COVID-19 remains relentless in challenging the community as it continues to evolve. Here are some of the top news for the week.
COVID-19 remains relentless in challenging the community as it continues to evolve. Here are some of the top news for the week.
Remdesivir Has No Clinical Benefit, Says European Scientists
European scientists observed that remdesivir offered no clinical benefit for patients who were hospitalized for COVID-19, were symptomatic for over seven days, and required oxygen support.
The Phase III open-label, adaptive, multicenter, and randomized DisCoVeRy trial covered 48 locations across Europe and evaluated adult patients admitted for SARS-CoV-2. The patients were given different doses of remdesivir and assessed at day 15 based on the WHO seven-point ordinal scale. The scientist found no significant difference between the drug and control groups, and the proportion of deaths at day 28 were not significantly different either.
AbCellera Drug Combination Gets Expanded Emergency Use Authorization
The U.S. Food and Drug Administration (FDA) expanded the emergency use authorization (EAU) for AbCellera’s bamlanivimab 700 mg and etesevimab 1400 mg administered together as post-exposure prophylaxis (PEP) in certain individuals to prevent SARS-CoV-2 infection.
The combination can now be used to treat high-risk individuals ages 12 years and up who have not been fully vaccinated against COVID-19 or are not expected to have enough immune response to complete vaccination, and have been exposed to somebody infected or are in an environment that places them at a high risk of exposure.
“More than 535,000 patients have been treated with bamlanivimab alone or together with etesevimab, potentially keeping more than 25,000 patients out of the hospital and saving more than 10,000 lives. With this expanded authorization, these antibodies, which have been shown to be effective against the highly contagious Delta variant, can now be used to protect some of the most at-risk people exposed to the virus,” commented Carl Hansen, Ph.D., CEO and President of AbCellera.
Moderna President Urges Vaccine Makers To Step Up as Delta Gets Smarter
Moderna President Stephen Hoge told Yahoo Finance in a video interview Wednesday that the Delta virus is so “good at infecting people and replicating” that it pressures vaccine makers to step up in their efforts to create more advanced and targeted solutions.
His comments came after Moderna released new data on “breakthrough” cases to call for the need to push vaccine booster shots.
New Nasal Vaccine Exhibits Rapid Immune Response In 7 Days
University of Houston scientists announced the creation of a nasal vaccine that can act as a first barrier against the virus before it is inhaled into the lungs. NanoSTING, the product, functions as an adjuvant for intranasal vaccination to promote the body’s immune response. It has a small particle size of about 100 nanometers.
According to study author Navin Varadarajan from the University of Houston, the vaccine formulation has been found to be safe and can produce rapid immune responses against SARS-CoV-2 within seven days. NanoSTING has yet to be approved for actual use.
Government Advisers Remain Unsure About Pfizer Booster Dose
U.S. government advisers debated Wednesday whether or not to use Pfizer’s COVID-19 vaccine as a booster dose, as some question its safety and effectiveness. Pfizer argues that although protection from the virus is strong, immunity can start to wane at around six to eight months after the second dose, based on its study on 306 people. The company also pointed to Israel, which has already started giving booster doses, as an example.
For now, the U.S. provides extra shots of Moderna or Pfizer vaccines to people with severely weak immune systems. The situation on the booster dose has not been resolved to date.
Canada Steps Up Vaccine Development Efforts With Providence, Emergent Deal
Canada is stepping up its local COVID-19 vaccine development efforts. Emergent BioSolutions signed a five-year $90 billion deal to provide Providence Therapeutics with CDMO services, including drug development, bulk drug substance creation, and product manufacturing. If plans go smoothly, production will begin in 2022. The focus product is Providence’s PTX-COVID19-B candidate drug, which is currently in Phase II trials.
The effort is significant for Emergent, which recently ran into trouble with the U.S. government after several J&J and AstraZeneca vaccine batches got contaminated, leading to an FDA investigation and a temporary closure of its business in the country. Emergent was allowed to resume operations in late July 2021.
