Pfizer–BioNTech COVID-19 vaccine
The Pfizer–BioNTech COVID-19 vaccine, sold under the brand name Comirnaty,[2][32] 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.[44][45] It is authorized for use in humans to provide protection against COVID-19, caused by infection with the SARS-CoV-2 virus.[2][30] The vaccine is given by intramuscular injection.[34] 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.[46] Initial guidance recommended a two-dose regimen, given 21 days apart;[34][47][48][49] this interval was subsequently extended to up to 42 days in the United States,[34][50] and up to four months in Canada.[51][52]
"Pfizer vaccine" and "BioNTech vaccine" redirect here. For the manufacturers, see Pfizer and BioNTech.Vaccine description
BNT162b2, COVID-19 mRNA vaccine (nucleoside-modified), COVID-19 Vaccine (mRNA)[4]
- AU: B1[5]
- AU: S4 (Prescription only)[6][5][7][8][9][10][11][12][13][14][15][16]
- BR: Approved[17][18]
- CA: ℞-only / Schedule D[19][20][21][22][23][24]
- UK: Conditional marketing authorization granted[25][26][27][1]
- US: ℞-only with standing order; Approved for those aged 12+;[28][29][30] Emergency Use Authorization for those aged 6 months–11 years[31][32][30][33][34][35][36][37][38][39]
- EU: Marketing authorization granted[2][3][40]
- CH: Rx-only[41]
Clinical trials began in April 2020;[47] by November 2020, the vaccine had entered phase III clinical trials, with over 40,000 people participating.[53] 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.[49][54] Most side effects are mild to moderate in severity and resolve within a few days.[2][55] Common side effects include mild to moderate pain at the injection site, fatigue, and headaches.[56][57] Reports of serious side effects, such as allergic reactions, remain very rare[a] with no long-term complications documented.[2][59]
The vaccine is the first COVID‑19 vaccine to be authorized by a stringent regulatory authority for emergency use[60][61] and the first to be approved for regular use.[41] In December 2020, the United Kingdom was the first country to authorize its use on an emergency basis.[59] It is authorized for use at some level in the majority of countries.[62][63][64][65] 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).[29][32][66] The logistics of distributing and storing the vaccine present significant challenges due to the requirement for its storage at extremely low temperatures.[67]
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.[68][69][70][71] The following month, the BA.1 version of the bivalent vaccine (Comirnaty Original/Omicron BA.1 or tozinameran/riltozinameran)[72] was authorized as a booster for use in the UK.[73][74][75] 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][40]
In addition to the mRNA molecule, the vaccine contains the following inactive ingredients (excipients):[26][120][113]
The first four of these are lipids. The lipids and modRNA together form nanoparticles that act not only as carriers to get the modRNA into the human cells, but also as adjuvants.[131] ALC-0159 is a polyethylene glycol conjugate, i.e., a PEGylated lipid.[132]