









































                                                                                                                         2021, Vol. 1 (S4) 13-14 
 https://doi.org/10.47488/dhrp.v1iS4.26 

  
 

http://dhrproceedings.org 13 © DHR Health Institute for Research and Development 
 

 

EDITORIAL 

Messenger RNA Vaccines are Safe & Effective and do not Modify Host DNA
 

Despite the fact that over 5.3 billion doses of 
COVID-19 vaccines have been administered 
globally, there still exists measurable hesitancy in a 
select cohort of the population to get vaccinated. 
This reluctance seems to be more evident towards 
messenger RNA (mRNA) vaccines which is 
attributed largely to misinformation about their 
safety and efficacy and the unfounded fear that they 
may integrate into host DNA thus modifying it 
permanently. In this editorial, we plan to provide 
scientific evidence to repudiate these 
misconceptions and to alleviate concerns related to 
COVID-19 mRNA vaccines. 

On December 11, 2020, US Food & Drug 
Administration (FDA) issued its first Emergency 
Use Authorization (EUA) for Pfizer/BioNTech 
COVID-19 vaccine for the prevention of COVID-
19 caused by SARS-CoV-2 in individuals 16 years 
of age and over (1). The Pfizer/BioNTech vaccine 
is a nucleoside-modified mRNA encoding for the 
viral spike glycoprotein of SARS-CoV-2 
formulated in lipid particle (1). On May 10, 2021, 
FDA issued another EUA approving the use of 
Pfizer/BioNTech vaccine for prevention of 
COVID-19 in individuals 12-15 years of age (2). 
Given the high risk of infection with the Delta 
variant of vaccinated individuals with 
immunosuppressed status, on August 12, 2021, 
FDA modified its EUA allowing Pfizer/BioNTech 
vaccine to be administered as a third dose to this 
select cohort of patients.  

With the availability of additional safety and 
efficacy data from millions of people who have 
been vaccinated supplemented by that obtained 
from double-blinded placebo-controlled clinical 
trials, Pfizer submitted a Biologics License 
Application (BLA) with FDA requesting full 
approval of the Pfizer/BioNTech vaccine for use in 
individuals 12 years of age and older. After careful 
review, FDA approved Pfizer’s BLA on August 23, 
2021, making it the first and only vaccine for 
prevention of infection with SARS-CoV-2 (3). 

Pfizer/BioNTech vaccine is now marketed under 
the generic name of Comirnaty. 

Subsequently, on December 18, 2020, FDA issued 
another EUA for Moderna COVID-19 vaccine for 
the prevention of COVID-19 caused by SARS-
CoV-2 in individuals 18 years of age and over (4). 
The formulation of Moderna’s mRNA vaccine is 
very similar to Pfizer/BioNTech vaccine and was 
recommended at a dosing regimen of two doses 
administered one month apart. Moderna mRNA 
vaccine was also approved by the FDA for a third 
dose in select vaccinated immunocompromised 
individuals who are at high risk of developing 
infection with SARS-CoV-2. 

The process outlined above underscores the 
scrupulous details with which, the Federal 
regulatory agencies review and approve EUA’s and 
BLA’s. This process is stringently coordinated by 
various independent oversight committees 
including but not limited to the Advisory 
Committee on Immunization Practices – an entity 
within the US Centers for Disease Control & 
Prevention that is composed of experts in the field 
of infectious diseases and immunology and is 
responsible for providing guidance for the most 
effective control of diseases that can be prevented 
using vaccines. 

Both Pfizer/BioNTech and Moderna vaccines are 
strands of messenger ribonucleic acid (mRNA) 
encapsulated in lipid nanoparticles. The mRNA 
encodes for the antigenic glycoproteins of the Spike 
(S) domain of SARS-CoV-2 with two proline 
substitutions (K986P and V987P mutations) which, 
stabilizes the perfusion conformation of the 
glycoprotein.  Once delivered by intramuscular 
administration, the lipid nanoparticles facilitate the 
uptake of the mRNA vaccine by the host antigen 
presenting cells (such as dendritic cells or 
macrophages) and its entry into the cytosol (the part 
of the cell that is outside the nucleus which houses 
the DNA) [Figure 1]]. Utilizing the host cell’s 



DHRP, 2021, Vol. 1 (S4) 13-14  Editorial 

  
 

http://dhrproceedings.org 14 © DHR Health Institute for Research and Development 
    
 

ribosomes (organelle that help in protein synthesis), 
the mRNA vaccine is translated into Spike proteins 
which are presented on the cell surface to raise T 
and B cell responses. The mRNA vaccine in the 
cytosol is degraded by the cell in a few days 
whereas, similar to other proteins made by the body, 
the Spike protein survives for a few weeks and is 
ultimately cleared from the system. 

