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Cheat Sheet: COVID-19 Vaccine Pipeline

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Cheat Sheet: COVID-19 Vaccine Pipeline Cheat Sheet: COVID-19 vaccine pipeline Primary sponsor(s) Description Platform Funders Status Considerations Read more Pfizer / BioNTech Comirnaty mRNA Pfizer ($500M) Ph. I/II ongoing: 456/Germany Efficacy: Interim analysis shows that the candidate was safe and well-tolerated with New York Times mRNA that encodes for USG ($1.9M) Ph. II planned: 960/China an efficacy rate of 95%. SARS-CoV-2 spike protein. Warp Speed Finalist Ph. II/III ongoing: 44K US +5 Manufacturing/delivery: mRNA vaccines are relatively easy to scale and Authorization: EUA in EU, US, +9; WHO manufacture. Emergency Validation Platform history: No previous mRNA vaccines licensed for use. Approval: Bahrain, New Zealand, Saudi Arabia, Switzerland Moderna mRNA-1273 mRNA USG ($2.48B) Ph. I ongoing: 155/US Efficacy: Interim analysis shows that the candidate was safe and well-tolerated Moderna Synthetic messenger RNA CEPI/GAVI (Undisclosed) Ph. II/III ongoing: 3000 (12 to 17 years)/ US with an efficacy rate of 94.5%. Statement that encodes for SARS- Warp Speed Finalist Ph. III ongoing: 30,000/US Manufacturing/delivery: mRNA vaccines are relatively easy to scale and CoV-2 spike protein. COVAX Portfolio Authorization: EUA in Canada, EU, manufacture (potential for 1B doses by 2022); likely to require two doses, but a AVAC Israel, US third may be necessary. Webinar Approval: Switzerland Platform history: No previous mRNA vaccines licensed for use. U. of Oxford AZD1222 Viral USG ($1.2B) Ph. II ongoing: 300 vols (6-17 years)/ UK Efficacy: Ph. III interim analysis shows vaccine was safe and well-tolerated, efficacy Science AstraZeneca Chimpanzee Adeno vector vector CEPI/GAVI ($750M) Ph. II/II ongoing: 12,390/UK; 1700/India averaged 70.4% (62 - 90% depending on dose); <25% efficacy against mild to expressing SARS-CoV-2 EU ($923M) Ph. III ongoing: 40K /US+; 10K/Brazil moderate illness in South Africa. spike protein. Warp Speed* Finalist Authorization: EUA in Argentina, India, UK Manufacturing/delivery: Adeno vector vaccines can be manufactured quickly and COVAX** Portfolio Approval: None at scale (capacity to produce 2B doses has been secured). Platform history: Vaccine utilizing the Ad26 platform (Ad26.ZEBOV) has been approved for use against Ebola Virus Disease. Sinopharm / Beijing BBIBP-CorV x 2 Whole No Funding Disclosed Ph. I/II: ongoing: 640/China Efficacy:Ph. III interim analysis showed an effficacy of 86%. Cell Institute of Biologic inactivated Ph III ongoing: 45K/UAE. Bahrain, Jordan, Manufacturing/delivery: Inactivated vaccines may require booster doses; GEN Products / Egypt; 3K/Argentina; 6K/Peru relatively shelf-stable compared to other platforms. Wuhan Authorization: EUA in Egypt Platform history: Numerous whole inactivated vaccines, including polio, Hep A Institute Approval: Bahrain, China, UAE and rabies. Gamaleya Research Sputnik V Viral Ministry of Health- Russia Ph. I complete: 38/Russia; 38/Russia Efficacy:Ph. III analysis shows vaccine was safe and well-tolerated; efficacy averaged Sputnik V Institute Combination Ad5 and vector Ph. II/III planned: 1600/ India 91.4% and >90% in individuals over 60. Ad26 vector expressing Ph. III ongoing: 40K/Russia Manufacturing/delivery: Adeno vector vaccines can be manufactured quickly and at the SARS-CoV-2 spike Ph. III planned: 100/Belarus;1000/UAE; scale (Russia has orders for 1.2 billion doses from 50 countries). glycoprotein 2000/ Venezuela Platform history: Vaccine utilizing the Ad26 platform (Ad26.ZEBOV) has been Authorization: EUA in Argentina; Early/ approved for use against Ebola Virus Disease. limited use in Belarus, Russia Approval: None J&J JNJ-78436735 Viral J&J investment (~$500M) Ph. I and I/II ongoing: 250/Japan; 1045/ Efficacy: Initial results show that the vaccine has an efficacy of 72% in the US, Nature Ad26 vector expressing vector USG ($1.45B) Belgium, US 64 percent in South Africa and 61% in Latin America. SARS-CoV-2 spike protein. Warp Speed Finalist Ph. II ongoing: 550/Germany, Netherlands, Manufacturing/delivery: Product does not need to be stored at subzero Spain temperatures, and it may require just a single dose. Ph. III ongoing: 30K (2 dose)/France, Platform history: Utilizes the same technology used to make its Ebola vaccine, Germany, RSA+6; 60K(1 dose)/Argentina, which was granted European regulatory approval in May 2020. Brazil, Chile+7 Authorization: Bahrain, US Continued on page 2 The COVID-19 vaccine pipeline ‘Cheat Sheet’ reflects front-runner candidates along with products with significant investments from the USG, CEPI and the ACT-A COVAX pillar. Cold Chain Considerations Doses Emergency Use Authorization: A regulatory mechanism to facilitate the availability and use of unapproved Refrigeration (2-8O