EU Regulators Determine J&J Vaccine Is Safe (Enough)
In an ideal world, vaccines would only prevent diseases and not also cause them. In an ideal world, a vaccine would be categorized as “effective” or “not effective” and not as “relatively beneficial.” Unfortunately, the world is far from ideal and far more complex.
The European health regulators faced the same difficult question for the second time in recent weeks: Which outweighs the other: the risks of the Covid-19 vaccine or the risks of the disease?
After cases of serious and unusual blood clots in people who were vaccinated with the Johnson & Johnson Covid-19 vaccine were reported in the U.S., the company decided to “proactively delay the rollout in Europe.” This was not the news Europe was hoping to hear.
Europe needs vaccines, and it needs the J&J vaccine. A one-shot vaccine that is relatively easy to distribute might very well be the game-changer Europe was waiting for in order to turn things around and accelerate its controversially slow vaccination campaign.
The EU had ordered 55 million doses to be delivered through June, and a total of 200 million doses through the end of the year. In early March, J&J warned Europeans that it might not meet the delivery schedule due to supply issues. This prompted concern.
Then came the blood clots and the “proactive delay.” The EMA, the European regulator, wanted to solve the issue safely but also quickly and thus expedited the investigation of the matter.
Some European countries, like Belgium and the Netherlands, announced they will not administer the vaccine until more information is given. Most other countries said that they are planning to go forward with administering the J&J shot unless directly instructed otherwise.
It took one week for the EMA to reach a conclusion. Some Europeans are saying that the experience with the same blood clots issues found in AstraZeneca’s vaccine helped speed the process along as the EMA was already experienced with this sort of risk issue.
The conclusion is complex, and not one out of an ideal world. According to the EMA, there is a possible link between the J&J vaccine and rare cases of blood clots and low blood platelets. However, the agency weighed the potential risks with the vaccine’s benefits and determined it is safer to be vaccinated with the J&J vaccine than to be infected with Covid-19.
The EMA approved the vaccine and concluded that the vaccination campaign should proceed as planned.
“I have to stress again that [these side effects] are very rare, and that, in the vast majority of cases, these vaccines are going to prevent death and hospitalization from Covid-19,” the head of the EMA said in a press briefing.
The EU health commissioner, like other EU leaders, celebrated the decision.
While the “all clear” ruling is naturally good news for Europe, it is important to bear in mind that countries throughout the continent are now facing different levels of the pandemic, and so not every country is poised to evaluate the benefit-risk ratio in the same way.
That is why while most EU countries resumed administrating the AstraZeneca vaccine, Denmark decided to completely stop its rollout. It has been reported that Denmark is now seeking to swap its shelved AstraZeneca vaccines with other countries.
With their infection level dropping to one of the lowest rates in the continent and with the vaccine campaign going relatively well, Denmark's benefit-risk ratio for the AstraZeneca vaccine isn’t the same as, let’s say, that of struggling France.
The Danish example goes to show that even with the EMA’s guidelines and recommendations, it is up to the individual country to decide whether or not to use a specific vaccine. There isn’t one clear answer to that question.
The EMA issued the J&J vaccine the green light but did so with a small blinking warning sign.