 

Figure 1: The normal “physiological” pathway 
utilized by the COVID-19 mRNA vaccines to 
produce Spike proteins that raise both cell and 
antibody mediated immune responses. 

In conclusion, mRNA-based vaccines are safe, 
effective, and capable of raising both antibody-
mediated and cellular immune responses against 
SARS-CoV-2. Additionally, all available scientific 
data provides unequivocal evidence that mRNA-
based vaccines follow the normal physiological 
pathways and once they enter, they remain confined 
to the extra-nuclear part of the host cell and are not 
designed to gain entry into the nucleus and are 
therefore incapable of modifying the DNA. Gaining 
public confidence is paramount in the success of the 
ongoing vaccination efforts to mitigate the spread 
of COVID-19. Therefore, every effort must be 
made to discount the misinformation and provide to 
the community facts that are informed by strong 
scientific evidence. 

References  

1. US Food and Drug Administration’s Letter of Emergency Use 
Authorization for Pfizer/BioNTech mRNA Vaccine for 
individuals 17 years of age and older. December 11, 2020, 
https://nps.edu/documents/111291366/124403968/Pfizer-
BioNTech+COVID-
19+Vaccine+EUA+LOA+%2811+Dec+2020%29.pdf/106e966
2-956c-aa94-8d4b-a945a6a10b87?t=1608071313236   

2. US Food and Drug Administration’s Letter of Emergency Use 
Authorization for Pfizer/BioNTech mRNA Vaccine for 
individuals 12-16 years of age. May 10, 2021. 
https://www.fda.gov/media/144412/download 

3. US Food and Drug Administration’s Letter of Approval of 
Biologics License Application for Pfizer/BioNTech vaccine. 
August 23, 2021. https://www.fda.gov/media/151710/download   

4. US Food and Drug Administration’s Letter of Emergency Use 
Authorization for Moderna mRNA Vaccine. December 18, 
2020. https://immunize.utah.gov/wp-
content/uploads/2020/12/Moderna_COVID-
19_Vaccine_EUA_Letter_of_Authorization.pdf 

 

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 

Manish Singh, MD, FACS 

Chief Executive Officer, DHR Health, 5501 S. McColl 
Road, Edinburg, Texas 

Disclosures: None 

ORCID: Manish Singh: https://orcid.org/0000-0003-
4146-3282  

 

 

 

 

 

 

 

https://nps.edu/documents/111291366/124403968/Pfizer-BioNTech+COVID-19+Vaccine+EUA+LOA+%2811+Dec+2020%29.pdf/106e9662-956c-aa94-8d4b-a945a6a10b87?t=1608071313236
https://nps.edu/documents/111291366/124403968/Pfizer-BioNTech+COVID-19+Vaccine+EUA+LOA+%2811+Dec+2020%29.pdf/106e9662-956c-aa94-8d4b-a945a6a10b87?t=1608071313236
https://nps.edu/documents/111291366/124403968/Pfizer-BioNTech+COVID-19+Vaccine+EUA+LOA+%2811+Dec+2020%29.pdf/106e9662-956c-aa94-8d4b-a945a6a10b87?t=1608071313236
https://nps.edu/documents/111291366/124403968/Pfizer-BioNTech+COVID-19+Vaccine+EUA+LOA+%2811+Dec+2020%29.pdf/106e9662-956c-aa94-8d4b-a945a6a10b87?t=1608071313236
https://www.fda.gov/media/144412/download
https://www.fda.gov/media/151710/download
https://immunize.utah.gov/wp-content/uploads/2020/12/Moderna_COVID-19_Vaccine_EUA_Letter_of_Authorization.pdf
https://immunize.utah.gov/wp-content/uploads/2020/12/Moderna_COVID-19_Vaccine_EUA_Letter_of_Authorization.pdf
https://immunize.utah.gov/wp-content/uploads/2020/12/Moderna_COVID-19_Vaccine_EUA_Letter_of_Authorization.pdf
https://orcid.org/0000-0001-5027-9992
https://orcid.org/0000-0001-5027-9992
https://orcid.org/0000-0003-4146-3282
https://orcid.org/0000-0003-4146-3282

