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23 December 2020
In contrast to the United Kingdom, which approved its first COVID-19 vaccine on 2 December 2020 and subsequently began administering it on 8 December 2020, Belgium is following the lead of the European Commission and the European Medicines Agency (EMA) with respect to its COVID-19 vaccine strategy. The European Commission, on behalf of EU member states, has already concluded six advance purchase agreements with vaccine suppliers for a potential total of almost 2 billion doses. Belgium's share presently amounts to a total of 22.4 million vaccines. Purchasing and administering the first vaccine will kick off in the 2020 Christmas holiday period, given that the first vaccine was only very recently demonstrated to be safe and effective and was granted a conditional marketing authorisation by the European Commission.
Over the past year, vaccine developers have been moving at breakneck speed to develop effective and safe vaccines against COVID-19. Currently, 56 candidate vaccines are being tested worldwide in clinical trials on humans and several vaccines are showing promising results in Phase III clinical trials.
Belgium has joined the pan-EU strategy for COVID-19 vaccines. This strategy consists of a parallel, combined effort by the European Commission and the EMA. The EMA is leading the evaluation of the potential vaccines on the basis of so-called 'rolling reviews', which means that its Committee for Medicinal Products for Human Use (CHMP) is reviewing the data as it becomes available from ongoing studies to speed up the regulatory process. The European Commission is leading the pan-EU negotiation of advance purchase agreements, financed via the Emergency Support Instrument, in which Belgium is participating.
The first vaccine that is likely to be made available in Belgium is the mRNA-based vaccine from BioNTech and Pfizer: BNT162b2. The first interim efficacy analysis of the Phase III clinical trial, which started on 29 April 2020 with approximately 43,500 participants, has demonstrated that the vaccine is up to 95% effective. Following a rolling review, the EMA recently recommended granting a conditional marketing authorisation for their vaccine Comirnaty on 21 December 2020, which the European Commission effectively did by Implementing Decision of the same day. The advance purchase agreement allows EU member states to purchase 200 million doses of the vaccine, with the option to request a further 100 million doses. Belgium would purchase around 5 million doses, the first 5.000 of which would be administered already between Christmas 2020 and New Year 2021. Knowing that each person would require two doses, this would enable 2.5 million people to be vaccinated in Belgium.
A second vaccine that is already in a more advanced stage and high on Belgium's list is Moderna's mRNA-based vaccine, mRNA-1273. The first interim efficacy analysis of Moderna's Phase III clinical trial, which started on 27 July 2020 with 30,000 participants, demonstrates an efficacy of 94.5%. The EMA is reviewing Moderna's application for a conditional marketing authorisation. The CHMP is expected to conclude its evaluation by 6 January 2021. The advance purchase agreement concluded with Moderna allows EU member states to purchase 80 million doses of the vaccine, with the option to request a further 80 million doses. Belgium would purchase around 2 million doses, which, given the vaccine's two-dose regimen, would allow 1 million people to be vaccinated.
AstraZeneca/University of Oxford vaccine
Another potential vaccine for Belgium is the recombinant adenovirus vaccine developed by AstraZeneca and the University of Oxford. It is presently in large-scale Phase III clinical trials, which started on 28 August 2020 with approximately 40,000 participants. The first results have shown that the vaccine has an average efficacy of 70%. The CHMP has started a rolling review of the vaccine. The advance purchase agreement concluded with AstraZeneca allows EU member states to purchase 300 million doses of the vaccine, with the option for a further 100 million doses to be distributed on a population-based pro rata basis. Belgium has ordered 7.5 million doses, which would enable 3.75 million people to be vaccinated.
Belgium's own Janssen (part of Johnson & Johnson) is developing a COVID-19 vaccine candidate, Ad26.COV2.S. This vaccine makes use of the AdVac technology platform, which was also used to develop a vaccine for Ebola and other diseases. The vaccine is in large-scale Phase III clinical trials, which started on 7 September 2020 with approximately 60,000 participants. Although administered in a single dose instead of two, as with the other vaccines, Johnson & Johnson has recently announced that it will initiate a second two-dose regimen clinical trial. The CHMP has started a rolling review of the vaccine candidate. The advance purchase agreement allows EU member states to purchase vaccines for 200 million people, with the option to request vaccines for an additional 200 million people. Belgium would purchase around 5 million doses. Depending on the final dosage regimen, this could mean between 2.5 and 5 million people would be vaccinated.
Belgium also has its eye on Curevac's mRNA-based vaccine, CVnCoV. The vaccine is in large-scale Phase III clinical trials, which started on 30 November 2020 with approximately 36,500 participants. The advance purchase agreement allows EU member states to purchase up to 225 million doses of the vaccine, with the option to request a further 180 million doses. Belgium could purchase 2.9 million doses, which would enable 1.45 million people to be vaccinated.
The European Commission has also negotiated an advance purchase agreement with Sanofi and GSK. The pharmaceutical companies have developed an adjuvanted, recombinant protein-based COVID-19 vaccine. The first Phase 1/2 clinical trial demonstrated an insufficient response in older adults. Therefore, the companies will launch a new Phase 2b clinical trial with an improved antigen formulation. The agreement allows EU member states to purchase up to 300 million doses of the vaccine. At the time of writing, Belgium had not placed an order.
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