I’m pressing pause on the J&J Covid-19 vaccine

As of April 25, 2021, the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) recommend resuming use of Johnson & Johnson’s Janssen (J&J/Janssen) Covid-19 vaccine within the U.S. after a brief pause (CDC , April 25, 2021). Analysis of opposed events following the J&J/Janssen vaccine suggests an increased risk of thrombosis with thrombocytopenia syndrome (TSS), but the advantages outweigh the potential risks. This complication is rare and occurs in roughly 7 per million vaccinated women aged 18 to 49 years and 0.9 per million vaccinated women aged 50 years and older. As of April 23, 2021, there have been 15 reports of girls who received the J&J/Janssen vaccine who later developed TSS 6 to fifteen days after vaccination. Women under 50 years of age ought to be informed concerning the risk of TSS and about other Covid-19 vaccines available for which this risk has not been observed. If you may have received the J&J/Janssen Covid-19 vaccine, it is best to look ahead to symptoms of blood clots with low platelet counts, equivalent to severe or persistent headache or blurred vision, shortness of breath, chest pain, leg swelling, abdominal pain or easy bruising or small spots of blood under the skin outside the injection site. The CDC and FDA will proceed to watch the protection of all Covid-19 vaccines.

Earlier this week, my sister called me concerned and anxious about news of great blood clots related to the Johnson & Johnson (J&J) Covid-19 vaccine. She is 44 years old and just received the vaccine 6 days ago. I assured her that this complication was very rare, but to be on the secure side, I asked her to watch closely for unwanted side effects, equivalent to severe headache, pain or swelling within the legs, abdominal pain, or shortness of breath, and told her to see her doctor immediately in the event that they occurred. . of those symptoms. My two sisters, my brother, his wife and my brother-in-law received the J&J Covid-19 vaccine. I needed to do urgent research to grasp the importance of this opposed event. Here’s what I discovered.

Effective April 13, 2021, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) paused administration of the Johnson & Johnson (J&J) COVID-19 vaccine to research the occurrence of great complications related to blood clots. The cases are much like those reported in March last yr with the Oxford-Astrazeneca Covid-19 vaccine, Vaxzevria. Both the J&J and AstraZeneca vaccines use viral vector technology, an inactivated, genetically modified cold virus or adenovirus that carries the SARS-CoV-2 spike glycoprotein code, to induce an immune response to the virus (CDC, 2021).

As of April 7, 2021, of the 25 million individuals who have received Vaxzevria, 62 cases of cerebral venous sinus thrombosis (CVST), a rare clot within the veins of the brain, and 24 cases of intra-abdominal splanchnic vein thrombosis have been reported. Europe, mainly in women under 60 years of age (European Medicines Agency [EMA], 2021). Unfortunately, 19 of those cases resulted in death. Rare blood clots related to low platelet counts occurred inside 2 weeks after vaccination. One hypothesis is that the vaccine may induce an immune response that will result in an atypical syndrome much like heparin-induced thrombocytopenia (HIT). This mechanism could also be related to platelet-activating antibodies against platelet factor-4 (PF4) (CDC, 2021), which may cause arterial and venous thrombosis. Health authorities within the UK and Europe have confirmed a correlation between Vaxzevria and the occurrence of blood clots, but haven’t established a causal link (Jiminez, 2021). After analyzing the info, the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) concluded that Vaxzevria’s advantages proceed to outweigh its risks for most individuals (EMA, 2021).

Since receiving Emergency Use Authorization (EUA) in February, 6.8 million doses of the Johnson & Johnson COVID-19 vaccine have been administered within the U.S. Among those vaccinated, seven cases of CVST related to thrombocytopenia (low platelet count below 150,000) were reported. has been reported in women aged 18 to 48 years who experienced symptoms 6 to 13 days after vaccination (FDA, 2021). This equates to lower than 1 in 1,000,000 people developing a complication. Two of the six were also diagnosed with splanchnic and portal vein thrombosis, and 4 developed cerebral interstitial hemorrhage, one in every of whom didn’t survive (CDC, 2021). In comparison, the incidence of cerebral venous thrombosis in the overall population is estimated at 2–5 per million people per yr (Ferry and Canhao, 2020). Additionally, a retrospective population-based study by Devasagayam, Wyatt, Leyden, and Kleinig (2016) found that the incidence could also be even higher, as high as 15.7 per million people per yr.

