Vaccine Overview

Covaxin™ (BBV152) An Investigational Whole-Virus Inactivated COVID-19 Vaccine*

Key Findings: Phase 3 Clinical Trial Involving 25,800 subjects

Protective Eﬀect

78% All Disease

65% Delta Variant

93% Severe Disease

AE Profile

12% Adverse Events**

<0.5% Serious Adverse Events**

*Post hoc analysis
**Placebo group

Covaxin (BBV152) Characteristics

Both humoral & cellular responses generated against multiple viral proteins
Induces a Th1 response (cell-mediated immunity)
Technology platform used to produce Polio, Inﬂuenza and Rabies vaccines

Adjuvant: Algel+IMDG (TLR7/8)¹

Administration: 2 doses, 28 days apart

Premixed and stable at standard refrigerated
conditions (2°-8° C), with a 2 year shelf life

Role of Adjuvant in Immune Response^2,3

Whole virion inactivated vaccines are typically formulated with Alum to induce an antibody response. These vaccines have demonstrated a primarily Th2 humoral immune response with limited cellular immunity. Emerging evidence suggests both antibody (humoral) and primarily T-cell mediated immunity are necessary for eﬀective COVID-19 protection. Covaxin (BBV152) is formulated with Alum + IMDG, a novel adjuvant that has been shown to illicit a strong Th1 biased antibody response and provide BOTH humoral antibody and cellular (T-cell) immune responses. Covaxin (BBV152) is the ﬁrst whole virion COVID-19 vaccine reported to induce a Th1 biased response.

Covaxin is an Investigational Whole Virus Inactivated Vaccine

Covaxin™ (BBV152)

(multiple targets)

mRNA and Adenovirus-Based Vaccines

(only one target)

Covaxin (BBV152) is an investigational whole-virus inactivated vaccine, which means it is designed to help the body build an immune response to multiple antigen targets. During natural immune response (i.e. individuals naturally infected with the whole virus) high titers of antibodies are generated to BOTH spike (S) and nuclieoprotein (N).³ IgG titers to these key proteins (S and N) increased rapidly after administration of Covaxin (BBV152)².

1. Novel adjuvant developed in collaboration with NIH/NIAID

2. Lancet Infect. Dis. 2021; 21:950-61

3. Nat Rev Immunol 20, 615–632 (2020) J. Mangalakumari et al

Fold Change in Neutralization Titer— by Sera Type

When comparing fold reduction in titer levels to variants, a lower number indicates higher immune response. Covaxin (BBV152) is designed to provide adequate neutralization titers against novel variants Delta and Beta, limiting fold reduction from the original.

1. https://www.biorxiv.org/content/10.1101/2021.05.31.445871v1
2. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)01290-3/fulltext
3. https://www.biorxiv.org/content/10.1101/2021.05.09.443299v1
4. https://www.biorxiv.org/content/10.1101/2021.06.05.447177v1
5. https://www.biorxiv.org/content/10.1101/2021.04.23.441101v1

Rare Adverse Event Proﬁle

1. https://www.fda.gov/media/150054/download
2. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-04-23/06-COVID-Oliver-508.pdf
3. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-05-12/07-COVID-Shimabukuro-508.pdf
4. National AEFI report– India Gov.

This table is for informational purposes and not meant for direct comparison. The data are from pharmacovigilance and not a comparative clinical study.

Covaxin’s (BBV152) Manufacturing Process:
The Vero Platform

Covaxin (BBV152) is manufactured utilizing the Vero Cell platform. This is the same platform historically used to manufacture routine childhood vaccines, like the polio vaccine. This process has been used for ~35 years.¹