J&J, NOVAVAX, And Kevzara Coronavirus Vaccine

J&J, NOVAVAX, And Kevzara Coronavirus Vaccine

For the last few days’ media has received information about several major medical news, some of them are related to coronavirus vaccine.

According to the still going OWS (warp speed operation) coronavirus vaccine search continues. Sanofi and Regeneron’s Kevzara recently announced failing their IL-6 inhibitors in COVID-19. The study with severe and critical patients showed that rheumatoid arthritis medicine is not effective as a coronavirus treatment.

“Although this trial did not yield the results we hoped for, we are proud of the work that was achieved by the team to further our understanding of the potential use of Kevzara for the treatment of COVID-19,” said John Reed, M.D., Ph.D., Global Head of Research and Development, Sanofi. “In times like these, commitment to properly designed, controlled clinical trials, provides the information and understanding the scientific community needs for fact-based decision making.  At Sanofi, we are committed to help combat the global COVID-19 pandemic, including developing vaccine candidates that can be manufactured at large-scale.”

Remdesivir Remains the Only Antiviral Drug Authorized to Treat COVID-19

Against this background Gilead Veklury, also known as remdesivir, remains the only antiviral drug authorized to treat the illness. FDA give their approval after phase 3 data showing moderate patients who were on a 5-day course of Veklury, plus standard care, were 65% more likely to have their condition improve compared with patients on standard care alone. For patients on a 10-day course, the chances of improvement weren’t statistically significant.

The company actually won FDA emergency use authorization back in May, and donated about 120,000 treatment courses to the U.S.

“With the growing understanding of the utility of Veklury to help improve outcomes for a range of patients with COVID-19, we welcome the FDA’s decision to expand emergency use authorization,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “As we learn more about COVID-19, and we further establish the efficacy and safety profile of Veklury, we see benefit to making the drug available to patients at earlier stages of the disease. Today’s action by the FDA enables physicians to consider a broader range of eligible patients to potentially receive Veklury.”

Canadian Government Will Buy Coronavirus Vaccine From J&J And Novavax inc.

At August 31 Novavax inform that, Novavax and Canada expect to finalize an advance purchase agreement under which Novavax will supply doses of NVX-CoV2373 to Canada beginning as early as the second quarter of 2021. This purchase arrangement will be subject to licensure of the Novavax vaccine by Health Canada.

“We are pleased to work with the Canadian government on supply of our COVID-19 vaccine, an essential step to ensure broad access of our vaccine candidate,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “We are moving forward with clinical development of NVX-CoV2373 with a strong sense of urgency in our quest to deliver a vaccine to protect the world.”

“We are pleased to announce this agreement with Novavax, which will give Canadians access to a promising COVID-19 vaccine candidate. This is an important step in our government’s efforts to secure a vaccine to keep Canadians safe and healthy, as the global pandemic evolves,” said The Honourable Anita Anand, Minister of Public Services and Procurement, Government of Canada.

The Janssen Pharmaceutical Companies of Johnson & Johnson agreed to supply the Government of Canada with doses of its SARS-CoV-2 vaccine candidate, Ad26.COV2.S. “We are deeply committed to providing global access to our SARS-CoV-2 vaccine candidate. As we proceed with development of our vaccine, we are simultaneously working with partners around the world, including the Government of Canada, to ensure our vaccine is made available to citizens globally, if proven to be safe and effective”, said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. If the parties concerned agreed, the Government of Canada would purchase up to 38 million doses of Janssen’s Ad26.COV2.S vaccine.

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