Europe To Establish Emergency Biodefense Plan To Respond To Coronavirus Variants – More Local Manufacturing For Rapid Scale Up Of New Vaccines & Boosters
The European Comission has announced a new plan to respond to coronavirus variants

The European Commission will establish an emergency biodefense plan to prevent, mitigate and respond to new variants of the coronavirus that are supercharging transmission and threatening the performance of available vaccines. Creation of a voluntary licensing mechanism involving local manufacturers is one of the strategies proposed in the plan to hasten the production of updated vaccines.

“This very real threat of variants requires determined, collective and immediate action,” said the European Commission on Wednesday. “The Commission will establish and operate a new bio-defence preparedness plan called HERA Incubator, to access and mobilise all means and resources necessary to prevent, mitigate and respond to the potential impact of variants.”

With at least €75 million ($90.2 million) in initial funding, the EU’s five-pronged plan aims to rapidly detect variants and to adapt vaccines accordingly, while ensuring their approval is fast-tracked and that production is upscaled.

“The Commission will foster the creation, if need be, of a voluntary dedicated licensing mechanism, which would allow technology owners to retain a continued control over their rights whilst guaranteeing that technology, know-how and data are effectively shared with a wider group of manufacturers.”

Specifically, the Commission aims to urgently work towards:

  1. Rapid detection of variants;
  2. Swift adaptation of vaccines;
  3. Setting up a European Clinical Trials Network;
  4. Fast-tracking regulatory approval of updated vaccines and new or repurposed manufacturing infrastructures;
  5. Enable upscaling of production of existing, adapted or novel COVID-19

Until now, only one major European vaccine-developer, AstraZeneca, has licensed its vaccine voluntarily with a number of manufacturers around the world – thus sharing the vaccine know-how with producers in India, the Republic of Korea and Brazil, among other countries.

The EC initiative comes on the heels of a call by the new Director General of the World Trade Organization, Ngozi Okonjo-Iweala, to encourage vaccine pharma companies to issue more voluntary licenses to manufacturers in low- and middle-income countries so as to open up the global bottleneck in access to vaccines.  She also called upon countries to support the ramping up of such local production capacity in low- and middle-income countries, noting that on the African continent, for instance, 90% of medical products are imported, Iweala said shortly after her election by the WTO General Council on Monday.

Medicines Access Advocates Say European Commission Plan Is To Euro-Centric

While seeming to echo Iweala’s approach, health advocacy groups voiced concerns that the EC initiative was too Eurocentric.

Notably, the Commission’s plan did not explictly mention any push to expand voluntary licensing internationally – through efforts such as the WHO-backed initiative to created a COVID-19 Technology Access Pool (C-TAP) for the voluntarily licensing of COVID-19 vaccines and other COVID health products. Nor did the EC explicitly mention the WHO co-sponsored global vaccine facility COVAX – which is struggling to recruit more funds and vaccines to distribute to low- and middle-income countries

“The EU proposal today, and the comments by the incoming WTO DG Ngozi Okonjo-Iweala, as well as earlier comments on CTAP by [WHO Director General] DrTedros seem at odds. EU proposal on licensing seems focuses on EU needs, not global,” said Knowledge Ecology International’s Jamie Love in a tweet.

In a followup remark to Health Policy Watch, Love added, “we have some details but there is a lot we don’t know yet [about the EC plan].” I am guessing that the EU sees any new capacity as serving the whole world, but it seems to focus on ramping up EU based manufactureing and addressing EU vaccine security needs, as its priority, very similar to what other governments, including the US, have done.

“If the EU wants to work on a more global technology transfer initiative, it would want to engage in C-TAP, and maybe even help C-TAP get its programme off the ground in a meaningful way.”

On the other hand, the EC plan stresses that the benefits of the European initiative will extend “far beyond” the EU’s borders through cooperation with low- and middle-income countries, particularly in Africa and global health bodies like the World Health Organization, GAVI, The Vaccine Alliance and the Coalition for Epidemic Preparedness Initiatives (CEPI). “In the medium and long-term, the EU should cooperate with lower and middleincome countries, in particular in Africa to help scale up local manufacturing and production capacities,” said the Commission’s plan.

The European Commission plan also “emphasizes that the sharing of know-how will be restricted and controlled,” Love added. “Such conditionality diverges from the open-access vision of the WHO co-sponsored C-TAP, but that  “may be what is feasible” for vaccines already being marketed now as products with patent restrictions.

However, for new products, Love said the EU model would be more effective if it were based around “open sharing of the tech, and even some existing technology can be put into the public domain through tech buyouts. There is too much embracing the model of proprietary manufacturing know-how, when that is the opposite of what is needed for scaling up and making access more fair.”

The European Union’s Vaccine Strategy has so far secured access to more than 2 billion doses of coronavirus vaccines, which is roughly double the amount needed to vaccine the EU’s 450 million citizens. And just this Wednesday, the European Commission sealed a deal with Moderna for 150 million additional doses of its vaccine, bringing its order to a total of 310 million doses for this year, and an option to purchase 150 million extra doses in 2022.

Image Credits: almathias.

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