London grants drug companies immunity in exchange for vaccinating earlier

Somewhat slower, but also more secure. While Russian citizens receive the first Sputnik V vaccines and the same happens in the United Kingdom with those of Pfizer, the European institutions defend their authorization model as the most rigorous and reliable. According to the latest calculations by the European Medicines Agency (EMA), Pfizer’s vaccine will receive the green light on the 29th, after an extraordinary meeting of its expert committee, and Moderna’s will have to wait until January 12. This means that until the first days of 2021 the citizens of the most vulnerable groups of the Twenty-seven will not have access to the antidote.

Does British speed have something to do with Brexit? Not really. Despite the fact that the vaccine is being used for propaganda purposes, it has only chosen an emergency procedure that is available to all countries that want to use it. It is the same possibility that Hungary has taken advantage of to supply under its responsibility the Russian vaccine Sputnik V, which is not part of the pre-purchase contracts signed by Brussels with a total of six laboratories.

Although the British Isles left the bloc on January 31, 2019, during the transition period that expires on December 31, the country is in a legal limbo for which it must continue to apply community law, but without being able to be part of its decisions. London has decided not to participate in the centralized vaccine purchasing system led by the Commission and to which the 27 members have joined, and in this case the United Kingdom has also signed a purchase contract with Pfizer on its own.

London has opted for an emergency validation system allowed by the EMA, while the rest of the countries have preferred to follow the “conditional commercialization” process which, although somewhat slower than the one used on the other side of the English Channel, also it is used in special situations. It means that the green light will come with less data than is collected in a traditional process, as European experts consider that the benefits outweigh the risks.

This authorization will be valid for one year and then must be renewed for the vaccine to remain available. Normal procedures consist of a 5-year authorization. Diplomatic sources explain that the agency has been in permanent contact with the laboratories in the testing process and that this allows for faster deadlines. The EMA has published a report with data from July 2006 to June 2016. During this period, 30 drugs have been marketed with this conditional procedure and none have been withdrawn due to adverse effects.

After the EMA’s verdict, the European Commission will endorse this green light in just three days, when in normal situations it usually lasts up to 67 days, which includes consultations with the States. This will be possible since the translations into the 23 official languages ​​of the European club, with all the scientific information on the vaccine, will be carried out after the green light and not before, as usual.

Why is this process safer than the one used by London when we are talking about the same vaccine? First of all because of the legal consequences. According to European diplomatic sources, the British emergency procedure exonerates the laboratories of all civil responsibility for the authorization, since it falls on the country and not on the companies. Despite this, the pharmaceutical companies will have to answer for the rest of the legal consequences in case of damages due to the use of the antidote. Second, this conditional validation of the EMA forces laboratories to continue providing information on the medium-term consequences of their tests. Thus, it is possible to act in case of side effects in some population group, which will allow knowing the duration of immunity.

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