Verband Forschender Arzneimittelhersteller [Association of Research-Based Pharmaceutical Companies]: Angepasste Impfstoffe zum Schutz vor Omikron [Customized vaccines to protect against omicron] (September 24, 2022), online in: https://www.vfa.de/de/arzneimittel-forschung/coronavirus/omikron-impfstoffe (Retrieved: October 18, 2022).
In its article, the Verband Forschender Arzneimittelhersteller e. V. (VFA), representing the interests of 45 pharmaceutical companies in Germany, presents the status of vaccine development against the omicron variant. At the time of publication, there are three vaccines approved in the EU from two companies (BioTech/Pfizer and Moderna) that are adapted to both the original strain and the BA.1. and BA.4./5. subvariants, respectively. In addition, other pharmaceutical companies besides BionTech/Pfizer and Moderna are developing or beginning to develop adapted vaccines. In the U.S., the U.S. Food and Drug Administration (FDA) requested regulatory submissions for vaccine versions in July 2022 without having tested the adapted vaccines in volunteers prior to approval. Such emergency approvals, which have also been common for decades for influenza vaccines, were granted for BionTech/Pfizer and Moderna vaccines in August 2022. The VFA article concludes with an explanation of the European Medicines Agency’s (EMA) intended guidelines for approving adapted vaccines.