Valneva heads to Paris as its Lyme vaccine clears the first procedural hurdle at the EMA

(Il Sole 24 Ore Radiocor) - Valneva’s shares soared on the Paris Stock Exchange after clearing a first major procedural hurdle at the EMA regarding its Lyme disease vaccine. The French biotech company’s shares rose by over 22 per cent. Valneva, together with its US partner Pfizer, has announced that the European Medicines Agency (EMA) “has validated the application for marketing authorisation for PF-07307405, the candidate vaccine against Lyme disease” and “will begin assessing the application”.

The application – explains the French company – “is based on the encouraging efficacy, in excess of 70 per cent, observed in the Phase 3 VALOR clinical trial, which assessed whether the vaccine candidate was capable of preventing cases of Lyme disease in individuals aged five years and over. The vaccine was well tolerated in the trial, with no safety concerns identified.” The Valneva and Pfizer vaccine is currently the most advanced product in the world for the prevention of Lyme disease.

However, this step is only the start of the evaluation of the candidate vaccine and does not constitute pre-authorisation. As experts point out, the entire procedure at the EMA is lengthy and involves three stages. Firstly, the scientific assessment, during which the CHMP, the EMA’s scientific committee, will evaluate the efficacy, safety and quality of the product. The process involves up to 210 days of active assessment, to which periods of suspension may be added should the manufacturer need to respond to queries from the EMA. In practice, the process generally takes between 12 and 15 months.

The CHMP then issues its decision, which may be favourable (possibly subject to conditions) or unfavourable. Finally, the European Commission makes the decision regarding marketing authorisation and, in most cases, follows the CHMP’s opinion. Although there is still a long way to go before final approval, analysts’ reactions have been positive. Researchers at Stifel have confirmed their ‘buy’ rating on Valneva shares with a target price of €7.50. In a note, they explain that the announcement regarding the EMA will trigger the formal regulatory review process in Europe and they expect the vaccine to be approved in the third quarter of 2027. The US investment bank points out that this is a market in which over 200 million people live in at-risk areas in Europe and that the disease affects over 100,000 people a year in the region.

Analysts point out that the news represents a significant risk-reduction event for the investment. Attention will now focus on the anticipated approval of the application for marketing authorisation of the biologic drug by the US Food and Drug Administration (FDA) in the coming months, which is expected to be the next key regulatory catalyst.