The EU’s drugs agency EMA has started evaluating an application for conditional marketing authorisation for US biotech firm Novavax’s COVID-19 vaccine, Nuvaxovid. If granted, this will be the fifth vaccine authorised in the European Union.
The assessment will proceed under an accelerated timeline, and an opinion on the marketing authorisation could be issued within weeks if the data submitted are sufficiently complete to show the efficacy, safety and quality of the vaccine.
Such a short timeframe is only possible because the European Medicines Agency (EMA) has already reviewed a substantial portion of the data on the vaccine during a rolling review.
If EMA concludes that the benefits of Nuvaxovid outweigh its risks in protecting against COVID‑19, it will recommend granting conditional marketing authorisation. The European Commission will then fast-track its decision-making process with a view to granting a conditional marketing authorisation valid in all EU and EEA member states within days.
The Commission has so far given four conditional marketing authorisations for the vaccines developed by BioNTech and Pfizer, Moderna, AstraZeneca, and Janssen Pharmaceutica NV, following EMA positive assessment of their safety and efficacy. Several other vaccines are at different stages of assessment by the EMA.
4.6 billion doses secured
Novavax vaccine takes part in the Commission’s secured portfolio of vaccines to be produced in Europe, Other already signed contracts include AstraZeneca, Sanofi-GSK, Janssen Pharmaceutica NV, BioNTech-Pfizer, CureVac, Moderna, and Valneva, with which the advance purchase agreement was signed last week.
On Wednesday (November 10), the European Commission approved the eighth contract with Valneva, securing 60 million doses of inactivated COVID-19 vaccine VLA2001, topping up its vaccine portfolio up to 4.6 billion doses.
The contract with Valneva will enable all EU member states to purchase almost 27 million doses in 2022. It also includes the possibility to adapt the vaccine to new variant strains, and for the member states to make a further order of up to 33 million additional vaccines in 2023.
Valneva is a European biotechnology company developing an inactivated virus vaccine, made of the live virus through chemical inactivation, a technology used in most flu and childhood vaccines.
This is currently the only inactivated vaccine candidate in clinical trials against COVID-19 in Europe.
The vaccine is intended for active immunization of at-risk populations during the ongoing pandemic and potentially later for routine vaccination including addressing new variants.
VLA2001 may also be suited for boosting, as repeat booster vaccinations have been shown to work well with the whole virus inactivated vaccines, Valneva announced.
Health Commissioner Stella Kyriakides said that “the Valneva vaccine adds another option to our broad portfolio, once it is proven to be safe and effective by the European Medicines Agency”.
Marking the agreement, European Commission President, Ursula von der Leyen said that “the contract allows for the vaccine to be adapted to new variants. Our broad portfolio will help us to fight COVID and its variants in Europe and beyond”.
At the time the secured portfolio of vaccines is dominated by mRNA platform-based vaccines with 2.4 billion Comirnaty vaccine doses secured. Other vaccines in the portfolio are based on adenovirus and protein platforms, together with the already mentioned inactivated virus vaccine.
The European Commission is following a European Strategy to accelerate the development, manufacturing and deployment of effective and safe vaccines against COVID-19, presented in June 2020.
In return for the right to buy a specified number of vaccine doses in a given timeframe, the Commission finances part of the upfront costs faced by vaccine producers in the form of Advance Purchase Agreements.
In view of the current and new escape SARS-CoV-2 variants, the Commission and the member states are negotiating new agreements with companies already in the EU vaccine portfolio that would allow purchasing rapidly adapted vaccines in sufficient quantities to reinforce and prolong immunity.
Vaccine contracts between the Commission and vaccine manufacturers have also received some criticism.
Five MEPs of the Greens/EFA group submitted the case application to the European Court of Justice on 22 October “after months of correspondence between the Greens/EFA and the Commission, during which the Commission did not agree to provide transparent access to the contracts,” according to a press release from 29 October.