EU medicines regulator in talks with Chinese vaccine producers

The European Medicines Agency (EMA), the main drug regulator in the EU, has been in contact with a company representing China’s Sinopharm vaccine and hopes to bring it to the evaluation stage, Emer Cooke, executive director at the agency said on Tuesday.

“I think you’re probably all aware that a number of Chinese vaccines have been developed. We’re in discussions with a company representing one of the Chinese vaccines, it’s the Sinopharm vaccine, and we hope we will be at a stage to also evaluate that vaccine as well,” Cooke stated at the meeting of the European Parliament’s environment and public health committee.

She stressed that the EU needs “every safe, effective and quality vaccine” that is available for its citizens and global partners.

The latest development comes at a time a number of European countries are eyeing Chinese COVID-19 vaccines amid a delivery crisis.

Hungary and Serbia are currently spearheading mass inoculation of their populations with China’s Sinopharm COVID-19 vaccine in Europe. This as other countries in the region struggle against vaccine shipment challenges and exploring a way out of lockdown and into economic recovery.

“This deal will speed up vaccination, which could save the lives of thousands of people and contribute to lifting restrictions sooner,” Hungarian Foreign Minister Peter Szijjarto said when his country signed up for the Chinese vaccines.

German Chancellor Angela Merkel and French President Emmanuel Macron have also expressed openness of their countries to any vaccines approved by the European Medicines Agency.

Four vaccines are currently authorized for use in the EU, including Pfizer/BioNTech (up to 600 million doses), Moderna (two contracts for up to 460 million doses), AstraZeneca (up to 400 million doses), and Johnson & Johnson (contract for 400 million doses with an option to buy additional 200 million).

The EU has also signed deals with the French-British manufacturer Sanofi-GSK for 300 million doses and German CureVac for 235 million with a possible extension of up to 180 million. So far, both companies have not yet applied for the market authorization of their vaccines in the EU. On February 12, CureVac requested a rolling review of its drug.

The European Commission has also been negotiating shipments with a French-Austrian company Valneva (for up to 60 million doses of the vaccine) and American Novavax (up to 200 million doses).

In total, the EU members have guaranteed access to 2.6 billion coronavirus vaccines through various contracts. European authorities expect to vaccinate about 70 percent of the population by mid-September.

The shortage of approved vaccines in Europe has been drawing increasing public criticism and prompting demands for alternative solutions.

Russia’s Sputnik V vaccine has been undergoing the rolling review procedure with the EMA since March 4. On Monday, the EMA confirmed that it has been applying same standards to its evaluation as to any other vaccine and is planning inspections of the manufacturing and clinical sites in Russia. Later in the day, Russian Health Minister Mikhail Murashko disclosed that the arrival of EMA’s expert group in the country is scheduled for April 10.


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