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
Emergency use authorisation
Two COVID-19 antivirals get FDA nod for emergency use
Paxlovid is not recommended for patients with severe kidney or liver disease, and if given to people with uncontrolled or undiagnosed HIV infection may result in HIV drug resistance. Molnupiravir is not recommended for use during pregnancy as the drug may harm the foetus. If full vaccination with any of the COVID-19 vaccines greatly reduces … Continue reading Two COVID-19 antivirals get FDA nod for emergency use
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
Government passes off factually incorrect vaccination information as ‘fact’
While Dr. Vinod Paul, Chair of the National Expert Group on Vaccine Administration for COVID-19, said no country is vaccinating children, the U.S. has been vaccinating children older than 16 years since April 20. On May 10, the FDA authorised Pfizer vaccine in children 12-15 years, and five other countries too have approved the vaccine … Continue reading Government passes off factually incorrect vaccination information as ‘fact’
India sets a dangerous precedent with COVID-19 vaccination programme
The unprecedented, hare-brained policy that requires States to buy vaccines, and at a far higher price than what the Central government pays, and framed without consulting the States or giving them prior notice, combined with profiteering by vaccine manufacturers in the thick of the pandemic and vaccine shortage will surely exacerbate vaccine inequity. In the … Continue reading India sets a dangerous precedent with COVID-19 vaccination programme
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’
Pfizer vaccine can be stored at -15 to -25 degree C for two weeks
On February 19, the U.S.-based Pfizer claimed in a release that its COVID-19 vaccine is stable when stored low temperature of -25 to -15 degree C, which are commonly found in pharmaceutical freezers and refrigerators. The stability data has been generated on batches manufactured over the past nine months of COVID-19 vaccine development. On Friday, … Continue reading Pfizer vaccine can be stored at -15 to -25 degree C for two weeks
Indian scientists divided over restricted use approval for Covaxin
While some scientists have raised concerns about granting restricted use approval to Covaxin even in the absence of efficacy data, four-dozen scientists have in a statement slammed them saying “reprehensible utterances are causing huge credibility crisis for the Indian scientific community”. Apparently, questioning the approval process by the Indian regulator is seen as being anti-Indian … Continue reading Indian scientists divided over restricted use approval for Covaxin
Vaccine dilemma: To take or not to take Covaxin
Since COVID-19 vaccination is not compulsory, a person walking into a site that provides only Covaxin can choose not to get vaccinated. But is it ethical to offer one health-care worker the Covaxin whose efficacy is unknown and another health-care worker the Covishield whose efficacy is known even though both face the same risk of … Continue reading Vaccine dilemma: To take or not to take Covaxin
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