HONG KONG – In a surprisingly candid statement, the director of China’s Centers for Disease Control (CDC) conceded that the efficacy of Chinese coronavirus vaccines is "not high" and may require improvements. George Gao, director of China’s CDC, stated that Chinese vaccines “don’t have very high protection rates” at the National Vaccines and Health conference in the southwestern city of Chengdu on Saturday. Though it has recorded better efficacy numbers in Indonesia and Turkey, Sinovac Biotech Ltd.’s vaccine was found to have an efficacy rate as low as 50.4% in phase III trials in Brazil. Ahead of peer review, Brazilian researchers had also found two injections of the vaccine was 49.1% effective when given shorter than three weeks apart, lower than the 50% bar set by the World Health Organization. However, studies on a small subgroup showed that the efficacy rate increased to 62.3% when the doses were given at intervals of three weeks and longer.
Astrazeneca vaccine risk prompts Australian government to recommend Pfizer COVID-19 vaccine for under 50
PERTH, Australia – The Australian government is recommending that Australians under 50 take the Pfizer Inc. COVID-19 vaccine due to the risk of rare blood clots associated with Astrazeneca plc’s COVID-19 vaccine. The move jeopardizes Australia’s vaccine rollout as it had planned for the majority of Australians to receive the Astrazeneca vaccine, which is being locally manufactured by CSL Ltd. During a press conference announcing the local manufacture of the vaccine in March, officials were gloating about what a fabulous job the country had done in fighting the COVID-19 pandemic. Now it looks as if it is falling behind on vaccinating its citizens, and Prime Minister Scott Morrison said that essentially “all bets are off” on whether Australians will be vaccinated by the end of the year. Previously, he had said that all Australians would be vaccinated by October.
Kiniksa’s monoclonal antibody posts strong COVID-19 data
Among a spate of COVID-19-related therapy developments to start the week, Kiniksa Pharmaceuticals Inc. produced positive phase II data of its monoclonal antibody, mavrilimumab, in treating non-mechanically ventilated patients with severe COVID-19 pneumonia and hyperinflammation. The study’s primary endpoint was the proportion of patients who survive and are free of mechanical ventilation at day 29. The data come from the global, double-blind, placebo-controlled study of patients randomized to receive placebo or a single I.V. dose of mavrilimumab 10 mg/kg, 6 mg/kg. Mavrilimumab is a fully human monoclonal antibody targeting granulocyte macrophage colony stimulating factor receptor alpha.
Sanofi buys mRNA-focused Tidal Therapeutics in $470M deal
In a move that Sanofi SA said will bring it an mRNA-based research platform with applications in oncology, immunology and other diseases, the company has acquired Tidal Therapeutics Inc. for $160 million up front and up to $310 million in milestone payments. The preclinical startup, led by Merrimack Pharmaceuticals Inc. and Torque Therapeutics Inc. co-founder Ulrik Nielsen, is based in Cambridge, Mass.
AACR 2021: Research points to ways to fight cachexia's bite
Cachexia, Teresa Zimmers told the audience at the Annual Meeting of the American Association for Cancer Research (AACR), is "woefully understudied for the outsized impact it has on cancer patients." The condition, which is currently defined as weight loss and muscle wasting, is the direct cause of death in an estimated 25% to 30% of cancer patients. But it is the main subject of only 0.1% of research papers, and 0.2% of clinical trials. More than 160 years after the term "cachexia" was coined, there are no approved treatments in the U.S. or EU. Zimmers, who is the founding director of the Indiana University Simon Cancer Center Cachexia Working Group and the Center for Cachexia Research Innovation and Therapy at Indiana University-Purdue University Indianapolis, is among the researchers working to change that state of affairs.
White House budget proposal for FY 2022 long on ambition, short on details
The Biden administration has released an exceedingly brief budget framework for fiscal year 2022 that includes $6.5 billion for an advanced research program at the NIH, which mimics a similar program at the Department of Defense. Beyond that, there is a clear indication that the CDC will see an uptick in monies, but the proposal offers no numbers for the FDA budget, making this one of the skinnier budget proposals to come out of the White House in recent memory.
MACPAC tackles 'accelerated' prices
If the U.S. Congress is receptive to recommendations approved by the Medicaid and CHIP Payment and Access Commission (MACPAC) April 9, the FDA's accelerated approval path for innovative new drugs could lose a bit of its appeal. One of the recommendations would require drug manufacturers to pay a higher Medicaid rebate for drugs with accelerated approval. Once a drug is fully approved, the rebate would drop to the normal level for a single-source drug, according to the MACPAC proposal.
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