LONDON - The EU is taking concerted action to detect new variants of SARS-CoV-2, investing €225 million (US$270 million) to increase viral genome sequencing to 5% of positive cases across Europe, and to carry out research on their evolution and transmissibility.
At the same time, existing advance purchase agreements with vaccines manufacturers may be updated to cover protection against threatening variants, and there will be moves by EMA to speed up approvals of vaccines that are adapted to be active against them, based on the annual flu vaccine model.
While chasing the variants, the European Commission is trying to plug a hole in its COVID-19 vaccines strategy, in that although it signed contracts for 2.6 billion doses on behalf of all member states, it then stood back and failed to provide support for clinical trials and manufacturing scale-up.
These and other measures are being portrayed as a testing ground for a proposed Health Emergency Preparedness and Response Authority (HERA), modelled on the U.S. Biomedical Advanced Research and Development Authority, which through Operation Warp Speed has put $12 billion into COVID-19 vaccines.
A full legal proposal for HERA is in the works. The commission said this will build on the initiatives announced on Feb. 17 and provide a central and permanent home for risk modeling and global surveillance, while supporting technology transfer, manufacturing capacity, supply chains and vaccines research.
“New variants of the virus are emerging fast. We must adapt our response even faster,” said the president of the European Commission Ursula von der Leyen. The measures will both be a testing ground for HERA and “pull together all available resources to respond” to the threat of variants, she said.
Apart from Denmark, which increased its viral genome sequencing in response to the discovery SARS-CoV-2 had infected farmed mink and then been passed back to humans, countries in the EU are doing very little work on viral genomics.
The commission told member states to increase sequencing capacity to 5% of samples and to share sequences and related epidemiological data “in quick time and comparable formats” to ensure variants of concern are identified and responded to rapidly. €75 million from the EU’s COVID-19 emergency response fund is being made available for this, and for the development of PCR tests that pick up new variants.
The remaining €150 million will fund research into risk factors for the development and transmissibility of variants and the likely impact on vaccine efficacy, and for a centralized system for exchange of data on variants.
Vaccines research will be supported by a virtual COVID-19 clinical studies network, through which hospital sites will be available across Europe to test vaccines. Vaccines to be tested will include multivalent vaccines, heterologous regimens and prime boost.
The commission’s failure to follow through its advance purchase agreements with support for local manufacturing scale-up, as the U.S. and U.K. did, led to an undignified row with Astrazeneca plc when initial batches produced at a contract manufacturing plant in Belgium generated lower yields than expected.
That was coupled with Pfizer Inc. upgrading its facility, also in Belgium. Once complete the upgrade will increase production, but output has been reduced while the work is in progress.
Now, the commission said existing advance purchase agreements “may have to be updated to cover protection against variants” and based on the lessons it has learned about guaranteeing supplies, it will be a “prerequisite” for manufacturers to provide “a detailed and credible plan, showing capability to produce vaccines in the EU,” and “deliver on a reliable timescale.”
But the commission also was forced to acknowledge producers can face bottlenecks in many parts of the supply chain, such as lipid nanoparticles for mRNA vaccines, production equipment for single use bioprocessors, and glass vials and needles.
Increasing manufacturing and fill and finish capacities can mean sharing technological know-how and intellectual property, to shorten the time necessary for technology transfer. The commission said if needs be, it will foster the creation of a voluntary licensing mechanism. The idea is to allow patent holders to retain control over their rights, whilst guaranteeing that technology, know-how and data are effectively shared with a wider group of manufacturers.
EMA said last week that it will publish guidelines setting out which data and studies will be needed to support modifications of existing vaccines to address current variants, and of new variants that occur in the future.
On Feb. 17, the commission said the rules, “will be amended to accelerate the approval of COVID-19 vaccines to the new variants,” following current procedures for flu vaccines.
An EMA spokesman told BioWorld a robust surveillance system in the EU and globally, would be of great value in “rapidly and proactively” identifying emerging variants that could be of concern for vaccines efficacy.
“Genome sequencing efforts should be strengthened. Viral sequencing should also be incorporated in vaccines effectiveness studies, and in case of vaccine breakthrough, as an important element to understand how the vaccines perform with respect to the variants,” he said.