PFIZER-BIONTECH COVID-19 VACCINE

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer-BioNTech COVID-19 Vaccine, for active immunization to prevent COVID-19 in individuals 16 years of age and older.

Recently in 2020 entire world was locked down because of the largest ever pandemic of Covid-19. No other pandemic was so severe enough in past to cause such a stringent lockdown affecting life of billions of people across the world.

Everyone was waiting for the effective vaccine for the Covid-19 and some companies are successful fidining out the solution.

The vaccination with Pfizer-BioNTech COVID-19 Vaccine has already begun in last month in USA and many other countries are in process to do so.

The Pfizer-BioNTech COVID-19 Vaccine is supplied as a frozen suspension in multiple dose vials; each vial must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine. 

Nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2
30 mcg
lipids0.43 mg (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate)
0.05 mg 2[(polyethylene glycol)-2000]- N,N-ditetradecylacetamide
0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine
0.2 mg cholesterol
potassium chloride0.01 mg
monobasic potassium phosphate0.01 mg
Sodium chloride0.36 mg
Dibasic sodium phosphate dihydrate0.07 mg
Sucrose6 mg
Diluent0.9% Sodium Chloride Injection, USP

How is the Pfizer-BioNTech COVID-19 Vaccine available?

Currently this vaccine is supplied as a carton containing multidose vials.

Multiple Dose Vials are supplied in a carton containing 25 multiple dose vials or 195 multiple dose vials. After dilution, one vial contains up to 6 doses of 0.3 mL. Vial labels and cartons may state that after dilution, a vial contains 5 doses of 0.3 mL

How is the Pfizer-BioNTech COVID-19 Vaccine vaccine stored?

For storage of this vaccine the guidelines provided by manufacturer are to be followed strictly. Not following the temperature and storage guidelines will damage the vaccine and it will be ineffective.

Cartons of this vaccine are provided in boces with dry ice. Once arrived at storage centre this vaccine is stored at minus 60 to minus 80 degree celsius. These vials are kept in original cartons till use and protected from light.

Thermal container that is provided with the carton of the vaccine can be used to store this vaccine temporarily till the deep freezer is available. The thermal container used properly can maintain temperature of minus 60 to minus 90 degree celsius. When vaccine cartons are stored in temparary thermal container it is filled with dry ice to the top of the container. This is not the ideal way to store this vaccine.

How is the Pfizer-BioNTech COVID-19 Vaccine given?

As we know this vaccine is stored at ultralow temperature we need to thaw this vaccine before use. For thawing there is certain procedure suggested by the manufacturer.

Thawing in refrigerator

This vaccine can be thawed under refrigeration. A carton of 25 vials or 195 vials may take up to 2 or 3 hours, respectively, to thaw in the refrigerator, whereas a fewer number of vials will thaw in less time. 

After thawing undiluted vaccine can be stored at 2-8 degree celsius for 5 days that is upto 120 hours.

Thawing at room temperature

For immediate use, thaw undiluted vials at room temperature [up to 25ºC (77ºF)] for 30 minutes. Thawed vials can be handled in room light conditions. 

Vials must reach room temperature before dilution. Undiluted vials may be stored at room temperature for no more than 2 hours.

Use after thawing

After dilution, store vials between 2°C to 25°C (35°F to 77°F) and use within 6 hours from the time of dilution. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. 

This vaccine is given 0.3 ml by intra muscular route of administration.

Any vaccine remaining in vials must be discarded after 6 hours. Do not refreeze

At what age is the Pfizer-BioNTech COVID-19 Vaccine given?

Currently this vaccine is approved for use by FDA for those above 16 years of age.

Use in children

Currently this vaccine has not been approved for use in children those below 16 years of age. 

Use in pregnancy

Currently there is insufficient data to examine this vaccine for safe use in pregnancy.

Old age

Clinical studies had participants of age above 65 years of age. The data from clinical studies indicate that this vaccine is safe and effective for those above 65 years of age.

What are side effects after Pfizer-BioNTech COVID-19 Vaccine?

In clinical trials the noted side effects are usually mild and they are listed as follows:

  • Redness and selling: It may appear at injection site withing few minutes to few hours of injection. Usually subsides by its own.
  • Pain at injection site: This is another side effect after taking this vaccine. Generally mild to moderate grade pain may occur at the injection site.
  • Fever: Generally this vaccine in few patients can cause fever. Fever is usually mild to moderate grade. It may subside by its own or may be reduced with oral treatment like paracetamol. Usually do not need admission for the management can be managed at home.
  • Fatigue: In some patients this vaccine may caise fatigue and generally reduces by its own.
  • Headache: In some patients it may cause headache that can be mild to  moderate grade. In very few patients it cause very severe headache.
  • Other mild side effects are chills, vomiting and diarrhea.
  • Muscle pain and joint pain
  • Serious adverse events were reported by 0.8% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 0.6% of placebo recipients who received at least 1 dose of Pfizer-BioNTech COVID-19 Vaccine or placebo, respectively. Currently very few serious side effects were noted and data is insufficient yet to prove the causal relationship between vaccine and serious side effects.

How does the Pfizer-BioNTech COVID-19 Vaccine work?

The modRNA in the Pfizer-BioNTech COVID-19 Vaccine is formulated in lipid particles, which enable delivery of the RNA into host cells to allow expression of the SARS-CoV-2 S antigen. 

This is active for immunity. When this vaccine is injected your immunity identifies the antigens form the vaccine and immunity is developed against it.

When the real infection occurs your trained immunity to fight the infection very vigorously fights the real infection. You are protected from the disease.

To whom Pfizer-BioNTech COVID-19 Vaccine should not be given?

If patient is allergic to any of its components or has got anaphylactic allergic reaction at the time of the first dose.




Disclaimer

This post is for just information purpose. We don’t encourage self diagnosis and medications without medical advise in any way.



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