The European Medicines Agency could issue an opinion on this antigen in mid-March.
The pharmaceutical Janssen has asked the European Medicines Agency (EMA) to authorization conditional to market its vaccine against Covid-19 in the European Union.
The agency’s committee for human medicines (CHMP) could issue an opinion mid-March 2021, provided that the data on the efficacy, safety and quality of the vaccine are sufficiently complete and robust. A forecast that matches that of the company itself.
The EMA began on December 1 of last year the process of continuous assessment of the data that the pharmacist was having available on their vaccine. During this time, the agency has studied the quality, efficacy, and safety results of the antigen. Thanks to this process, evaluation times have been speeded up.
Currently, the European regulator is evaluating additional data on efficacy and quality of the antigen developed by Janssen. In the event that the EMA concludes that the benefits outweigh the risks, It will recommend its approval to the European Commission. The EC will be the body that finally validates the conditional authorization for the use of the vaccine in all the countries of the European Union.
With Janssen, the EMA has already received four marketing authorization applications. If this vaccine is approved, the arsenal of antigens, until now made up of that of Pfizer and BioNTech, Moderna and AstraZeneca.
The Covid-19 vaccine that Janssen has developed has shown 66% effectiveness in phase 3 clinical trial that the company is carrying out in the United States, Latin America and South Africa.
This antigen, single dose, leverages the company’s ‘AdVac’ vaccine platform, which was also used to develop and manufacture the Ebola virus vaccine. It is stable in storage at 2-8ºC for three months and at -20ºC for two years.
The European Union will receive 400 million doses of Janssen’s Covid-19 vaccine, according to the contract signed between the company and the European Commission. Spain will account for around 40 million doses.
The agreed price, according to the amounts that a member of the Belgian Government published by mistake, is 7 euros per dose. As published by Invertia, the amount agreed by Brussels for this antigen is less than that paid by the Governments of the United Kingdom and the United States, which, in both cases, exceeds 8 euros per dose.