In Use

Anticipated Next Steps

Health Canada fully "approved" the vaccine in individuals 18 years of age and older on 11/24/2021; Phase I/IIa sub-study results published 7/14/2021; Johnson & Johnson statement on COVID-19 vaccine released 7/12/2021; Data on neutralizing activity against emerging variants announced 7/1/2021; U.K. MHRA granted "conditional marketing authorization" on 5/28/2021; CDC and FDA lift recommended pause on vaccine use in U.S. on 4/23/2021; Phase III ENSEMBLE primary data published on 4/21/2021; CDC and FDA recommended a pause on vaccine use in the U.S. as of 4/13/2021; Phase IIa trial expanded to include adolescents 12-17 years of age as of 4/2/2021; WHO issued "emergency use listing" on 3/12/2021; Granted Conditional Marketing Authorization by European Commission on 3/11/2021; Granted "Interim Order (IO) authorization" for emergency use by Health Canada on 3/5/2021; 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 2/28/2021; U.S. FDA issued "emergency use authorization" on 2/27/2021; Submitted "emergency use listing" to the World Health Organization (WHO) on 2/19/2021; Submitted "conditional marketing authorisation application" to the European Medicines Agency (EMA) on 2/16/2021; Janssen submitted application for "emergency use authorization" to the U.S. FDA on 2/4/2021; Phase III interim analysis results announced 1/29/2021; Phase I/IIa interim results published 1/13/2021; Phase III trial to study the safety and efficacy of a two-dose regimen began 11/15/2020 (ENSEMBLE 2); Phase III trial (ENSEMBLE) resumed recruitment on 10/23/2020, fully enrolled with ~45,000 participants as of 12/17/2020, 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 10/12/2020; 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

In Use

Anticipated Next Steps

Phase II/III KidCOVE study positive interim data announced 10/25/2021; Health Canada has approved the New Drug Submission (NDS-CV) for SPIKEVAX™ (elasomeran mRNA vaccine) in individuals 12 years of age and older as of 9/16/21; India granted "Emergency Use Authorization" on 6/29/2021; Clinical update on mRNA-1273's neutralizing activity against emerging variants announced 6/29/2021; Submitted authorization application to Swissmedic for use in adolescents on 6/14/2021; Filed for authorization with U.S. FDA for use in adolescents (12-18 years of age) on 6/10/2021; Filed for authorization with Health Canada for use in adolescents on 6/7/2021; Filed for conditional marketing approval (CMA) with the European Medicines Agency (EMA) for use in adolescents on 6/7/2021; Initiated rolling submission process with the U.S. FDA for a Biologics License Application (BLA) on 6/1/2021; Phase II/III study in adolescents met its primary immunogenicity endpoint as of 5/25/2021, data is expected to be submitted to regulators globally in early June 2021; Phase II initial booster data against variants announced 5/5/2021; World Health Organization (WHO) granted Emergency Use Listing (EUL) on 4/30/2021; Antibody persistence data published 4/6/2021; Phase II/III study (KidCOVE) dosed in pediatric population less than 12 years of age on 3/16/2021; Phase I study of next generation COVID-19 vaccine candidate, mRNA-1283, dosed on 3/15/2021; First participants dosed with modified COVID-19 vaccines, designed to address the potential need for booster vaccine candidates, in an amendment to the ongoing Phase II clinical study on 3/10/21; Provided strategy update for addressing SARS-CoV-2 variants of concern, including a variant-specific booster candidate (mRNA-1273.351) based on the B.1.351 variant first identified in the Republic of South Africa, on 2/24/2021; Results from an in vitro study on neutralization of variants of SARS-CoV-2 by mRNA-1273 vaccine-elicited sera announced January 2021; Phase I/II dosed in Japan (TAK-919) on 01/21/2021; Switzerland "authorized" on 01/12/2021; U.K. MHRA granted "temporary authorization" on 01/08/2021; European Commission granted a "conditional marketing authorization" on 01/06/2021; Israel granted "authorization to import" on 01/04/2021; Phase III interim safety and primary efficacy results published on 12/30/2020; Health Canada "authorized" on 12/23/2020; U.S. FDA issued "emergency use authorization" on 12/18/2020; Phase II/III study in adolescents ages 12 to less than 18 dosed on 12/10/2020; Submitted Emergency Use Authorization (EUA) request to the U.S. FDA on 11/30/2020; Phase III primary efficacy analysis results announced 11/30/2020; European Medicines Agency (EMA) started rolling review on 11/17/2020; Phase III interim analysis results announced 11/16/2020; Swissmedic started rolling review on 11/13/2020; UK Medicines and Healthcare products Regulatory Agency (MHRA) started rolling review on 10/27/2020; EMA confirmed marketing authorization submission eligibility on 10/14/2020; Health Canada rolling submission initiated on 10/13/2020; Study protocol for late-stage clinical trials released September 2020; Phase I interim data from older adult cohorts released Aug 2020 and published Sep 2020; Phase III COVE study began July 2020, completed enrollment on 10/22/2020; Animal study results published July/Aug 2020; Phase I interim results published July 2020; FDA fast track designation granted May 2020; Selected for US Operation Warp Speed in April 2020

