The EMA’s safety committee has announced that they are reviewing reports of menstrual disorders after people received COVID-19 vaccinations from Pfizer-BioNTech and Moderna.
This COVID-19 update covers new and emerging vaccines and treatments and links to menstrual disorders after vaccination.
European Union Regulator Reviews Menstrual Disorder Cases after mRNA COVID Vaccination
The European Medicines Agency’s safety committee has announced that they are reviewing reports of menstrual disorders after people received COVID-19 vaccinations from Pfizer-BioNTech and Moderna. It is not yet clear if there is a causal link between the vaccines and these reports.
In Dec. 2021, the agency also reported that it had not established a link between changes in menstrual cycles and COVID-19 vaccines after receiving results from a Norwegian study that showed people experienced heavier periods after being vaccinated. The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee has decided to request an evaluation of all available data, including reports from patients and healthcare providers, clinical trials and published literature.
Remdesivir Shows Antiviral Activity Against Current SARS-CoV-2 Variants
After the U.S. Food and Drug Administration recently curbed the use of Eli Lilly’s and Regeneron’s monoclonal antibody treatments for COVID-19 amidst data showing they are ineffective against Omicron-infected patients, Gilead has provided data, showcasing that their antiviral therapeutic remdesivir remains effective against emerging variants of SARS-CoV-2. Gilead reports that remdesivir produces antiviral activity against ten virus variants in vitro, including Delta and Omicron variants, making it an effective treatment for current patients with COVID-19. The results of Gilead’s study are consistent with other in vitro studies conducted independently in different research institutions globally. The FDA recently approved remedisivr treatment for non-hospitalized patients at high risk for COVID-19 disease progression.
NRx BriLife COVID-19 Investigational Vaccine Less Effective Against Omicron
NRx Pharmaceuticals reported remarks from its Israel vaccine development program, revealing that the BriLife COVID-19 vaccine is less effective against Omicron variants than neutralizing other variants. The vaccine utilizes a single-stranded RNA virus to engineer spike proteins against SARS-CoV-2, a method used for Ebola virus vaccines. Its current clinical study showed a three-fold decrease in vaccine levels against Omicron. Still, the director of the Israeli Institute for Biological Research, Dr. Shmuel Yitzhaki, states that the Pfizer vaccine shows a decrease of 8–20 fold. The trial for the vaccine will enter Phase II in the coming months, and NRx Pharmaceuticals is hopeful the vaccine will be more effective against other variants.
United States to Pay Eli Lilly $720M for COVID-19 Treatment
Eli Lilly has agreed to supply 600,000 doses of its investigational neutralizing monoclonal antibody bebtelovimab in exchange for $720 million from the U.S. government. The U.S. government will initiate the deal if the FDA grants the therapeutic emergency use authorization. Eli Lilly has submitted a request for the drug to treat mild to moderate COVID-19 in certain high-risk patients. Should the therapeutic be approved, the doses will be delivered on March 31 with an option to acquire 500,000 additional doses by July 31. Eli Lilly reports that bebtelovimab provides full neutralizing activity against Omicron and all other known variants of interest and concern, including BA.2.
