Sunday, January 24

The EMA tries to “clarify pending questions” with Moderna about its vaccine

A dose of Moderna's vaccine, already used in US hospitals

A dose of Moderna’s vaccine, already used in US hospitals

The European Medicines Agency (EMA) assured this Tuesday that it is “working intensively to clarify outstanding issues” with the American pharmaceutical company Moderna about the vaccine it has developed for covid-19, while its experts will continue to evaluate the drug with a view to its approval.

In a short note, the EMA stressed that the committee for human medicines (CHMP), made up of scientists from all 27 European Union (EU) countries, failed to conclude at Monday’s meeting in Amsterdam whether Moderna should great a license. Conditional use for its vaccine, the same as the one granted by the European Commission on December 21 to the pharmaceutical company Pfizer-BioNTech. “The meeting will continue on Wednesday, January 6, 2021, meanwhile our experts are working hard to clarify pending issues with the company, “the agency explained.

Unlike the day in which the CHMP finished its evaluation of the drug developed by Pfizer, the first authorized against covid-19 in the EU, the EMA will not explain the details of its conclusions on Wednesday at a press conference and will limit itself to reporting its final views, if it reaches them, in writing “as soon as possible after the meeting.”

Next Friday, the agency will organize a public event in which it will explain “to European citizens”, with questions from experts and interested parties from the entire community area, the evaluation of the new covid-19 vaccine.

The European Commission, which has the final word on the use of any vaccine in the EU, you cannot approve a Conditional use license until the EMA completes its scientific analysis about the entire vaccine data package, including the production process, ingredients, and clinical data from human trials.

Moderna is the second pharmaceutical company that has asked the EMA to study the possibility of giving it a Conditional Marketing Authorization (CMA) so that European countries can use their drug in the vaccination campaigns that began last week, after great Pfizer a license for its vaccine.

Brussels has purchased a total of 160 million doses of Moderna’s vaccine, of which two injections per person are required with a month difference between the first and second, although, unlike Pfizer’s, it offers the advantage of what does not have to be stored at a temperature of 70 degrees Celsius below zerobut at 20 below zero.

Although they have not yet applied for a license, the EMA is also studying in real time the data shared by the British company AstraZeneca and Oxford University, on the one hand, and Janssen, a subsidiary of the American Johnson & Johnson, on the other, in anticipation they ask for it in the next few weeks.

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