The basis on which India approves precaution dose remains unclear

On November 22, 2021, Dr. Balram Bhargava said there is no scientific evidence so far to support the need for a booster vaccine dose against COVID-19. The priority was on administering the second dose to all adults. No new evidence from India has become available to support an additional dose after Dr. Bhargava's assertion. There … Continue reading The basis on which India approves precaution dose remains unclear

Does the Omicron variant make a case for booster doses?

What is the major objective of a booster dose -- to protect from infection or protect from severe disease and death, who should get it first whenever it is approved, is there enough evidence recommending for their use, and should we give boosters when primary immunisation is not complete? Dr. Chandrakant Lahariya, physician epidemiologist and … Continue reading Does the Omicron variant make a case for booster doses?

Soon mRNA vaccines for young children who rarely suffer from severe disease

Young children rarely suffer from severe disease, yet mRNA vaccines might soon be greenlighted by the FDA after Pfizer submitted Phase-2/3 data for initial review. The company expects to submit data of children 2-4 years and 6 months to 1 year by the end of the year. Vaccinating young children while even health-care workers in … Continue reading Soon mRNA vaccines for young children who rarely suffer from severe disease

India ill prepared despite lessons learnt in the first wave

After painfully negotiating numerous hurdles during the first wave that peaked in mid-September last year, India appears to have learnt little as more ferocious second wave is ravaging the country. After painfully negotiating numerous hurdles during the first wave that peaked in mid-September last year, India appears to have learnt little as more ferocious second … Continue reading India ill prepared despite lessons learnt in the first wave

Can Covaxin booster dose prolong protection?

When only two doses of the vaccine are given with a gap of 28 days between doses, the immunity would last for about a year or so. But If a third dose is administered four-five months after the second dose, the immunological principle is that the immunity will be long-lived. In a meeting held on … Continue reading Can Covaxin booster dose prolong protection?

In a major shift, India fast-tracks restricted use approval for vaccines developed in other countries

On April 13, India permitted fast-track approval of COVID-19 vaccines developed, tested and approved outside the country. The decision has been taken to “expand the basket of vaccines for domestic use and hasten the pace and coverage” of COVID-19 vaccination. But before mass roll out of the vaccines that are developed and tested abroad can … Continue reading In a major shift, India fast-tracks restricted use approval for vaccines developed in other countries

SEC allows Bharat Biotech to unblind all participants above 45 years

The Subject Expert Committee (SEC) has permitted Bharat Biotech to unblind all phase-3 trial participants above 45 years and offer the vaccine to those who received a placebo. The reason: vaccines (including Covaxin) are already available under the immunisation programme, and therefore all the eligible age groups should be unblinded for vaccination.

Will intranasal vaccines confer sterilising immunity?

HPV is the only vaccine that confers sterilising immunity even though it is an intramuscular vaccine. Even if the COVID-19 intranasal vaccine does not confer sterilising immunity, the local mucosal immunity is likely to reduce the possibility of infection and in all probability might prevent transmission. While all COVID-19 vaccines administered through the intramuscular route … Continue reading Will intranasal vaccines confer sterilising immunity?

Should Covaxin trial continue till 130 cases are recorded?

Considering that recruitment and complete vaccination of all trial participants has been achieved, the drug regulator has to take a decision on the number of cases required for licensing — currently available cases (which is likely to be more than 43), second endpoint of 87 cases or 130 cases as originally planned, for which the … Continue reading Should Covaxin trial continue till 130 cases are recorded?

Covaxin should no longer be available in ‘clinical trial mode’

Though the first interim analysis is based on only 43 cases, which is smaller compared with other vaccines that have been approved by other regulators, the vaccine appears safe and efficacious in phase-3 and early stages of human clinical trials and animal studies. The Indian regulator should therefore revise the restricted emergency use approval such … Continue reading Covaxin should no longer be available in ‘clinical trial mode’