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It was noted that the efficacy of the vaccine is based on studies in which the first and second doses were given to study participants 19 to 42 days apart. If there were any change to this practice, it would presumably also need to reconsider the marketing authorization of the vaccine and more clinical trials would be needed to support the efficacy of lower doses.
Otherwise, the manufacturer could be less responsible for the vaccine, so the vaccine would be used off-label (off-label or off-label use means prescribing an officially registered drug other than the official prescription).
Meanwhile, the agency also announced that the EMA Committee for Medicinal Products for Human Use (CHMP) will meet shortly to discuss Moderna’s vaccination.
If approved, Moderna will be the second Covid-19 vaccine licensed in the European Union.
On December 21, the EMA approved a vaccine developed by the US pharmaceutical company Pfizer and its German partner, BioNTech, which has been in use in EU member states since last week.
Moderna announced Monday that it will produce at least 600 million doses of the vaccine in 2021, 100 million more than previously planned. Currently, the company is working on investments and loans to expand its capacity to one billion doses.
The EMA (European Medicines Agency) said last week that although the British pharmaceutical company AstraSeneca and the University of Oxford were approved in the UK on Wednesday, it is unlikely that it will be licensed in the European Union in January.
While the United States and Great Britain have urgently licensed the marketing of two vaccines, the EMA is under great pressure to speed up the authorization process, mainly from Germany.
Cover image: Getty Images
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