This discussion is an addendum to a recent Pharmacist Consult post titled Just The Basics: Pfizer-BioNTech COVID-19 Vaccine.
After months of rapid vaccine development, the United States Food and Drug Administration (FDA) announced the emergency use authorization (EUA) of the second COVID-19 vaccine in the United States. This comes about a week after the United States authorized the first COVID-19 vaccine in the United States through an EUA – the vaccine produced by Pfizer-BioNTech.
The Moderna COVID-19 vaccine, referred to here simply as the ‘vaccine’, is a vaccine that may help prevent COVID-19.
This discussion will sift through a series of common questions that are relevant to this vaccine. In addition, the table at the bottom of the article, Table 1, includes various external links for additional information regarding this topic.
FDA Announcement: “On December 18, 2020, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.”
What is Moderna?
The first COVID-19 vaccine authorized in the United States was from Pfizer and BioNTech. Although BioNTech may not be widely known in the United States, Pfizer is a pharmaceutical giant with a significant history in the country. Pfizer and BioNTech partnered together to create their vaccine. Compared to Pfizer, Moderna may be slightly less well known.
Moderna is a biotechnology company based out of Cambridge, Massachusetts, USA – just outside of Boston. Like the name implies, Moderna is a company that specializes in producing mRNA-based therapeutics. Moderna’s products focus on treating infectious diseases, cancer, and rare diseases; the company was first formed in 2010. Moderna’s pipeline of products aside from its COVID-19 vaccine can be found here.
Even though Moderna may be less-well known than Pfizer, its vaccine is thought to be equally as effective as the Pfizer-BioNTech vaccine.
What should I know about this vaccine in comparison to other vaccines?
This vaccine uses mRNA technology – a relatively innovative vaccine delivery platform. However, the technology in itself is not new; it is just new for vaccines.
Most other vaccines fall under the categories of being either ‘live’ or ‘inactive’, but mRNA vaccines do not fall under either descriptor and instead form their own grouping. Regardless, COVID-19 mRNA vaccines have been rigorously tested for safety before being authorized for use in the United States.
In its simplest form, mRNA could be described as “instructions” for the human cell on how to make a piece of the “spike protein” that is unique to the virus that causes COVID-19. After this piece of the spike protein is made from the prompting of the mRNA vaccine, the cell breaks down the mRNA strand and disposes of the remnants using certain enzymes. Once displayed on the cell surface, the piece of the spike protein helps cause the immune system to begin producing antibodies and certain cells to fight off what it falsely thinks is an infection. These antibodies are specific to the virus that causes COVID-19 and this means the immune system is better primed to help protect against future infection.
Mechanism aside, this vaccine should be administered alone and it should be separated from all other vaccines by at least 14 days both before and after vaccination. For example, if the vaccine is administered on January 1, 2021, then no other vaccines should be given between December 18, 2020 and January 15, 2021.
The Pfizer-BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine work in the same manner.
Who is eligible to receive the vaccine?
Individuals who are 18 years and older are eligible to receive this vaccine in the United States. Note – this is a higher age limit than the Pfizer-BioNTech COVID-19 vaccine (16 years and older). At this time, children and adolescents 17 years of age and younger should not receive this vaccine.
For individuals that have already recovered from a prior COVID-19 infection, vaccination is still recommended. However, individuals with a current, active COVID-19 infection should receive vaccination only after the illness has subsided and the corresponding quarantine period has ended in accordance with local, state, and/or federal guidelines.
There is limited data (as of the publication date/time of this article) regarding this vaccine and its use in pregnancy and lactation. Individuals who are pregnant or lactating should speak with a healthcare professional to weigh the risks and benefits of receiving the vaccine.
Individuals who have a history of severe allergic reaction to any ingredient within the vaccine should avoid receiving the vaccine. In addition, individuals who have had a severe allergic reaction to any vaccine or injectable therapy should not receive this vaccine at this time.
How is the vaccine administered?
The vaccine is administered into the muscle of the upper arm, similarly to a flu shot. However, this is a 2-dose series given 28 days (1 month) apart. Both doses are necessary for optimal protection that may be gained from the vaccine series.
If receiving both doses of the vaccine 28 days apart is not possible due to scheduling conflicts, a reported grace period of less than or equal to 4 days is permissible for the 2nd dose. However, if more than 28 days have lapsed since the 1st dose, the 2nd dose should be administered as soon as possible. No doses need to be repeated.
