Pharma COVID Roundup: News from Pfizer, Moderna, Merck & Co., GSKBy
The latest on COVID-19 vaccines/drugs from Pfizer, Moderna, Merck & Co., Lilly, GlaxoSmithKline, SK bioscience, CureVac, and Novavax.
Updates on COVID-19 treatments and vaccines
FDA To Hold Meeting on Pfizer’s/BioNTech’s COVID-19 Vaccine Booster
The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee will hold a virtual meeting on September 17, 2021 to discuss additional doses of COVID-19 vaccines and specifically to discuss the Pfizer’s/BioNTech’s supplemental biologics license application for administration of a third (booster) dose of Comirnaty, the companies’ COVID-19 vaccine, in individuals 16 years of age and older.
The FDA says it intends to make background material available to the public, including the meeting agenda and committee roster, no later than two business days before the meeting.
Source: US Food and Drug Administration
Moderna Submits Data to FDA for COVID-19 Vaccine Booster
Moderna, a bio/pharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, has initiated its submission to the US Food and Drug Administration (FDA) for the evaluation of a booster dose of its COVID-19 vaccine, mRNA-1273, at the 50-µg dose level.
The company expects to submit data to the European Medicines Agency (EMA) and other regulatory authorities globally in the coming days (as reported on September 1, 2021).
The Phase II study of mRNA-1273 was amended to offer a booster dose of mRNA-1273 at the 50-µg dose level to interested participants six months following their second dose. An additional analysis showed that a booster dose of mRNA-1273 at the 50-µg dose level induced antibody responses and increased geometric mean titers for all variants of concern, including Beta (B.1.351), Gamma (P.1), and Delta (B.1.617.2).
FDA Updates EUA to Lilly/AbCellera COVID-19 Combo Therapy
The US Food and Drug Administration (FDA) has made changes to the emergency use authorization (EUA) for the COVID-19 treatment of bamlanivimab and etesevimab, administered together, from Eli Lilly and Company and AbCellera, a Vancouver, British Columbia, Canada-based bio/pharmaceutical company.
The EUA now authorizes the use of bamlanivimab and etesevimab, administered together, only in states, territories, and US jurisdictions in which recent data show the combined frequency of variants resistant to bamlanivimab and etesevimab administered together is less than or equal to 5%.
The FDA has posted a list of states, territories, and U.S. jurisdictions in which bamlanivimab and etesevimab administered together are currently authorized and are not currently authorized, and says it will periodically update both lists as new data and information becomes available.
Source: US Food and Drug Administration
GSK, SK bioscience Start Phase III Trial of Adjuvanted COVID-19 Vaccine
GlaxoSmithKline (GSK) and SK bioscience, a vaccine developer and manufacturer based in South Korea, have initiated a Phase III clinical study of SK’s COVID-19 vaccine candidate, GBP510, in combination with GSK’s pandemic adjuvant following positive interim Phase I/II results.
GBP510 is a self-assembled nanoparticle vaccine candidate targeting the receptor binding domain of the SARS-CoV-2 Spike protein, combined with GSK’s pandemic adjuvant. The antigen is being developed by SK in collaboration with the Institute for Protein Design at the University of Washington with support from the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations, public–private partnership focused on vaccine development against emerging infectious diseases.
The global trial will enroll around 4,000 participants from a range of countries and will aim to evaluate GBP510’s safety and immunogenicity compared to an active comparator, the AstraZeneca/Oxford University COVID-19 vaccine.
Results from the Phase III study are expected in the first half of 2022 after which, subject to positive results and regulatory approval, the vaccine is expected to be supplied at scale globally through the COVAX facility, which was established to allocate and distribute vaccines equitably to participating countries.
Merck & Co., Ridgeback Initiate Phase III Study for COVID-19 Drug
Merck & Co. and Ridgeback Biotherapeutics, a Miami, Florida-based bio/pharmaceutical company have initiated a Phase III clinical trial to evaluate molnupiravir, an investigational oral antiviral agent for the prevention of COVID-19 infection.
The global study is enrolling individuals who are at least 18 years of age and reside in the same household as someone with laboratory-confirmed SARS-CoV-2 infection with symptoms. The trial is being conducted globally in countries including Argentina, Brazil, Colombia, France, Guatemala, Hungary, Japan, Mexico, Peru, Philippines, Romania, Russia, South Africa, Spain, Turkey, Ukraine, and the US.
Additionally, the safety and efficacy of molnupiravir is also currently being evaluated in Part 2 of an ongoing global Phase III multi-site study of non-hospitalized adult patients with laboratory-confirmed mild- to moderate COVID-19 and at least one risk factor associated with poor disease outcomes. Data from the study is expected in the second half of 2021.
Source: Merck & Co.
CureVac Publishes Phase IIb/III Data for COVID-19 Vaccine
CureVac, a Tubingen, Germany-based clinical-stage bio/pharmaceutical company developing messenger ribonucleic acid (mRNA) therapeutics and vaccines, has published Phase IIb/III primary data of CVnCoV, its COVID-19 vaccine candidate.
The study enrolled approximately 40,000 participants in 10 countries across Latin America and Europe, in the predefined age groups 18 to 60 and above 60. For the final analysis, COVID-19 cases were caused by 15 different virus variants.
The data were based on 228 adjudicated COVID-19 cases, occurring at least two weeks after administration of the second vaccine dose. The company reported that CVnCoV demonstrated overall vaccine efficacy of 48% against COVID-19 disease of any severity, including single non-respiratory mild symptoms. Among participants in the age group of 18 to 60, efficacy of 53% was shown against disease of any severity and across all 15 identified strains; protection against moderate-to-severe disease for this age group was calculated to be 77%. In the same age group, CVnCoV provided 100% protection against hospitalization or death.
CureVac says it is in close interaction with the European Medicines Agency (EMA) and will continue to seek regulatory approval for CVnCoV. Submission of comprehensive clinical data packages to the EMA is ongoing as part of a rolling submission initiated in February 2021 and is expected to be finalized toward the end of the third quarter of 2021.
CDC Updates Guidance for Novavax COVID-19 Vaccine
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, reports that the US Centers for Disease Control and Prevention (CDC) has provided an updated guidance for those who have been vaccinated with Novavax’s recombinant nanoparticle protein COVID-19 vaccine, NVX-CoV2373, as part of Novavax’s clinical trial in the US. The CDC updated guidance states that participants in the Novavax Phase III clinical trial meet the criteria to be considered fully vaccinated two weeks after they have completed the vaccine series.
Novavax reported that the safety and efficacy of NVX-CoV2373 demonstrated 90% overall efficacy and 100% protection against moderate and severe disease.