The European Medicines Agency said on Tuesday that it has begun an ongoing review of China’s Sinovac COVID-19 vaccine to assess its efficacy and safety, the first step towards a possible approval of the vaccine in a 27-member block.
The EMA said the decision to start the review was based on preliminary laboratory and clinical findings that suggest the vaccine triggers the production of antibodies that target the SARS-CoV-2 virus and may help protect against the disease it causes, COVID-19. … Preliminary evidence has yet to be published in a peer-reviewed medical journal.
“The EMA will evaluate the data as it comes in to decide if the benefits outweigh the risks. The current review will continue until sufficient evidence is available to formally apply for a marketing authorization, ”the agency said in a statement.
To read: Denmark Says It Will Not Use J&J COVID-19 Vaccine Due To Blood Clotting Problems
The news comes a day after Denmark became the first country to eliminate the COVID-19 vaccine developed by medical company Johnson & Johnson JNJ.
from his immunization program, due to problems with blood clots. Denmark also permanently phased out the vaccine developed by the British-Swedish pharmaceutical company AstraZeneca AZN last month.
citing similar concerns.
The J&J vaccine is one of four vaccines that have received Emergency Use Authorization from the EMA, along with a vaccine co-developed by the German biotechnology company BioNTech BNTX.
and the American pharmaceutical company Pfizer PFE,
developed by the American biotechnology company Moderna MRNA,
and one made by AstraZeneca in collaboration with the University of Oxford.
The agency is also conducting rolling reviews of three other vaccines: a vaccine developed by German biotechnology company CureVac CVAC,
from the American vaccine developer Novavax NVAX,
and the Russian Sputnik V.
Sequential reviews are designed to expedite the approval process by allowing researchers to submit data in real time until there is sufficient evidence to submit a formal marketing authorization application.
To read: BioNTech and Pfizer Seek European Regulatory Approval to Allow Children 12-15 Years to Vaccinate
The EMA did not provide a timeline for the rolling review of Sinovac, but stated that “the assessment will take less time than usual … due to the work done during the current review.”
The World Health Organization is expected to make a final decision on requests for listing for emergency use of both the Sinovac vaccine and the COVID-19 vaccine developed by China’s Sinopharm 1099.
by the end of this week.
To read: Senior Official Admits COVID-19 Vaccines In China Are Poor Effectiveness
Sinovac vaccine has been shown to be 50% to 90% effective in various studies and is currently approved for use in China, Indonesia, Brazil and Turkey. It contains inactivated or dead versions of the SARS-CoV-2 virus, which help the human immune system to produce antibodies.