C) Freezer (-20 C) Deep Freeze (-70 C) Anticipated number of doses medical products, including vaccines, during public health emergencies. Last updated March 5, 2021 avac.org 1 Primary sponsor(s) Description Platform Funders Status Considerations Read more Novavax NVX-COV2373 Protein CEPI ($388M) Ph. I ongoing: 130/Australia Efficacy: Interim analysis shows that the candidate had an efficacy of nearly 90% Novavax Full-length recombinant Subunit USG ($1.6B) Ph. II ongoing: 2900/ RSA in the UK, but only 50% in South Africa against the variant B.1.351. statement SARS-CoV-2 glycoprotein Warp Speed Finalist Ph. III ongoing: 15,000/ UK; 30K/US, Manufacturing/delivery: GMP production initiated with capacity for large-scale nanopartical vaccine COVAX Portfolio Mexico manufacturing (est. 1B doses by end of 2021). adjuvanted with Matrix M. Platform history: The same nanoparticle platform succeeded in a Ph. III trial for NanoFlu, an influenza vaccine for older adults. Sinovac Biotech CoronaVac Whole No Funding Disclosed Ph. I/II ongoing: 1166/China Efficacy:Varying reports of efficacy reported, ranging from just over 50 percent in medRxiv inactivated Ph III ongoing: 8K/Brazil, 1600/ Indonesia, Brazil to 91 percent in Turkey. Pharmaceutical 4K/Bangladesh, 13K/Turkey, 1K/China Manufacturing/delivery: Inactivated vaccines may require booster doses; relatively Technology Authorization: EUA for limited use in China shelf-stable compared to other platforms. Approval: China Platform history: Numerous whole inactivated vaccines, including polio , Hep A, and rabies. Bharat Biotech/ Covaxin Whole No funding disclosed Ph. I/II ongoing: 755/ India Immunogenicity: Ph. I/II trial data showed the vaccine was safe and triggered an medRxiv Indian Council of inactivated Ph. III ongoing: 25.8K/ India antibody response. Medical Research Authorization: EUA in India; still pending Manufacturing/delivery: Inactivated vaccines may require booster doses; relatively final Ph. III efficacy data shelf-stable compared to other platforms. Covaxin is stable at room temperature for Approval: None atleast a week. Platform history: Numerous whole inactivated vaccines, including polio, Hep A and rabies. CanSino Biologics Convidecia Viral No funding disclosed. Ph. I complete: 108/China Immunogenicity: Ph. I participants developed binding antibodies, neutralizing Lancet Ad5 vector expressing vector Ph. II ongoing: 508/China antibodies and T-cell responses; potential for pre-existing immunity against Ad5. FiercePharma SARS-CoV-2 spike Ph.III ongoing: 40K/ Argentina, Chile, Manufacturing/delivery: TBC. glycoprotein. Mexico, Pakistan, Saudi Arabia Platform history: Vaccine utilizing the Ad26 platform (Ad26.ZEBOV) has been Authorization: EUA in Mexico, Pakistan. approved for use against Ebola Virus Disease. Limited use in Chinese military as a “specially needed drug” Approval: None Inovio INO-4800 DNA CEPI ($17.2M) Ph. I ongoing: 40/US Immunogenicity: Preliminary Ph. I data shows antibody and cellular immune Inovio Ph. 1 DNA plasmid vaccine with BMGF ($5M) Ph. II/III ongoing: 160/S Korea responses. Statement electroporation. USG ($83M) 6K/US Manufacturing/delivery: INO-4800 is stable at room temperature for more than a COVAX Portfolio year and is not required to be frozen in transport or storage. Platform history: No licensed DNA vaccines for use in humans. CureVac CVnCoV mRNA CEPI ($8.3M) Ph. I ongoing: 284/Belgium, Germany Immunogenicity: TBC. CureVac mRNA vaccine that EU ($$421M) Ph. II ongoing: 691/Panama, Peru Manufacturing/delivery: mRNA vaccines are relatively easy to scale and statement encodes for the spike USG. (Undisclosed) Ph. II/III ongoing: 36,500/ Germany manufacture. protein formulated with COVAX Portfolio Ph. III ongoing: 2520/ Germany Platform history: No previously licensed mRNA vaccines. lipid nanoparticles. (TBC) Imperial College Synthetic self-amplifying Self- UK ($50.7M) Ph. I/II ongoing: 300/UK Immunogenicity: TBC. New York Times RNA producing SARS- amplifying Philanthropies ($6.2M) Ph. III planned: 6000/UK Manufacturing/delivery: Imperial College created a special-purpose company to CoV-2 spike protein. RNA sell the vaccine (VacEquity) at lowest possible cost in UK and LMICs. PRODUCT BEING REFORMULATED TO Platform history: No licensed self-amplifying RNA vaccines. (TBC) ADDRESS VARIANTS Continued on page 3 Last updated March 5, 2021 avac.org 2 Primary sponsor(s) Description Platform Funders Status Considerations Read more Sanofi / GSK DNA from the surface Subunit USG ($2.1B) Ph. I/II ongoing: 440/US Immunogenicity: Interim results showed insufficient response in older adults; Sanofi Statement protein of the SARS-CoV-2 Warp Speed Finalist Ph. III planned: 30K/ Sanofi refining antigen concentration to address. virus is inserted into insect US+ (Delayed) Manufacturing/delivery: The adjuvant system is designed
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