Clinical bridging trials of Johnson & Johnson’s single – dose COVID – 19 vaccine to begin shortly in India :
Johnson & Johnson ( J&J ) has recently communicated with the CDSCO[1] to ramp up vaccine availability in the country. The company has sent a letter to the Indian regulator on this matter. It stated that it would soon seek out the CDSCO’s permission for conducting bridging trials of its vaccine in India.
Owing to the second surge of the coronavirus in India, the country currently faces high COVID vaccine demands. This, in addition to the rapid depletion of supplies in some states, has pressured the government for vaccine doses.
J&J COVID vaccine: The bridging trial that will be conducted by J&J will be similar to the one conducted by Dr. Reddy’s for the Sputnik V vaccine. Serum Institute of India has also conducted a bridging trial for the AstraZeneca – Oxford vaccine.
Bridging trials usually enroll around 1000 participants and are done to establish the safety and immunogenicity of the vaccine. The efficacy of the vaccine is not tested by this trial. This is because this trial is performed only when other trials have established the vaccine’s efficacy.
J&J has tied up with Biological E to expand its vaccine manufacturing capacities in India.
J&J COVID vaccine: USFDA approval
USFDA[2] has issued an Emergency Use Authorization of J&J’s vaccine in February 2021. J&J Janssen Pharmaceutical Companies developed this vaccine. This approval was granted based on the data submitted from the phase 3 ensemble study of this vaccine.
This study revealed that the vaccine is 85 % effective in preventing severe disease. This vaccine is 66 % to 72 % effective in preventing moderate to severe COVID – 19. However, the protection against COVID – 19 related hospitalization and death begins only 28 days after vaccination.
The single – shot vaccine was delivered to the US by the end of March 2021. This was for immunizing the entire adult population of the country.
J&J is using its AdVac vaccine platform for this new vaccine (J&J COVID vaccine). The AdVac also used this to develop and manufacture Jansenn’s European Commission–approved Ebola vaccine. Other investigational vaccine candidates for Zika, RSV[3], and HIV[4] have also been developed using this platform. The AdVac vectors are based on a genetically modified adenovirus. This virus can no longer replicate in humans and so cannot cause disease.
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COVID – 19 in India
On 8 April 2021, the Union Health Minister of India reassured that the government was taking steps to enhance vaccine supply. He further added that the current situation was being monitored continuously. Around 2.4 crores doses of COVID – 19 vaccines are available for use as per his claims. He also revealed that over 9 crore doses had been administered, and around 4.3 crores doses are in stock at present.
He had also rebuked the statements made by Maharashtra’s Health Minister regarding the unfair distribution of vaccines. On this note, he stressed that the health ministry delivered around 1,06,19,190 doses to Maharashtra. This made it the state to receive the maximum doses in India. The total doses delivered to Gujarat amounted to about 1,05,19,330, while that of Rajasthan was over 1,04,95,860. Despite such a large number, the number of cases in Maharashtra far outnumbers that in Gujarat and Rajasthan. These were all reported by the Union Health Minister in his tweet.
Abbreviation :
- 1. Central Drugs Standard Control Organization
- 2. United States Food and Drug Administration
- 3. Respiratory syncytial virus
- 4. Human Immunodeficiency virus