The FDA has approved Moderna’s and Pfizer’s updated COVID-19 vaccines targeting the KP.2 variant, an offshoot of the Omicron strain that was dominant in the U.S. in May 2024. More recently, KP.3 variants are gaining ground. As of August 20, 2024, CDC Nowcast projections estimate KP.3.1.1 accounts for approximately 37% of new COVID-19 cases in…
RedHill Biopharma announces positive data for oral COVID-19 drug
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced positive results from a Phase 2 U.S. study involving its opaganib in hospitalized COVID-19 patients with pneumonia. The study indicated that opaganib reduced the need for supplemental oxygen therapy and an earlier hospital discharge. RedHill also concluded that the drug was well-tolerated based on the placebo-controlled Phase 2 study,…
CureVac’s interim vaccine efficacy is 47% in Phase 2b/3 study
Germany-based CureVac (NSDQ:CVAC) announced that its mRNA vaccine was 47% effective against COVID-19 in a second interim analysis of a pivotal study involving approximately 40,000 participants in 10 countries. The rise of COVID-19 variants played a role in the disappointing results. At least 13 COVID-19 variants were present in the study population who contracted the…
Pfizer to seek FDA approval for COVID-19 vaccine, will seek authorization for kids above 2
Pfizer CEO Albert Bourla said the company will soon seek full FDA approval and authorization for further age groups for its COVID-19 vaccine. Speaking during the company’s first-quarter earnings call yesterday, transcribed by The Motley Fool, Bourla outlined the regulatory pathways that the company is pursuing for the vaccine it developed with BioNTech, which is…
Dyadic and Medytox team up on vaccines targeting SARS-CoV-2 variants
The Korean biopharma Medytox and Jupiter, Fla.–based Dyadic International are partnering to develop vaccines that would protect against multiple COVID-19 variants. The companies plan on using Dyadic’s C1-cell protein production platform in the development of the vaccines. The vaccines would use a similar strategy to flu vaccines, which are often trivalent or quadrivalent. The former…
BREAKING: J&J’s Phase 3 COVID-19 vaccine study results raise more alarms about new variants
Johnson & Johnson (NYSE:JNJ) announced results from its COVID-19 vaccine trial that show decreased effectiveness against new virus variants. The vaccine candidate from Johnson & Johnson’s Janssen Pharmaceutical Companies was 66% effective overall in preventing moderate to severe COVID-19 28 days after vaccination. But it proved less effective in South Africa, where a new variant of…
New COVID-19 variants could diminish vaccine efficacy
COVID-19 is mutating. And while early data suggest vaccines will be effective against more infectious COVID-19 variants that emerged in the U.K., South Africa and Brazil, the mutations could have a measurable impact on vaccine efficacy. There’s perhaps a 50/50 chance that such new variants could lead to a “numerically meaningful drop” in vaccine efficacy,…