Pfizer-BioNTech COVID-19 Vaccine (FDA, EUA)

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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. (Refer: FDA)

Pfizer-BioNTech COVID-19 Vaccine (FDA, EUA)

Name: BNT162b2

Manufacturer: Pfizer, Inc., and BioNTech

Type of vaccine: mRNA

Number of shots: 2 shots, 21 days apart

How given: Shot in the muscle of the upper arm

Does not contain:

  • Eggs
  • Preservatives
  • Latex

You are being offered the Pfizer-BioNTech COVID-19 Vaccine to prevent Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2. The Pfizer-BioNTech COVID-19 Vaccine is a vaccine and may prevent you from getting
COVID-19.

WHAT IS COVID-19?

COVID-19 disease is caused by a coronavirus called SARS-CoV-2. This type of
coronavirus has not been seen before. You can get COVID-19 through contact with another person who has the virus. It is predominantly a respiratory illness that can affect other organs. People with COVID-19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness. Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.

WHAT IS THE PFIZER-BIONTECH COVID-19 VACCINE?

The Pfizer-BioNTech COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19. There is no FDA-approved vaccine to prevent COVID-19. The FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine to prevent COVID-19 in individuals 16 years of age and older under an Emergency Use Authorization (EUA).

Who should not get vaccinated (Refer: CDC)

  • If you have had a severe allergic reaction (anaphylaxis) or an immediate allergic reaction—even if it was not severe—to any ingredient in an mRNA COVID-19 vaccine,  you should not get an mRNA COVID-19 vaccine.*
  • If you have had a severe allergic reaction (anaphylaxis) or an immediate allergic reaction—even if it was not severe—after getting the first dose of the vaccine, you should not get another dose of an mRNA COVID-19 vaccine.*
  • An immediate allergic reaction means a reaction within 4 hours of getting vaccinated, including symptoms such as hives, swelling, or wheezing (respiratory distress).
  • This includes allergic reactions to polyethylene glycol (PEG) and polysorbate. Polysorbate is not an ingredient in either mRNA COVID-19 vaccine but is closely related to PEG, which is in the vaccines. People who are allergic to PEG or polysorbate should not get an mRNA COVID-19 vaccine.
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WHAT ARE THE INGREDIENTS IN THE PFIZER-BIONTECH COVID-19 VACCINE? (Refer: FDA)

The Pfizer-BioNTech COVID-19 Vaccine includes the following ingredients: 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, and sucrose.

HAS THE PFIZER-BIONTECH COVID-19 VACCINE BEEN USED BEFORE?

The Pfizer-BioNTech COVID-19 Vaccine is an unapproved vaccine. In clinical trials, approximately 20,000 individuals 16 years of age and older have received at least 1 dose of the Pfizer-BioNTech COVID-19 Vaccine.

WHAT ARE THE BENEFITS OF THE PFIZER-BIONTECH COVID-19 VACCINE?

In an ongoing clinical trial, the Pfizer-BioNTech COVID-19 Vaccine has been shown to prevent COVID-19 following 2 doses given 3 weeks apart. The duration of protection against COVID-19 is currently unknown.

Summary of safety data

  • In clinical trials, reactogenicity symptoms (side effects that happen within 7 days of getting vaccinated) were common but were mostly mild to moderate.
  • Side effects (such as fever, chills, tiredness, and headache) throughout the body were more common after the second dose of the vaccine.
  • Most side effects were mild to moderate. However, a small number of people had severe side effects—defined as side effects affecting a person’s ability to do daily activities.
  • Although few people in the clinical trials went to the hospital or died, data suggest that people who got the Pfizer-BioNTech vaccine were less likely to have these more serious outcomes compared to people who got the saline placebo.

Information on how well the vaccine works

  • Based on evidence from clinical trials, the Pfizer-BioNTech vaccine was 95% effective at preventing laboratory-confirmed COVID-19 illness in people without evidence of previous infection.

Side effects that have been reported with the Pfizer-BioNTech COVID-19 Vaccine
include:
• injection site pain
• tiredness
• headache
• muscle pain
• chills
• joint pain
• fever
• injection site swelling
• injection site redness
• nausea
• feeling unwell
• swollen lymph nodes (lymphadenopathy)
• non-severe allergic reactions such as rash, itching, hives, or swelling of the face
• severe allergic reactions

Disclaimer: This article may be outdated, therefore we encourage you to visit the CDC and FDA website for any updates. We have tried to summaries important information and links to the CDC and FDA related pages.

This article is a summary to what has been published by the CDC and FDA. This article is not intended to substitute any medical information from experts

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