The Hera incubator has been designed to tackle viral mutations.

UM – 03/2021

The good news first: With the conditional approval of a vaccine against the SARS-CoV-2 virus from Janssen, a Dutch subsidiary of the American Johnson & Johnson Group on March 11, 2021, another vaccine against COVID-19 will be available in Europe in the foreseeable future.

America moves on

The bad news: It is unclear when and in what quantities the vaccine will actually be available to Europeans. It is true that the EC has now ordered 200 million vials and optioned another 200 million. Delivery is expected in mid-April at the earliest, or later as necessary. American contracts will be fulfilled prior to shipping the serum to Europe. Even though production will be in Europe, the new vaccine will be bottled in the USA. The pace of vaccination there is expected to increase significantly under the new president, Joe Biden.

Secure supply chains are needed

This demonstrates the importance of continuing to push vaccine development and secure the supply chains. According to Commission President Ursula von der Leyen in a statement, the EU wants to speed up the approval procedures for vaccines and the certifying of new manufacturing structures by adapting the relevant legal frameworks, as well as expanding production capacities in Europe and promoting mass production.

A look at the virus variants

Special attention should also be paid to virus mutations, to which the protective serums must be adapted in case of doubt. Acting quickly in this area is the main objective of the "HERA incubator" - a precautionary plan against biological hazards that aims to forge public/private collaborations between academia, biotechnology companies and manufacturers as well as government and regulatory agencies. Specifically,

 

  • new variants will be detected more quickly through intensified sequencing and more samples will be sequenced than ever before (five percent instead of one percent).
     
  • Research into vaccines for virus variants will also be promoted and clinical vaccine studies will be better coordinated through a European network. The VACCELERATE network, which involves 21 countries, was also launched with the HERA incubator for this purposes.
     

The EC is providing an initial additional 225 million euros; 75 million euros to support genome sequencing in member states and the development of new standardised tests for variants and 150 million euros to modify previously licensed vaccines to tackle virus mutations.

Mutations require rapid action

As the name suggests, the "incubator" measures are intended to provide a basis for establishing the future EU crisis authority HERA (see News February 2021), through which the EU wants to be able to detect and combat future pandemics at an early stage. The EC intends to present a legislative proposal about this at the end of 2021. We do not want to wait so long because of the already existing and the expected further virus mutations.