Author: Biotech Express

The percentage of deaths vis-à-vis the total Covishield doses administered stands at 0.000217, which means two out of every 10 lakh person who took Covishield died due to AEFI. As for Covaxin, the number was 0.00008 percent, meaning less than one in every 10 lakh vaccinated person died due to AEFI. Since India’s COVID-19 vaccination drive began on January 16 this year, more than 26,000 cases of Adverse Events Following Immunisation (AEFI) have been reported. As many as 488 deaths linked to post-vaccination complications have also been reported till June 7, of which 301 were men and 178 were women,…

The recruitment for the clinical trial of the country’s first indigenously-developed Covid vaccine –– Covaxin, among children falling in the age group of 6-12 years has begun at the All India Institute of Medical Sciences (AIIMS), Delhi. This will be followed by the clinical trial of 2-6 years’ children. The enrolment of children volunteers aged 12-18 years at the AIIMS has been completed and they have already been given the first dose of Covaxin. The trial is to be conducted in three parts — 175 volunteers each in the groups aged 12-18, 6-12 and 2-6 years. The Drugs Controller General…

Amid reports of forging deaths due to coronavirus in many states, the Central governmnet has written to many states on the same. The Centre in a letter to West Bengal, Uttar Pradesh, Tamil Nadu, Maharashtra, Kerala, Bihar and Karnataka has asked to provide data of deaths as per date and district wise. There have been ample reports that many states have been forging numbers about the deaths caused by coronavirus. Many anecdotal evidence and surveys of obituary notices in local newspapers had made it clear the official death toll in the ongoing second wave of the pandemic was an undercount…

Shares of AstraZeneca dipped in trading after the company announced its COVID-19 antibody therapeutics failed to provide high levels of protection for individuals who have had contact with a symptomatic COVID-19 patient. AstraZeneca announced its COVID-19 antibody therapeutics failed to provide high levels of protection for individuals who have had contact with a symptomatic COVID-19 patient.AstraZeneca said the Phase III STORM CHASER trial assessing AZD7442, a long-acting antibody (LAAB) combination, failed to meet the primary endpoint of post-exposure prevention of symptomatic COVID-19 compared to placebo. The failure marks a setback in the hunt for means other than vaccines to provide…

India’s vaccination drive is about to get another push as its largest vaccine manufacturer said Wednesday that it hopes to launch Novavax’s COVID-19 vaccine ‘Covovax’ in India by September as its trials are in an advanced stage of completion. Serum Institute of India CEO Adar Poonawalla told CNBC-TV18 that the trial of Novavax’s coronavirus vaccine in India is likely to conclude by November. However, as per the latest guidelines by the Drugs Controller General of India (DCGI), the company can still apply for licensure of the vaccine before completion of the trial on the basis of global test results. Novavax…

By Kamal Pratap Singh Covaxin approval has been delayed after EUA rejection by FDA which will delay the use of COVAXIN in USA and other countries, instead the FDA has suggested for direct Biologics License Applications BLA or full use. Covaxin Approval from WHO is also pending next month i.e. July 2021. International travel is also depending on vaccination status, many countries are now using it as a benchmark for allowing vaccinated foreign nationals to travel. Out of the three vaccines approved for use in India, only one—Covishield—features on the emergency use listing (EUL) of the World Health Organization (WHO).…

Prof Guntaka was first scientist who introduced recombinant biotech drugs in India by making Hep-B  vaccine for Shantha biotech company in 1990s. Now he is running his company Sudarshan Biotech and is involved in the discovery of Hep-C vaccine which is not available anywhere in the world. It is a privilege to have Dr. Ramareddy in the Advisory Board of Biotech Express magazine. Biotech Express welcome Prof Guntaka on its editorial board and we believe his accord will be much useful in current viral pandemic times. Prof Ramareddy V Guntaka Current Affiliations: Chairman and Chief Scientist, Sudarshan Biotech Pvt Ltd.,…

The Drugs Controller General of India (DCGI) has given approval to the CSIR and Laxai Life Sciences Private Limited to conduct a clinical trial of Colchicine on COVID-19 patients, according to a statement on Saturday (June 12, 2021). Laxai Life Sciences CEO Ram Upadhayay said the enrolment of patients has already begun at multiple sites across India and the trial is likely to be completed in the next 8-10 weeks. Ram Vishwakarma, the advisor to the CSIR Director-General, said Colchicine in combination with standard care will be an important therapeutic intervention for COVID-19 patients with cardiac co-morbidities and also for…

PhD scholars of the Central University of Gujarat in Gandhinagar, Gujarat have accused a professor working in the School of Chemical Sciences, of forcing students – over the limit stipulated by the UGC – to complete their PhD research under them even though he is not an expert in that particular branch of Chemistry to boost the Academic Performance Indicators (API) score. API gives an idea the growth of a student, teacher or institution and was introduced by the UGC in 2010. The institutions review the API scores to determine if they would promote them or not. But API has…

Third member of the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee has resigned in protest over the agency’s approval of Biogen’s Aduhelm (aducanumab) for Alzheimer’s disease. Two members, David S. Knopman, a neurologist at the Mayo Clinic, and Joel S. Perlmutter, a neurologist at Washington University in St. Louis, resigned in protest earlier. Now, Aaron Kesselheim, a professor of Medicine at Harvard Medical School, has stepped down. Kesselheim served on the advisory committee since 2015. “My rationale was that the FDA needs to re-evaluate how it solicits and uses the advisory committees ……