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Tag: European Medicines Agency

No application received for EU authorisation of Covishield, says European Medicines Agency | India News – Times of India
Politics

No application received for EU authorisation of Covishield, says European Medicines Agency | India News – Times of India

NEW DELHI: The European Medicines Agency (EMA) said it has not received any application from the Covid-19 vaccine Covishield maker Serum Institute of India (SII) for authorisation. "For the Covid-19 vaccine Covishield to be evaluated for use in the EU, the developer needs to submit a formal marketing authorisation application to EMA, which to date has not been received," the EMA said at a press briefing. The EMA has approved Pfizer BioNTech's Comirnaty, Moderna's Spikevax, AstraZeneca's Vaxzevria and Johnson and Johnson's Janssen as vaccines for Covid-19. SII was confident of receiving approval from the European Medicines Agency (EMA) for its Covid-19 vaccine Covishield in a month, the company's CEO Adar Poonawalla had earlier said. Speaking at India Global Forum 2021, Poonawalla said, ...
EU agency says two jabs ‘vital’ to battle Delta variant – Times of India
Politics

EU agency says two jabs ‘vital’ to battle Delta variant – Times of India

THE HAGUE: The EU's medicines watchdog said on Wednesday two jabs by approved vaccine makers were "vital" to provide maximum protection against the highly infectious coronavirus Delta variant, urging countries to speed up their inoculation drives. The Delta strain, first detected in India, is making a rapid march across the continent will constitute 90 percent of all cases by the end of the summer. "Preliminary evidence suggests that both doses of a two-dose Covid-19 vaccine... are needed to provide adequate protection against the Delta variant," the European Medicines Agency said. "Adherence to the recommended vaccination course is vital to benefit from the highest level of protection." Calling it a "variant of concern", the Delta strain "is spreading fast in Europe and may seriously h...
BREAKING | Double Covid Jab ‘Protects’ Against Delta Variant, Says European Medicines Agency
Politics

BREAKING | Double Covid Jab ‘Protects’ Against Delta Variant, Says European Medicines Agency

The Hague: The European Medicines Agency (EMA) on Thursday said data shows that two doses of Covid vaccine appear to provide protection against the rapidly spreading Delta variant of the coronavirus.Marco Cavaleri, the EMA head of vaccine strategy, said the “emerging data from real world evidence are showing that two doses of vaccines are protective against the Delta variant”.READ: Canada And US Record Highest-Ever Temperature, Hundreds Of People Feared DeadCavaleri, who was speaking at a press conference, asserted the Amsterdam-based watchdog was “aware of concerns caused by the rapid spread of the Delta variant”.“Right now it seems the four vaccines approved in the European Union are protecting against all the strains circulating in Europe, including the Delta vari...
No Trial Needed For Single-Dose COVID-19 Vaccine Janssen In India, Says Johnson & Johnson
Politics

No Trial Needed For Single-Dose COVID-19 Vaccine Janssen In India, Says Johnson & Johnson

New Delhi: The requirement to conduct a bridging clinical study of its single-dose Janssen Covid-19 vaccine no longer exists in India, pharmaceutical company Johnson & Johnson has said.The US-based company said it was following the recent announcement by the Drug Controller General of India (DCGI) that there was no longer any requirement for conducting post-approval bridging clinical trials for Covid-19 vaccines in India.The approval from DGCI is not required for covid vaccines restricted to use in case those are already approved for restricted use by the US Food and Drug Administration (FDA), European Medicines Agency (EMA), UK Medicines and Healthcare products Regulatory Agency  (MHRA), Pharmaceuticals and Medical Devices Agency (PMDA) Japan or listed in WHO Em...
Covid-19: EU advises adding condition to AstraZeneca label – Times of India
Politics

Covid-19: EU advises adding condition to AstraZeneca label – Times of India

LONDON: The European Medicines Agency says it's recommending that people who have had a rare blood vessel syndrome not be immunised with AstraZeneca's Covid-19 vaccine. In a statement on Friday, the EU drug regulator said it reviewed cases of six people who had capillary leak syndrome after they had received a shot of the AstraZeneca vaccine. The vaccine has previously been linked to rare blood clots, but health officials say its benefits still outweigh the small risks. EMA experts also concluded that the capillary leak condition should be added to the product information as a new side effect of the vaccine. The agency said it is continuing its review of heart inflammation in a small number of people who developed conditions after getting immunized with the vaccines made by Pfizer-BioNT...