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Table 1 Main recombinant, subunit or oligomeric vaccines approved for human or veterinary use

From: Recombinant vaccines in 2022: a perspective from the cell factory

 

Pathogen

Antigen

Names

Year of 1st Approval (FDA/EMA)

Production system

Formulation

Human

Hepatitis B virus

Hepatitis B Surface antigen (HBsAg)

Engerix-B, Heplisav-B, Pediarix, HBVaxPRO, Recombivax, Twinrix, Vaxelis,

Heplisav-B

1986

Yeast (S. cerevisiae)

Yeast (H. Polymorpha)

VLPs

 

Papillomavirus

L1 capsid protein

Gardasil, Gardasil 9

Cervarix

2006

2009

Yeast (S. cerevisiae)

Insect cells-BVES

VLPs Adjuvanted

 

Hepatitis E virus

ORF2 protein

Hecolin

2012*

E. coli

VLPs

 

Influenza A & B virus

Hemagglutinin (HA)

Flublok, Flublok RIV4, Supemtek

2013

Insect cells-BVES

NPs

No adjuvant

 

Neisseria meningitidis serogrup B

2 fHbp variants

Trumenba

2014

E. coli

No adjuvant

 

Malaria

HBsAg + RTS chimera

Mosquirix

2015

Yeast (S. cerevisiae)

VLPs

 

Varicella Zoster virus

Truncated gE

Shingrix

2017

CHO cells

Adjuvanted

 

SARS-CoV-2

Spike (S) protein

Nuvaxovid

2021

Insect cells-BVES

NPs

 

SARS-CoV-2

Spike protein

Covifenz

2022**

Plant (Nicothiana benthamiana)

VLPs

Swine

A. pleuropneumoniae

ApxII, TbpB, CysL, Om1A proteins

Pleurostar APP

n.s

n.s

 
 

Classical Swine Fever virus

E2 protein

Porcilis Pesti,

Bayovac CSF E2

2000

Withdrawn

Insect cells-BVES

Subunit

Adjuvanted

 

Porcine Circovirus Type 2

ORF-2 protein

Ingelvac CircoFLEX,

Porcilis PCV,

Circogard,

Circumvent PCV

2008

Insect cells-BVES

Fom VLPs Adjuvanted

 

Porcine parvovirus (PPV)

PPV 27a VP2

Reprocyc ParvoFLEX

2019

Insect cells-BVEs

VLPs

Adjuvanted

Canine

Borrelia burgdorferi

OspA & C chimeric

OspA

Vanguard crLyme, Recombitek Lyme

n.s

E. coli

No adjuvant

 

Leishmania

A2 different species

Leish-Tec

2004

n.s

Adjuvanted

 

Leishmania

Chimeric Protein Q

Letifend

2016

E. coli

No adjuvant

Poultry

Newcastle disease virus

Hemagglutinin-neuraminidase

Approved by USDA, not commercialized

2006

Plants (tobacco suspension cells)

 

Feline

Feline leukemia virus

P45 env. antigen

Leucogen

Nobivac LeuFel

2009

E. coli

Subunit

Adjuvanted

Equine

Streptococcus equi

CCE, mEq84, IdeE

Strangvac

2021

E. coli

Adjuvanted

  1. * Only approved in China; ** Only approved in Canada; VLP, virus-like particle; NP, nanoparticle; fHbp, lipidated factor H binding protein; gE, glycoprotein E; n.s., not specified; LiESP, L. infantum Excreted-Secreted protein, BVES, baculovirus expression system