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Sanofi-GSK Covid-19 Vaccine Has Been Approved For Phase 3 Trials In India
Covid-19 Vaccine Has Been Approved For Phase 3 Trials In India (Photo/indianexpress)
- The pharma regulator has given Sanofi and GlaxoSmithKline approval to include participants to perform a component of the worldwide Phase 3 efficacy study of their protein-based Covid-19 vaccine candidates.
- The Indian population will be included in the first worldwide clinical study for a Covid-19 vaccination.
The pharma regulator has given Sanofi and GlaxoSmithKline approval to include participants to perform a component of the worldwide Phase 3 efficacy study of their protein-based Covid-19 vaccine candidates. The Indian population will be included in the first worldwide clinical study for a Covid-19 vaccination.
According to Sanofi's recent application, on June 25, to the Clinical Trials Registry of India, the global trial would comprise 37,430 participants over the age of 18 among 13 sites in the United States, Asia, Africa, and Latin America. Among 37,430 participants, India will hold 3,000 participants participating in the trials. Aartham Multi Super Specialty Hospital in Ahmedabad, Maharaja Agrasen Super Specialty Hospital in Jaipur, and Nizam's Institute of Medical Sciences (NIMS) in Hyderabad have been chosen to perform the Indian portion selected to perform the trial.
The permission by DCGI is the first of its kind for a global trial of a foreign Covid vaccination in India, and enrollment is likely to begin soon. According to the most recent information accessible on CTRI, NIMS is currently waiting for confirmation from its ethics committee, while the other two locations gained approval from non-independent ethics committees on June 21 and 24. Before being used in the trials, batches of the vaccines are expected to be tested at the Central Drugs Laboratory in Kasauli.
The United States, Japan, Sri Lanka, Pakistan, Colombia, Dominican Republic, Honduras, Mexico, Kenya, Nigeria, Ghana, and Uganda are among the countries participating in the protein-based vaccine candidate trial. At this time, it's unknown how well the remaining 34,430 participants will be distributed amongst these countries. The experiment will evaluate the potential of monovalent and bivalent adjuvanted recombinant protein vaccines to prevent symptomatic Covid-19 cases affected by two strains of the SARS-CoV-2 virus.
The vaccine's safety will be investigated even more in the trial. This will evaluate the neutralizing antibody response evolved towards the two variants among those that don't have any existing safeguards against SARS-CoV-2 because they have not been infected with the virus and who have been exposed to the virus.
According to Sanofi, therecent scientific evidence suggests that antibodies developed against the Beta variant may give wide cross-protection against other more transmissible variants. The adjuvanted recombinant Covid vaccine candidate produced high rates of neutralizing antibody responses, with 95-100 percent seroconversion rates, according to worldwide Phase 2 interim results.
Sanofi claimed that high neutralizing antibody levels were also created after a single injection in individuals with signs of prior SARS-CoV-2 infection, indicating the considerable potential for thedevelopment of a booster vaccine.
