There have been at least three instances where the drug regulator has approved a drug or vaccine but the COVID-19 National Task Force has taken a diametrically opposite stand and not included the drug/vaccine in the national treatment protocol. But the task force was quick to accept the and include the approval given to repurposed … Continue reading Conflicting signals from drug regulator, COVID-19 national task force
Even as the government flatly denies that its decision to increase the Covishield dose interval to 12-16 weeks is not due to vaccine shortage and is instead based on real-world data, there is no such real-world data to support its decision while it is common knowledge that acute shortage of vaccines is leading to a … Continue reading I would be reluctant to change Covishield dose interval at a time when we still have intense transmission: Gagandeep Kang
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?
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
After months of secrecy around the identity of the SEC members who approved Covaxin for restricted use despite no efficacy data, the Health Ministry finally revealed the names of the 10 members on March 23 in response to a question by Congress MP Syed Nasir Hussain. The names of the 10-member Subject Expert Committee (SEC) … Continue reading Health Ministry reveals the names of SEC members for vaccine approval
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?
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’
When the standard of care is available only to a section of the population, the priority groups at the moment, then it is not standard of care for the rest of the population. Therefore, it is ethical to continue with a placebo in the population outside the priority groups, as long as that non-priority status … Continue reading With two vaccines approved for restricted use, can placebos be used in trials?
Vaccine as a biological cause is least likely to cause deaths. The adenovirus vector and the genetic material that helps in making the spike protein are unlikely to cause deaths. But other ingredients in the vaccine and the quality of the vaccine in the particular batches that were used in these situations should be investigated. … Continue reading Causality assessment of COVID-19 vaccine deaths will be made public, says National AEFI Committee advisor
The preprint shows that Oxford vaccine efficacy was high when the interval between the two doses was two months and continued to increase with a longer dose interval. Vaccine efficacy after two standard doses increased from 54.9% when the gap between the two doses was less than six weeks to 82.4% when the gap between … Continue reading Updated efficacy results underline the benefits of delaying second dose of Oxford vaccine