European Union approval of Russia's Sputnik V coronavirus vaccine will be delayed because a June 10 deadline to submit clinical trial data was missed ...
BERLIN (June 16): European Union approval of Russia's Sputnik V coronavirus vaccine will be delayed because a June 10 deadline to submit data was missed, two people familiar with the matter told Reuters, diminishing the shot's prospects in the EU's pandemic response.
One of the sources, a German government official, said the failure to provide the necessary clinical trial data to the EU medicines watchdog would postpone any go-ahead in the bloc until at least September.
"Approval of Sputnik will be delayed probably until September, maybe until the end of the year," the official said, speaking on condition of anonymity.
The European Medicines Agency (EMA) had previously been expected to conclude its review of the Russian vaccine and issue a decision in May or June.
A second source said the June 10 cut-off date was not met and that the vaccine's developer, Russia's Gamaleya Institute, said it will file the requested data next week or at the latest at the end of the month.
The Russian Direct Investment Fund (RDIF), which markets the vaccine, said the EMA review was on track.
"All of the information on the Sputnik V vaccine clinical trials has been provided and GCP (General Clinical Practice) review has been completed with positive feedback from the European Medicines Agency," the RDIF said.
"While it is up to EMA to decide on the timing of the approval procedure, the Sputnik V team expects the vaccine approval with the next two months," it added.
EMA was not immediately available for comment.
German Chancellor Angela Merkel's government has held talks to buy Sputnik V but has made any purchase contingent on EMA approval.
Frustrated by a sluggish immunisation campaign, some regional German states including Bavaria earlier this year flagged interest in placing orders for Sputnik V, but vaccination has since picked up speed.
Slovakia became the EU's second country after Hungary to start inoculating people with Sputnik V this month, despite lack of EU approval.
April 22, 2021 18:55 pm +08
GENEVA (April 22): Technical experts from the World Health Organization (WHO) are due to start the next round of their review of Russia's Sputnik V vaccine against Covid-19 jointly with the European Medicines Agency (EMA) on May 10, the WHO said on Thursday.
Russia is seeking WHO emergency-use listing for the vaccine developed by Gamalaya Institute. So far Covid-19 vaccines made by Pfizer, AstraZeneca, and Johnson & Johnson have been listed — an endorsement of their safety and efficacy that helps guide countries' regulatory systems.
"Inspections for good manufacturing practices will take place from 10 May to first week of June," the WHO told Reuters in reply to a query.
A joint team from the WHO and the EMA are currently carrying out inspections for good clinical practices related to Sputnik V, it said.
Asked about clinical data from Sputnik V vaccine trials, the WHO said: "We are still receiving information from the producer."
Russian deputy health minister Sergei Vershinin held talks in Geneva on Tuesday with WHO director-general Tedros Adhanom Ghebreyesus, who later wrote on Twitter: "@WHO appreciates Russia's efforts to fulfill the Emergency Use Listing criteria for vaccines."
https://www.theedgemarkets.com/article/who-ema-inspect-sputnik-v-manufacturing-may-%E2%80%94-who
