Europe wants a mutant COVID clause built into its vaccine supply contracts
In an effort to get its inoculation drive on track, the European Union’s executive arm will vow to accelerate research, authorization, procurement and distribution for vaccines that fight variants of the coronavirus, while also asking member states for more money to back the drive.
The European Commission wants to adapt existing contracts and strike new purchase agreements with pharmaceutical companies to secure shots that protect against Covid-19 mutations, according to a draft proposal of the strategy seen by Bloomberg. The contracts will include safeguards to avoid earlier missteps that tarnished the current vaccine rollout.
“Existing agreements may have to be updated to cover protection against variants,” according to the plan, which will be published on Wednesday and could still be changed. “Based on the lessons learned, a detailed and credible plan showing capability to produce vaccines in the EU on a reliable timescale will be a prerequisite. This should not prevent the EU from considering sources from outside the EU if needed.”
Brussels has come under criticism for the sluggish pace of inoculations across the bloc compared to the U.S. and the U.K. The Commission also engaged in a very public dispute with AstraZeneca Plc over expected supplies and amid calls in recent days by several member states to get ahead of a possible need for booster shots to tackle new Covid mutations.
A Commission spokeswoman declined to comment on the draft proposal.
The spread of variants which are more transmissible and potentially less sensitive to existing vaccines has spooked EU governments, which next week will vow to “uphold tight restrictions,” according to a draft communique seen by Bloomberg. Over a video summit on Feb. 25-26, the bloc’s leaders will declare that non-essential travel must remain restricted, adding that “variants pose additional challenges.”
“We need to accelerate the authorization, production and distribution of vaccines, as well as vaccination, in the weeks and months to come,” leaders will say next week, in a wording that could signal the governments’ discontent with how the bloc’s executive arm handled purchase agreements of the life-saving shots.
At the summit, the Commission will invite the 27 leaders to endorse and mandate its proposals. “Given the race against time, sufficient funding will need to be made quickly available,” the draft states.
As part of the proposals, the Commission will create and manage a new bio-defense preparedness program that will cover five different fronts:
- Rapid detection of variants
- Swift adaptation of vaccines
- Setting up a European Clinical Trials Network
- Fast-tracking regulatory approval of updated vaccines and new or repurposed manufacturing infrastructures
- Enable upscaling of production of existing, adapted or novel Covid-19 vaccines.
The EU’s health commissioner, Stella Kyriakides, anticipated aspects of the decision to fast-track the approval of vaccines updated to target mutations of the coronavirus in an interview with a German newspaper over the weekend.
Additionally, the Commission is set to announce that it will create and fund a new trial network called “Vaccelerate” to ensure that vaccine trial sites are available across Europe. The bloc’s executive arm will also support research and rapid mass testing to detect new variants and will again urge that member states mobilize resources to ensure a genome sequencing capacity of at least 5% of positive test results can be reached. It will make available 30 million euros ($36.5 million) of funds to boost existing research projects around variants.
The U.K. medicines regulator also said Tuesday it was looking at a rapid review of any new vaccines targeting variants, confirming that drugmakers will not have to go through the same extensive approval process as the first-generation shots and comparing the likely process to the annual flu vaccine updates.
“It won’t be a full re-run of the first vaccine approvals, it will be very modified, and very focused, and very much quicker,” June Raine, chief executive officer of the Medicines & Healthcare Products Regulatory Agency, said at a public board meeting. “We’re well aware that with the threat posed by particularly a pathogenic or a seriously harmful variant we need to act fast.”
The EU will also pledge to scale up industrial capacity across the bloc by working closely with manufacturers to monitor supply chains, tackle bottlenecks and support manufacturing of additional vaccines as part of an “EU Fab” project.
Brussels will also foster “the creation of a collaborative licensing tool, which would allow technology owners to retain a continued control over their rights while guaranteeing that technology, know-how and data are effectively shared with a wider group of manufacturers,” the draft proposals say.