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As soon as the COVID-19 virus was declared a public health threat, pharma giant Pfizer wanted to help end it. Using BioNTech’s mRNA technology, they announced their collaboration in creating a vaccine sometime in March of 2020. Among the companies that started to work on a vaccine, Pfizer is the first to be allowed by the FDA to test efficacy on children aged 12 years and up.
Roughly a month later, testing begins on German participants and, another month later, expands to participants in the United States. No one thought that anyone could develop the vaccine as quickly, achieving impressive vaccine efficacy based on clinical trials. And soon enough, the Pfizer vaccine became the first to be issued an Emergency Use Authorization (EUA) from the FDA. The Moderna COVID-vaccine that Nao Medical has in its offices, got its EUA a few days later.
General Information
Name: BNT162b2
Manufacturer: Pfizer, Inc., and BioNTech
Type of Vaccine: mRNA
FDA EUA Status: Pfizer’s vaccine was authorized by the United States Food and Drug Administration (FDA) on December 11, 2020. This allows the vaccine to be used for preventing the spread of COVID-19 caused by SARS-CoV-2 in the U.S.
Multidose vial: Up to 6 doses per vial
Dosage: 0.3 mL
Age indications: 16 years of age and older
Schedule: 2-dose series separated by 21 days. (Both doses must be from Pfizer BioNtech)
Administer: Intramuscular (IM) injection in the muscle of the upper arm (deltoid muscle)
Ingredients: The Pfizer BioNTech COVID-19 Vaccine ingredients are:
- Messenger ribonucleic acid (mRNA)
- 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)
- Potassium chloride
- Monobasic potassium phosphate
- Sodium chloride
- Dibasic sodium phosphate dihydrate
- Sucrose
How does the Pfizer vaccine work
Pfizer COVID vaccine’s mRNA carries genetic instructions to human cells on how to create a spike protein. After the spikes are made, the enzymes in the cells break down the mRNA, naturally removing any trace of it in the body.
The spike protein goes to the surface of the cells, calling the attention of the immune system. An immune response is generated and the immune system sends out antibodies to get rid of the foreign proteins. When the Coronavirus spikes show up, the immune system would already be equipped and ready to fight it off. The vaccine will begin to provide protection within about 10 to 14 days of the first dose.
COVID Pfizer vaccine trial summary
Mild to moderate side effects often occur within 7 days after vaccination during clinical trials. Common conditions, such as fever, chills, fatigue, and headache occur after the second shot. Only a few experienced severe side effects that affected the ability to perform daily tasks.
The Pfizer BioNTech COVID vaccine is 95% effective at preventing COVID-19. This was based on results generated from participants vaccinated with the full 2-dose series, having no previous experience of getting infected with Coronavirus.
The vaccine shows high effectiveness regardless of a person’s age, sex, race, or ethnicity. It is also quite effective for people who have underlying medical issues. Adverse reactions occurred more on those who got the saline placebo than those who got vaccinated with the Pfizer vaccine.
Demographic information from clinical trials (Phase 2 and 3):
- Racial and ethnic categories – 81.9% White, 26.2% Hispanic/Latino, 9.8% African American, 4.4% Asian, and less than 3% from other races/ethnicities.
- Age and sex breakdown – 50.6% male, 49.4% female, and 21.4% 65 years and older
- Around 82% of participants were workers who were at risk of exposure to SARS-CoV-2, 25.4% of whom are healthcare workers.
- 22.3% had at least one high-risk condition, such as lung or heart disease, obesity, diabetes, liver disease, or HIV infection.
- 4% of the participants had at least two high-risk conditions.
Who can get vaccinated
The Pfizer vaccine is recommended for people aged 16 years and older.
Who should not get vaccinated:
- People who experienced a severe allergic reaction (anaphylaxis) to any of the ingredients of the vaccine should not get vaccinated.
- Individuals who experience hives, swelling, or wheezing within 4 hours after vaccination.
- People allergic to polyethylene glycol (PEG) and polysorbate should not be vaccinated.
- Pregnant women and breastfeeding mothers should consult with their health care providers.
Storage, Preparation, and Administration
Preparation
The Pfizer COVID vaccine may be thawed in the refrigerator between 2°C and 8°C (36°F and 46°F) for 2 hours and 30 minutes. It may also be thawed at room temperature for up to 25⁰C (77⁰F) between 30 minutes and 2 hours. Vials at room temperature must be mixed with their diluent (0.9% sodium chloride) within 2 hours or returned to the refrigerator.
With a 21-gauge needle (or narrower), withdraw 1.8 mL of 0.9% sodium chloride and inject it into the vaccine vial. Gently invert 10 times prior to injecting.
Storage
Pfizer mRNA vaccines arrive in a thermal shipping container with dry ice. They should be transferred for long term storage in an ultra-cold freezer ( -80°C and 60°C (-112°F to -76°F). The vials may also be kept in the refrigerator between 2⁰C and 8⁰C (36⁰F and 46⁰F) for up to 120 hours.
For more detailed information, check the Storage and Handling Summary at the Centers for Disease Control and Prevention website.
Side effects
The vaccinated arm may experience pain, redness, and swelling. Common side effects are fever, chills, headache, joint pain, and tiredness.
After vaccination
Patients should be checked for allergic reactions 30 minutes after vaccination, for those with a history of anaphylaxis (caused by anything), and 15 minutes afterward for other people.
Severe allergic reactions include one or more of the following:
- Difficulty breathing
- Swelling of the face and throat
- Rapid heartbeat
- A bad rash all over the body
- Dizziness and fatigue
