The fate of Johnson & Johnson’s one-shot vaccine was decided on Friday, and is there enough data to meet with a committee of the US Centers for Disease Control and Prevention to determine if it is safe to resume its use? I will consider it.
Options include full resumption, age and gender restrictions, or an extension of the current suspension, casting a shadow over safety.
The vaccine has been promised to be a breakthrough for hard-to-reach communities, from isolated ranch towns in eastern Sierra to homeless shelters in San Francisco. However, of the 6.8 million people vaccinated with Johnson & Johnson, after the federal government reported six rare health problems (severe stroke-like blood clots with decreased platelet counts). The distribution has been suspended. Similar reactions were seen with the European AstraZeneca vaccine, which uses a similar approach.
The risk of this side effect is 0.008%, which is lower than the risk of being struck by lightning when driving to the injection site, said Dr. John Swartzberg, an infectious disease expert at the University of California, Berkeley.
“It would be a shame if people were delayed in getting vaccinated because they didn’t want to get the J & J vaccine and then got sick with COVID, which is a much bigger risk,” he said.
For 10 days after the vaccine was shelved, experts have examined the data to confirm the link between the vaccine and blood coagulation disorders. They reached out to warn all American health departments and doctors. And they are competing to understand the underlying problem.
Meanwhile, European countries are preparing to resume their use this week after EU drug regulators approve the firing. Some countries are expected to impose age restrictions.
Friday’s recommendations by the CDC’s Advisory Committee on Immunization and Implementation (ACIP) are non-binding, but guide the implementation of state and local health departments, as well as individual physicians.
We asked a local expert to explain the process.
Q: Q: All of these J & J vaccines are kept while people get sick with COVID-19. Why did ACIP take 10 days?
A: The biggest thing that’s happening is … waiting. ACIP needed more data. And the only way they could get more data was to get more time. After vaccination, it seems that it takes 1 to 3 weeks for blood clots to develop. However, about half of all J & J doses were given within the last two weeks of ACIP’s first meeting. Therefore, we needed at least another week of data.
They needed to see if more cases would come out next week. They didn’t want to be surprised by the sheer number of new cases.
They also inform the medical community about the clinical symptoms of this disorder, what it looks like. And how to treat the patient or not, and how to report the case. They needed to make sure that all public health departments in all states and counties had the proper protocols.
— John Swartsburg, MD
Q: Q: What kind of data are experts looking for?
A: It is important to know the frequency of this rare coagulopathy in the general population — so we know if it is associated with a vaccine. There is no such data.
This disorder may have nothing to do with the vaccine, it’s just a coincidence. Perhaps we were so careful about the safety of these vaccines that the association was formed.
One approach to creating the data is to dig retroactively into the literature to see how many case reports are there. Next, try some estimation of the possible range of cases in unvaccinated people.
Another approach is to see if this is happening with the Pfizer and Moderna mRNA vaccines. That is our “control group”.
— Joel Ernst, MD, Professor of Medicine, Dean of Experimental Medicine, University of California, San Francisco
Q: Q: What warned the CDC of the problem?
A: The events that caught people’s attention were the somewhat unusual symptoms of low platelet counts and abnormal positions of blood clots, as well as low platelet counts. Most blood clots are on the human foot. In these cases, they were in the veins of the head. It’s a much rarer place.
It was a similarity between this collective discovery of thrombocytopenia and blood clots in interesting places and the case of AstraZeneca outside the United States.
This strange collection of blood clots in an abnormal location low in platelets has been described in several other medical situations. One of them is associated with a problem called heparin-induced thrombocytopenia (HIT). However, these people did not take heparin.
— Andrew Leavitt, MD, Director of UCSF Program for Non-Cancer Blood Diseases
Q: Q: Is there a theory about the cause?
A: There is this hypothesis that there are other negatively charged molecules such as heparin that can cause this problem. Therefore, clinicians searched for and tested the types of autoantibodies that people form when they undergo HIT. And these people had them — antibodies against a protein called platelet factor 4.
The big question is what are the negatively charged molecules that interact with platelet factor 4 and allow the production of new antibodies? Is it part of the patient’s immune response? Is it something in the vaccine itself? No one knows, but it’s clearly an important focus of the investigation.
— Andrew Leavitt, MD
Q: Q: Why does your body make these antibodies?
A: That’s because the immune system isn’t always fully regulated and makes antibodies to what it shouldn’t. That may be what is happening here.
And testing for those antibodies is not widely available. It’s pretty professional. It is not something that a practitioner can send a tube of blood to the lab and get the answer back in a day or two.
And the cost of testing is very likely to exceed the cost of vaccines. If the frequency is one in a million, you are stealing resources from other, more likely problems.
— Joel Ernst, MD
Q: Q: What can we learn from these patients?
A: Understanding the mechanisms that trigger a response to a vaccine is very important from a diagnostic and therapeutic point of view. However, understanding the mechanism is not as urgently important as trying to understand the epidemiology of this phenomenon.
For example, what can we learn about patients who may suggest risks to other people in the way they are vaccinated? Perhaps being a man may put you at less risk. Or being a menopausal woman. There may be something in common about the particular medications people were taking. Or a specific underlying disorder.
— John Swartsburg, MD
It’s been 10 days. Do we know what’s causing J&J vaccine side effects? – Times-Herald Source link It’s been 10 days. Do we know what’s causing J&J vaccine side effects? – Times-Herald