COVID-19 Vaccines Pipeline Update

14 December 2020 Who’s Who? Global Effort

ACT-A: Global collaboration to accelerate US Effort development, production and equitable access to new diagnostics, therapeutics and vaccines • Operation Warp Speed (OWS): USG body Vaccines: COVAX Facility (GAVI, CEPI, WHO) • responsible for strategic approach, Diagnostics: FIND, Global Fund • coordination and resource allocation Treatment: Unitaid, Wellcome Trust • Health Systems Strengthening: World Bank, ACTIV: NIH established public-private Increasing divide between US Global Fund partnership for coordinating COVID-19 efforts and the response rest of the world CEPI: Global partnership to accelerate development COVPN: NIH funded networks being utilized of vaccines against emerging infectious diseases and for COVID-19 Phase 3 trial design and enable equitable access execution GAVI: Global vaccine alliance with goal of creating equal access to new and underused vaccines CONCVACT: Africa Centres for Disease Control and Prevention Consortium for COVID-19 Vaccine Clinical Trials COVID Vaccine Pipeline

Clover U. of U of * AZ/ Sanofi* J&J* Pfizer Moderna Novavax* Inovio Merck Bio- Queens- CureVac Hong Oxford* pharm land Kong France USA USA USA UK USA USA USA/ China Australia German China Austria y DNA Viral mRNA mRNA Viral Protein DNA Viral Protein Protein mRNA Viral Vector Vector Vector Vector

Ph 1 Ph 3 Ph 2/3 Ph 3 Ph 3 Ph 2 Ph1 Pre- Ph1 Ph1 PH1 Pre- Initial Pending Start Start Clinical Program Clinical EUAs EUA 9/2020 8/2020 halted in granted review 12/2020 US: 2.1B US 1.45B US 1.9B US 2.48B US 1.2B US 1.6B US 83M US 38M CEPI 3.5M CEPI 10.6M CEPI 8.3M CEPI 620K CEPI 750M CEPI 388M CEPI 17.3M EU 421M EU 923M EU 5M

Overlapping USG and COVAX investments

USG Funding COVAX Portfolio *Operation Warp Speed Finalist An Unprecedented Timeline

SARS-CoV-2 Sequenced

First Phase 3 Testing Begins

First Sars-CoV-2 Clinical Trial Begins

First Efficacy Data Released

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Vaccine Platform Refresher

DNA-based vaccines work by inserting synthetic DNA of Viral vector vaccines insert a gene for a viral protein viral gene(s) into small DNA molecules (called plasmids). into another, harmless virus (replicating or non- Cells take in the DNA plasmids and follow their instructions replicating), which delivers the viral protein to the to build viral proteins, which are recognized by the immune vaccine recipient, triggering an immune response. system, and prepare it to respond to disease exposure

RNA vaccines introduce an mRNA sequence Subunit vaccines introduce a fragment of the virus into coded for a disease-specific antigen. Once this the body. This fragment is enough to be recognized by antigen is reproduced within the body, it is the immune response and stimulate immunity. recognized and triggers an immune response

Inactivated vaccines consist of the whole virus, Live attenuated vaccines are made up of whole viruses that which has been killed with heat or chemicals so it have weakened in a lab. They tend to elicit a stronger can't cause illness. immune response than inactivated vaccines. Experts estimate that in each trial, ~150 infections will be The Race to Efficacy Data required to demonstrate 60% efficacy with statistical significance. Speed of enrollment and rate of infection will determine when efficacy data will be available