To prioritize patient safety, CDC and FDA will collect and analyze more data and take essential steps to guard the general public. They recommend that patients who’ve received the J&J COVID-19 vaccine seek medical attention immediately in the event that they experience any of the next symptoms (CDC, 2021):

• Dyspnoea
• Pain within the chest
• Swelling or pain within the lower limbs
• Persistent abdominal pain
• Severe and protracted headaches or blurred vision
• New neurological symptoms
• Severe back pain
• Ecchymosis or small, pinpoint red spots on the skin (not including the injection site)
• New or easy bruising

The CDC (2021) recommends that each one healthcare providers closely monitor patients for these signs and symptoms. If a patient develops a thrombotic event with thrombocytopenia after receiving the J&J COVID-19 vaccine, the platelet count ought to be checked, evaluated with a screening enzyme-linked immunosorbent assay (ELISA) for PF4, and a hematologist ought to be consulted. Blood clots following vaccination shouldn’t be treated with heparin (unless the HIT test is negative) as this may increasingly worsen the issue. The use of anticoagulants aside from heparin and high-dose intravenous immunoglobulin could also be considered. All physicians should report opposed events to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.html and patients scheduled to receive the J&J COVID-19 vaccine should seek an alternate vaccine from Moderna or Pfizer-BioNTech.

It can be as much as the CDC and FDA to judge these cases and determine the impact it would have on the distribution of J&J’s Covid-19 vaccine. The potential impact on vaccine confidence and vaccine hesitancy is concerning and we must do not forget that most, if not all, drugs and coverings carry risks. The current rate of CVST reported with the J&J Covid-19 vaccine is roughly 1 per million people in comparison with the speed typically seen in the overall population (5-15 people per million). We have lost over half 1,000,000 people to Covid-19 within the US and almost 3 million worldwide. The query stays whether the vaccine’s advantages proceed to outweigh its risks, and if regulators analyze the info and reach this conclusion, sharing the science with the general public can be critical.

Bibliography:

Centers for Disease Control and Prevention (2021, April 25). The CDC recommends using Johnason & Johnson’s CV for the Janssen Covid-19 vaccine. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/JJUpdate.html

Centers for Disease Control and Prevention (2021, April 13). Cases of cerebral venous sinus thrombosis with thrombocytopenia after receiving the Johnson & Johnson Covid-19 vaccine. . https://emergency.cdc.gov/han/2021/han00442.asp

Devasagayam, S., Wyatt, B., Leyden, J., and Kleinig, T. (2016). The incidence of cerebral sinus venous thrombosis is higher than previously thought: a retrospective population-based study. , (9), 2180–2182. https://doi.org/10.1161/STROKEAHA.116.013617

European Medicines Agency (2021, April 4). Astrazeneca’s Covid-19 vaccine: EMA finds possible link to very rare cases of bizarre blood clots and low platelet counts. https://www.ema.europa.eu/en/news/astrazenecas-covid-19-vaccine-ema-finds-possible-link-very-rare-cases-unusual-blood-clots-low-blood

Federal Medicines Agency (2021, April 13). Joint statement from the CDC and FDA on the Johnson & Johnson Covid-19 vaccine. . https://www.fda.gov/news-events/press-announcements/joint-cdc-and-fda-statement-johnson-johnson-covid-19-vaccine

Ferro, J. M., & Canhao, P. (2020, May 1). Cerebral vein thrombosis: etiology, clinical features and diagnosis. . https://www.uptodate.com/contents/cerebral-venous-thrombosis-etiology-clinical-features-and-diagnosis

Jiminez, D. (2021, April 12). AZ Covid-19 vaccine and blood clots: risks explained. . https://www.pharmaceutical-technology.com/features/az-covid-19-vaccine-blood-clots-risks-explained/