Johnson & Johnson, AstraZeneca and the University of Oxford have begun investigating whether adjusting their COVID-19 vaccines could reduce or eliminate the risk of rare, deadly blood clots.
First reported by The Wall Street Journal, sources say scientists are working to identify the causes behind the blood clots and possibly redesign the shots to be distributed by next year.
Both the J&J and AstraZeneca vaccines have been linked to clots, along with a condition with a low platelet count known as thrombocytopenia, which researchers have termed vaccine-induced immune thrombocytopenia (VITT).
A J&J spokesperson told The Journal that the New Jersey-based company “supports ongoing research and analysis as we work with medical experts and global health authorities,” but did not answer specific questions about the early stage of research.
An AstraZeneca spokesperson explained, saying the company is “actively working with regulators and the scientific community to understand these extremely rare blood clotting events, including information to encourage early diagnosis and intervention and appropriate treatment.”
While it’s unknown if the vaccines can even be modified, it could lead to changes in proprietary rights or regulatory approval, the paper reported.
The news comes just a day after it became known that the US Food and Drug Administration (FDA) is adding a new warning to the label of J&J’s vaccine due to the risk of a rare autoimmune disease.
Johnson & Johnson (left) AstraZeneca and the University of Oxford (right) have begun investigating whether their COVID-19 vaccines could be modified to lower the risk of blood clots, along with low platelet counts known as thrombocytopenia
Scientists hope to identify the causes behind the blood clots and perhaps retake the shots next year
Both AstraZeneca and J&J immunization are known as viral vector vaccines.
They combine genetic material from the new virus with the genes from the adenovirus – which causes the common cold – to elicit an immune response.
The shots were considered game-changers because they don’t need to be stored in freezing temperatures like the Pfizer-BioNTech and Moderna vaccines.
In addition, because J&J’s vaccine only requires one injection, it was expected to be used to inoculate difficult-to-serve populations, such as those living in rural areas and seniors who live in home.
The ability to modify their vaccines to eliminate the risk of blood clots could increase confidence in the shots.
In April. the J&J vaccine was interrupted for 10 days by the Centers for Disease Control and Prevention (CDC) and FDA after six women under the age of 50 developed Cerebral Venous Sinus Thrombosis (CVST), a rare blood clot that forms in the venous sinuses in the brain .
The women developed CVST in combination with thrombocytopenia.
In the US, J&J’s vaccine is linked to 0.3 cases of rare blood clots per 100,000 doses of the 12.8 million injections administered, and AstraZeneca’s injection is linked to 1-2 cases per 100,000
This figure was later updated to include 28 people, including a 45-year-old woman who died.
The pause was lifted and the FDA added a warning to J&J’s coronavirus vaccine that rare blood clotting events could occur, primarily in women under the age of 50.
Data from the CDC suggests that the clotting rate is about 0.3 cases per 100,000 doses of the J&J vaccine.
Meanwhile, in April, the European Medicines Agency’s Safety Committee ruled that blood clots with a low platelet count should be listed as a very rare side effect of the AstraZeneca-Oxford vaccine.
According to data from the UK and Europe, the rate of blood clotting with the AstraZeneca vaccine is slightly higher, about one or two per 100,000 doses.
Several countries, including the UK, have recommended that people under the age of 60 be vaccinated with other vaccines because their risk of blood clotting is higher.
Earlier this year, German researchers from the Goethe University of Frankfurt and the University of Ulm, in Helmholtz, believe the problem lies in the adenovirus vector, the common cold virus used so that both vaccines can enter the body.
They believe that in some people, the immune system sees the vaccine as a threat and makes too many antibodies to fight it.
These lead to the formation of clots in the blood, which can become deadly if the clots travel to vital organs and cut off the supply.
“The companies are making rapid progress and I think their desire to change the vector or vaccine is parallel to explaining.” [the clots]said Dr. Mortimer Poncz, chief of the pediatric hematology division at the Children’s Hospital of Philadelphia, told The Journal.
Recently, both J&J’s and AstraZeneca’a vaccines have been linked to Guillain-Barré syndrome, a rare autoimmune disease in which the immune system attacks the peripheral nervous system, temporarily paralyzing parts of the body.
On Monday, The Washington Post reported that the FDA is adding a warning to the J&J label about the condition.
The CDC said it has received about 100 preliminary reports from Guillain-Barré following the single-dose vaccine
Most cases have occurred about two weeks after vaccination and mostly in men 50 years and older – and this has not been seen with the Pfizer-BioNTech or Moderna vaccines.
And a report of the American Neurological Association in June detailed 11 cases of patients who developed Guillain-Barré after receiving the AstraZeneca vaccine.
Q&A: EVERYTHING YOU NEED TO KNOW ABOUT COVID VACCINES AND THEIR SMALL RISK OF BLOODS
IS THERE ANY EVIDENCE THAT THE JAB CAUSES THE BLOOD CLOTS?
Scientists have repeatedly insisted that there is no evidence yet that coronavirus vaccines cause the extremely rare complication: blood clots that occur alongside low platelets.
But officials are still investigating the link — found in recipients of both AstraZeneca and Johnson and Johnson’s vaccines — and can’t rule it out completely.
DO SCIENTISTS HAVE A THEORY FOR WHICH THE CONNECTION MAY BE?
Experts are baffled as to why the vaccines can cause blockages in very rare cases.
But researchers in Germany believe the problem lies in the adenovirus vector — a cold virus used so that both vaccines can enter the body.
Academics investigating the matter say the complication is “completely absent” in mRNA vaccines like those from Pfizer and Moderna because they have a different delivery mechanism.
Experts from the Goethe-University of Frankfurt and the University of Ulm, in Helmholtz, say the AstraZeneca vaccine penetrates the cell nucleus – a blob of DNA in the middle. In comparison, the Pfizer jab enters the liquid around it which acts as a protein factory.
Pieces of coronavirus proteins entering the nucleus can break apart, and the unusual fragments are then expelled into the bloodstream, where they can cause clotting in a small number of people, scientists claim.
WHAT SYMPTOMS DO THEY CAUSE?
The EMA said symptoms can strike up to three weeks after vaccination.
UK regulators say the complication usually occurs four days after people are first stung.
Symptoms of the two blood clots can include:
- shortness of breath
- swollen legs
- Persistent stomach pain
- Severe or persistent headache
- Blurred vision
- epileptic attacks
- Skin bruising outside the injection site