FDA on Phase III interim analysis results announced Phase I/IIa interim results published Phase III trial to study the safety and efficacy of a two-dose regimen began (ENSEMBLE 2) Phase III trial (ENSEMBLE) resumed recruitment on, fully enrolled with ~45,000 participants as of, interim data expected by the end of January 2021 Janssen Pharmaceutical Companies of Johnson & Johnson voluntarily paused dosing to allow independent review of safety data on Phase III trial (ENSEMBLE) began and study protocol released September 2020 Phase I/IIa began end of July 2020, interim results released September 2020 Animal study results published July and September 2020 Selected for US Operation Warp Speed in February 2020 and awarded funding in August 2020
FDA issued "emergency use authorization" on Submitted "emergency use listing" to the World Health Organization (WHO) on Submitted "conditional marketing authorisation application" to the European Medicines Agency (EMA) on Janssen submitted application for "emergency use authorization" to the U.S. CDC's Advisory Committee on Immunization Practices (ACIP) has recommended the first single-shot COVID-19 vaccine for individuals 18 years of age and older on U.S. as of Phase IIa trial expanded to include adolescents 12-17 years of age as of WHO issued "emergency use listing" on Granted Conditional Marketing Authorization by European Commission on Granted "Interim Order (IO) authorization" for emergency use by Health Canada on U.S. on Phase III ENSEMBLE primary data published on CDC and FDA recommended a pause on vaccine use in the U.S.
MHRA granted "conditional marketing authorization" on CDC and FDA lift recommended pause on vaccine use in U.S. Phase I/IIa sub-study results published Johnson & Johnson statement on COVID-19 vaccine released Data on neutralizing activity against emerging variants announced U.K.
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The Egyptian Drug Authority (EDA) granted the Sinovac/VACSERA vaccine an emergency use license on Phase I/II clinical trials results in healthy children and adolescents aged 3-17 in China published World Health Organization (WHO) granted Emergency Use Listing (EUL) on Summary of clinical trial data released on Emergency use approval, or conditional marketing authorization, has been granted by over 30 countries as of Malaysia granted "conditional approval" on China's NMPA granted "conditional marketing authorization" on Phase III results (Brazil, Turkey, Indonesia, Chile) announced on Phase I/II safety, tolerability, and immunogenicity data in adults aged 60 years and older published on Sinovac filed for "conditional market authorization" with China’s National Medical Products Administration (NMPA) on Chile granted "emergency use" approval on Brazil granted "temporary authorization for emergency use" on Turkey granted "emergency use authorization" on Indonesia granted "emergency use approval" on Phase III efficacy results (Brazil) released early January 2021 Phase I/II complete analysis results published Phase III trial resumed in Brazil on, Phase III trial suspended in Brazil on Received approval for Phase I/II trial in adolescents and children in September 2020 Phase III trial began end of July 2020 Phase II began June 2020, mid-phase II results released August 2020 Preliminary results from Phase I/II trials released June and September 2020 (aged 60+) 2020 Received early approval for "emergency use" in China (Aug 2020)