One thing that I am not is Eurosceptic. Having led Ireland into the European Economic Community (EEC) in 1973, my party Fianna Fáil has campaigned on the pro-European side in all referenda.
Additionally, the European parliamentary group Barry Andrews and I are members of, the Renew Europe Group, is known as the pro-European group. However, being pro-European does not mean turning a blind eye to failings in the union.
Sadly, I feel the EU is failing when it comes to the roll-out of the Covid-19 vaccine programme.
Obviously, Member States have to take responsibility for the actual vaccination of people once they receive the vaccines, but until that happens, it’s the responsibility of the European Commission and the manufacturers.
💉 #CovidVaccine: Renew Europe calls on the @EMA_News and the @EU_Commission to provide a clear explanation of current approval processes, purchases and a timetable of next steps. pic.twitter.com/pzzDeMJMSz— Renew Europe (@RenewEurope) January 6, 2021
Last autumn, the Commission engaged in a significant level of self-congratulation as it signed advanced purchase agreements with a number of pharma companies. They secured billions of doses for EU citizens at lower prices than other countries. Sounds like victory to me.
I was a strong advocate of the EU response demonstrating our strength and solidarity. This approach should have allowed us to leverage the EU’s collective size to secure fair deals and prevent competition amongst Member States.
Except, the EU is now lagging behind other countries such as Israel, the UK, Bahrain, even the United States, in terms of the number of citizens vaccinated. Recent data suggests that Israel has administered over 14 doses per 100 people versus an EU average of less than one.
With yesterday’s decision by the European Medicines Agency to approve the Moderna vaccine, two of six vaccines that we signed contracts for have now been approved and are ready for use. Importantly, however, the decision on the Oxford Astrazeneca vaccine will not be made until early February 2021.
Worryingly, the EMA has issued minimal communication on the reasons for the delays or when approval may be expected. While it must follow its robust regulatory processes, I get a sense that it is quite removed from the concerns and worries of ordinary people.
What must be explained is why the EMA has determined that the Moderna and Oxford Astrazeneca vaccines must go through the longer Conditional Marketing Authorisation process rather than the more efficient Emergency Procedure.
The pandemic is raging again right across Europe.
I am reminded of what the World Health Organisation Emergencies Director, Mike Ryan said last spring: “Perfection is the enemy of the good.”
Safety cannot be compromised in favour of speed but we know it’s possible to move faster. There is no need for the EMA to start from scratch and reinvent the wheel. Other medicines regulators have already approved these drugs following large-scale Phase III trials.
The Commission also has questions to answer. Last summer, it was offered the chance to purchase an extra 500 million doses of the Pfizer BioNTech vaccine in addition to the 200 million already agreed. The Commission turned them down.
Eventually, an additional 100 million had to be secured in December 2020 after delays in the approval of other vaccines caused considerable concern.
Obviously, the Commission needs to be confident that Member States will purchase these vaccines but no government worth its salt would turn down an opportunity to ramp up its vaccination programme using Pfizer BioNTech vaccines.
MEPs and Member States are rightly asking questions about this decision. Ireland, under its agreed 1.1% allocation, would have secured an extra 5.5 million doses of the Pfizer vaccine - enough to vaccinate half the population. There would be no need to wait for further regulatory approvals.
Bear in mind, six weeks of lockdown in Ireland costs the Irish State roughly €1 billion and risks many thousands of jobs. The cost of not buying these additional vaccines would be considerably less than the cost of further lockdowns.
There may be very valid scientific reasons for the EMA’s failure to quickly approve the Moderna and Oxford Astrazeneca vaccines but failing to keep the public in the loop is simply not acceptable. People are frustrated, tired, worried and scared. An absence of information breeds misinformation and helps feed the anti-vax movement.
This week, I wrote to the Chair of the European Parliament’s Environment, Climate Change and Public Health Committee requesting that officials in charge of the vaccine programme be invited to urgently address our concerns.
📣 Good news! 📣#ENVI Chair @pcanfin has confirmed that Health Commissioner @SKyriakidesEU has been invited to explain the Commission’s management of vaccine programme next week. @EMA_News Executive Director Emer Cooke will address committee on 25 Jan. #COVID19 @RenewEurope pic.twitter.com/gqaMLOIpAs— Billy Kelleher MEP (@BillyKelleherEU) January 5, 2021
It has now been confirmed that Health Commissioner Stella Kyriakides has been invited to address the committee next week, and the EMA Executive Director, Emer Cooke will answer questions on January 25.
Being pro-European is about not being blind to the EU’s shortcomings. It’s about recognising the benefits of solidarity and working collectively but also recognising when things can and should be better.
No one, even the most ardent pro-European, should be afraid to call out failings and ensure that mistakes made in the past stay in the past.
- Billy Kelleher is a Fianna Fàil MEP for Ireland South