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. 2023 Jun 23:105438. Online ahead of print. doi: 10.1016/j.yrtph.2023.105438

Table 2.

Species selection in vaccine specific (A) Repeated dose Toxicity (RDT) studies and (B) Developmental and Reproductive Toxicity (DART) studies of COVID-19 vaccine candidates. Vaccines are anonymized based on their vaccine concept: mRNA(x) (un)modified mRNA-based vaccine encapsulated in lipid nanoparticle (LNP). Adeno(x) = recombinant replication-incompetent adenoviral vector encoding the spike protein antigen of SARS-CoV-2. InAct(x) = inactivated SARS-CoV-2 virus formulated with adjuvant. Sub(x) = subunit: modified spike protein of SARS-CoV-2 formulated with adjuvant.

RDT
Species Vaccine concept (total nr. of studies) Age of animals Number of animals (females + males)
Wister Han Rat mRNA1 (2) 9 weeks 90
54/60 days (∼8 weeks) 241
mRNA3 (1) 9/11 weeks 110
InAct2 (1) 6/7 weeks 60
Sprague Dawley Rat mRNA2 (1) 7 weeks 40
New Zealand White Rabbit Sub1 (2) 12/14 weeks 40
21 weeks 160
Sub2 (1) ∼15 weeks 90
Adeno2 (1) 13/15 weeks 40
CD-1 mouse Adeno (1) 7/8 weeks 170
DART
Species Vaccine concept (total nr. of studies) Age of animals Number of animals (females only)
Wistar Han Rat mRNA1 (1) 11 weeks 132
mRNA3 (1) 7 weeks 60
InAct2 (1) (at least) 10 weeks 88
Sprague Dawley Rat mRNA2 (1) 74 days (∼11 weeks) 88
Sub2 (2) (at least 8 weeks) 4 (pilot study)
6.6 weeks 150
New Zealand White Rabbit Sub1 (1) 16/19 weeks 132
Adeno2 (1) 5/6 months 92
CD-1 mouse Adeno1 (1) 11 weeks 64