*Oxford / AZ – 2B 10K, UK, SA – started May 2020 *Oxford / AZ - 2B 2K, Brazil – started June 2020 *Pfizer - 3 44K, US, Brazil, Germany, Argentina – started July 2020 *Moderna - 3 30K, US – started July 2020 Novavax – 2B 3K, South Africa – started Aug 2020 Novavax – 3 15K, UK– started Sep 2020 Oxford/AZ - 3 30K, US – started Sept 2020 J & J - 3 40K, US, SA, Argentina, Brazil, Chile, Colombia, Mexico, Peru, Ukraine – started Sep 2020 INOVIO – 2/3 6K, US – started Nov 2020 CureVac- 2/3 40K, Germany – started Nov 2020 Novavax - 3 30K, US, Mexico, Puerto Rico – started Nov 2020 J & J - 3 30K, US, UK, France, Germany, SA, Belgium, Colombia, Philippines, Spain – started Nov 2020 Sanofi -3 Planned 40K US+ Q120 Q220 Q320 Q420 Q121 Q221 Q321 Q421 Q122 Q222 Q322 Q422 Bold color is proposed enrollment period; shaded color is estimated follow-up period *Interim or final analysis displaying efficacy has been concluded Pipeline Highlights

The UK, Bahrain, Canada, Moderna applied to the FDA Full results published on • UAE & Bahrain approved Kuwait and Mexico granted and the European Medicines December 8th in the Lancet Sinopharm/Beijing Institute of emergency use authorization to Agency for emergency reveal that AstraZeneca and Biological Products the Pfizer-BioNTech vaccine, authorization of its University of Oxford’s vaccine inactivated vaccine with Saudi Arabia granting full coronavirus vaccine on is safe and 70% effective in • Sanofi-GSK vaccine delayed approval. On December 11th, November 30th and preventing infection, with till late 2021 after early-phase the FDA approved the vaccine December 1st, respectively. efficacy ranging from 62% to data revealed reduced for emergency use in the US The company will also begin 90% based on dose. The immunogenicity in older and inoculations are set to testing its vaccine in 12 to Serum Institute has applied for adults begin within days. The vaccine 17-year-olds this month in a emergency use authorization • Clinical development of is also pending regulatory 3000-person phase 2/3 trial of the AZD1222 vaccine in University of Queensland review in India. in the US. India. candidate abandoned following false-positive HIV results in some participants COVID Authorization Approval Status

Pfizer- BNT162b2 Bahrain, Kuwait, Mexico

*CanSino Bio- Ad5-nCoV China

*Gamaleya - Sputnik V Emergency Use Russia mRNA vaccine Authorization (EUA) No previously licensed *Vector Institute -EpiVacCorona vaccine *Products approved for Russia limited/ early use in advance of Phase 3 data *Sinovac- CoronaVac Adenovirus type 5 viral vector China No licensed vaccine

*Sinopharm- Unnamed China Inactivated virus vaccine EUA by Stringent Pfizer- BNT162b2 IPV, Hep A, Rabies Regulatory Authority UK, Canada, US Approval Sinopharm- BBIBP-CorV United Arab Emirates, Bahrain Full Approval Pfizer- BNT162b2 Saudi Arabia COVID Vaccine Pipeline Diversity

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Viral Vector mRNA 15 DNA Protein subunit 7 Inactivated Virus 280+ Other pre-clinical PHASE 1 PHASE 1/2 PHASE 2 PHASE 2/3 & 3 development *does not include repurposed vaccines Planned Clinical Trials December 2020 2020 Ph3 Studies

• Moderna- Ongoing • AstraZeneca- Ongoing • Pfizer- Ongoing • Sinopharm- Ongoing • J&J- Ongoing • SinoVac- Ongoing • CanSino Bio- Ongoing • Sinopharm- Ongoing • Novavax- Ongoing • Gamaleya - Ongoing • Bharat Biotech- Ongoing • Anhui Zhiefi- Ongoing • Sanofi- Planned AVAC Resources

• COVID Vaccine Overview/Cheat Sheet on Platforms and Products • Advocates Guide to the risks, benefits, and potential opportunities and complications of expedited COVID vaccine research • Regulatory Approval Primer for Vaccine Advocates • Advocate’s Guide to COVID-19 Vaccine Access • New York Times Coronavirus Vaccine Tracker • US FDA Guidance Document for Development and Licensure of Vaccines to Prevent COVID-19 • COVID-19 Pipeline • COVID Mythbusters • COVID Resources

More resources at https://www.avac.org/covid