Over the past year, vaccine developers have been moving at breakneck speed to develop effective and safe vaccines against COVID-19. Currently, 52 candidate vaccines are being tested worldwide in clinical trials on humans and several vaccines are showing very promising results in phase III clinical trials.
Belgium has joined the pan-EU strategy for COVID-19 vaccines. This strategy consists of a parallel and 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. Let’s take a look at what is expected to be on the Belgian ‘menu’:
- The first vaccine that is likely to be available in Belgium is the mRNA-based vaccine from BioNTech and Pfizer: BNT162b2. The first interim efficacy analysis of the phase III clinical trial, with around 43,500 participants and that started on 29 April 2020, has demonstrated that the vaccine is up to 95% effective. Following a rolling review, the EMA is currently reviewing Pfizer’s application for a conditional marketing authorisation and the CHMP is expected to conclude its evaluation by 29 December 2020. The Advance Purchase Agreement allows the EU member states to purchase 200 million doses of the vaccine, with an option for a further 100 million doses. Belgium would purchase around 5 million doses. Knowing that each person would require two doses, that 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 the mRNA-based vaccine called mRNA-1273 from the pharmaceutical company Moderna. 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 currently reviewing Moderna’s application for a conditional marketing authorisation. The CHMP is expected to conclude its evaluation by 12 January 2021. The Advance Purchase Agreement concluded with Moderna allows the EU member states to purchase 80 million doses of the vaccine, with an option for a further 80 million doses. Belgium would purchase around 2 million doses, which, given the two dose regimen for the vaccine, would allow 1 million people to be vaccinated.
- 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 with around 40,000 participants that started on 28 August 2020. The first results have shown the vaccine results in an average efficacy of 70%. The CHMP has started a rolling review of the vaccine candidate. The Advance Purchase Agreement concluded with AstraZeneca allows the EU member states to purchase 300 million doses of the vaccine, with an option for a further 100 million doses 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.
- Fourthly, Belgium’s own Janssen (part of Johnson & Johnson) is developing a COVID-19 vaccine candidate, Ad26.COV2.S, that 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 phase III clinical trials, which started on 7 September 2020 with around 60,000 participants. Although it was administered in a single dose instead of two as with the other vaccines, Johnson & Johnson has recently announced initiating a second two-dose regimen clinical trial. The CHMP has started a rolling review of the vaccine candidate. The Advance Purchase Agreement allows the EU member states to purchase vaccines for 200 million people and the possibility of purchasing vaccines for an additional 200 million people. Belgium would purchase around 5 million doses. Depending upon the final dosage regimen, this could mean between 2.5-5 million people would be vaccinated.
- Finally, Belgium also has its eye on the mRNA-based vaccine from the pharmaceutical company Curevac, called CVnCoV. A phase II clinical trial with 691 participants started on 28 September 2020 and the company expects to start with a phase III trial before the end of 2020. The Advance Purchase Agreement allows the EU member states to purchase up to 225 million doses of the vaccine, with an option for a further 180 million doses. Belgium could purchase 2.9 million doses, which would enable 1.45 million people to be vaccinated.
- For the sake of completeness, the Commission has also negotiated an Advance Purchase Agreement with the pharmaceutical companies Sanofi and GSK. The companies have developed an adjuvanted, recombinant protein-based COVID-19 vaccine. The companies initiated a phase 1/2 clinical trial on 3 September with 440 participants and plan to start a phase III trial in December 2020. The agreement allows the EU member states to purchase up to 300 million doses of the vaccine, although Belgium has at the time of the writing this blog post not yet placed an order.