“The CDC and FDA introduced April 13, 2021, that they might be suspending use of the one-dose Johnson & Johnson COVID-19 vaccine due to very uncommon negative effects. JUSTIN TALLIS/AFP by way of Getty Photos
The Facilities for Illness Management and Prevention (CDC) and the Meals and Drug Administration (FDA) on April 13, 2021, halted use of the one-dose Johnson & Johnson COVID-19 vaccine that has been given to six.eight million individuals within the U.S. The pause is because of reviews of blood clotting in six individuals who have obtained the vaccine.
Dr. William Petri, an infectious illness doctor and immunologist on the College of Virginia Faculty of Medication, solutions questions to assist put this growth in context.
What Is This Potential Facet Impact of the J&J Vaccine for COVID-19?
The potential facet impact is a blood clot within the veins that drain blood from the mind. That is referred to as central venous sinus thrombosis. Within the vaccine-associated instances of this, platelets in blood, that are essential for making clots, have been decrease than regular. Whereas researchers have no idea for sure why that is so, platelet counts could possibly be decrease maybe as a result of they’ve been used up making these clots.
How Many Individuals Have Skilled This Attainable Response?
About one in one million: Six instances out of the 6.eight million doses of the J&J vaccine administered within the U.S. These six instances all occurred in girls ages 18 to 48, and from six to 13 days after vaccination. That is about half as possible as getting struck by lightning in a yr.
What’s being decided now could be what’s the regular background variety of instances we would see within the basic inhabitants with out the vaccine as an element. It will make it potential to find out if the clotting downside is a vaccine facet impact or not.
What Do I Do If I Acquired the J&J Shot?
The CDC and FDA are recommending that individuals who have obtained the J&J vaccine inside the final three weeks who develop extreme headache, stomach ache, leg ache or shortness of breath ought to contact their well being care supplier.
Thankfully, the sort of blood clot is treatable with the usage of blood thinners or anticoagulants. If a affected person has low platelets, nevertheless, a physician wouldn’t prescribe the extensively used anticoagulant heparin however as an alternative one other form of blood thinner. Untreated, these blood clots may be deadly.
What Are the CDC and FDA Particularly Recommending for the J&J Vaccine?
Due to this uncommon prevalence, though it has not been proven to be as a result of vaccine, the CDC and FDA have advisable a pause in use of the J&J vaccine till these instances may be additional reviewed.
What Are the Subsequent Steps?
The CDC will convene a gathering of the Advisory Committee on Immunization Practices April 14, 2021. The ACIP is an unbiased board of 15 scientific and medical specialists chosen by the well being and human providers secretary that advises the CDC on vaccines for kids and adults. Individuals with ties to vaccine producers are excluded from the ACIP membership due to potential battle of curiosity.
The ACIP will evaluation the accessible proof and make suggestions to the CDC, primarily based to a fantastic extent on the chance that the complication is vaccine associated.
Is This Just like What Occurred With the AstraZeneca Vaccine in Europe?
The same uncommon downside of blood clotting with low platelets within the cerebral venous sinus and likewise within the stomach veins and arteries has been seen in reference to the usage of the AstraZeneca COVID-19 vaccine utilized in Europe. There, 182 instances have been reported in 190 million doses — once more, roughly 1 in 1 million individuals vaccinated. The European Medicines Company investigated this and concluded that central venous sinus thrombosis with low platelets must be listed as a potential "very uncommon facet impact" of the AstraZeneca vaccine.
On April 13, 2021, Johnson & Johnson introduced it’s delaying the rollout of its vaccine in Europe in response to the U.S. evaluation.
What Is the Take-home Message?
The U.S. has a complete of three vaccines approved below emergency use authorization for COVID-19, and this facet impact has not been noticed within the different two vaccines, developed by Moderna and Pfizer. The Moderna and Pfizer vaccines don’t use the identical expertise used within the J&J and AstraZeneca vaccines. So vaccination in opposition to COVID-19 can proceed, whereas efforts are made to find out if the clotting dysfunction is expounded by likelihood or a real, however extraordinarily uncommon, facet impact of the J&J vaccine.
I consider it’s a testomony to the emphasis by the CDC and FDA on vaccine security that J&J vaccinations have been paused whereas that is studied by unbiased scientists and medical specialists.
This text is republished from The Dialog below a Artistic Commons license. You could find the authentic article right here.
William Petri is a professor of drugs on the College of Virginia. He receives funding the Nationwide Institute of Well being, the Gates Basis, PBM C19 and Regeneron Inc.