2021 – the year of the vaccine

New Year’s Eve, 2020 marked a full-year since the first case of SARS-CoV-2 was reported to the World Health Organisation China Office. What unfolded next shocked the world to its core as our global economy was brought to its knees and human resilience was pushed to its limits.

Within the first three months of 2020, over 100 countries worldwide had instituted restrictions in a bid to stop the spread of the virus, affecting the majority of the world’s population.

If 2020 was the year of lockdowns and restrictions, then 2021 will certainly be the year of the vaccine. Let’s look at how far we’ve come already and where the challenges lie in the months ahead as the EU and Member States role out their vaccination strategies.

Developing the vaccines is the start of the process, but securing doses for citizens, regulatory approval and roll-out are all critical to their success.

2020 was a phenomenal year for science – the speed at which lifesaving vaccines have been developed is nothing short of amazing.

The combination of existing knowledge and research on related viruses and faster methods of manufacturing vaccines was supported by enormous funding that allowed companies to run multiple trials in parallel, condensing a complicated process that usually takes 10-15 years into a matter of months.

New ways to develop vaccines, including the use of messenger RNA (mRNA), have been validated and mainstreamed following the COVID-19 vaccine experience.

It’s not too optimistic to hope this pandemic may have a lasting legacy on future vaccine development for the better.

Moving beyond development, it’s remarkable to see the new level of cooperation the EU has achieved through the EU’s Vaccine Strategy, and subsequently the European Commission’s efforts to secure vaccine doses for EU citizens in the form of Advance Purchase Agreements (APAs).

Five years ago, it’d have been unthinkable to see such action at a supranational level on a health-related matter. Yet the Commission stepped up and has so far negotiated and signed six contracts on behalf of its member states – securing a portfolio of more than two billion doses.

Whilst the low number of doses purchased from specific manufacturers such as Pfizer-BioNTech have been criticised, let’s remember there is also room for member states to conduct their own negotiations. At the same time, the Commission’s joint-action strives to avoid nasty vaccine nationalism in Europe.

We should be certain the pandemic has paved the way for more EU level action on health matters, with this as the first bold step…

Of course, vaccines are only as good as their market approval. Despite the European Medicines Agency (EMA) moving at record speed to get vaccines on the market, it’s still lagging behind the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) and the US’s Food and Drug Administration (FDA).

Public criticism flooded in when EMA announced it didn’t expect to approve the Pfizer-BioNTech vaccine until December 29, ultimately expediting the process to announce approval on December 21. The MHRA and the FDA approved the vaccine on December 2 and December 11 respectively. The same is happening for other vaccines awaiting approval.

We’ve seen how the length approval timelines for both pharmaceuticals and vaccines can be reduced during times of crisis, putting into question “business as usual”. The Commission has recognised these lengthy EMA timelines were falling short in its new Pharmaceutical Strategy and will work to speed up the processes.

If we can be this quick when the threat is considered imminent, can we also be quicker in the delivery of other lifesaving products in the future.

Yet it’s the implementation of national vaccine strategies that seems to be causing the most controversy to date. If this isn’t done efficiently, the threat of lasting damage to European policymakers is perhaps greater than that of 2020’s lockdowns.

Israel, the UK and US are speeding ahead of Europe in terms of vaccine roll-out. With Boris Johnson proudly stating that the UK has vaccinated more people than the rest of Europe combined, finger pointing is already taking place in larger member states such as France and Germany.

Whilst some nations have been quick to point fingers at the Commission for not ordering enough vaccines in the first place, it’s evident that lack of preparedness at national level is really the culprit for the slow start.

Just ask Denmark, who’s roll-out is actually ahead of the UK’s on a per capita basis, whilst other member states currently lack the infrastructure to provide more than a fraction of the vaccine doses available to them.

The next challenge that the Commission should mitigate, is member states hastily placing bilateral orders to vaccine producers to secure more doses and speed up national vaccine rollout. If not done in full transparency, we risk undermining the whole purpose of an EU-wide vaccine strategy.

Vaccines signal the beginning of the end of this pandemic. As the Commission continues to successfully negotiate vaccine agreements on behalf of member states and regulators move at a quicker pace than usual, Europe has every right to be optimistic about its work to date.

Yet the real test will now come in the vaccine roll-out. Member states cannot fall short on national vaccine strategies and most need to tighten their approach to date. It’s also imperative that Europe does everything it can to avoid vaccine nationalism and where possible, ensure continuation of its united and coordinated approach.

  • Emma Cracknell

    Emma leads FleishmanHillard EU’s Health and Lifesciences team, providing public affairs and corporate communications sectoral expertise to clients. Emma has worked on high-profile pieces of EU health legislation, including the General Pharmaceutical Legislation and EU-wide HTA, and has a particular passion for supporting clients to...

    See profile