![]() Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Moderna COVID-19 Vaccine.Do not administer the vaccines to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the Moderna COVID-19 Vaccine.MRNA-1273.815 has not yet been authorized or approved by the FDA.Įmergency uses of the Moderna COVID-19 Vaccine, Bivalent, have not been approved or licensed by the FDA, but have been authorized by the FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19). To learn more, visit AUTHORIZED USE IN THE U.S. Moderna has been named a top biopharmaceutical employer by Science for the past eight years. Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio and integrated manufacturing facilities that allow for rapid clinical and commercial production at scale. Moderna's clinical trial data around its updated COVID-19 vaccine's effectiveness against BA.2.86 have been shared with regulators and submitted for peer review publication. The emergence of BA.2.86, in addition to the growing prevalence of the EG.5 and FL1.5.1 variants, underscores the need for vaccination with an updated COVID-19 vaccine, which can help reduce severe disease and hospitalizations caused by current circulating strains. Public health authorities are vigilantly monitoring the BA.2.86 variant, a highly-mutated strain of COVID-19 with over 30 mutations as compared to prior Omicron strains, with some governments accelerating COVID-19 vaccination campaigns due to its potential to break through protective immunity generated from previous COVID-19 vaccination or infection. "Moderna will continue to rapidly assess global public health threats and is committed to leveraging our mRNA platform against COVID-19." Taken together with our previously communicated results showing a similarly effective response against EG.5 and FL.1.5.1 variants, these data confirm that our updated COVID-19 vaccine will continue to be an important tool for protection as we head into the fall vaccination season," said Stephen Hoge, M.D., President of Moderna. "These results demonstrate that our updated COVID-19 vaccine generates a strong human immune response against the highly mutated BA.2.86 variant. The Centers for Disease Control (CDC) indicates that the highly mutated BA.2.86 variant may be more capable of causing infection in people who previously had COVID-19 or were vaccinated with previous vaccines, noting that updated COVID-19 vaccines may be effective in reducing severe disease and hospitalization. Food and Drug Administration for the fall 2023 vaccination season, generates an 8.7-fold increase in neutralizing antibodies in humans against BA.2.86 (Pirola), a variant under monitoring. (NASDAQ:MRNA) today announced that clinical trial data from its research assay confirm its updated COVID-19 vaccine, which is pending approval by the U.S. With governments accelerating the timing of COVID-19 vaccination campaigns due to the potential risk of BA.2.86, Moderna has shared this data with regulators and is ready to supply its updated COVID-19 vaccine pending regulatory approvalĬAMBRIDGE, MA / ACCESSWIRE / Septem/ Moderna, Inc. ![]() CDC notes that the BA.2.86 (Pirola) variant may be more likely to break through existing immunity from previous vaccination or infection, highlighting the need for vaccination with an updated COVID-19 vaccine for the fall 2023 seasonĬlinical trial data from research assay confirmed Moderna's updated COVID-19 vaccine showed an 8.7 to 11-fold increase in neutralizing antibodies against circulating variants, including BA.2.86, EG.5, and FL.1.5.1 variants
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