Vaccine Authorisation: An Overview of the Last 12 Months

by Aylin Pelut, Consultant
at Scendea

Introduction

Vaccines have been in the spotlight in recent years and are a hot topic. Indeed, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been a focus, but other vaccine development has not halted. In the last 12 months alone a number of vaccines have been authorised in the EU and U.S and are presented below and discussed in this short summary.  

Table 1 - vaccines authorised in EU and US (2022)

The data indicates that global pharmaceutical companies such as GlaxoSmithKline (GSK) were amongst the predominant marketing authorisation holders, with vaccine approvals in both Europe by the European Medicines Agency (EMA) and the U.S. The U.S. Federal Drug Administration (FDA) approved several vaccines over the last 12 months for an expanded indication.

We also see Merck Sharp & Dohme Corporation’s vaccine Vaxneuvance was the first pneumococcal conjugate vaccine against invasive pneumococcal disease within the paediatric population in the U.S. GSK’s Boostrix vaccine was also the first approved vaccine to help protect infants younger than two months from whooping cough in the U.S.

Although there were no reported withdrawals of vaccines within the last 12 months in the U.S or EU, by April 18, 2023, the FDA updated existing guidelines to no longer authorise the use of monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines. They announced authorisation of the bivalent vaccine (Original and Omicron BA.4/BA.5 strains) to simplify the vaccination schedule.

Vaccine development has not slowed down, some key take aways are:

• There are 100 vaccine candidates in the pipeline of Vaccines Europe 15 member companies (end of July, 2022)1. 

• Diseases that vaccine candidates aim to address for which no vaccine has been approved include:

o Epstein-Barr virus

o Nipah virus

o Zika virus

o Human Immunodeficiency Virus (HIV).

o In addition to this, Pfizer recently announced receival of positive FDA advisory committee votes for their Respiratory syncytial virus (RSV) vaccine in the U.S, for which there is currently no authorised vaccine. 

o Similarly, on the April 26, 2023, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended authorisation of GSK’s Arexvy vaccine for RSV in adults 60 years of age and older. 

Ultimately, there is a continuous growth and development in a very dynamic environment for the development of vaccines to address current and future health threats.

At Scendea, our expertise and experience in vaccine development has positioned us as a trusted partner in helping vaccines gain regulatory approval in the UK, US, and European markets. Throughout the last 12 months, we have supported vaccine manufacturers through the complex process of authorisation. By leveraging our in-depth knowledge of regulatory requirements and our strong relationships with regulatory authorities.

If you are developing a vaccine and require support with your regulatory activities, book a 30-minute call with a member of our team today.