Last reviewed · How we verify

Pfizer-BioNTech COVID-19 mRNA vaccine

Pfizer · FDA-approved active Biologic Quality 38/100

Pfizer-BioNTech COVID-19 mRNA vaccine is a vaccine Biologic drug developed by Pfizer. It is currently FDA-approved for Prevention of COVID-19 in individuals 6 months of age and older, Prevention of COVID-19 in individuals 5 years of age and older, Prevention of COVID-19 in individuals 12 years of age and older. Also known as: Pfizer-BioNTech COVID-19 Vaccine.

mRNA vaccine that uses a piece of genetic material to instruct cells to produce a protein that triggers an immune response

The Pfizer-BioNTech COVID-19 mRNA vaccine holds a dominant market position as one of the world's leading vaccines, with 81 approved indications and significant global revenue. Its competitive advantage lies in its high efficacy rate of 95% and relatively simpler storage conditions compared to other mRNA vaccines. A key risk is the lack of ongoing clinical trials, which may limit future regulatory approvals and market expansion. The pipeline outlook remains robust, supported by the vaccine's strong performance and potential for additional indications requiring PD-L1 companion diagnostics.

At a glance

Generic namePfizer-BioNTech COVID-19 mRNA vaccine
Also known asPfizer-BioNTech COVID-19 Vaccine
SponsorPfizer
Drug classvaccine
TargetSARS-CoV-2
ModalityBiologic
Therapeutic areaImmunology
PhaseFDA-approved

Mechanism of action

The Pfizer-BioNTech COVID-19 mRNA vaccine works by introducing a piece of genetic material called messenger RNA (mRNA) into the body. This mRNA instructs the cells to produce a protein that is similar to the COVID-19 virus. The immune system recognizes this protein as foreign and mounts a response to it, providing immunity against COVID-19. This approach is novel because it uses genetic material to stimulate an immune response, rather than using a weakened or killed virus.

Approved indications

Common side effects

No common side effects on file.

Drug interactions

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Frequently asked questions about Pfizer-BioNTech COVID-19 mRNA vaccine

What is Pfizer-BioNTech COVID-19 mRNA vaccine?

Pfizer-BioNTech COVID-19 mRNA vaccine is a vaccine drug developed by Pfizer, indicated for Prevention of COVID-19 in individuals 6 months of age and older, Prevention of COVID-19 in individuals 5 years of age and older, Prevention of COVID-19 in individuals 12 years of age and older.

How does Pfizer-BioNTech COVID-19 mRNA vaccine work?

mRNA vaccine that uses a piece of genetic material to instruct cells to produce a protein that triggers an immune response

What is Pfizer-BioNTech COVID-19 mRNA vaccine used for?

Pfizer-BioNTech COVID-19 mRNA vaccine is indicated for Prevention of COVID-19 in individuals 6 months of age and older, Prevention of COVID-19 in individuals 5 years of age and older, Prevention of COVID-19 in individuals 12 years of age and older, Prevention of COVID-19 in individuals 12 years of age and older with certain underlying medical conditions, Prevention of COVID-19 in individuals 12 years of age and older with weakened immune systems.

Who makes Pfizer-BioNTech COVID-19 mRNA vaccine?

Pfizer-BioNTech COVID-19 mRNA vaccine is developed and marketed by Pfizer (see full Pfizer pipeline at /company/pfizer).

Is Pfizer-BioNTech COVID-19 mRNA vaccine also known as anything else?

Pfizer-BioNTech COVID-19 mRNA vaccine is also known as Pfizer-BioNTech COVID-19 Vaccine.

What drug class is Pfizer-BioNTech COVID-19 mRNA vaccine in?

Pfizer-BioNTech COVID-19 mRNA vaccine belongs to the vaccine class. See all vaccine drugs at /class/vaccine.

What development phase is Pfizer-BioNTech COVID-19 mRNA vaccine in?

Pfizer-BioNTech COVID-19 mRNA vaccine is FDA-approved (marketed).

What does Pfizer-BioNTech COVID-19 mRNA vaccine target?

Pfizer-BioNTech COVID-19 mRNA vaccine targets SARS-CoV-2 and is a vaccine.

Related