is available for a formal marketing authorization application,” the EMA said, adding that it could not predict timelines.

The announcement from the Amsterdam-based agency came a day after a top World Health Organization official said the WHO is set to decide this week whether to approve two Chinese COVID-19 vaccines for emergency use.

Such approval would mark the first time that a Chinese vaccine had been granted a so-called emergency use listing from the U.N. health agency, and would trigger a broader rollout of Chinese vaccines that are already being used in some countries beyond China.

Mariangela Simao, assistant director-general for access to medicines, vaccines and pharmaceuticals, says some “final arrangements” remain to be made before the crucial word from a WHO technical advisory group comes on the Sinopharm and Sinovac vaccines.

China and a number of other countries, including Brazil, Mexico, Indonesia and Turkey, already are using the Sinovac vaccine, which is made using killed or inactivated coronavirus.

No Phase 3 study data on the vaccine has yet been published in peer-reviewed journals. The vaccine has been studied in several countries. The most closely watched research involved about 12,000 health workers in Brazil, where researchers reported 50.7% effectiveness against symptomatic COVID-19 and much stronger protection against severe disease.

  • Associated Categories: Associated Press (AP), AP Health, AP World News, AP Business, AP Business - Corporate News
© Copyright 2021 AccessWDUN.com
All rights reserved. This material may not be published, broadcast, rewritten, or redistributed without permission.
UEFA details Euro 2020 rules for teams hit by virus issues
Teams hit by COVID-19 cases or mandatory quarantine at the European Championship can have games postponed for up to 48 hours to get new players in
6:50AM ( 7 minutes ago )
Mexico City metro overpass collapses onto road; 23 dead
Mexico City officials say an elevated section of the city's metro collapsed and at least 23 people have been killed
6:33AM ( 24 minutes ago )
Storms spawn twisters in Mississippi, kill 2 in Georgia
Much of the South is again at risk of severe weather Tuesday, forecasters say, after tornadoes struck parts of the region Sunday night and Monday, causing heavy damage in some parts of Mississippi
6:25AM ( 32 minutes ago )
Associated Press (AP)
The Latest: Kuwait to bar unvaccinated from traveling abroad
Kuwait’s government is barring unvaccinated residents from traveling abroad starting later this month, the latest attempt to tame the spiraling coronavirus outbreak in the Gulf Arab sheikhdom
3:58AM ( 3 hours ago )
Virus cases plunge and LA, San Francisco come back to life
California’s signature cities are leading the way as the state prepares to expand business openings after coronavirus shutdowns
1:10AM ( 5 hours ago )
'Horrible' weeks ahead as India's virus catastrophe worsens
A top expert is warning that the coming weeks in India will be “horrible,” as COVID-19 infections and deaths mount with alarming speed and there is no end in sight to the crisis
12:31AM ( 6 hours ago )
AP Health
Ethiopia 'at a crossroads' amid spiraling ethnic conflict
Ethiopia faces a growing crisis of ethnic nationalism that some fear could tear Africa’s second most populous country apart
4:04AM ( 2 hours ago )
US men await their fate as murder trial nears end in Rome
A jury in Rome will soon be weighing the fate of two young American men, charged with slaying an Italian police officer while they were on vacation in 2019
3:47AM ( 3 hours ago )
Mexico City metro overpass collapses onto road; 20 dead
Mexico City officials say an elevated section of the city's metro collapsed and at least 20 people have been killed
3:15AM ( 3 hours ago )
AP World News
Asian shares higher after strong earnings, data lift Wall St
Asian shares are mostly higher after strong corporate earnings and data lifted stocks on Wall Street
3:04AM ( 3 hours ago )
LEADING OFF: Minor league opening day, Dodgers' May needs TJ
From the Jacksonville Jumbo Shrimp to the Tri-City Dust Devils, minor league teams are set to host opening day across the country following more than a year of uncertainty and empty ballparks
3:04AM ( 3 hours ago )
Asian shares mixed after strong earnings, data lift Wall St
Asian shares are mixed after strong corporate earnings and data lifted stocks on Wall Street
11:30PM ( 7 hours ago )
AP Business
McConnell says GOP open to $600 billion for infrastructure
The top Republican in the Senate is opening the door to backing a smaller infrastructure bill
4:33PM ( 14 hours ago )
Intel: $3.5B investment is critical to microchip future
Intel will be investing $3.5 billion in its New Mexico plant to manufacture what executives say will fuel a new era of advanced computing as demands increase for the tiny microchips used in nearly all modern devices
4:25PM ( 14 hours ago )
Wall Street logs gains Monday on strong earnings
Stocks are closing solidly higher Monday as investors cheer a strong dose of positive earnings reports as well as economic data that showed the U.S. economy is growing
4:08PM ( 14 hours ago )
AP Business - Corporate News
UEFA details Euro 2020 rules for teams hit by virus issues
Teams hit by COVID-19 cases or mandatory quarantine at the European Championship can have games postponed for up to 48 hours to get new players in
6:50AM ( 7 minutes ago )
Mexico City metro overpass collapses onto road; 23 dead
Mexico City officials say an elevated section of the city's metro collapsed and at least 23 people have been killed
6:33AM ( 24 minutes ago )
Storms spawn twisters in Mississippi, kill 2 in Georgia
Much of the South is again at risk of severe weather Tuesday, forecasters say, after tornadoes struck parts of the region Sunday night and Monday, causing heavy damage in some parts of Mississippi
6:25AM ( 33 minutes ago )
G7 foreign ministers meet face-to-face after pandemic pause
Foreign ministers from the Group of Seven wealthy industrialized nations are gathering in London to grapple with threats to health, prosperity and democracy
5:37AM ( 1 hour ago )
Flurry of diplomatic contacts fuel Iran deal speculation
A flurry of diplomatic activity and reports of major progress suggest indirect talks between the United States and Iran may be nearing a conclusion
5:29AM ( 1 hour ago )