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J&J files COVID-19 vaccine application with U.S. FDA

4 Min Read (Reuters) - Johnson & Johnson said on Thursday it has asked U.S. health regulators to authorize its single-dose COVID-19 vaccine for emergency use, and it will apply to European authorities in coming weeks. The drugmakerโ€™s application to the U.S. Food and Drug Administration (FDA) follows its Jan. 29 report in which it said the vaccine had a 66% rate of preventing infections in its large global trial. The FDA said on Thursday evening that it has scheduled a meeting of its Vaccines ...
United States South Africa United Kingdom Paul Stoffels Peter Henderson Matthew Lewis

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J&J files COVID-19 vaccine application with U.S. FDA | The Mitchell Republic

J&J files COVID-19 vaccine application with U.S. FDA J&Js single-shot vaccine could help boost supply and simplify the U.S. immunization campaign, amid concerns of fresh surges due to the more contagious UK coronavirus variant and the potential of lower vaccine efficacy against the variant that first emerged in South Africa. Written By: Vishwadha Chander / Reuters | 9:38 pm, Feb. 4, 2021 ร— Vials with a sticker reading, "COVID-19 / Coronavirus vaccine / Injection only" and...
United States South Africa United Kingdom Paul Stoffels Peter Henderson Matthew Lewis

BioNTech SE: Pfizer and BioNTech Provide Data from German Phase 1/2 Study Further Characterizing Immune Response Following Immunization with Lead COVID-19 Vaccine Candidate BNT162b2

(2) Analysis of 37 participants immunized with BNT162b2 showed a broad immune response with SARS-CoV-2-specific neutralizing antibodies, T H1 type CD4+ T cells, and strong expansion of CD8+ T cells of the early effector memory phenotype All vaccinated participants demonstrated neutralizing antibody as well as T cell responses. T cell responses were directed against multiple regions of the spike protein, including the RBD, suggesting immune recognition of multiple independent epitopes Data conf...
Saudi Arabia Andy Widger Kathrinu Jansen Epstein Barr Fosun Pharma Sylke Maas

Pfizer Inc.: Pfizer and BioNTech Announce Publication of Results from Landmark Phase 3 Trial of BNT162b2 COVID-19 Vaccine Candidate in The New England Journal of Medicine

(2) Data from 43,448 participants, half of whom received BNT162b2 and half of whom received placebo, showed that the vaccine candidate was well tolerated and demonstrated 95% efficacy in preventing COVID-19 in those without prior infection 7 days or more after the second dose Vaccine efficacy observed in the overall study population was also generally consistent across subgroups defined by age, gender, race, ethnicity, baseline body mass index (BMI), or presence of other underlying co-morbidit...
United States South Africa Sylke Maas Kathrinu Jansen Chuck Triano Amy Rose

Pfizer and BioNTech Announce Publication of Results from Landmark Phase 3 Trial of BNT162b2 COVID-19 Vaccine Candidate in The New England Journal of Medicine

Data from 43,448 participants, half of whom received BNT162b2 and half of whom received placebo, showed that the vaccine candidate was well tolerated and demonstrated 95% efficacy in preventing COVID-19 in those without prior infection 7 days or more after the second dose Vaccine efficacy observed in the overall study population was also generally consistent across subgroups defined by age, gender, race, ethnicity, ...
United States South Africa Sylke Maas Kathrinu Jansen Chuck Triano Amy Rose

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