Coronavirus: Questions and answers on conditional marketing authorization of vaccines 

Welcome, health colleagues, to the European Alliance for Personalised Medicine update before your well-earned weekend – great progress was made at the EAPM lung-cancer screening event on 10 December, so more of that below, writes EAPM Executive Director Denis Horgan.

Real progress can be made with lung cancer through screening

More than 130 high-level delegates and speakers attended the conference on 10 December, with representatives of leading medical societies, MEPs, Commission officials as well as a host of member states delegates and patients. Lung cancer is the biggest killer of all in terms of cancer-related mortality but, unfortunately, the odds against effective implementation of lung-cancer screening across member states in the near future are still high.

Consensus was reached in the conference that the enormous challenge of reducing morbidity and mortality from lung cancer will continue for many years. Low-dose CT (LDCT) scan screening is effective in reducing lung cancer mortality and given the scale of the lung cancer pandemic, LDCT screening can play an important role in reducing deaths from the disease. But a large-scale impact of screening on lung cancer mortality will not be achieved without widespread implementation – and that appears to depend heavily at present on strong presentation of strong arguments from LCS stakeholders to policymakers to take the necessary action.

A key outcome of the conference was there needs to be concrete actions at both EU and member state levels to tackle lung cancer through screening. The EU-27 should look to improve all aspects of screening going forward. There is still much to be decided then, crucially in the context of the European Beating Cancer Plan when it is implemented, and there is a need for greater efforts, supported by collaboration between member states and professional, organizational and scientific support for those countries seeking to implement or improve population-based screening programmes. This will be a key policy priority for EAOM going forward. A report on the EAPM lung-cancer screening conference will be available in due course, stay tuned.

EU COUNCIL NEWS

EU leaders agree

€5.1 billion for the EU4Health programme is now set to be allocated, after EU leaders agreed to the 2021 budget and recovery fund on Thursday (10 December). And European Commission President Ursula Von der Leyen “offered European leaders a sneak peek into the Commission’s plans for a pro-vaccine communication campaign, to be rolled out in two phases”. “The first will ‘explain the product’ in all languages, while the second will encourage people to get vaccinated and aim to dispel scepticism — with the help of influencers such as ‘UEFA football stars,’ von der Leyen said.

EU Council announces deal on coronavirus recovery plan

As a first order of business, the leaders on Thursday (10 December) adopted conclusions on addressing the ongoing coronavirus pandemic — essentially granting formal approval to a series of steps that they discussed previously during several informal videoconferences, including the development of national plans for deploying vaccines, and support for creating a European Health Union that would give Brussels more legal power over health policy during pandemics. Leaders reached agreement on a long-term coronavirus recovery package, after weeks of resistance from Poland and Hungary, according to EU Council President Charles Michel. The two countries had initially blocked the €1.1 trillion ($1.3 trillion) seven-year budget and €750 billion recovery package over stipulations that tie the funds to upholding the rule of law.

EU4Health steering board

The EU4Health Civil Society Alliance has expressed its wish to highlight the absolute importance of an inclusive governance framework with direct, clear and meaningful participation of public interest civil society. Only an inclusive EU4Health Programme, which includes public interest and civil society’s expertise can unleash its full potential to improve public health, the Alliance states, adding that it believes that the EU4Health Steering Board proposed by the European Parliament, with the direct involvement of public interest civil society, complements the expertise of the member states and EU institutions and will ensure a clear and meaningful role for civil society in the governance of the programme, facilitating co-production and ensuring a concrete platform for civil society involvement.

CORONAVIRUS NEWS

Sweden steps up for Norway and Iceland on coronavirus vaccine

Non-EU Norway and Iceland will get access to some of the vaccines obtained by the European Union thanks to Sweden, an EU member that will buy more than it needs and sell them to Norway, right after New Year, the health ministry announced on Wednesday (9 December). Sweden is acting as the ‘reseller’ and will handle the financial transactions. “Sweden has undertaken a key role in the delivery of vaccines to its Nordic neighbours,” Norway’s Health Minister Bent Høie said. “The close co-operation with Sweden means that Norway has access to vaccines on equal terms with the EU member states and ties Norway closer to the EU’s vaccine work.”

Northern Ireland announces vaccine roll-out plans

Northern Ireland has announced its plans concerning the BioNTech/ Pfizer vaccine. Concerning the key question of its distribution to care homes, the government says it will deploy mobile teams of staff who will deliver it directly to patients, such as the elderly and care home residents, who cannot get to vaccination centres. Staff will also be vaccinated during this phase of the programme, which is set to begin on 14 December.

EU gets behind co-ordinated coronavirus testing and vaccine certificates

The European Council said on December 11 that it welcomes the recent positive announcements on the development of effective vaccines against COVID-19 and the conclusion of advance purchase agreements by the European Commission, but added that “the arrival of vaccines does not mean that the pandemic is over”. “The epidemiological situation in Europe remains worrying, even though the considerable efforts made by all are starting to yield results,” the EU leaders said in a statement of conclusions adopted at the European Council meeting. “We must therefore sustain our efforts to counter the spread of the virus with a view to preventing further waves of infections,” the statement said. The European Council said that it welcomes the co-ordination of efforts at EU level so far and commits to strengthening this co-ordination, in particular in preparing for a gradual lifting of restrictions and a return to normal travel, including for cross-border tourism, when the sanitary situation allows.

Conditional marketing authorization (CMA) ‘most likely’ for COVID-19 vaccine, EMA says

The most likely scenario for COVID-19 vaccine candidates in the EU is a one-year conditional marketing authorization (CMA), European Medicines Agency (EMA) sources have said. A conditional marketing authorization allows the approval of a medicine or a vaccine that addresses an unmet medical need with a positive benefit-risk balance. It is based on less complete data than is normally the case, and with specific conditions to be met within defined timelines after authorization.The source added that CMAs are valid for one year and can be renewed annually.

And that is all for this week from EAPM – do enjoy a safe, relaxing weekend, and see you next week with a full report on our lung-cancer screening event.