Insights & news

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®.  

Attachments:

Key contacts

Related practice areas

Related insights

Sign up for updates
    • 18/01/2021
    • Articles

    Belgium – Publication of Law on Medical Devices

    The Belgian Official Journal publishes today (i.e., 18 January 2021) the Law of 22 December 2020 on medical devices (Wet van 22 december 2020 betreffende medische hulpmiddelen / Loi du 22 décembre 2020 relative aux dispositifs médicaux – the Law). The Law implements in Belgium (i) Regulation (EU) 2017/745 of 5 April 2017 on medical devices (the MDR); and (ii) chapter IV of Regulation (EU) 2017/746 of 5 April 2017 on in vitro diagnostic medical devices, i.e., the chapter on notified bodies. Following its adoption by the federal Chamber of Representatives’ Committee for Public Health and Equal Opportunities on 8 December 2020, the Law was adopted in plenary session on 17 December 2020. The adopted text is identical to that of the Bill which the federal Government submitted to the Chamber of Representatives on 29 September 2020. For a discussion of the Law, we refer to our news alert of 3 December 2020 (see, Van Bael & Bellis Life Sciences News Alert of 3 December 2020). Subject to exceptions, the Law will enter into force on 26 May 2021, i.e., on the currently scheduled date of entry into force of the MDR.

    Read more
    • 04/01/2021
    • News

    Medicinal Products under the EU-UK Trade and Cooperation Agreement

    The attached note discusses the status of medicinal products under the recent EU-UK Trade and Cooperation Agreement

    Read more
    • 23/12/2020
    • Articles

    Brexit - European Commission Guidance on Application of Pharmaceutical Law to Cyprus, Ireland, Malta and Northern Ireland on 1 January 2021

    Amidst rumours that a Brexit trade deal is closer than ever, the EU Official Journal publishes today, on 23 December 2020, a Commission notice on the “application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period” (see, attached copy; the Notice). The Notice indicates that, in view of their historical dependence on medicine supplies from or through Great Britain, Cyprus, Ireland, Malta and Northern Ireland may need some additional time to adapt supply chains and take account of the end of the transition period, on 31 December 2020, during which EU law continued to apply to and in the UK. According to the Notice, the key difficulties faced by these four markets in complying with the EU’s pharmaceutical acquis are as follows: (i) a lack of operators holding a manufacturing authorisation required for importing medicinal products from third countries (including Great Britain); (ii) difficulties to carry out quality control testing (“batch testing”) in the absence of a batch release site established in the EU; and (iii) difficulties to comply with the requirements of the Falsified Medicines Directive relating to the placement of the unique identifier on medicinal products for human use. To prevent medicine shortages and to ensure a high level of health protection, the Notice provides for regulatory flexibility in these areas. First, the Notice authorises the health authorities of Cyprus, Ireland, Malta and the United Kingdom with respect to Northern Ireland to allow medicines to be imported from Great Britain by wholesalers which are not in possession of a manufacturing authorisation. Strict conditions apply. The authorisation will only be valid in 2021 and applies both to human and veterinary medicinal products and investigational medicinal products. Second, and again subject to strict conditions, the Notice allows importers placing medicinal products supplied from or through Great Britain on the market in Cyprus, Ireland, Malta or Northern Ireland or wholesale distributors placing such medicinal products on those markets (see, previous point), to have certain controls carried out in Great Britain. This deviates from EU law in that quality control testing (“batch testing”) should normally take place in the European Economic Area. Finally, the Notice exempts economic operators responsible for the export of medicinal products from the EU to Great Britain (placed on the market in the EU, exported to Great Britain and then imported into Cyprus, Ireland, Malta or Northern Ireland) from the obligation to decommission the unique identifier that may have already been affixed to the pack prior to the export. At the same time, it authorises, subject to conditions, the import into Ireland, Malta, Cyprus and Northern Ireland of medicinal products from Great Britain bearing non-decommissioned unique identifiers. The Notice explains that this derogation from EU law is necessary as there are currently no importers holding a manufacturing authorisation located in Cyprus, Ireland, Malta and Northern Ireland with capacity to meet the obligation to affix a new unique identifier as required by EU law as of 1 January 2021.

    Read more

Subscribe to our updates

Please select the practice areas you are interested in: *