Janssen vaccine could receive approval soon

17.02.2021 - 15:04
epa08931898 A nurse prepares a dose of the Oxford/AstraZeneca Covid-19 vaccine at the NHS vaccine mass vaccination centre that has been set up in the grounds of Epsom Race Course, in Surrey, Britain 11 January 2021. The UK government has announced that mass vaccination centres will start operating from 11 January in London, Newcastle, Manchester, Birmingham, Bristol, Surrey and Stevenage.  EPA-EFE/DOMINIC LIPINSKI / POOL
The Belgian pharmaceuticals company Janssen, which is a subsidiary of Johnson & Johnson, has now formally applied for a marketing licence for its COVID-19 vaccine from the European Medicines Agency. It is expected the application will be processed in the middle of March. The vaccine has been under phase-evaluation since early December. Iceland has more vaccines from Janssen on order than from any other manufacturer.

According to information from the Icelandic Medicines Agency, the European Medicines Agency will assess all collected data on the vaccine’s effectiveness, safety, and quality. If the Agency concludes the product’s benefits outweigh any risk, it will recommend the issuing of a marketing licence. 

The Agency can fast-track drugs or vaccines deemed more beneficial than risky, on the condition that manufacturers submit required further data by a specified date. 

Massimo Scaccabarozzi, the director of Janssen Italy, told Corriere della Sera last week that he hopes a European licence will be issued in March. A study on 44,000 people indicates that the vaccine is effective in providing protection against COVID-19. El País reports, meanwhile, that Janssen seems well-prepared and has opened a factory in Catalonia that will be able to produce up to 250 million doses a year. 

The Icelandic authorities signed a contract with Janssen just before Christmas for enough of the vaccine to immunise 235,000 people. Deliveries are expected to start during the second quarter of this year. 

A panel of FDA experts in the USA will meet on 26th February to discuss Janssen’s application for an emergency licence for its vaccine in the USA as well. 

Janssen’s would be the fourth vaccine granted such a licence in Europe, after those from Pfizer, Moderna, and AstraZeneca. Unlike the other three, however, only one dose of the Janssen vaccine is required, rather than two. That injection provides 66 percent protection against medium and serious COVID-19 symptoms. 

Two further vaccines are under review in Europe: CureVac and Novavax. The EU has not yet signed a purchase contract for the Novavax vaccine, but is expected to do so in the coming days. 

Iceland hopes to be able to immunise 190,000 people by the end of June using the three vaccines already on the market. That number would be higher if the Janssen vaccine joins the market. Iceland plans to invite a total number of 280,000 over-16-year-olds for immunisation as soon as supplies allow.

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