The US is temporarily halting giving this vaccine, pending further study, because of the potential danger of blood clots. Six women developed a rare form of blood clots after receiving this vaccine and one died.
The acting FDA chief, Janet Woodcock, said: “We’re recommending this pause while we work together to full understand these events.” The decision was taken in coordination with the CDC.
US health agencies have recommended states pause the administration of the Johnson & Johnson coronavirus vaccine, after reports of rare and severe blood clots emerged in six women. More than 6.8m doses have been administered nationally.
The concerns mirror those of drugs agencies in Europe and Australia over the AstraZeneca vaccine, which has not been authorized in the US. There have been no significant safety concerns raised about the two other vaccines that make up the majority of US supply, from Pfizer-BioNTech and Moderna.
Woodcock said: “Right now, I’d like to stress these events appear to be extremely rare. However, Covid-19 vaccine safety is a top priority for the federal government. We take all reports of adverse events related to the vaccine very seriously.”
The FDA and CDC said in a joint statement: “People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their healthcare provider.”
Over six million J&J vaccines have been given so the incidence rate of clotting is tiny, smaller than the risk of getting seriously ill by contracting covid-19. It is not yet clear if the vaccine is even the cause of the clotting. So why the pause?
One can understand the problem for the FDA and CDC. When they learned of the clot cases they had to reveal its existence for the sake of transparency. Hiding such information is never a good idea because not only would it be wrong but because if it gets out (and you can be pretty sure it will), that will ruin any credibility that these organizations have built up with the public. But once you reveal the existence of the potential problem, your options become limited. You cannot just announce the problem and do nothing. If you pause the use of the vaccines saying that you are going to study the issue, it makes people comfortable that you are talking safety seriously. On the other hand, it will likely increase vaccine hesitancy, especially among those who were already on the fence. And it gives also more ammunition to the anti-vaxxers. But I think they had not choice but to announce the pause until they have looked more closely at the evidence.
As I mentioned some time ago, I received the Johnson & Johnson vaccine, so I was interested in this news but not particularly worried. Partly this is because I received mine five weeks ago, past the time window of three weeks that people are supposed to be alert for clotting symptoms and I also have not had any of the associated symptoms. But also partly because at my age there are a whole host of small risk items from which I could die on any given day. This is just one more to add to the list, hardly worth losing sleep over.
Risks need to be evaluated compared with other risks and for me the risk of getting covid-19 outweighs the risks of the vaccine. And the conclusion of the experts is still the same: take the first vaccine you are offered.