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Santa comes early with EMA approval of coronavirus vaccine – but so does new mutation




Welcome, welcome, to the last European Alliance for Personalised Medicine (EAPM) update of the year, as Christmas approaches. It has been one of the strangest, hardest years in a generation, but EAPM is looking forward to the end of COVID-19 in 2021 as well as the establishment of the European Health Union supported by the EU4Health funding mechanism, writes EAPM Executive Director Denis Horgan.

A big thank you

As Christmas looms, now is the time for EAPM to thank all of its stakeholders and the EU health institutions for their support during this very difficult year, it is very much appreciated. In addition, we wish all of our collaborators the very best for 2021 and look forward to collaborating on the many policy issues that we will have on our doorsteps in January. From a regulatory/policy perspective, chief among these are the EU Health Data Space, Pharma Strategy, Orphan Regulation as well as the EU health Union and lest we forget, the EU Beating Cancer Plan. 

EMA approves vaccine, but Christmas by and large cancelled for UK

The European Union’s medicines regulator has recommended the Pfizer-BioNTech coronavirus vaccine for use in the bloc’s 27 states. The European Medicines Agency (EMA) authorised the drug for the EU’s nearly 448 million inhabitants after it went into circulation in the UK and the US. Hours after the EMA’s decision, the European Commission gave its own formal approval for the use of the jab. 

Shipments of the BioNTech/Pfizer vaccine could leave Belgian warehouses as soon as tomorrow, BioNTech’s chief business officer Sean Marett confirmed today (22 December).

In addition, the World Health Organization (WHO) is expected to give the BioNTech/Pfizer vaccine an emergency use listing by the end of the month, which is a step to it becoming available in many more countries around the world. The WHO Strategic Advisory Group of Experts on Immunization (SAGE) is then expected to issue its recommendation on how the vaccine should be used in the first week of January, said WHO Chief Scientist Soumya Swaminathan.


That’s the good news.

The bad news, at least for the United Kingdom, is the fact that, with the advent of the latest coronavirus mutation, which is said to be some 70% more effective at infection, a host of countries, including the Netherlands, Belgium, Italy, France and Canada, have temporarily suspended travel to the UK. 

Discussions are ongoing between all parties as to when such suspensions may be lifted, with hundreds of lorries and other heavy goods vehicles queuing back to back outside Dover, but, because of the new disease variant, UK Prime Minister Boris Johnson has conducted a U-turn over the proposed relaxation of restrictions for Christmas, with those living in London and south-eastern England now not being allowed to mix with any other households for the holiday. 

Most other parts of the UK still can mix with up to three households, but only for Christmas Day — not five days as previously planned — but no-one is permitted to socialize with another household in indoor hospitality areas.

Agreement on EU health programme, EU4Health

The negotiators of the European Parliament and the German Presidency representing the Council of the European Union have agreed on the European Union’s health programme for 2021-2027, EU4Health. Its budget will amount to €5.1 billion and will be part of the EU budget.The EU health programme aims to help remedy the shortcomings exposed by the COVID-19 pandemic by increasing the quality and resilience of EU health systems. 

As reported last week,  increasing the resilience of health systems, EU4Health will better prepare the European Union to face serious cross-border health threats. This is to help the European Union deal not only with future epidemics but also with long-term challenges such as population aging and health inequalities.

The COVID-19 crisis has exposed many weaknesses in national health systems, including their dependence on non-EU countries for the provision of drugs, medical devices and personal protective equipment. The programme will therefore support activities that favor the production and supply of products.

Seth Berkley, the CEO of GAVI, the alliance in charge of procurement for the COVAX vaccine effort, sought to reassure reporters that vaccines will be delivered on time to lower- and middle-income countries. 

That is expected to start in the first quarter of 2021, contingent upon regulatory approvals and countries’ readiness for delivery, GAVI says. The agreements put it closer to securing 2 billion doses of vaccine candidates to be deployed around the world in 2021, GAVI said.  The latest deals include an advance purchase agreement with AstraZeneca for 170 million doses of its vaccine candidate and a memorandum of understanding with J&J for 500 million doses of its vaccine. 

Joe Biden receives vaccination live to prove safety

US President-elect Joe Biden received his first dose of the coronavirus vaccine on live television as part of a growing effort to convince the American public the inoculations are safe. 

The event came the same day, 21 December, that a second vaccine, produced by Moderna, began arriving in US states, joining Pfizer’s in the nation’s arsenal against the COVID-19 pandemic, which has now killed more than 317,000 people in the United States and upended life around the globe.”I don’t want to get ahead of the line, but I want to make sure we demonstrate to the American people that it is safe to take,” Biden said of his decision. 

And that is all from EAPM for 2020 – we would just take this opportunity to wish all of our health colleagues the safest and happiest possible Christmas, and all the very best for 2021. We look forward to catching up with you again in January if not before.

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