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Covid-19 Vaccine Moderna® Is Second Covid-19 Vaccine Recommended by European Medicines Agency for Use in European Union

  • 06/01/2021
  • Articles

The European Medicines Agency (EMA) issued today its recommendation that the European Commission (the Commission) should grant a conditional marketing authorisation for the vaccine Covid-19 Vaccine Moderna®, a medicine developed by Moderna which will be indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older (see, attached press release). The Commission is expected to give its approval shortly, possibly still today, paving the way for an expansion of existing vaccination programmes in the European Union.
The recommendation follows a similar recommendation given on 21 December 2020 for Comirnaty®, a vaccine developed by BioNTech and Pfizer (see, Van Bael & Bellis Life Sciences News Alert of 21 December 2020). As is the case for Comirnaty®, Covid-19 Vaccine Moderna® contains a molecule called messenger ribonucleic acid (mRNA) which harbours instructions for making the spike protein which is characteristic of the SARS-CoV-2 virus and allows the virus to enter the human body’s cells. The vaccine thus causes the recipient’s body to recognise and produce the spike protein temporarily which, in turn, will activate the person’s immune system and cause it to produce antibodies and activate white blood cells to attack it. The person’s immune system is thus readied for an attack with the genuine SARS-CoV-2 virus and defend the body against it.
The EMA made its recommendation on the basis of placebo-controlled clinical trial data involving 30,000 people. Efficacy was calculated in around 28,000 persons and showed a significant 94.1% reduction in the number of symptomatic Covid-19 cases in persons who were given the vaccine compared with persons from the control group who received a dummy injection. These strong results applied irrespective of pre-existing risk-enhancing conditions such as chronic lung disease, heart disease or diabetes and regardless of age (18 and up), gender, race or ethnicity.
The marketing authorisation awarded to Covid-19 Vaccine Moderna® will be conditional in that the marketing authorisation holder will be required to continue providing results from the ongoing main trial which is scheduled to last two years. Additional trials will seek to gain fresh information regarding the length of protection afforded, the level of protection created against severe Covid-19 infections and the degree of protection established for the benefit of specific groups, including immunocompromised patients, children, and pregnant women. Further research will also focus on the vaccine’s ability to prevent asymptomatic cases. Other checks will result from the application of the EU’s safety monitoring plan for Covid-19 vaccines and from the risk management plan for Covid-19 Vaccine Moderna®.  


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