Pfizer–BioNTech COVID-19 vaccine

Pfizer–BioNTech COVID-19 vaccine
A vial of the Pfizer–BioNTech COVID‑19 vaccine for the U.S. market
Vaccine description
TargetSARS-CoV-2
Vaccine typemRNA
Clinical data
Trade namesComirnaty[1][2][3]
Other namesBNT162b2, COVID-19 mRNA vaccine (nucleoside-modified), COVID-19 Vaccine (mRNA)[4]
AHFS/Drugs.comMonograph
MedlinePlusa621003
License data
Pregnancy
category
Routes of
administration		Intramuscular
ATC code
Legal status
Legal status

ZA: Section 21[44][45]

Full list of Pfizer-BioNTech vaccine authorizations
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The Pfizer–BioNTech COVID-19 vaccine, sold under the brand name Comirnaty,[2][33] is an mRNA-based COVID-19 vaccine developed by the German biotechnology company BioNTech. For its development, BioNTech collaborated with the American company Pfizer to carry out clinical trials, logistics, and manufacturing.[46][47] It is authorized for use in humans to provide protection against COVID-19, caused by infection with the SARS-CoV-2 virus.[2][31] The vaccine is given by intramuscular injection.[35] It is composed of nucleoside-modified mRNA (modRNA) that encodes a mutated form of the full-length spike protein of SARS-CoV-2, which is encapsulated in lipid nanoparticles.[48] Initial guidance recommended a two-dose regimen, given 21 days apart;[35][49][50][51] this interval was subsequently extended to up to 42 days in the United States,[35][52] and up to four months in Canada.[53][54]

Clinical trials began in April 2020;[49] by November 2020, the vaccine had met the primary efficacy goals of the phase III clinical trial, with over 40,000 people participating.[55] Interim analysis of study data showed a potential efficacy of 91.3% in preventing symptomatic infection within seven days of a second dose and no serious safety concerns.[51][56] Most side effects are mild to moderate in severity and resolve within a few days.[2][57] Common side effects include mild to moderate pain at the injection site, fatigue, and headaches.[58][59] Reports of serious side effects, such as allergic reactions, remain very rare[a] with no long-term complications documented.[2][61]

The vaccine is the first COVID‑19 vaccine to be authorized by a stringent regulatory authority for emergency use[62][63] and the first to be approved for regular use.[43] In December 2020, the United Kingdom was the first country to authorize its use on an emergency basis.[61] It is authorized for use at some level in the majority of countries.[64][65][66][67] On 23 August 2021, the Pfizer–BioNTech vaccine became the first COVID-19 vaccine to be approved in the US by the Food and Drug Administration (FDA).[30][33][68] The logistics of distributing and storing the vaccine present significant challenges due to the requirement for its storage at extremely low temperatures.[69]

In August 2022, a bivalent version of the vaccine (Pfizer-BioNTech COVID-19 Vaccine, Bivalent) was authorized for use as a booster dose in individuals aged twelve and older in the US.[70][71][72][73] The following month, the BA.1 version of the bivalent vaccine (Comirnaty Original/Omicron BA.1 or tozinameran/riltozinameran)[74] was authorized as a booster for use in the UK.[75][76][77] The same month, the European Union authorized both the BA.1 and the BA.4/BA.5 (tozinameran/famtozinameran) booster versions of the bivalent vaccine.[2][3][42] In August 2024, the FDA approved and granted emergency authorization for a monovalent Omicron KP.2 version of the Pfizer–BioNTech COVID-19 vaccine.[78][79] The approval of Comirnaty (COVID-19 Vaccine, mRNA) (2024-2025 Formula) was granted to BioNTech Manufacturing GmbH.[78] The EUA amendment for the Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) was issued to Pfizer Inc.[78]

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