After months of rapid vaccine development, the United States Food and Drug Administration (FDA) announced the emergency use authorization (EUA) for the first COVID-19 vaccine in the United States. This comes about a week after the United Kingdom authorized the same vaccine – the first governing body in the world to do so.
The Pfizer-BioNTech COVID-19 vaccine, referred to here simply as the ‘vaccine’, is a vaccine that can help prevent COVID-19.
FDA Announcement: “On December 11, 2020, the U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.”
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.
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 December 15th, 2020, then no other vaccines should be given between December 1st and December 29th.
Who are candidates to receive the vaccine?
Individuals who are 16 years and older are eligible to receive the vaccine in the United States.
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 their healthcare provider 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 21 days (3 weeks) apart. Both doses are necessary for optimal protection that may be gained from the vaccine series.
If 21 days exactly is not possible due to scheduling conflicts, a reported 4-day grace period is permissible for the 2nd dose. However, if more than 21 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 Pfizer-BioNTech vaccine is given for the 1st dose, the Pfizer-BioNTech product must also be given for the 2nd dose.
What ingredients are in the vaccine?
Ingredients within the vaccine include:
- Nucleoside-modified messenger RNA (mRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2
- Lipids ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-distearoyl-sn-glycero-3-phosphocholine, and cholesterol)
- Polyethylene glycol
- Potassium chloride
- Monobasic potassium phosphate
- Sodium chloride
- Dibasic sodium phosphate dihydrate
- Sucrose
- 0.9% Sodium Chloride Injection, USP
- Note: the vaccine does NOT contain preservatives or latex
What side effects might I expect if/when I receive the vaccine?
Potential mild-moderate side effects that have been reported thus far in clinical trials are injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, feeling unwell, and swollen lymph nodes. A small number of severe side effects have been reported.
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, thus it cannot cause COVID-19. Additionally, mRNA from the vaccine never enters the nucleus of the cell and does not affect or interact with a person’s DNA.
Table 1: Links and Resources
| Resource | Resource Description |
| CDC Pfizer-BioNTech 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 Pfizer-BioNTech COVID-19 vaccine has not undergone the same type of review as an FDA-approved or cleared product. The FDA has made the Pfizer-BioNTech COVID-19 vaccine available under an EUA (emergency use authorization). |
| FDA EUA Announcement | The FDA announced the EUA for the Pfizer-BioNTech COVID-19 vaccine on 11 December 2020. This announcement is sourced here with full details. |
| Pfizer and BioNTech Collaboration Plan | For historical context, this article from April 2020 discusses how and why Pfizer and BioNTech teamed up in this joint vaccine development effort. |
| Vaccine Fact Sheet for Recipients and Caregivers | This fact sheet contains information to help recipients and caregivers understand the risks and benefits of the Pfizer-BioNTechCOVID-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:
- Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers). United States Food and Drug Administration. Revised December 2020. Accessed 14 December 2020.
- Fact Sheet for Recipients and Caregivers. United States Food and Drug Administration. Revised December 2020. Accessed 14 December 2020.
- Mbaeyi S. Use of Pfizer-BioNTech COVID-19 Vaccine: Clinical Considerations. ACIP COVID-19 Vaccines Work Group. Centers for Disease Control and Prevention (CDC). Published 12 December 2020. Accessed 14 December 2020.
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