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Abstract
The spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has led to a global coronavirus disease-19 (COVID-19) pandemic. Several vaccine types, such as inactivated, viral vector-, or mRNA-based, have received approval against SARS-CoV-2. The ability to induceT-helper-1 cell (Th1) responses is desirable from an effective vaccine against this virus. Covaxin (BBV152) is a wholevirion inactivated SARS-CoV-2 vaccine adjuvanted with Algel-Imidazoquinoline (IMDG) molecule, a toll-like receptor (TLR) 7/8 agonist. The mRNA-based vaccine use is hindered because of cold storage requirement, whereas covaxin is stored between 2°C and 8°C, making it suitable for countries with limited resources. The Drug Controller General of India (DCGI) has approved the BBV152 vaccine. Therefore, it is of interest to document known data on BBV152 vaccine phase I, phase II and phase III human clinical trials to evaluate the safety, reactogenicity, tolerance, and immunogenicity of the whole-virion inactivated SARS-CoV-2 vaccine (BBV152).
Highlights
Covaxin (BBV152) is a wholevirion inactivated SARS-CoV-2 vaccine adjuvanted with Algel-Imidazoquinoline (IMDG) molecule, a toll-like receptor (TLR) 7/8 agonist
SARS-CoV-2 that causes COVID-19 is an enveloped, single- A total of 375 individuals were enrolled for thetrial,with 100 stranded, positive-sense RNA virus that belongs to the Ħ-genus individuals assigned to each of the three vaccine groups- one for of Sarbecovirus and is a close relative of SARS-CoV [1]
Booster administration did not enhance the pain or swelling, and only 1%-2% of participants exhibited mild pain in the groups treated with 3 μg and 6 μg Different phases of BBV152 vaccine trials BBV152 (A-C) vaccine animal trials A whole-virion inactivated SARS-CoV-2 vaccine candidate (BBV152A-C) was developed against the virus pathogenic and predominant strain-National Institute of Virology (NIV)-2020-770.BBV152 was formulated in aluminium hydroxide (Algel) or Algel-Imidazoquinoline (AlgelIMDG)
Summary
SARS-CoV-2 that causes COVID-19 is an enveloped, single- A total of 375 individuals were enrolled for thetrial,with 100 stranded, positive-sense RNA virus that belongs to the Ħ-genus individuals assigned to each of the three vaccine groups- one for of Sarbecovirus and is a close relative of SARS-CoV [1]. SARS-CoV-2 strain NIV-2020-770 (which contains the D614G at the injection site after the first dose (5 % of the individuals mutation) with ß-propiolactone.The vaccine was developed and administered with 3 μg and 6 μg Algel-IMDG, 1% of those treated is manufactured in the Bio-Safety Level 3 (BSL-3) high with 6μg Algel, and 3% in the Algel-only control group).
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