EU pharma rules, EAPM newsletter and treaties

Another Easter is around the corner, a further EAPM dispatch for your delight and delectation…and more developments in the current COVID-19 crisis as a new holiday looms. With the aforementioned Easter weekend coming up, it will be interesting to see how many Europeans defy strong recommendations to stay at home. And taking into account the day that it is, EAPM’s newsletter is available here, writes European Alliance for Personalised Medicine Executive Director Dr. Denis Horgan.

In other news....

Changes to EU pharma rules en route

The European Commission has inched a little closer to the wide-ranging changes to EU pharma rules envisioned in its Pharmaceutical Strategy, publishing today (30 March) a document that sets out the objectives of upcoming policy reports and proposals on the topic. 

Plans to cut the time it takes to gain regulatory approval for medicines and medical devices, and drive the development of new antibiotics and other products for treating rare diseases, have been outlined in a wide-ranging new pharmaceutical strategy for Europe.

The strategy, developed by the European Commission, is patient-focused and seeks to build on the collaborative efforts of industry seen during the coronavirus crisis. The Commission hopes to deliver the strategy over a number of years.

Its new Pharmaceutical Strategy seeks "to ensure affordable, safe, quality, innovative and solutions-oriented pharmaceuticals for all citizens in the EU", Vice President Margaritis Schinas announced at the strategy's unveiling.  The 25-page document is packed with technical suggestions to fine-tune Europe's pharma system, but the challenge will be to translate these into tangible changes for European consumers. Experts think the strategy — if properly implemented — has the potential to make drugs more affordable, boost the variety of treatments available, drive forward innovation and firm up supply chain resilience. 

COREPER vaccine controversies

An internal squabble with COREPER over extra vaccines was just the latest controversy as the EU tries to speed its inoculation campaign. The decision to seek arbitration among the ambassadors came after Austrian Chancellor Sebastian Kurz virtually sabotaged the meeting by insisting that his country receive extra doses, even though European Commission data shows Austria faring relatively well among EU nations in terms of vaccine supplies. 

Kurz in a corner

A discussion tomorrow (31 March) will focus on Austrian Chancellor Sebastian Kurz’s attempt to get more vaccines. On 12 March, the 34-year-old vehemently accused the EU of unfairly distributing vaccine doses among its 27 member states. 

Lashing out at the ‘EU bazaar’, he demanded adjustments in favor of member states that received less doses than others. Kurz took the dispute all the way to the European Council meeting in Brussels last week, taking precious time away from pressing issues on the agenda—transatlantic relations, a common vaccination “passport,” and possible vaccine export bans. German Chancellor Angela Merkel reportedly got so annoyed with Kurz that she reminded the group that vaccine contracts were signed by member states themselves “and not by some stupid bureaucrats” in Brussels.

Pandemic treaty push

Leaders from 23 countries, the EU and WHO today (30 March) backed a push for a new global treaty to better prepare the world to tackle future pandemics. The call came in an op-ed published internationally that was signed off by leaders from five continents, including Germany’s Angela Merkel, Britain’s Boris Johnson, France’s Emmanuel Macron, South Korea’s Moon Jae-in and South Africa’s Cyril Ramaphosa. “We believe that nations should work together towards a new international treaty for pandemic preparedness and response,” the op-ed said. 

“Such a renewed collective commitment would be a milestone in stepping up pandemic preparedness at the highest political level.”The push to bolster common efforts comes as the planet struggles to combine forces to overcome the COVID-19 pandemic that has killed almost 2.8 million people worldwide. 

The spread of the virus has seen blame traded between capitals and accusations that rich nations have hoarded vaccines as economies around the globe have been battered.

“Together, we must be better prepared to predict, prevent, detect, assess and effectively respond to pandemics in a highly coordinated fashion,” the leaders said. “At a time when COVID-19 has exploited our weaknesses and divisions, we must seize this opportunity and come together as a global community for peaceful cooperation that extends beyond this crisis.”

ECDC – immune transmission

More than one year into the SARS-CoV-2 pandemic, over 120 million people have been infected with the virus across more than 200 countries. Reinfections following natural infections with the same or a new SARSCoV-2 variant have been reported sporadically and questions remain concerning the duration of immunity following natural infection, and whether asymptomatic reinfected individuals may be able to transmit the virus.

COVID-19 vaccines have been evaluated for their efficacy and effectiveness against symptomatic COVID-19 infection and for reducing and/or preventing mild, moderate, or severe COVID-19 disease, including mortality. However, the vaccine trials have not been designed to measure reduction in transmission risk from infected vaccinated individuals to susceptible contacts.

In this context, it is important to understand the available scientific evidence on the extent to which previous SARS-CoV-2 infection or COVID-19 vaccination prevents onward transmission from infected individuals to susceptible contacts. Therefore, ECDC has conducted a review of published and pre-print literature on duration and characteristics of immunity following a natural SARS-CoV-2 infection due to any variant or after COVID-19 vaccination with any of the EU-authorized vaccines now available.

Evidence from studies specifically designed to assess the impact of previous infection on the risk of transmission is currently lacking. Infection with SARS-CoV-2 does not provide sterilising immunity for all individuals and some who are reinfected might still be able to transmit SARS-CoV-2 infection to susceptible contacts. 

There is evidence that reinfection remains a rare event. Results from cohort studies confirm that the protective effect of previous SARS-CoV-2 infection ranges from 81% to 100% from Day 14 following initial infection, for a follow-up period of five to seven months. Protection against reinfection is lower in individuals aged 65 years and older. 

As the number of individuals acquiring natural immunity increases, the total number of infections is expected to decrease significantly, leading to decreased transmission overall, unless the genetic changes in the circulating variants induce significant immune escape. 

Brain on centre stage

The launch of the OneNeurology Partnership, a new initiative from the European Federation of Neurological Associations (EFNA), has taken place — together with the European Academy of Neurology, European Brain Council, World Stroke Organisation and Alzheimer’s Disease International, the partnership is aiming to raise the profile of brain diseases. The goal is “to build political interest” so that the Commission and member countries pay attention to the disease group and start formulating national-level neurology plans. The Commission can act as an organizer and facilitator to co-ordinate different national plans. 

EU vaccine chief says vaccine passports to be launched in June

Internal Market Commissioner Thierry Breton, who back in February this year was put in charge of the new vaccine production task force by the Commission, has unveiled the prototype of the announced EU vaccine passports.

During an interview for RTL radio and TV channel LCI, Commissioner Breton also said that the new documents which will prove that the traveller has been vaccinated, recovered from COVID-19, or his/her test results in case none of the two first has taken place, will be issued to EU citizens somewhere in mid-June ideally.

“From the moment we can be sure that every European who wants to be vaccinated will have fair access to the vaccine, as will be the case in the next two to three months – it will be good to have a health certificate that demonstrates your condition,” the commissioner said.

The Commission brought forward its proposal for the creation of a Digital Green Certificate in a bid to restore travel amid COVID-19 for those who have been vaccinated against the virus, SchengenVisaInfo.com reports.

And that is all from EAPM for now – don’t forget to have a read of our newsletter here, and our very best wishes to you all for a safe and happy Eastertide. Here is the link to our newsletter again. 

Stay safe until next time.

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