PHARMA LITERATI

Pune-based Serum Institute of India (SII), world's largest vaccine manufacturer by volume, claims to have achieved a breakthrough in developing a vaccine for the dreaded coronavirus contagion. It says the virus-vaccine strain developed in laboratories has reached the animal clinical trial stage, with possible results within two months. Serum Institute had partnered with the US-based biotech drug research company Codagenix three weeks ago to jointly develop a live-attenuated vaccine (creating a vaccine by reducing the virulence of the pathogen, but still keeping it alive) to fight the coronavirus. The company claims it is the first vaccine to progress from the laboratory to the pre-clinical trial phase and can be market ready by 2022. " Serum Institute and Codagenix have been working with utmost diligence and meticulous effort to develop a preventive vaccine against the novel coronavirus. The vaccine-virus strain is identical to the original virus and can generate a r...

Pfizer Inc. announced the launch of its Vaccines Division’s Centers of Excellence Network, a global programme of collaborations with academic institutions to conduct real-world epidemiologic research to accurately identify and measure the burden of specific vaccine-preventable diseases and potentially evaluate vaccine effectiveness affecting adults. Pfizer Vaccines has designated the University of Louisville as its first Center of Excellence with a second global center anticipated in the first half of 2020. “ The Centers of Excellence will complete comprehensive, disease surveillance and real-world vaccine effectiveness studies, which are distinctly different from clinical safety and efficacy research ,” said Luis Jodar, Pfizer Vaccines, chief medical and scientific affairs officer. “ With strategically located research centers around the world, we anticipate being able to better define and understand global disease burden in adults and vaccine effectiveness, which will help prov...

Vaccine major Serum Institute of India Pvt. Ltd. on Thursday said it has launched a new variant of its World Health Organization prequalified rotavirus vaccine Rotasiil, called Rotasiil - Liquid. Available in a single dose tube, Rotasiil - Liquid can be directly administered in 2 ml dose orally, thus saving time as well as cold chain space. It can be stored at 2-8 degrees Celsius for up to 24 months,  Serum Institute of India said in a statement. Rotavirus is a very contagious virus that causes diarrhoea. Rotasiil - Liquid will be available across domestic and international markets. The initial production aim of the vaccine is around 25-30 million doses per annum, which will be augmented to over 80 million doses per annum, it added. "The new launch will propel us towards improving the health of our children and reduce hospitalization and conditions related with diarrhea such as malnutrition, delayed physical and mental development amongst children," Serum Instit...

Pune-based Serum Institute of India has said that it may look at evaluating a candidate vaccine to combat Nipah virus, and that can be rolled out in three to four years if the country decided to develop the preventive on a priority. However, the institute clarified that the government hasn’t asked Serum to develop a vaccine yet. Rajeev Dhere, executive director at the Serum Institute of India, said: “If the nation decides that it is a priority to develop a vaccine to combat Nipah virus, Serum may look at evaluating a candidate vaccine. It can be rolled out in three to four years, which is the normal development and licensing period, if considered on fast track.”  Even as the government machinery is busy trying to contain the spread of the Nipah virus outbreak in Kerala, there is no vaccine yet to fight the disease. Attempts are being made to prevent the infection of Nipah virus by containing the epidemic in a restricted area. Going by human vulnerability, the virus is a co...

The group is likely to prioritize a list of diseases that a larger working group, comprising of representation from the drug regulator and pharmaceutical firms, will focus on before the next meeting. A joint working group (JWG) formed under the aegis of the Indian Council of Medical Research and Sun Pharmaceuticals Ltd, along with experts from International Centre For Genetic Engineering and Biotechnology and All India Institute of Medical Sciences , is planning to propose an overhaul for the drug regulatory system, vaccine development and clinical trials in the country. The initial ideas mooted for updating the drug regulatory system include political support for the Drug Controller General of India’s regulatory framework, making public the decision for rejection or approval of a drug, maintaining timelines for regulatory approvals, regulatory control on data quality and appointment of specialized reviewers of drug process approval. The meeting, conducted on Thursday, ...

India is all set to lead the global fight against epidemics as it is a key member of the newly formed Coalition for Epidemic Preparedness Innovations (CEPI) with its headquarters at the Norwegian Institute for Public Health, in Oslo. The coalition will not focus on diseases that already have sufficient attention, but will be guided by WHO’s R&D blueprint (2016), which lists eleven illnesses to focus on, including Chikungunya, Middle East Respiratory Syndrome (MERS), Crimean-Congo Haemorrhagic fever. Dr K Vijay Raghavan, secretary, Department of Biotechnology, India , has been chosen as the chairperson of the interim board. In this interview, he talks about the coalition and its goals. What will be India’s role as a leader of this coalition? When disease outbreaks occur, depending on the mode of transmission they can spread very rapidly to affect people very far from where the outbreak starts. In India, we recognise that preparedness to handle outbreaks also includes stra...

Economic times published the interview of  Jayasree K. Iyer,  Executive Director, Access to Medicine Foundation, Netherlands . The excerpts: What makes vaccines so important today? Since the first vaccine was discovered in 1796, no other health commodity has had such a profound effect on children's lives. Many communities cannot fully access the vaccines needed to protect children, and newer vaccines are less available than the older ones. Many stakeholders such as the general public, governments, investors and producers of vaccines can do something about this issue and improve vaccine reach and coverage. What is the role of vaccine manufacturers? As innovators who develop and produce these life-saving vaccines, vaccine manufacturers can do a lot early in the vaccine supply chain, to help solve this problem. Manufacturers can make sure that vaccines developed are easy to use, stable in tropical climates (and reduce the need for refrigeration), etc. The idea is a...

Bharat Biotech, an Indian biotech company based in Hyderabad , has developed two Zika virus vaccine candidates: an inactivated vaccine and a recombinant vaccine. If the Indian Government would fast-track the regulatory approvals, the Indian company announced that the inactivated vaccine could be available in two years, once the pre-clinical trials proved to be successful. Testing of the recombinant vaccine might take more time, but pre-clinical testing of the inactivated vaccine could be completed in just five months. According to Mr. Krishna Ella, including the clinical trials the process for a vaccine to get commercialized can take up to seven years. However, if the Indian Government declares national emergency, the Zika vaccine could move aggressively through regulatory approvals and be made available much faster. Adults of both genders and especially women would be the prime target group for the vaccine. According to Reuters, Krishna Ella, chairman and managi...