With input from Dr. Monica Vasudev

1429: Interim final-phase data:Bharat Biotechs Covid shot is 81% effective.

1.     Overmore than a million doses of Covaxin, the countrys first indigenous vaccine,have been administered to the priority group comprising healthcare andfrontline workers.

2.      BharatBiotech said on Wednesday that its vaccine against Covid-19 had demonstrated 81percent interim efficacy in phase 3 clinical trials in protecting participantswithout prior infection following the administration of the second dose.

3.      Covaxin,developed by Bharat Biotech and the Indian Council of Medical Research (ICMR), receivedregulatory approval for emergency use in "clinical trial mode," wherebeneficiaries have to sign a consent form before being vaccinated — at thebeginning of January.

4.      Theinterim trial data will be submitted to the regulator seeking emergency useauthorization similar to the one that has been granted to Covishield.

5.     Thedata given by an independent data safety monitoring board will be presented tothe regulator.

6.      Theresults are the first interim efficacy data of a Covid-19 vaccine beingclinically tested in India. The serum is relying on efficacy data from the UKand Brazil trials for Covishield.

7.     Underthe clinical trial mode, individuals administered Covaxin are tracked andmonitored after vaccination. In case of serious adverse events, the vaccinemanufacturer is liable to pay compensation if the event is proven to becausally related to the vaccine. Besides, in case of any adverse event, thecompany provides the standard of care in designated health centres, as in regularclinical trials.

8.      Thecompany said that the first interim analysis was based on 43 cases, of which 36cases of Covid-19 were observed in the placebo group versus 7 cases observed inthe Covaxin group, resulting in a point estimate of vaccine efficacy of 80.6percent.

9.      Additionalinterim analysis was planned for 87 cases, and the final analysis was plannedfor 130 cases, the company said.

10.  Bharat Biotech alsosaid that an interim analysis on the safety of the vaccine had "showed thatsevere, serious, and medically attended adverse events occurred at low levelsand were balanced between vaccine and placebo groups."

11.  Covaxin demonstrates ahigh clinical efficacy trend against Covid-19 and significant immunogenicityagainst the rapidly emerging variants.

12.  Earlier, the expertbody recommending the approval to the regulator had said that the permissionwas in the public interest, "especially in the context of infection bymutant strains." Since the vaccine was based on inactive whole viriontechnology, it had the potential, theoretically, to target mutated coronavirus strains.

13.  The firm is currentlyconducting one of the largest phase 3 trials in India across 21 sites, with 25,800participants between 18-98 years of age, including 2,433 over the age of 60 and4,500 with comorbidities have been included in the trial.

Dr KK Aggarwal

President CMAAO, HCFI and Past NationalPresident IMA