Conflicting signals from drug regulator, COVID-19 national task force

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

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

Restrictive voluntary license of COVID-19 antivirals compromises access, says Leena Menghaney

On the face of it, the agreement signed between the Medicines Patent Pool and the two pharmaceutical companies Merck and Pfizer appear to be making it easy to access COVID-19 antiviral drugs molnupiravir and Paxlovid, respectively. Yet, the voluntary license restricts the countries and population that have easy access to the antivirals. It even restricts … Continue reading Restrictive voluntary license of COVID-19 antivirals compromises access, says Leena Menghaney

Pfizer’s antiviral Paxlovid is a major advancement potentially for all coronaviruses, says Gagandeep Kang

Gagandeep Kang Besides 89% efficacy in preventing death and hospitalisation in specific groups that have high risk of progressing to severe disease when treatment is initiated within five days of symptoms showing up, Pfizer's antiviral against SARS-CoV-2 virus has been found to limit damage to lung tissue in human cells and mouse models of SARS-CoV-2. … Continue reading Pfizer’s antiviral Paxlovid is a major advancement potentially for all coronaviruses, says Gagandeep Kang

‘Pandemic far from over’ even as global death toll crosses five million

The global death toll from COVID-19 crossed five million on November 1 and yet the the global number of reported cases and deaths from COVID-19 is now increasing for the first time in two months. The first million deaths were recorded on September 8, 2020, nearly nine months after the first death occurred, while the two-million mark was breached three and a … Continue reading ‘Pandemic far from over’ even as global death toll crosses five million

SARS-CoV-2 virus less likely to develop resistance to molnupiravir: Gagandeep Kang

Preliminary data, which is yet to be peer-reviewed, shows molnupiravir can reduce risk of hospitalisation or death by 50% in non-hospitalised adult patients with mild-to-moderate COVID-19 disease. The trial included only those older than 60 years and have at least one comorbidity. On October 11, just 10 days after Merck announced via a press release … Continue reading SARS-CoV-2 virus less likely to develop resistance to molnupiravir: Gagandeep Kang

Merck’s unlicensed Ebola vaccine shows 97.5% efficacy in Congo

Merck's Ebola vaccine, which underwent phase-3 trial during the 2014-2015 Ebola epidemic in west Africa, has shown 97.5% efficacy in preventing Ebola disease when used during the current epidemic in Congo. Due to vaccine shortage and increasing outbreaks, the dosage will be halved to match the dose tested in phase-3 trial. The efficacy of lower … Continue reading Merck’s unlicensed Ebola vaccine shows 97.5% efficacy in Congo

Growing interest in HPV vaccination in India

Delhi and Punjab have introduced HPV vaccination and are expanding it, while a few States have shown interest. And the National Technical Advisory Group on Immunisation is considering the introduction of HPV vaccination as part of the Universal Immunisation Programme. After the suspension of the human papillomavirus (HPV) vaccine trial in 2010 carried out on … Continue reading Growing interest in HPV vaccination in India

Editorial: HPV trial – Collusion of the worst kind

When regulators become violators, who is to regulate them? That perplexing question is what arises from the damning report of the Parliamentary Standing Committee that investigated alleged irregularities in the conduct of the human papilloma virus vaccine trial on nearly 23,500 girls in the 10-14 age group in Vadodara, Gujarat and Khammam, Andhra Pradesh. But … Continue reading Editorial: HPV trial – Collusion of the worst kind

Drugs board wants ban on Pioglitazone diabetes drug revoked

The Drugs Technical Advisory Board (DTAB) on Friday recommended revoking the ban on pioglitazone — an oral anti-diabetic drug which was banned on June 18. But the DTAB, which was kept in the dark when the decision to ban was taken, has also recommended that the medicine be sold with a boxed warning (that the … Continue reading Drugs board wants ban on Pioglitazone diabetes drug revoked