This vaccine is not interchangeable with other COVID-19 products. If the Moderna vaccine is given for the 1st dose, the Moderna vaccine must also be given for the 2nd dose. If the Pfizer-BioNTech vaccine is given for the 1st dose, then the Pfizer-BioNTech vaccine must be given for the 2nd dose. However, between the two different vaccines, one should not be preferred over the other; whichever COVID-19 vaccine is offered first is the best option available.
Data are currently being analyzed to decide if this vaccine will be a one-time series, an annual vaccine series, or some other frequency. More details to come regarding this.
What ingredients are in the vaccine?
Ingredients within the vaccine include:
- Nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 virus
- Lipids (SM-102, polyethylene glycol [PEG], dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]
- Tromethamine
- Tromethamine hydrochloride
- Acetic acid
- Sodium acetate
- Sucrose
- Note: the vaccine does NOT contain preservatives or latex.
What side effects might I expect if/when I receive the vaccine?
Potential side effects that have been reported thus far in clinical trials are injection site pain, fatigue, headache, muscle aches, joint pain, chills, nausea/vomiting, armpit swelling/tenderness, fever, swelling at the injection site, and redness at the injection site. However, these effects are mostly transient and tend to subside hours to days after administration.
As time goes on, additional side effects will be collected and reported via VAERS (Vaccine Adverse Event Reporting System).
Is it possible for this vaccine to cause COVID-19?
No – this vaccine does not contain SARS-CoV-2, the virus that causes COVID-19. It cannot cause COVID-19. Additionally, mRNA from the vaccine never enters the nucleus of the human cell and it does not affect or interact with a person’s DNA.
However, after 2 doses of the vaccine, it is reported to be up to 94.1% effective at preventing COVID-19.
Is mask wearing and social distancing necessary after the first and/or second dose of the vaccine?
Yes. Even after being vaccinated with one or both doses of the vaccine, everyone should continue to follow the Centers for Disease Control and Prevention’s (CDC) recommendations on wearing masks, washing hands, and social distancing.
Table 1: Links and Resources
| Resource | Resource Description |
| CDC Moderna COVID-19 Vaccine Information | This is a general CDC website link that has many additional links about factual tidbits regarding this vaccine. |
| Explaining Operation Warp Speed (OWS) | OWS is a United States government initiative with a goal to produce/deliver 300 million doses of COVID-19 vaccines with initial doses available by January 2021. See more details, including an OWS progression timeline since March 2020, within this link. |
| EUA Basics | The Moderna COVID-19 vaccine has not undergone the same type of review as an FDA-approved or cleared product. The FDA has made the Moderna COVID-19 vaccine available under an EUA (emergency use authorization). |
| FDA EUA Announcement | The FDA announced the EUA for the Moderna COVID-19 vaccine on 18 December 2020. This announcement is sourced here with full details. |
| Moderna COVID-19 Manufacturer Website | The Moderna COVID-19 vaccine EUA website contains additional information about its vaccine. The site is stylized with graphics and bright colors which makes readability slightly easier. |
| Vaccine Fact Sheet for Recipients and Caregivers | This fact sheet contains information to help recipients and caregivers understand the risks and benefits of the Moderna COVID-19 vaccine. |
| Vaccine Fact Sheet for Healthcare Providers | This fact sheet is a more detailed version of the ‘Recipients and Caregivers’ fact sheet and it is tailored to healthcare providers. |
| Vaccine Adverse Event Reporting System (VAERS) | VAERS is the reporting tool that is utilized to track suspected adverse events that may be due to a vaccine. Anybody can submit a report to VAERS. |
| V-Safe | The V-Safe After Vaccination Health Checker “is a smartphone-based tool that uses text messaging and web surveys to provide personalized health check-ins after you receive a COVID-19 vaccination. Through V-Safe, [vaccine recipients] can quickly tell the CDC if [a vaccine recipient] has any side effects after getting the COVID-19 vaccine.” Participation in V-Safe is completely voluntary and self-enrollment is required. |
| Understanding mRNA Vaccines | This CDC resource discusses how messenger RNA (mRNA) vaccines are made, how they work, and what makes them unique. |
This is a topic that is ongoing and continually updated on a daily basis. Please continue to defer to the CDC and FDA for the most up-to-date information regarding the COVID-19 vaccination effort.
Resources:
- Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines Currently Authorized in the United States. Centers for Disease Control and Prevention (CDC). Revised December 2020. Accessed 21 December 2020.
- Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers). United States Food and Drug Administration. Revised December 2020. Accessed 21 December 2020.
- Fact Sheet for Recipients and Caregivers. United States Food and Drug Administration. Revised December 2020. Accessed 21 December 2020.
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