"Safe and effective": Johnson & Johnson vaccine gets green light ... in Europe

A rare COVID-19 vaccine moment in which the EU pulls its collective head out of its nether regions more quickly than the US. After reviewing the data on Johnson & Johnson’s vaccine and the one-in-a-million risk of blood-clot complications, their FDA equivalent gave it the green light to proceed with inoculations. The US, meanwhile, is still reviewing the same data while millions of doses stand by:

European regulators on Tuesday said the coronavirus vaccine made by Johnson & Johnson should carry a warning about rare blood clots, but they placed no restrictions on the use of the vaccine inside the European Union.

The decision by the European Medicines Agency was based on the same U.S. data that led American regulators last week to pause the use of the vaccine inside the United States.

Johnson & Johnson said after Tuesday’s announcement that it would resume distribution in Europe. But the U.S. hold remains in place as American authorities make an independent evaluation. …

The European regulators said Tuesday that unusual blood clots with low blood platelets should be listed on the packaging of the vaccine as “very rare side effects,” but they took no further action. The regulators assessed that, overall, the vaccine is safe and effective.

The EMA actually believe they found a link between the vaccine and the blood clots, they told reporters.  Their safety committee announced that warnings had to be issued to anyone with low platelet levels, which appear to be the slightly higher risk set. However, the benefits of the vaccine far outweigh the risks, especially since COVID-19 itself has a far higher incidence of blood-clot complications than the vaccine:

BEAUBIEN: Yeah, so this safety committee from the European Medicines Agency – they looked at all the data they could find on these blood clots. And that included eight cases from the United States, one of which was fatal. And they determined that, yes, there does appear to be a link between these unusual clots and the Johnson & Johnson vaccine. But it’s really rare. The rate is about one clot occurring in every 1 million people who get vaccinated. Emer Cooke – she’s the head of the European Medicines Agency. She pointed out today that the world has just passed 3 million deaths from COVID, and tens of thousands of people are getting infected with it every day in Europe.

EMER COOKE: I don’t need to tell you that there is untold human suffering behind all of these cases, and these vaccines play an immensely important role in combating this pandemic.

BEAUBIEN: And that was really their central argument. She says the benefits of getting people vaccinated against COVID far outweigh the risks from the Johnson & Johnson vaccine from what they’ve seen. …

BEAUBIEN: Yeah, and they talked about that, and they’re looking at that. And it’s true that of these eight cases, seven of the eight are women. The median age was 33. The regulators, however, said, you know, at this point, this is just too small of a data set. They just don’t have enough numbers, they feel, to be able to say, look; it should only be used with this group, or this vaccine should only be used with men. But they did say that they are seeing some clear patterns with these clots. They tend to hit a week or two after vaccination. The person shows stroke-like symptoms, so they’re recommending the clotting condition be listed as a side effect of this vaccine. And they’re saying health care workers should be monitoring for these rare symptoms. And if they do occur, they have guidance on how to treat the clots, which they say can greatly improve a person’s recovery.

In other words, the EMA used risk-benefit analysis properly, if slightly belatedly, in relation to the vaccine. A one-in-a-million risk for blood clotting is a risk, but the transmission and death rates for unvaccinated people for COVID-19 are far, far higher. A fatality rate of 0.2%, which is on the lower end of estimates for COVID-19, means two deaths for every thousand people, and therefore 2,000 for every million. In contrast, there has been just one death associated with the J&J vaccine in nearly seven million inoculations. And it’s still not yet clear that the vaccine was the cause of the death or merely correlative.

Even on blood clots, the risk is higher without rather than with the vaccines. An Oxford study of real-world data showed that an acute COVID-19 infection is 95 times more likely to result in blood-clot complications than in normal conditions, while the risks of all vaccines are at 8 cases per million or lower. That data suggests that you’re more likely to prevent blood clot issues by taking the vaccine than by refusing it, especially if you end up getting exposed to COVID-19.

This is the risk-benefit calculation that should have been immediately applied, both here and in the EU. The fact that the FDA still hasn’t lifted its “pause” recommendation shows that the US has become so risk-averse that it ends up perversely putting more people at risk due to analysis paralysis than by the safe and effective vaccines it helped develop.