









































                                                                                                                         2021, Vol. 1 (S2) 1-2 
 https://doi.org/10.47488/dhrp.v1iS2.12 

  
 

http://dhrproceedings.org 1 © DHR Health Institute for Research and Development 
 

 

EDITORIAL 

Is the Public Outcry for Johnson & Johnson Jansen’s COVID-19 Vaccine  
Causing Blood Clots Justified? 

 
As of today, globally, over 139 million people have 
been infected with SARS-CoV-2 virus and over 2.9 
million have died as a result of this infection (1). In 
the United States, over 31 million people have been 
diagnosed with COVID-19, a disease caused by 
SARS-CoV-2 virus and over 565,000 people have 
encountered a fatal outcome. On February 27, 2021, 
the US Food & Drug Administration (FDA) 
approved the use of Johnson & Johnson (J&J) 
Jansen COVID-19 vaccine for individuals 18 years 
of age or older under Emergency Use Authorization 
(2). While the J&J Jansen COVID-19 vaccine only 
had 72% efficacy, a single shot of this vaccine was 
100% effective in preventing death and 
hospitalization caused by COVID-19 in clinical 
trials (3). Since its approval, it is estimated that over 
6.8 million people in the United States have been 
vaccinated with J&J Jansen COVID-19 vaccine (4). 
Recent reports have confirmed blood clots in six 
individuals who have received J&J Jansen COVID-
19 vaccine (4). All of these six vaccine recipients 
were females between the ages of 18 and 48 years; 
symptoms occurred 6-13 days after vaccination, and 
all had a previous diagnosis of suffering from 
thrombocytopenia. The form of blood clotting 
reported in the recipients of J&J Jansen COVID-19 
vaccine is known as the cerebral venous and sinus 
thrombosis (CVST), a form of disease only 
encountered in less than 1% of strokes (5). While it 
is a rare and severe form of CVST, it is important to 
recognize that it was only witnessed in 0.000009% 
of J&J Jansen COVID-19 vaccine recipients. 

Based on these early reports, on April 13, 
2021, both FDA and the Center for Disease Control 
& Prevention (CDC) recommended to pause the use 
of J&J Jansen COVID-19 vaccine pending further 
review and to convene a meeting of the Advisory 
Committee on Immunization Practices (ACIP) to 
review the available clinical data to make further 
determination (4). The ACIP met on April 16, 2021 
and recommended to extend the pause to allow for 

additional review of available clinical data (6). 
While these precautionary actions are justified, the 
observed complication following J&J Jansen 
COVID-19 vaccination must be viewed in light of 
the fact that the risk of developing 
thromboembolism (TE) following infection with 
SARS-CoV-2 and observed mortality is much 
higher (7). As reported by Malas, et.al, overall 
arterial TE rate in patients with COVID-19 was 2% 
with overall pulmonary embolism rate of 13%. Of 
equal concern is the observation that pooled odds of 
mortality are 74% higher among patients with TE 
and COVID-19 as compared to those without TE 
(7). Of note is the fact that the risk of developing 
blood clots for women of childbearing age using 
birth control pills is much higher than that observed 
after vaccination with J&J Jansen COVID-19 
vaccine (8). Equally, the risk of blood clots 
associated with cigarette smoking is higher than that 
observed after vaccination with J&J Jansen 
COVID-19 vaccine (9).   

While the precautionary measures taken by 
the CDC and the FDA to examine the data in detail 
is in the best interest of the public, it must be argued 
that the low risk of blood clot following vaccination 
with J&J Jansen COVID-19 vaccine as compared to 
that following infection with SARS-CoV-2 may 
justify its continued use to vaccinate people as a 
means to prevent infection and subsequent 
hospitalization. 

 

References  

1.  COVID-19 Dashboard by the Center for Systems Science and 
Engineering at Johns Hopkins University. April 16, 2021; 12:01 
PM CST.  https://coronavirus.jhu.edu/map.html  

2. Letter of Emergency Use Authorization from Rear Admiral 
Denise M. Hinton to Janssen Biotech, Inc., dated February 27, 
2021. https://www.fda.gov/media/146303/download 

3. Vaccines and Related Biological Products Advisory Committee 
Meeting February 26, 2021. FDA Briefing Document Janssen 

https://coronavirus.jhu.edu/map.html
https://www.fda.gov/media/146303/download


DHRP, 2021, Vol. 1 (S2) 1-2  Editorial 

  
 

http://dhrproceedings.org 2 © DHR Health Institute for Research and Development 
    
 

Ad26.COV2.S Vaccine for the Prevention of COVID-19. 
https://www.fda.gov/media/146217/download 

4. Joint CDC and FDA Statement on Johnson & Johnson COVID-
19 Vaccine. https://www.fda.gov/news-events/press-
announcements/joint-cdc-and-fda-statement-johnson-johnson-
covid-19-vaccine 

5. Masuhr F, Einhäupl K. Treatment of cerebral venous and sinus 
thrombosis. Front Neurol Neurosci. 2008;23:132-43. doi: 
10.1159/000111375. PMID: 18004059. 

6.  CDC Recommendation to Pause Use of Johnson & Johnson’s 
Janssen COVID-19 Vaccine. 
https://www.cdc.gov/coronavirus/2019-
ncov/vaccines/safety/JJUpdate.html   

7. Malas BM, Naazie, IH, et.al. Thromboembolism risk of 
COVID-19 is high and associated with a higher risk of 
mortality: A systematic review and meta-analysis. 
EClinicalMedicine. 2020; 29-30. doi: 
https://doi.org/10.1016/j.eclinm.2020.100639 

8. Sidney S, Cheetham TC, et.al. Recent combined hormonal 
contraceptives (CHCs) and the risk of thromboembolism and 
other cardiovascular events in new users. Contraception. 2013 
Jan;87(1):93-100. doi: 10.1016/j.contraception.2012.09.015. 
Epub 2012 Oct 19. PMID: 23083525. 

9. Cheng Y-J, Liu Z-H, Yao F-J, Zeng W-T, Zheng D-D, Dong Y-
G, et al. (2013) Current and Former Smoking and Risk for 
Venous Thromboembolism: A Systematic Review and Meta-
Analysis. PLoS Med 10(9): e1001515. 
https://doi.org/10.1371/journal.pmed.1001515  

 

 Sohail Rao, MD, MA, DPhil 

Executive Vice President, DHR Health, 5501 S. McColl 
Road, Edinburg, Texas 

President & Chief Executive Officer, DHR Health 
Institute for Research & Development, 5323 S. McColl 
Road, Edinburg, Texas 

 

Corresponding author email: s.rao@dhr-rgv.com 

Disclosures: None 

ORCID: Sohail Rao: https://orcid.org/0000-0001-5027-
9992 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
 

https://www.fda.gov/media/146217/download
https://www.fda.gov/news-events/press-announcements/joint-cdc-and-fda-statement-johnson-johnson-covid-19-vaccine
https://www.fda.gov/news-events/press-announcements/joint-cdc-and-fda-statement-johnson-johnson-covid-19-vaccine
https://www.fda.gov/news-events/press-announcements/joint-cdc-and-fda-statement-johnson-johnson-covid-19-vaccine
https://doi.org/10.1159/000111375
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/JJUpdate.html
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/JJUpdate.html
https://doi.org/10.1016/j.eclinm.2020.100639
https://doi.org/10.1371/journal.pmed.1001515
https://orcid.org/0000-0001-5027-9992
https://orcid.org/0000-0001-5027-9992

