The UK has its own medicine agency, the MHRA, and you can use it. Until now it did not usually do so due to the joint policy of the European Union.
Although Spain also has its own drug agency (the Spanish Agency for Medicines and Health Products), in this country only what is authorized in Europe is approved. However, the country behind Brexit, being outside the European system as of December 31 of this year, can follow its own regulation without strings attached.
In the United States, the FDA (Food and Drug Administration) is more closely related to what is decided in the European agency, the EMA (European Medicines Agency). These two entities have decided not to start vaccination until the results of clinical trials are evaluated and the raw data are reviewed.
Is this vaccine safe?
MRNA vaccines, such as Moderna’s and Pfizer’s, have not produced serious adverse effects, so far. While adenovirus vaccines, such as AstraZeneca / Oxford, have been reporting several adverse effects.
In these vaccines the safety is already proven. But you don’t just have to look at safety, but also efficiency. That is, you have to ask yourself: Is it useful for what we have prepared it for? Will it be used only for asymptomatic people? And for serious cases?
It should be borne in mind that clinical trials are carried out with healthy people, patients are almost never included. In fact, in the case of Pfizer they have not been included, or at least they have not disclosed this data.
Therefore, when making a decision, we must pay attention to these two concepts and wait until the end of the clinical trials. However, companies have priorities and probably in the United Kingdom the decision has gone hand in hand with a political issue, in which the urgency has favored the regulatory agency to go faster.
A hasty decision could have dire results
It is disturbing to think that this decision could have a terrible effect. Vaccines have always been trusted in Spain. In fact, anti-vaccine movements are extremely low. But news like this could create the opposite effect.
That is, people who previously relied on vaccination to preserve global health may begin to fear doing so now. They may think that things are not being done well.
In the European case, the European agency has confirmed that it will wait three more weeks for experts to evaluate the results of clinical trials. It may be that this implies having to work 24 hours a day, because we are facing an emergency situation. But until they have all the raw data together, they won’t evaluate it.
This is the right decision, why? Because if we don’t do it like that, we will give the public the image that all the rules can be changed. They will think that these vaccines are not that safe. With this decision, the anti-vaccine movements can grow and cause people who were not afraid to get vaccinated now do.
It is important that the population know this information since safety is not really what is being evaluated now. This is evaluated in the early stages. Efficacy is now being studied. In other words, it is intended to determine what and for whom it will be useful.
The vaccine will not end the pandemic
Having a vaccine does not mean that the pandemic is over. It will be a global issue. So far we have generated very little group immunity. In fact, in the places where there has been more immunity, such as Madrid, we have not had more than 12%.
That is why it is important that the media, politicians and health workers do a good education and report that having a vaccine does not mean that the virus is gone. We must continue to maintain the distancing measures, masks, etc. The vaccine prevents, but does not prevent 100% or eliminate the virus, it is not an antiviral drug.
For the coronavirus pandemic to end, we will have to wait until we all have good immunity. With vaccines we will achieve it faster. We need to realize that health is not something individual. In the case of vaccination, health is something collective.
A European decision
This is the reason why in the European Union we do not want to have different regulations on a health issue like this one. All the countries of the European Union are very close. As soon as a wave starts, it quickly spreads to other countries. The virus does not care if you are in Madrid, Berlin or Paris.
Therefore, all decisions related to the vaccine must be unified, as we are continuously trying to unify our own health system. If we don’t do it that way, we won’t make it.
When will the vaccine arrive in Spain?
The vaccine will arrive in Spain when the EMA evaluates it. That is, it is expected to be in three weeks, which is when the clinical trial ends. At that time we will have all the data and the evaluators will study it. They will do it in record time, yes. But they will evaluate everything together. In the UK they are only evaluating partial things, not to wait three more weeks.
Safety has to come first because we are causing people to stop believing that getting vaccinated is safe. The UK’s decision has been too hasty. They didn’t mind waiting three more weeks.
Carmen Álvarez Domínguez, Biochemist and molecular biologist, professor of Health Processes at the Faculty of Education and researcher in Immunotherapy, UNIR – International University of La Rioja
This article was originally published on The Conversation. Read the original.
