By now you have heard that administration of the Johnson and Johnson vaccine has been paused in most US locations due to a rare side effect of blood clots, pending further investigation. The AstraZeneca vaccine has also been dogged by reports of rare side effects. It has not been approved in the US, though we have several million doses stockpiled. The administration has "lent" doses to Mexico, where the Astra Zenica is the most common vaccine.
It is feared by public health officials that news of the problems with vaccines will fuel vaccine hesitancy. But it seems fairly obvious that the worst thing the government and the manufacturers of the vaccines could do is to hide the data, or obfuscate about the problems.
There is an ethical dilemma of what should be done with the vaccines with the negative publicity. Should they be shared with countries which have already given approval, and which need them? Or is it a matter that countries such as the US, which have the less problematic Moderna and Pfizer vaccines will be seen as palming off the ones perceived as of lesser quality on poorer countries?
This article has some good charts and statistics outlining which countries are using which vaccines, and how many have been vaccinated so far. By far the Astra Zeneca is out in front as to number of countries using it, at 110.
This article on global vaccine efforts has a good chart comparing efficacy of the various vaccines used worldwide. The highest for efficacy are the Moderna and Pfizer at 95%. Only the Sinovac, which is one of those used in China, has a relatively poor rating of around 50%. Even with the problems, Johnson and Johnson is rated at 61-72%, And the AstraZeneca at 62-90%. Objectively speaking, the protection provided is greater than the relatively small risk.
My understanding is that only women have had the problem. If so, then couldn't the J&J could still be administered to men? But that sounds too straightforward, I guess.
ReplyDeleteI wonder if there is something about women's biochemistry predisposing them to the blood clots. It also seems to happen to relatively young people. Blood clots are also a complication of Covid itself.
DeleteMy guess is, it's from an exagerrated immune response which correlates with women having a stronger immune system. Also, younger people have stronger immune responses. The 1918 pandemic killed more younger people due to their overresponsive immune systems.
DeleteIt is possible, and I am guessing also likely, that the government will examine the prevalence of the clotting and determine that J&J vaccine doesn't pose an inordinate risk. In that case the pause could end n
ReplyDeleteI'm guessing that will be the likely outcome also. I think the government had to avoid anything that looked like a cover-up, and figured a pause would be least corrosive to public trust.
DeleteI think the main reason for the pause is to educate the medical community toward greater vigilance in detecting and responding to the symptoms when they resume.
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ReplyDeleteThe information that there is a one in a million chance of a serious side effect is not really much news. Many of the medications that we take probably have that information listed in their fine print.
ReplyDeleteThat information needs to be known by medical personnel that are treating people who have received this vaccine. However beyond informed consent, it is not very worthwhile for the average patient to know this. There is always the possibility that patients will decide they will not take a particular medication or be vaccinated. That is the cost of informed consent. Personally I prefer to be informed since I can always choose not to read the fine print.
The information that we are pausing the use of this drug while reviewing and evaluating the data is news. Unfortunately it suggests to many Americans that they should also pause and evaluate whether or not they should be getting any vaccine, or at least this specific vaccine.
Maybe we need something like a one month (or more) caution period, a yellow light rather than a red light, in which physicians and patients would be invited to be extra careful in using the vaccine. Perhaps that would provide everyone with a sense of ownership in the monitoring and decision making.
Sorry, republishing my comment as my first attempt didn't format the excerpt correctly:
ReplyDeleteHere are a couple of excerpts from The Dispatch's daily enewsletter:
"... across the country, we’re starting to hit that inflection point where our quest for herd immunity will have more to do with vaccine demand than vaccine supply. And a development yesterday [i.e. the pause in administering the J&J vaccine] has the potential to dramatically affect uptake among the vaccine hesitant ...
"Looking just at the topline numbers—six cases of clotting out of 6.8 million doses, with only one being fatal—a nationwide pause may seem like overkill. The CDC reported 38,659 motor vehicle traffic deaths in 2018; you’re nearly 800 times more likely to die in a car accident driving to get your vaccine than from a blood clot after receiving it. And yesterday alone, 893 deaths were attributed to the disease from which the vaccine offers protection.
