EU Launches Vaccine Incubator to Take on Coronavirus Variants

The EU yesterday unveiled a plan to speed up regulatory approvals and manufacturing of vaccines against emerging strains of the SARS-CoV-2 virus that causes COVID-19.

A new initiative under the EU’s Health Emergency Response Authority (HERA), the HERA Incubator will adopt the same approach as is used for the annual flu vaccine, the European Commission said.

The incubator will bring together researchers, biotech companies, manufacturers, regulators and public authorities to “monitor variants, exchange data and cooperate on adapting vaccines,” the commission said. It is also tasked with “facilitating the certification of new or repurposed manufacturing infrastructures; and supporting the speedy mass production of adapted or novel COVID-19 vaccines.”

The incubator will initially receive $271 million in funding, including $90 million to support genomic sequencing in EU member states and to develop new standardized tests for the variants, and $181 million for existing and new research projects on variants. Most EU member states currently have less than 10 percent of the needed capacity to conduct genetic sequencing tests on coronavirus strains.

Variant SARS-CoV-2 strains are an increasing global concern, and the highly infectious strain first identified in the UK now “appears to be on course to become dominant over the previous strains in the EU,” according to the European Centre for Disease Prevention and Control.

In the U.S., the UK variant is increasingly being detected in addition to at least half a dozen others. The FDA is expected to release draft guidance within weeks on the data it will require from vaccine sponsors who modify their vaccines to address new coronavirus variants (DID, Feb. 8). — Martin Berman-Gorvine