In Use

Anticipated Next Steps

Phase III topline results from a longer-term analysis in individuals 12 through 15 years of age announced 11/22/2021; U.S. FDA expanded the EUA of a booster dose to include individuals 18 years of age and older as of 11/19/2021; U.S. FDA Advisory Committee voted on 10/26/2021 to recommend the FDA grant Emergency Use Authorization (EUA) for the companies’ COVID-19 vaccine in children 5 to <12 years of age; Phase III topline results of the efficacy and safety of a 30-µg booster dose announced on 10/21/2021; Initial results from Phase II/III study (in participants 5 to 11 years of age) submitted to the U.S. FDA for the Agency’s initial review on 9/28/2021; U.S. FDA granted EUA for a booster dose in individuals 65 years of age and older, and individuals ages 18 through 64 within certain high-risk groups as of 9/22/2021; Phase II/III study (in participants 5 to 11 years of age) topline results announced 9/20/2021; U.S. FDA approved the Biologics License Application (BLA) for COMIRNATY® to prevent COVID-19 in individuals 16 years of age and older on 8/23/2021; U.S. FDA granted Priority Review designation for the Biologics License Application (BLA) on 7/16/2021 and the Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in January 2022; Vietnam granted "emergency use" approval on 6/12/2021; European Union expanded Conditional Marketing Authorization (CMA) to include individuals 12-15 years of age on 5/28/2021; U.S. FDA expanded Emergency Use Authorization (EUA) to include individuals 12-15 years of age on 5/10/2021; Announced initiation of Biologics License Application (BLA) with the U.S. FDA on 5/7/2021; Phase III updated topline results announced 4/1/2021; Phase III trial in adolescents (12-15 years) topline results announced 3/31/2021; Phase I/II/III continuous study in children 11 years to 6 month old dosed March 2021; Real-world data gathered by the Israel Ministry of Health announced on 3/11/2021; Evaluation of the safety and immunogenicity of a third dose (30 µg booster of the current vaccine) 6 to 12 months after receiving initial two-dose regimen began 2/25/2021; New stability data at standard freezer temperature was submitted to the U.S. FDA as of 2/19/2021; Phase II/III study in healthy pregnant women 18 years of age and older dosed 2/18/2021; Results from in vitro studies on neutralization of variants of SARS-CoV-2 by BNT162b2 vaccine-elicited sera announced January 2021; Phase I (China) preliminary safety and immunogenicity data released January 2021; World Health Organization (WHO) granted Emergency Use Listing (EUL) on 12/31/2021; Argentina authorized under "emergency registration" on 12/22/2020; European Commission granted a "conditional marketing authorisation" (CMA) on 12/21/2020, following European Medicines Agency (EMA) recommendation to grant CMA; U.S. FDA issued "emergency use authorization" on 12/11/2020; Mexico COFEPRIS granted "emergency use authorization" on 12/11/2020; Saudi Food and Drug Authority (SFDA) "approved the registration" of the vaccine on 12/10/2020; Health Canada "authorized" on 12/9/2020; Bahrain granted "emergency use authorization" on 12/4/2020; U.K. MHRA granted "temporary authorization for emergency use" on 12/2/2020; Submitted Emergency Use Authorization (EUA) request to the U.S. FDA on 11/20/2020; Phase III complete analysis results announced 11/18/2020, interim analysis results announced 11/09/2020; Phase I data published October 2020; FDA approved late-stage trial enrollment of children 12 years and older in October 2020; EMA rolling submission initiated on 10/6/2020; Study protocol for late-stage clinical trials released Sept 2020; Amended protocol to FDA to expand trial enrollment to 44,000 participants; Phase IIb/III trial began Jul 2020; FDA granted Fast Track designation for BNT162b1 and BNT162b2 in Jul 2020; Selected for US Operation Warp Speed in Jul 2020; Phase I/II began Apr 2020; preliminary data released Jul 2020, additional data published Aug, Sept, and Dec 2020; Pre-clinical data released Sept 2020 and Dec 2020

