The medicine can never be worse than the disease, but when it comes to launching experimental vaccines of which the public knows very little, governments and pharmaceutical companies could care less about safety and effectiveness.
The authorization granted by the United Kingdom to the first vaccine against covid-19 is not as complete as the one that the European Medicines Agency will give in less than a month.
The UK and the EU have different procedures when evaluating and permitting the circulation of medicines, especially those in experimental phases.
Ironically, in the UK and the U.S., the authorization of experimental vaccines will be aimed at the most vulnerable populations, those with more compromised immune systems, and those who, therefore, could suffer more with the unexpected side effects that experimental vaccines can have.
Little has been talked about in terms of COVID vaccines and their side effects.
One of the most important things about vaccines and biological medicines is to ensure that the batches are the same, that when you manufacture them they always have, for example, the same amount of antigen.
In these highly complex molecules, where it is so easy for messenger RNA to degrade, small variations could lead to changes in effects.
In emergency use, you still do not have all the data on the medicine, but you do have partial data and since you are in a serious situation, in this case in a pandemic, even lacking data should not be enough to authorize experimental vaccines such as those of Pfizer and Moderna.
The legislation that allows it is common to the rest of European countries. Another difference is that a marketing authorization of a product rests with the company, while so-called “compassionate use” is exempted of responsibility if they cause damage because it is not an authorized drug, but one that is allowed to be distributed due to the pandemic situation in what is called a risk-benefit analysis.
In a situation in which epidemiologically it does not seem that we are going to get worse, advancing vaccination by a week or two, without knowing potential risks, represents very little benefit.
All drug decisions are based on that relationship. A very large risk can be accepted if you are going to have a profit that exceeds it. That is how pharmaceutical companies function: profits over health.
Similarly, with a very small benefit and no risk you can also take it, but with an uncertain benefit, and with two weeks to a full authorization, taking that risk does not seem very justified. And an authorization granted in the same way as other medicines helps to generate more trust in people.
What has been done in the UK is what politicians tend to do out of habit: be negligent.
Meanwhile, the European Medicines Agency defends its slower evaluation of the vaccine: “It is the most appropriate mechanism.” The EU supports a procedure that requires a “level of evidence and controls” higher than the emergency for which London has approved the prototypes of Pfizer and BioNTech.
The European Union has come out in a storm to defend its mechanism for the approval of covid-19 vaccines against the speed shown by the United Kingdom.
London gave the green light to the commercialization of the prototype from the Pfizer and BioNTech laboratories, activating a controversial national emergency mechanism.
On the other hand, the European Medicines Agency (EMA), the body in charge of giving the go-ahead to new vaccines in the EU, will not meet its committee of experts to make a decision on these same points until December 29, almost one month after.
The EMA, based in Amsterdam, was the first to defend the rigor of its work in the face of the rush in a statement of unusual forcefulness.
“The EMA considers that the conditional marketing authorization is the most appropriate regulatory mechanism during the emergency of the pandemic,” it has responded in reference to its evaluation mechanism, according to Reuters.
The European Health Commissioner, Stella Kyriakides, has also spoken out firmly, defending that it is the procedure that requires a “level of evidence and controls” that the emergency level that London has used lacks.
“It is crucial that we make sure that the vaccines that we approve and commercialize in the European market are safe and effective,” she said after a meeting by videoconference with the 27 EU Health Ministers, in which the matter was discussed.
The organization added that the European regulator will not shorten the deadlines and will take the “time it needs” to issue its scientific evaluation.
With the British decision, the EU is suddenly faced with one of the scenarios it tried to avoid when it launched a joint vaccine strategy in June to avoid fragmentation, imbalances and the embarrassing global push that was experienced with medical supplies in the dawn of the pandemic.