Bharat Biotech’s Covaxin Safe Is According to Phase 1 Study Data – India News

India’s first domestically manufactured vaccine against Covid-19, Covaxin, elicited a robust immune response and did not report any serious adverse events. This shows results of the placebo-controlled, randomized, double-blind phase 1 study on safety and immunogenicity carried out by Bharat Biotech in a pre-print study on Wednesday.

According to the study, only one serious adverse event that was not related to the vaccination was reported.

Covaxin’s Phase 1 results had not yet been publicly released, although the data was first presented to the Indian Drug Control Officer (DCGI) on October 2 when the company applied for approval to start phase 3 trials.

“BBV152 induced binding and neutralizing antibody responses … Vaccine-induced neutralizing antibody titers have been reported with two different SARS-CoV-2 strains. BBV152 is stored between 2 ° C and 8 ° C, which is compatible with all cold chain requirements of the national vaccination program, ”says the paper, which has yet to be peer-reviewed.

However, the data from the study published on Wednesday only relate to the first of the three-phase clinical trials for the approval of vaccines. In Phase 1, initial tests of the vaccine candidate are carried out on a small number of healthy adults, primarily to test its safety. The results of this phase do not play a role in the market approval.

Other organizations that have developed Covid-19 vaccines released data from their Phase 1 studies a few months ago. For example, Moderna Inc released its Phase 1 data in July. The Pfizer / Biontech vaccine, which has already been given in the US and UK, released data from its vaccine’s Phase 1 results in August.

Phase 2 involves a larger number of subjects and focuses on data on the ability of a vaccine to safely achieve its desired effect (immunogenicity).

Phase 3 is the central study on which the licensing is based and it tests the effectiveness of the immune response triggered by the vaccine. The effectiveness of the vaccine will only be determined in phase 3 studies. The results of phase 3 are finally presented as data for which approval is given. Bharat Biotech has not yet presented any results from phase 3 trials that began in mid-November. On December 7th, the company applied to DCGI for emergency approval for Covaxin, whereupon the Subject Expert Committee (SEC) recommended that the safety and efficacy data from phase 3 studies be submitted so that its application can be considered.

In cooperation with ICMR, Bharat Biotech has developed the fully virion-inactivated SARS-CoV-2 vaccine candidate (BBV152).

In the phase 1 study, a total of 375 participants were equally randomized to receive three vaccine formulations (n ​​= 100 each). The control arm had 75 participants. The vaccines were administered on day 0 (baseline) and day 14 on a two-dose intramuscular accelerated schedule. The primary results were reactogenicity and safety. The secondary results were immunogenicity. Follow-up visits were scheduled on days 7, 28, 42, 104, and 194.

However, experts say that much depends on the results of the Phase 3 study. “There are many promising vaccine candidates right now, but the results of the Phase 3 trial will be important in determining which will ultimately occur,” said public health expert Professor K Srinath Reddy, who is also a member of the National Task Force on Covid- is. 19 Management.