"But that calculation disregards some important context: If the affliction does primarily affect younger women, the key denominator is not 6.8 million but something much smaller. And because the data show the clotting manifests six to 13 days after vaccination—symptoms include severe headache, abdominal pain, leg pain, and/or shortness of breath—the number of reported cases could rise above six now that recipients know what to look for.
"And that, ultimately, is why the regulators made the decision. “The reason to pause is to say, ‘Is it really at this very low rate, or are there some that we’re missing?’ Because that would change the risk-benefit calculation,” Dr. Megan Ranney, an emergency physician and health policy professor at Brown University, told The Dispatch. The suspension will also provide time to establish how to treat these clots nationwide. “You don’t treat [them] the way that you would treat a regular blood clot,” Ranney said. “You have to treat it a little bit differently because of the low platelets.”
"“The issue here with these types of blood clots is that if one administers the standard treatments that we, as doctors, have learned to give for blood clots, one can actually cause tremendous harm or the outcome can be fatal,” Marks told reporters. “So one needs to make sure that providers are aware that if they see people who have low blood platelets, or if they see people who have blood clots, they need to inquire about a history of recent vaccination and then act accordingly in the diagnosis and management of those individuals.”"
Thanks for the excerpts, Jim. It makes sense that the doctors need to be aware how to treat it. Hopefully it is just a temporary glitch, and people aren't scared away from vaccination. Especially since the J&J is only like 5% of the total number of people vaccinated.
DeleteSeems like the hardest problem to solve is getting vaccine to the developing countries.
From the NYT, as the CDC advisory committee fails to find any quick answer:
ReplyDeleteAlready, doctors say, the recent pauses have heartened vaccine skeptics and made many others feel duped.
“People, especially those who were vaccinated, felt like they had been tricked in a way — they were asking, ‘How do we get rid of the vaccine in our body?’” said Precious Makiyi, a doctor and behavioral scientist in the Eastern African nation of Malawi, where health workers have been racing to empty their shelves of nearly expired AstraZeneca doses. “We fought so hard with vaccine messaging, but what has happened this past week has brought us back to square zero.”
In developed countries, too, the Johnson & Johnson woes could erode public confidence. The vaccine is considered ideal for rural and underserved communities because it requires only one shot and is easier to store.
Advisory meetings usually end with a vote on whether or how to use a vaccine. But in this case, the members declined to vote after reviewing several options, including whether to limit use of the vaccine to older adults, saying that they did not have enough information to assess the potential risks.
Addressing the panel, Dr. Camille Kotton of Harvard Medical School warned that losing the Johnson & Johnson vaccine even temporarily represented a big blow to efforts to stop the pandemic, especially in underserved communities.
“Putting this vaccine on pause, for those of us that are frontline health care workers, has really been devastating,” she said.
Professionalism, like clericalism, is a pervasive phenomenon. These people show distain for the public. They think that we should all wait on their decision, then do whatever they tell us to do.
I once read a good article in a major medical journal that argued that each of us is our own primary diagnostician and primary caregiver. Each of us decides whether or not to ask a physician to diagnose us, and then whether to accept that diagnosis or not. Similarly with regard to treatment. Each of us decides whether of not to accept the treatment and/or whatever other treatments we decide to use. People consult a wide variety of sources of information, both formal and informal. In other words the medical profession needs to understand who really is running the show, and behave with a little more humility toward the real decision makers.
Well yes, we are our own decision makers. However...we all know there would be lawsuits against the vaccine manufacturers and the governments if they green-lighted the J&J and people were harmed. Even if it was caused by something else. I don't remember if it was Jack or Jim P. who suggested a "yellow light" approach. That makes sense, but the hesitant would still be hesitant. And the litigenous would still be litigenous if there were problems. This was a setback, but probably a necessary one.
Delete"Litigenous"... I think I might have made up a word there. Anyway, I meant someone who is likely to bring a lawsuit against a person or entity.
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