In Use

Anticipated Next Steps

Phase III safety and efficacy data published September 2021; Tolerability and immunogenicity results after a late second dose or a third dose released on 6/28/2021; Real-world data on vaccine effectiveness against hospitalizations due to the Delta variant released 6/14/2021; Japan granted authorization for "emergency use" on 5/21/2021; EMA updated guidance on very rare side effects announced 4/7/2021; Phase II dosing paused in children between the ages of 6 and 17 years pending MHRA review as of 4/6/2021; Phase III primary analysis (U.S. trial) results announced 3/25/2021; Phase III interim analysis (U.S. trial) results announced 3/22/2021; World Health Organization (WHO) granted Emergency Use Listing (EUL) on 2/15/2021; Phase II study in children between the ages of 6 and 17 years expected to begin in February 2021; Phase III (U.K., Brazil) and Phase I/II (U.K., South Africa) analyses data released on 2/3/2021; European Union (EU) granted "conditional marketing authorisation" on 1/29/2021; Brazil granted "temporary authorization for emergency use" on 1/17/2021; Pakistan granted "emergency use authorization" on 1/15/2021; India granted "emergency use authorisation" as well as Dominican Republic, El Salvador, Mexico and Morocco as of 1/6/2021; Argentina authorized under "emergency registration" on 12/30/2020; U.K. "authorised for emergency supply" on 12/30/2020; Phase I/II data (w/ booster dose) published on 12/17/2020; Phase III trials interim analysis results published 12/8/2020; Phase II/III (COV002) and Phase III (COV003) trial pooled interim analysis results released on 11/23/2020; Phase II/III trial interim results released Nov 2020; Study protocol for late-stage clinical trials released September 2020; AstraZeneca clinical trials resumed globally (in the UK on 9/14/2020, Brazil and South Africa on 9/15/2020, Japan on 10/2/2020, and the US on 10/23/2020); AstraZeneca voluntarily paused vaccination to allow independent review of safety data on 9/8/2020; Phase III trial began Jun 2020 and expanded into US in Aug 2020; Phase II/III began May 2020; Phase I/II trial interim results released Jul 2020; Selected for US Operation Warp Speed in May 2020

In Use

Anticipated Next Steps

China and Uzbekistan granted "emergency use" approval in March 2021; Phase III began December 2020; Phase I and II safety and immunogenicity data released December 2020; Phase II began July 2020; Received approval to launch clinical trials in China in June 2020

In Use

Anticipated Next Steps

Final results of trials are expected to be ready by October 2021; Demonstrated efficacy based on the analysis of data from vaccinated persons announced on 4/19/2021; Started rolling review process with the European Medicines Agency (EMA) on 3/4/2021; Authorized for "emergency use" in 39 countries as of March 2021; Phase III interim analysis results published on 2/2/2021; "Registered" in Belarus in December 2020; Phase III final control point data analysis results released December 2020, interim data analysis results released November 2020; Phase III (post-registration) trial began September 2020; Phase I/2 began June 2020, results published September 2020; Russian Ministry of Health "registered" vaccine in August 2020, Mass production expected to begin September 2020

In Use

Anticipated Next Steps

Indonesia granted "emergency use authorization" in November 2021; Phase III began June 2021; Received early approval for "emergency use" in China in May 2021; Phase I/II results announced April 2021; Phase I/II study began October 2020

In Use

Anticipated Next Steps

Authorized for "emergency use" in Argentina, Chile, Hungary, Pakistan, and Mexico, and for "conditional approval" in China as of June 2021; Filed "conditional marketing authorization" with China's National Medical Products Administration (NMPA) on 2/24/2021; Phase III dosed September 2020; Phase II began April 2020, initial results released May 2020, mid-phase results released July 2020; China’s Central Military Commission "approved the use of the vaccine by the military" in June 2020

