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J&J's vaccine recommended for emergency use authorization by independent experts. FDA will make a decision this weekend.Johnson & Johnson's (JNJ) single-dose COVID-19 vaccine is one step closer to emergency use authorization (EAU) after an independent panel voted Friday to recommend the U.S. Food and Drug Administration (FDA) issue the EUA.
Pfizer Inc and BioNTech SE said on Thursday they are testing a third dose of their COVID-19 vaccine to better understand the immune response against new variants of the virus. They are also in talks with regulatory authorities about testing a vaccine modified to protect specifically against the highly transmissible new variant found in South Africa and elsewhere, known as B.1.351, as a second arm of the same study. The companies believe their current two-dose vaccine will work against the South African variant as well as one found in the United Kingdom and elsewhere.
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today they have begun an evaluation of the safety and immunogenicity of a third dose of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to understand the effect of a booster on immunity against COVID-19 caused by the circulating and potential newly emerging SARS-CoV-2 variants. The study will draw upon participants from the Phase 1 study in the United States who will be offered the opportunity to receive a 30 µg booster of the current vaccine 6 to 12 months after receiving their initial two-dose regimen. The study is part of the Companies’ clinical development strategy to determine the effectiveness of a third dose against evolving variants.