• Vaccine Name: Comirnaty
• Target Pathogen: SARS-CoV-2
• Target Disease: COVID-19
• Product Name: BNT162b2
• Manufacturer: Pfizer, BioNTech
• Vaccine Ontology ID: VO_0004987
• CDC CVX code: 208
• CDC CVX description: SARS-COV-2 (COVID-19) vaccine, mRNA, spike protein, LNP, preservative free, 30 mcg/0.3mL dose
• Type: mRNA vaccine
• Status: Licensed
• Host Species for Licensed Use: Human
• Antigen: trimerized SARS-CoV-2 receptor-binding domain from S
• Immunization Route: Intramuscular injection (i.m.)
• Storage: -70°C ±10°C
• Description: A SARS-CoV-2 RNA vaccine formed from a lipid nanoparticle-formulated trimerized SARS-CoV-2 receptor-binding domain

Macaque Response

• Vaccination Protocol: Groups of six male, 2-4 year old rhesus macaques were immunized IM with 30 or 100 μg of BNT162b2 or saline control on Days 0 and 21. (Vogel et al., 2020)
• Immune Response: Seven days after Dose 2 (Day 28), the GMCs of S1-binding IgG were 30,339 units (U)/mL (30 μg dose level) and 34,668 U/mL (100 μg dose level). Fifty percent virus neutralisation GMTs, measured by an authentic SARS-CoV-2 neutralisation assay25, were detectable in rhesus macaque sera by Day 21 after Dose 1 and peaked at a GMT of 962 (Day 35, 14 days after Dose 2 of 30 μg) or 1,689 (Day 28, 7 days after Dose 2 of 100 μg; Fig. 3b). Robust GMTs of 285 for 30 μg and 310 for 100 μg dose levels persisted to at least Day 56. Strong IFNγ but minimal IL-4 responses were detected by ELISpot after Dose 2. BNT162b2 elicited strong S-specific IFNγ producing T-cell responses, including a high frequency of CD4+ T cells that produced IFNγ, IL-2, and TNF but a low frequency of CD4+ T cells that produced IL-4, indicating a TH1-biased response. BNT162b2 also elicited S-specific IFNγ+ producing CD8+ T cells. (Vogel et al., 2020)
• Challenge Protocol: Six rhesus macaques that had received two immunisations with 100 μg BNT162b2 and three age-matched macaques that had received saline were challenged 55 days after Dose 2 with 1.05 × 106 plaque forming units of SARS-CoV-2 (strain USA-WA1/2020), split equally between intranasal and intratracheal routes. Three additional non-immunised, age-matched rhesus macaques (sentinels) were mock-challenged with cell culture medium. (Vogel et al., 2020)
• Efficacy: BNT162b2 immunization prevented lung infection in 100% of the SARS-CoV-2 challenged rhesus macaques, with no viral RNA detected in the lower respiratory tract of immunized and challenged animals. The BNT162b2 vaccination also cleared the nose of detectable viral RNA in 100% of the SARS-CoV-2 challenged rhesus macaques within 3 days after the infection. (Vogel et al., 2020)

Human Response

• Vaccination Protocol: Participants 19-55 years of age were vaccinated with BNT162b2 in Germany. Twelve participants per dose cohort were assigned to receive a priming dose of 1, 10, 20 or 30 μg on day 1 and a booster dose on day 22. (Sahin et al., 2020)
• Immune Response: BNT162b2 elicited strong antibody responses, with S-binding IgG concentrations above those in a COVID-19 human convalescent sample (HCS) panel. Day 29 (7 days post-boost) SARS-CoV-2 serum 50% neutralising geometric mean titers were 0.3-fold (1 µg) to 3.3-fold (30 µg) those of the HCS panel. The BNT162b2-elicited sera neutralized pseudoviruses with diverse SARS-CoV-2 S variants. In most participants, S-specific CD8+ and T helper type 1 (TH1) CD4+ T cells had expanded, with a high fraction producing interferon-γ (IFNγ). CD8+ T cells were shown to be of the early-differentiated effector-memory phenotype, with single specificities reaching 0.01-3% of circulating CD8+ T cells. Vaccination with BNT162b2 at well tolerated doses elicits a combined adaptive humoral and cellular immune response, which together may contribute to protection against COVID-19. (Sahin et al., 2020)
• Side Effects: No serious adverse events (SAE) and no withdrawals due to related adverse events (AEs) were observed at any dose level. Local reactions, predominantly pain at the injection site, were mild to moderate (grade 1 and 2) and were similar in frequency and severity after the priming and booster doses. The most common systemic AEs were fatigue followed by headache and only two participants reported fever, which was mild. Transient chills were more common after the boost, dose-dependent, and occasionally severe. Muscle pain and joint pain were also more common after the boost and showed dose-dependent severity. There were no grade 4 reactions. Generally, reactions had their onset within 24 hours of immunisation, peaked on the day after immunisation, and mostly resolved within 2-3 days. Reactions did not require treatment or could be managed with simple measures (e.g. paracetamol). (Sahin et al., 2020)