(AOF) – The World Health Organization (WHO) has issued recommendations for the use of Valneva’s inactivated vaccine against Covid-19. WHO’s interim recommendations for the use of Valneva’s VLA2001 vaccine were developed based on advice from WHO’s Strategic Advisory Group of Experts (SAGE) at its extraordinary meeting on 11 August 2022 and published in its reference document, confirmed the Franco-Austrian biotech.
The WHO interim recommendations also include a recommendation for a booster dose of VLA2001 four to six months after the complete primary series and note that a booster dose of VLA2001 after primary vaccination with ChAdOx1-S (AstraZeneca) may be considered .
WHO may update its interim recommendations to include other uses of Valneva’s COVID-19 vaccine as new data becomes available.
Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented: “We are pleased that WHO has released guidance on the use of Valneva’s inactivated Covid-19 vaccine and we believe these recommendations may help further ‘other countries to assess the potential of our vaccine to have a significant public health impact’.
Valneva currently has agreements for the supply of VLA2001 to certain EU Member States and the Kingdom of Bahrain.
Valneva holds stocks of VLA2001 for possible additional supply to these Member States should demand increase.
At the same time, the company is continuing its discussions with other governments around the world, with the aim of selling approximately eight to ten million doses of the remaining stocks in international markets in the next six to twelve months.
Given current order levels and existing inventory, Valneva has suspended production of the vaccine.
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Key points
– Specialist in the development of prophylactic vaccines against infectious diseases with limited therapeutic options;
– Turnover of €348m €bn drawn from Europe for 56%, ahead of the Americas (27%), then Asia-Oceania (9%) and Africa-Middle East (8%) ;
– Business model: portfolio of diversified vaccines for the general public, financing of clinical developments by a specialized infrastructure, 2 commercial vaccines (Ixiaro and Dukoral against Japanese encephalitis and cholera) and vaccine distribution rights for third parties;
– Capital held at 13.02% by the Grimaud la Corbière group and 8.19% by BPI France, Frédéric Grimaud chairing the 5-member supervisory board and Thamas Lingelbach the management board;
– Solid balance sheet with €307m in equity against €42m in debt, reinforced by net cash of nearly €350m in April 2022.
Challenges
– Medium-term strategy based on financing R&D through sales of the Ixiaro and Dukoral vaccines, extension of the manufacturing network (3 sites, in Scotland, Sweden and Austria) and partnerships promoting the group’s assets;
– Innovation strategy inherent in the business model, rich in a portfolio of 398 patents and supported by €173 million in R&D costs, with 3 main assets and 3 preclinical programs: the only vaccine in clinical development against Lyme, the only single-shot vaccine against chikungunya, the only inactivated and adjuvanted whole virus COVID-19 vaccine, vaccine candidates against human metapneumovirus, parvovirus and norovirus;
– Environmental strategy: energy efficiency, minimization of waste, optimal use of water and reduction of 5%, vs 2016, of CO2 emissions by 2025;
– Good visibility of the activity thanks to the agreements on vaccines with: the British government (orders of 100 million doses of anti-Covid vaccines and options out of 190 million by 2025, i.e. €1.4 billion in total), with Pfizer to co-develop and sell the one against Lyme disease ($308 million), with the American authorities for Ixiario against Japanese encephalitis ($70 million), with Bavarian Nordic for the marketing and distribution of specialized vaccines, with Batavia Biosciences to develop an inexpensive vaccine against polio, with the Butantan institute against chikingunya for low-income countries.
Challenges
– In 2022, launch of phase 3 trials for the vaccine against Lyme disease and awaiting the approval of the American authority for the sale of the vaccine against chikingunya and that of the European Union for the Covid 19 (60 million doses);
– Sensitivity to travel of sales of vaccines already on the market (against Japanese encephalitis and cholera);
– Uncertainties about the commercial success of the vaccine against Covid 19 in the United Kingdom, given the strong competition already established;
– 2022 objectives: excluding Covid vaccine, turnover between €430 and €590 million and R&D expenditure between €65 and €75 million.
An inevitable race for new blockbusters
The patent for Merck’s star product, the cancer drug Keytruda, which accounts for more than 35% of its sales, expires in 2028. Despite the loss, since 2019, of the patents for its three star products (Avastin, Herceptine, Rituxan) Roche was able to renew its portfolio by bringing new molecules to market. However, the discovery and launch of new drugs are increasingly expensive. AstraZeneca spends about $6 billion a year on R&D in a pharmaceutical industry where the life of a patent only lasts ten to fifteen years. This leads laboratories to withdraw from certain activities. Thus J&J, Pfizer, GSK and, no doubt, Novartis soon prefer to refocus on specialty drugs and abandon any ancillary activity.