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An Overview of COVID Vaccine Clinical Trial Results & Some Challenges

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An overview of COVID vaccine clinical trial results & some challenges DCVMN Webinar December 8th, 2020 Access to COVID-19 tools ACCESSACCESS TO TOCOVID-19 COVID-19 TOOLS TOOLS (ACT) (ACT) ACCELERATOR ACCELERATOR (ACT) accelerator A GlobalA GlobalCollaboration Collaboration to Accelerate tothe AccelerateDevelopment, the Production Development, and Equitable Production Access to New and Equitable AccessCOVID-19 to New diagnostics, COVID-19 therapeutics diagnostics, and vaccines therapeutics and vaccines VACCINES DIAGNOSTICS THERAPEUTICS (COVAX) Development & Manufacturing Led by CEPI, with industry Procurement and delivery at scale Led by Gavi Policy and allocation Led by WHO Key players SOURCE: (ACT) ACCELERATOR Commitment and Call to Action 24th April 2020 ACT-A / COVAX governance COVAX COORDINATION MEETING CEPI Board Co-Chair: Jane Halton Co-Chair: Dr. Ngozi Gavi Board Workstream leads + DCVMN and IFPMA-selected Reps As needed – R&D&M Chair; COVAX IPG Chair Development & Manufacturing Procurement and delivery Policy and allocation (COVAX) at scale Led by (with industry) Led by Led by R&D&M Investment Committee COVAX Independent Product Group Technical Review Group Portfolio Group Vaccine Teams SWAT teams RAG 3 COVAX SWAT teams are being set up as a joint platform to accelerate COVID- 19 Vaccine development and manufacturing by addressing common challenges together Timely and targeted Multilateral Knowledge-based Resource-efficient Addresses specific cross- Establishes a dialogue Identifies and collates Coordinates between developer technical and global joint effort most relevant materials different organizations/ challenges as they are across different COVID-19 and insights across the initiatives to limit raised and/or identified vaccines organizations broader COVID-19 duplications and ensure on an ongoing basis (incl. industry and other ecosystem to accelerate expertise is efficiently global networks) vaccine development and leveraged manufacturing Clinical SWAT Enabling Development Manufacturing teams sciences & Operations Regulatory Advisory Group 4 5 UPDATED ON NOVEMBER 26, 2020 COVID-19 Vx landscape – 48 candidates in human clinical trials Evidence on vaccine efficacy provided COVAX MoU or SoI signed1 CEPI agreement signed2 COVAX R&D candidate CEPI funded candidate for R&D outside COVAX R&D portfolio Technology platform Phase I Phase I/II Phase II Phase IIb/III and III Viral Shenzhen Merck / Vaxart ImmunityBio Merck / IAVI Shenzhen GIMI CanSino AstraZeneca GIMI Themis - hAd5-S- ChAdOx1-S vectors aAPC TMV-083 VXA-CoV2-1 Fusion rVSV LV-SMENP-DC Ad5-nCoV Wantai / IDT Gamaleya ReiThera Xiamen MVA-SARS- IIBR Gam-COVID- Janssen GRAd-COV2 DelNS1 2-S rVSV Vac Ad26.COV2-S Walvax Imperial Pfizer / mRNA Biotech LNP- CureVac BioNTech ARCoV nCoVsaRNA CVnCoV BNT162 Arcturus Moderna ARCT-021 mRNA-1273 Symvivo DNA bacTRL- Genexine Inovio Spike GX-19 INO-4800 Osaka / AnGes AG0301 / Zydus Cadila AG0302 ZyCoV-D Protein- Medicago Finlay Vaxine / Medigen FBRI.SRC SpyBio Bio E Anhui Zhifei Novavax FINLAY-FR- Medytox MVC- NVX-CoV2373 based VLP 2 COVAX-19 COV1901 EpiVac RBD BECOV2 RBD-Dimer Covaxx Clover Adimmune Finlay Sanofi / Sichuan CSL / U.Q UB-612 SCB-2019 AdimrSC-2f FINLAY- GSK RBD FR-1 Rec.Pro Sinovac / Inactivated Inst. of Medical Shenzhen Sinopharm / Butantan Biology / CAMS Kangtai WIBP CoronaVac Sinopharm / RIBSP BIBP Bharat Biotech QAZCOVID-IN BBIBP-CorV COVAXIN 1. For advanced purchase agreement (APA); 