Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for February 23, 2021.
News information is not all-inclusive and updates are published once a week on Tuesdays.
Diagnostics
LightDeck Diagnostics was awarded a $5.65 million contract to develop a rapid antigen test to detect SARS-CoV-2. The funding, provided by the Biomedical Advanced Research and Development Authority (BARDA) at the Department of Health and Human Services (HHS), is enough to advance the test to commercialization.
During the early stages of the coronavirus disease 2019 (COVID-19) pandemic, the U.S. Food and Drug Administration (FDA) allowed commercial diagnostic manufacturers to release their antibody COVID-19 tests into the market unreviewed. This move may have been a mistake, with divisions within the FDA now noting flaws in this open-door policy that could have been avoided with more rigorous testing protocols. Please read here for more information.
Testing Therapies, Antivirals and Vaccines
Public Health England (PHE) published real-world analyses of people in the U.K. who had received the first shot of the Pfizer-BioNTech COVID-19 vaccine. The data, which were published in The Lancet, showed that there was a decrease of about 70% in infections among healthcare workers after the first shot.
Similar to the PHE study, investigators from the Universities of Edinburgh, Strathclyde, Aberdeen, Glasgow and St Andrew’s and Public Health Scotland (PHS), evaluated a dataset of most of the Scottish population of 5.4 million people.
EAVE II data looked at infections between December 8, 2020, and February 15, 2021. During that time, 1.14 million vaccines were given, 650,000 the Pfizer-BioNTech and about 490,000 the Oxford-AstraZeneca. About 21% of the Scottish population received the first dose. In that study, among people 80 years or older, there was an 81% decrease in hospitalization risk in the fourth week, when data from both vaccines was combined.
RedHill Biopharma announced plans to expand its Phase II/III trial of opaganib in severe COVID-19 in the U.S., based on FDA review of the Phase II trial. The expansion will help speed enrollment and expand the trial to eight additional countries and about 40 recruiting sites.
The retooled COVID-19 vaccine promised by GlaxoSmithKline and vaccine giant Sanofi is entering Phase IIb testing, with new antigen dosages it hopes will boost the lackluster immune response seen in adults 50 and over during its last Phase I/II trial. Even if successful, the new recombinant-protein vaccine wouldn’t be available until at least the end of 2021.
Two Canadian researchers, Danute Skowronski, with the British Columbia Centre for Disease Control, and Gaston De Serres, with the Institut National de Sante Publique du Quebec, published a letter in The New England Journal of Medicine noting that the Pfizer-BioNTech vaccine had an efficacy of 94.8% against COVID-19 after two doses, but the efficacy of 52.4% after the first dose to before the second dose, according to original data presented to regulators such as the U.S. Food and Drug Administration (FDA). However, using the same data submitted to the FDA, they calculated that before the second dose, the vaccine was still “highly efficacious,” with an efficacy of 92.6%, a finding “similar to the first-dose efficacy of 92.1% reported for the mRNA-1273 vaccine (Moderna).”
In its quest to contribute to the fight against coronavirus disease 2019 (COVID-19), Immunome has isolated potent antibodies that may be able to neutralize several variants of the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), including the South African variant B.1.351.
Organizational Announcements
The U.S. Food and Drug Administration (FDA) issued new guidance for vaccine makers as it is preparing for the possibility of needing to approve COVID-19 booster shots against variants of the SARS-CoV-2 virus, that causes COVID-19. In the new guidance, acting FDA Commissioner Janet Woodcock stated that the FDA is seeking “efficient ways to modify medical products that either are in the pipeline or have been authorized for emergency use to address emerging variants.” FDA also published new guidance for diagnostic assay manufactures and makers of monoclonal-antibody drugs, suggesting ways they can best adapt their products to handle mutations/variants.
Something of the dark horse in the race to get a COVID-19 vaccine out to the public, Novavax announced a Memorandum of Understanding (MOU) with Gavi, the Vaccine Alliance, to provide 1.1 billion doses of NVX-CoV2373, its COVID-19 vaccine candidate, for the COVAX Facility. The vaccine will be manufactured and distributed around the world by Novavax and Serum Institute of India (SII). SII has an existing deal with Gavi.
In 2020, Vir Biotechnology and GlaxoSmithKline partnered to develop strategies against COVID-19. The two companies have expanded that collaboration to include work into new treatments for influenza and other respiratory viruses.
Other Industry News
Pfizer has been accused of bullying governments in Latin America over coronavirus disease 2019 (COVID-19) vaccine negotiations, a recent investigative article revealed. The accusations involve the company’s requests that some countries establish sovereign assets as a guarantee against the costs associated with future legal suits made on behalf of citizens who experience an adverse event after the shot.
An open letter from a group of scientists is urging the Biden administration to implement updates to guidance and standards that will better protect high-risk workers from the novel coronavirus that causes coronavirus disease 2019 (COVID-19).
