About a year-and-a-half after the sequencing of the SARS-CoV-2 virus and the onslaught of COVID-19 therapeutic and vaccine development that followed, the biopharma industry boldly tackles a slew of ongoing issues from vaccine hesitancy and supply inequities to the ramifications of a potential intellectual property waiver and the pressing need to prepare global systems for the next pandemic.
Diagnostics powerhouse Danaher Corp. has agreed to buy Aldevron LLC, a privately held biotech company that supplies a key ingredient for COVID-19 vaccines, from EQT VIII Fund for $9.6 billion in cash. Based in Fargo, N.D., with additional operations in Madison, Wis., Aldevron makes high-quality plasmid DNA, mRNA and recombinant proteins used in vaccines, gene and cell therapy, gene editing and diagnostic applications.
LONDON – Curevac NV blamed the high number of circulating SARS-CoV-2 variants after its COVID-19 vaccine failed to meet the primary endpoint in the interim analysis of the phase IIb/III trial. The vaccine, Cvncov, was only 47% effective in preventing COVID-19 infections in the 40,000-person study.
There’s been a mixed bag of data from Astrazeneca plc’s efforts against COVID-19, after data suggested Pfizer Inc.’s rival vaccine is more effective against the Delta variant and the failure of a trial involving its long-acting antibody therapy.
Novavax Inc. reported an overall efficacy rate of 90.4% in a phase III trial of its COVID-19 protein subunit vaccine, NVX-CoV2373, which it conducted in the U.S. and Mexico. The vaccine provided 100% protection against moderate and severe disease and 100% protection against variants of SARS-CoV-2 deemed not to be of concern or interest. Gaithersburg, Md.-based Novavax is on track to file for approval during the third quarter. By the end of that period, it aims to ramp up production to a monthly run rate of 100 million doses and it aims to scale that to a monthly run rate of 150 million doses by the end of the fourth quarter.
The FDA has authorized two batches of Johnson & Johnson’s COVID-19 vaccine from a troubled Emergent Biosolutions Inc. manufacturing facility to be made available under emergency use authorization (EUA) while determining that several other batches were unsuitable for use. While the FDA would not confirm the number of unsuitable batches, the newly authorized batches, however, can be used in the U.S. or exported.
The good of the many versus the good of the individual is the age-old question that faced the FDA’s Vaccines and Related Products Advisory Committee (VRPAC) June 10 as it considered the risk-benefit issues of COVID-19 vaccines in children. Panelist Cody Meissner, director of pediatric infectious disease at Tufts Medical Center, said while he believes a vaccine is needed for children, he wants to know that the safety of the vaccine is greater than the risk of hospitalization for people younger than 18.
Sinovac Biotech Ltd.'s inactivated COVID-19 vaccine, Coronavac, has been approved by Chinese regulators for emergency use in children aged between 3 and 17, the company’s CEO Yin Weidong told Chinese state media on June 4. Sinovac briefly unveiled phase I/II data in the age group back in April. Chinese state media, China Central Television, said it confirmed the news with an expert from China’s State Council, though an official announcement has yet to be made. Sinovac did not immediately respond to BioWorld’s query to confirm the news.