In Use

Anticipated Next Steps

Iran issued an emergency use permit in October 2021; Phase III trial dosed August 2021; Phase II trial dosed June 2021; Phase II and III trials will be initiated in Iran in the coming weeks as of May 2021; Phase I trial dosed July 2020

In Use

Anticipated Next Steps

Kazakhstan lauched nationwide vaccine roll out as of 4/27/2021; Kazakhstan granted "temporary registration for nine months" as of 1/13/2021; Phase III began December 2020; Phase I/II began September 2020

In Use

Anticipated Next Steps

Indonesia and the Philippines granted emergency use authorization (EUA) as of November 2021; Announced rolling regulatory submission to the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for authorization on 10/27/2021; Phase III (U.K. trial) final analysis results published 6/30/2021; Phase III efficacy data released 6/14/2021; Updated PREVENT-19 trial protocol released on 5/10/2021; Announced preclinical data from NanoFlu/NVX-CoV2373 combination vaccine study on 5/10/2021; Initiated a pediatric expansion (12-17 years of age) of its Phase III clinical trial on 5/3/2021; Announced participation in Phase II clinical trial called "Comparing COVID-19 Vaccine Schedule Combinations – Stage 2" (Com-COV2) on 4/14/2021; Announced the initiation of crossover arms in two ongoing clinical trials on 4/5/2021; Phase III (UK) and Phase IIb ( South Africa) final efficacy results released 3/11/2021; Phase I/II trial dosed in Japan on 2/26/2021; Phase III trial (PREVENT-19) completed enrollment in the US and Mexico on 2/22/2021; Announced the start of the rolling review process with several regulatory agencies worldwide on 2/4/2021, including the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), U.K. Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada; Phase III (UK) and Phase IIb ( South Africa) interim results released 1/28/2021; Phase III trial (PREVENT-19) initiated in the US and Mexico in December 2020, trial protocol released on website; FDA granted Fast Track Designation on 11/9/2020; Phase III dosed in the UK in October 2020, trial protocol released on website, interim data expected to be released in Q1 2021; Phase IIb trial began Aug 2020; Selected for US Operation Warp Speed July 2020; Phase I/II began end of May 2020, interim data expected to be released on 10/30/2020; Animal study & preliminary Phase I results released Aug 2020, Phase I results published Sept 2020

In Use

Anticipated Next Steps

China granted "conditional approval" on 2/25/2021; Applied for regulatory approval in China as of February 2021; Phase III trial began July 2020; Phase I/II early trial results released June 2020, Phase I/II interim analysis published August 2020; Received early approval for "emergency use" in China (Aug 2020) and the UAE (Sep 2020)

In Use

Anticipated Next Steps

The Egyptian Drug Authority (EDA) granted the Sinovac/VACSERA vaccine an emergency use license on 8/23/2021; Phase I/II clinical trials results in healthy children and adolescents aged 3-17 in China published 6/28/2021; World Health Organization (WHO) granted Emergency Use Listing (EUL) on 6/1/2021; Summary of clinical trial data released on 4/3/2021; Emergency use approval, or conditional marketing authorization, has been granted by over 30 countries as of 4/1/2021; Malaysia granted "conditional approval" on 3/2/2021; China's NMPA granted "conditional marketing authorization" on 2/8/2021; Phase III results (Brazil, Turkey, Indonesia, Chile) announced on 2/5/2021; Phase I/II safety, tolerability, and immunogenicity data in adults aged 60 years and older published on 2/3/2021; Sinovac filed for "conditional market authorization" with China’s National Medical Products Administration (NMPA) on 2/3/2021; Chile granted "emergency use" approval on 1/20/2021; Brazil granted "temporary authorization for emergency use" on 1/17/2021; Turkey granted "emergency use authorization" on 1/31/2021; Indonesia granted "emergency use approval" on 01/11/2021; Phase III efficacy results (Brazil) released early January 2021; Phase I/II complete analysis results published 11/17/2020; Phase III trial resumed in Brazil on 11/11/2020, Phase III trial suspended in Brazil on 11/09/2020; 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)

In Use

Anticipated Next Steps

Vietnam granted approval on 6/4/2021; World Health Organization (WHO) granted Emergency Use Listing (EUL) on 5/7/2021; Indonesia granted "emergency use" approval on 4/30/2021; Hungary granted "emergency use" approval on 1/29/2021; Pakistan granted "emergency use authorization" on 1/18/2021; China "granted conditional market approval" on 12/31/2020; Midterm clinical results released on 12/30/2020; Bahrain National Health Regulatory Authority (NHRA) "approved" on 12/13/2020; UAE Ministry of Health and Prevention (MOHAP) announced "official registration" on 12/9/2020, following review of Phase III interim analysis; Phase I/II results published October 2020; Phase III trial began July 2020; Received early approval for "emergency use" in China (Aug 2020) and the UAE (Sep 2020)

