Poliovirus vaccine inactivated paediatric(GlaxoSmithKline Plc)

“We wish to assure all stakeholders that there will be no shortage of IPV vaccines in India on our account,” a Sanofi India spokesperson told Fierce Pharma on Thursday. After press reports flagged the possibility of an inactivated polio vaccine (IPV) shortage in India, Sanofi says it's ready to supply the nation with a newly approved shot. Thursday, after the company gained an approval for a new polio vaccine, IMOVAX-Polio, Sanofi issued an assurance that it will be able to keep providing sufficient supplies. The developments come quickly on the heels of an Economic Times report alleging that a shortage crisis was looming following Sanofi’s decision to shut down certain vaccine manufacturing operations in the country. Last September, Sanofi revealed plans to discontinue its previous polio shot in India. Still, to hear Sanofi tell it, India shouldn’t be concerned. The company’s local branch remains “dedicated to supporting India’s public health program for polio,” a Sanofi India spokesperson told Fierce Pharma on Thursday. “To ensure that there is no interruption to the availability of IPV vaccines, we have already obtained approvals for our product IMOVAX-Polio,” she added. Regarding the company’s decision to discontinue its previous polio shot, Sanofi India’s spokesperson pointed to the rapidly shifting healthcare environment in the country following the COVID-19 pandemic. Amid rising demand for production capacity in India, Sanofi last year opted to discontinue its older polio shot. The company's spokesperson noted that the shot was only filled and packaged at the company’s factory in Hyderabad, while the antigens themselves were manufactured in France. Sanofi and its Indian affiliate Shantha Biotechnics pledged to supply polio vaccines for India’s universal immunization program through UNICEF back in 2015.  Sanofi got its hands on Shantha in 2009 when the French drugmaker’s vaccine division agreed to pay 550 million euros ($784 million) for the Merieux Alliance’s controlling stake in the Indian shot maker. Elsewhere in India, Sanofi last week called on local drugmakers Cipla and Dr. Reddy’s Laboratories to help sell its central nervous system (CNS) drugs and vaccines in country. Cipla is slated to market six Sanofi CNS medicines, including the leading epilepsy therapy Frisium, which Sanofi will continue to own, import and manufacture. Dr. Reddy’s, for its part, is on deck to sell five Sanofi vaccines in the country.

WYNNEWOOD, Pa., Dec. 9, 2022 /PRNewswire/ -- Human antibodies cloned by scientists at the Lankenau Institute for Medical Research (LIMR), part of Main Line Health, have been adopted by the World Health Organization as a crucial part of its plan to permanently eradicate polio, a disease believed to be quietly spreading throughout the world, including New York and possibly Philadelphia. Continue Reading The WHO Expert Committee on Biological Standardization approved the antibodies—created in the lab of LIMR faculty member Scott Dessain, MD, PhD—as the standard for quality-control testing of all inactivated polio vaccines (IPVs) worldwide in late October at a meeting in Geneva, Switzerland. The new test will increase assurance of the vaccines working properly when administered. The committee first advanced guidelines incorporating the LIMR antibodies to test IPV potency two years ago. We are proud of our achievement in this field of public health —George Prendergast Tweet this Worldwide vaccination efforts have reduced the annual number of polio cases from about 350,000 in 1988 to only 6 in 2021, according to WHO, due to widespread administration of oral poliovirus vaccine (OPV). OPV was developed by Albert Sabin and first made available in 1961. It is the predominant type used globally. IPVs, invented by Jonas Salk in 1953, are injected in the arm or leg. They have been the only kind given in the United States since 2000. One critical difference between the two vaccine types is that, unlike IPV, OPV uses weakened, live virus that can mutate and regain the ability to cause paralytic polio. Such mutated vaccine virus strains are causing the recent global resurgence of polio cases. In the United States, New York state officials alerted the public in July to a polio case in Rockland County apparently linked to OPV mutation. The case has raised concerns that poliovirus infections may be silently spreading in the United States and could cause disease in unvaccinated individuals. Recently, health officials in Philadelphia and other large metropolitan areas have announced they will test sewage for poliovirus because of the New York case and the subsequent detection of poliovirus in the New York region's sewage. "News of the New York case is a reminder of the need to continue to commit to polio vaccination efforts worldwide," said George Prendergast, PhD, president and CEO of LIMR. "The efforts of Dr. Dessain and his colleagues provide a key tool in quality control for the manufacture of high-potency IPV vaccines that can prevent polio outbreaks caused by mutated OPV across the world. We are proud of our achievement in this field of public health, which is among our finest in recent years." "The world is beginning to transition away from the oral vaccine because it is the only path to ultimately eradicating polio," said Dessain, who is director of the Center for Human Antibody Technology at LIMR and holds the Joseph and Ray Gordon Chair in Clinical Oncology and Research. "Making that transition meant developing a next-generation IPV and expanding production. But the vaccine manufacturers weren't using the same standards as one another. That made it necessary to find a way to not only determine the potency of the new vaccines from different manufacturers but also address the problem of quality control labs not all using the same potency test." Dessain and his team tackled the issue by identifying a set of human antibodies that can ensure that an IPV vaccine has been made correctly. Dr. Scott Dessain is available for interviews on this press release and related stories about polio vaccines. SOURCE Main Line Health