Company to initiate trials with around 30,000 volunteers
An expert panel in the Central Drugs Standard Control Organisation that met on Wednesday to consider emergency use authorisation applications will reconvene on Jan 1 to deliberate on the matter.
Covaxin, being developed in collaboration with the Indian Council of Medical Research and the National Institute of Virology, is now undergoing phase-3 trials
The discrepancy, reported for the first time by Reuters, centres on the regimen administered to a smaller group of volunteers in the late-stage trials, of half a dose followed by a full dose
The ethics committee has seven members, including a chairperson who has to be from outside the institution where the trial is being conducted.
Pfizer has not yet applied for holding clinical trials on Indian volunteers
The trial, which started at the city''s ICMR-National Institute of Cholera and Enteric Diseases (NICED), was inaugurated by state Governor Jagdeep Dhankhar
The press release did not specify as to how long the human trials are likely to take and by when the vaccine would be ready for use
The SEC had on October 5 asked the firm to re-apply stating it will have to conduct both phase 2 and 3 clinical trials and cannot directly hold phase 3 trial for the vaccine in India
Good momentum in US and domestic sales, along with Covid-19 treatment portfolio is already driving analysts to upgrade earnings estimates
On the issue of how the government plans to roll out the Covid-19 vaccine, he said that it is anticipated that supplies of vaccines would be available in limited quantities in the beginning
Health Secy says a vaccine should be available in first quarter of next year if everything goes according to plan
The 'antisera' is yet to undergo human clinical trials to establish safety and efficacy
Smaller players are bullish on playing crucial role in nation's vaccine infrastructure
Union Health Minister Harsh Vardhan clarified on Sunday that the government is yet to take a final decision on phase-3 trials of the Russian COVID-19 vaccine candidate Sputnik V.
French biz confidence up despite resurgence, China eases entry rules for some foreigners, tough times for airlines as attempts to reopen falter, and other pandemic-related news across the globe
Firm also ties up with Washington University's school of medicine for intransal vaccine for Covid-19
It said people with a history or laboratory evidence of prior novel coronavirus infection should be allowed to participate in trials if they did not have acute COVID-19 or other acute infectious illne
The U.S. company's vaccine is in mid-stage trials after an early-stage trial showed it produced high levels of antibodies against the novel coronavirus
The results showed protective efficacacy, increasing Sars-CoV-2 specific IgG and neutralising antibodies reducing the replication of the virus in the nasal cavity, throat and lung tissues of monkey