In Use

Anticipated Next Steps

Announced (10/26/2021) as one of two candidate vaccines to be included in the Solidarity Trial Vaccines with WHO and the Ministries of Health of Colombia, Mali, and the Philippines; Phase III began October 2021; Taiwan began vaccine rollout during the week of 8/23/2021; Phase III expected to complete the recruitment (1,000 participants) by Q3 2021; Taiwan granted EUA approval on 7/19/2021, clinical trials are ongoing; Phase II interim analysis results released 6/10/21; Phase II study in elderly adults (65 years and older) began May 2021; Booster trial with third dose began May 2021; Phase II second dose vaccination completed on 4/28/2021; Phase I interim analysis results announced 4/7/2021; Phase II dosed January 2021; Phase I dosed in early October 2020; Received conditional approval for clinical testing on Aug 31 and was given full approval on Sept 30; Pre-clinical data released August 2020 and published November 2020

In Use

Anticipated Next Steps

Phase I/II interim results published March 2021; Phase III trial began November 2020; "Registered" for use in Russia in October 2020; Phase I/II trial began end of July 2020

In Use

Anticipated Next Steps

World Health Organization (WHO) granted Emergency Use Listing (EUL) on 11/3/2021; Phase III efficacy analysis results announced on 7/2/2021; Phase III second interim analysis results announced on 4/21/2021; Authorized for "emergency use" in Nepal and Zimbabwe as of March 2021; Phase II interim analysis and Phase I follow-up results published 3/8/2021; Phase III interim analysis results announced 3/3/2021; Neutralization of UK-variant with vaccine-elicited sera announced January 2021; India granted "permission for emergency use" on 01/03/2021; Phase I and II safety and immunogenicity data released December 2020 and published January 2021; Phase III began November 2020; Phase I/II study: Phase I began July 2020 and Phase II began September 2020, initial results expected September 2020; Animal study results released September 2020, Approved for intranasal booster dose trials February 2022

In Use

Anticipated Next Steps

India granted "emergency use approval" for use in adults and children aged 12 years and above on 8/20/2021; Applied to the office of Drug Controller General of India (DCGI) for EUA on 7/1/2021; Phase III data expected to be announced May 2021; Phase III dosed January 2021; Pre-clinical results released January 2021; DCGI approved start of Phase III trial in January 2021; Phase I/II study: Phase I began July 2020 and Phase II began August 2020, initial results expected September 2020

In Use

Anticipated Next Steps

Cuba granted "emergency approval" on 8/20/2021; Iran began producing the vaccine (as PastuCovac) in August 2021; Phase III efficacy data announced 7/8/2021; Phase III preliminary data announced on 6/19/2021; Phase I/II pediatric study (ages 3-18 years) began June 2021; Cuba began rolling out the vaccine in a mass campaign in May 2021; Phase III began March 2021; Phase II began December 2020; Phase I began October 2020

In Use

Anticipated Next Steps

Cuba began rolling out the vaccine in a mass campaign in May 2021; Phase III began March 2021; Phase II began February 2021, Phase I (ABDALA) trial began December 2020

In Use

Anticipated Next Steps

Iran issued an emergency use license in November 2021; Phase III began September 2021; Phase II began April 2021; Phase I began February 2021

In Use

Anticipated Next Steps

Phase III began March 2021; Russia "registered" the vaccine in February 2021; Clinical trials began Ocotober 2020

In Use

Anticipated Next Steps

Phase I study in children ages 12-18 began November 2021; Iran granted emergency use authorization on 6/14/2021; Phase II/III trial in adults 18-75 years of age began March 2021; Phase I trial in adults 51-75 years of age began March 2021; Phase I trial in adults 18-50 years of age began December 2020

In Use

Anticipated Next Steps

Cuba granted emergency use authorization for use in convalescent individuals (19 years of age and older) on 9/23/2021; Phase I/II study in convalescent pediatric individuals (2-18 years of age) began September 2021; Phase II study in convalescent individuals began April 2021