2021, the year we have all been looking forward to. I say this because to many, 2021 is the year of promise. A promise of a better future, and a promise that our lives can start to recover from the Covid19 pandemic. And while many say that we should not count our chickens before they hatch, I am hopeful.
I am mostly hopeful because modern day medicine and scientific development have allowed for this, through the development of a number of vaccines which can ultimately protect us all from a disease which has crippled not only our healthcare systems, but our global economies and our general mental health and wellbeing.
Last week I was present for the European Parliament’s Committee on Environment, where the European Medicines Agency (EMA) Executive Director Emar Cooke had her first exchange of views with the Committee since taking up the post one month ago. During this meeting Director Cooke explained that around a month ago companies Pfizer and Moderna submitted two vaccines for the EMA’s approval. Being pre-emptive, the EMA had already been evaluating both of the vaccine’s development from before an application was submitted by both companies, in what can be referred to as a rolling evaluation.
Additionally, the EMA has also announced that it will issue its opinion 8 days earlier than the originally planned dates of 29 December for the Pfizer vaccine and 12 January for the Moderna Vaccine. All of this is part of the EMAs approval process, which follows the same steps as any other medicine authorisation with the same legally binding obligations and liabilities on the applicant, but in an expedited way building upon the research done in the rolling evaluation in the previous months. Such an accelerated procedure is foreseen in EU legislation for cases of public emergencies and allows the EMA to grant market authorization when the agency is convinced that the benefits outweigh the risks of such an action, while also ensuring the utmost safety and security.
This is accompanied by the political will and agreement made between the European Union’s Council of Health Ministers and the European Parliament Committee for Health, of which I am a part of. This agreement ensures that the smallest countries of the European Union are not forgotten by multinational companies which produce the vaccine, thanks to the EUs decision to buy the vaccine for all the EU to ensure every citizen is able to access the vaccine. In Malta, the first consignment is to arrive up to five days after the vaccine is approved.
As a politician who follows healthcare policy across the EU this gives me the assurance I want to know that the vaccine will arrive in the hands of Maltese, Gozitan and EU citizens in a safety and timely manner. While the UK, Canada and other countries are focusing on fast tracking, the EU is ensuring that the vaccine is passed through a number of rigorous tests, just as would any other vaccine or medicine.
The procedure involves two teams of assessors who are conducting scientific evaluations of the vaccine, with a second scientific committee reviewing the results of the first team to ensure the highest quality. In parallel, safety measures are also being assessed by the EMAs pharmaceutical vigilance committee, while the manufacturing side of things is being thoroughly assessed by the EMAs biotech experts. Additionally, each evaluation is made separately from the other.
Following the vaccines approval, the company applying for the vaccine’s authorization must ensure that additional data continues to be generated over the coming years in order for it to be reviewed and monitored on an ongoing basis by the EMA and by member state authorities.
It is clear by the European Union’s efforts that we are on the right track. While speed is of the essence for the EU, like other regions across the globe, safety and transparency are also of the ultimate priority. Ensuring the public is well informed about the vaccine, the procedure for its authorization and where we are at in terms of distribution is imperative to ensure a holistic approach to the current pandemic. Ensuring that no person, or place is left behind must be one of our top priorities to also ensure that everyone in our societies is given a fair chance to benefit from these scientific developments.
As a Member of European Parliament, I will continue to do my duty to help disseminate timely and transparent information about the vaccine and the efforts being made at EU level. As an elected official, I will also continue to be part of the negotiations moving forward with regards to new vaccines which could arrive at the EMA for authorization in 2021- and then, as I have now, I will ensure that regional access for smaller or more remote regions is made a priority on the European Union’s agenda.
Cyrus Engerer is a Labour MEP