2. For tech transfer, scale-out and reservation fees Source: CEPI Vx landscape 6 Speed: mRNA has demonstrated an unprecedented research and development pace COVID-19 sequence release Phase 1 Phase 3 12th January 2020 1st VE IA FSFV FSFV 9 weeks Moderna March 16th July 27th Nov 16th 18 weeks th July 27th 306 days Pfizer / BioNTech May 14 total 23 weeks Curveac June 19th Nov 9th 24 weeks rd Imperial June 23 300 days 25 weeks Walvax June 29th total 31 weeks Arcturus August 11th 7 UPDATED ON NOVEMBER 30, 2020 Latest results from Pfizer/BioNTech, Moderna, AstraZeneca and Gamaleya See next page Platform mRNA (0-21 days) mRNA (0-28 days) ChadOx 1 vector (0-28 days ?) Ad26 >> Ad5 prime-boost (0-21 days) Date of press November 18, 2020 November 30, 2020 November 23, 2020 November 24, 2020 release Preliminary point 95% (p<0.0001) 94.1% (p<0.0001) 70% (p<=0.0001) (pooled) 91.4% 28 days post dose I (7days estimate of vaccine 90% and 62% (LH and HH post dose 2) efficacy regimens1) (p<=0.0001) Statistical significance not reported Phase 3 study 43,661 participants to date, >30,000 participants UK trial - 12,390 subjects, 40,000 participants enrollment 41,135 of whom have received 2,742 with LH (90% efficacy) 22,000 vaccinated with the first and a second dose of the vaccine UK/Brazil trial – 10,300 HH >19,000 with second doses of the candidate 62% efficacy vaccine Total number of 170 cases (8 in vaccine 196 cases (11 in vaccine 131 cases across 2 trials 39 cases group) group) cases No severe cases in vaccines No information provided on case 10 severe cases (9 in placebo, 30 severe cases (incl. 1 death), severity 1 in vaccine group) all in placebo group Cold chain -800C, 2-80C for up to 5 days -200C, 2-80C for up to 30 days Storage, transport and handled 2 versions: 2-80C for up to 6 months Lyo 2-80C Liquid Frozen -200C Plans for licensure • US FDA for EUA Submitted on Nov 30th: EUA EMA, MHRA, PQ Emergency authorization in Russia with US FDA and EMA • Submitted on Dec 1st: EMA Plan for global license conditional marketing • WHO PQ authorisation 8 1 LH – Low dose followed by High dose, HH – 2 doses of high dose formulation UPDATED ON NOVEMBER 30, 2020 Deep dive AstraZeneca candidate Evaluation of current data/approach/… Interim analysis: Pooled data from the UK and Brazilian trials. Pfizer/ BioNTech Implications on other technology platforms/ candidates Together with Gamaleya (Ad36 >> Ad5) first results on a viral vector vaccine platform (2-dose regimen). Oxford / AZ vaccine regimen based on ChAdOx-1 Moderna for both, 1st and 2nd dose. Next steps/missing information Data Precise VE point estimates with 95% CIs (overlap of lo-hi and hi-hi VE AstraZeneca/ Univ. o. confidence intervals?) Oxford Trial group-specific immunogenicity (nAbs, ELISA, CMI) Influence of anti-vector immunity? Correlation of immune response and vaccine efficacy over time Stratified data (by trial / country, by age group, immunization schedule etc.) with respective 95% CIs Gamaleya Institute Confirmative data from other Oxford / AZ trials, in particular the RSA trial as well as the Ph3 trial in the USA PCR results re asymptomatic infection protection against infection? Manufacturing • Understand manufacturing: Oxford CTM facility versus CMO 9 based on 94 cases (IA): • Placebo: 86 • Vaccine: 8 based on 2nd 76 cases: • Placebo: 76 • Vaccine: 0 based on all 170 cases: • Placebo: 162 • Vaccine: 8 Privileged and confidential 10 [https://investors.biontech.de/node/8771/pdf, published 18th November 2020] Moderna, November 30th, 2020 Privileged and confidential 11 Challenges Moving Forward • Continue placebo-controlled trials or (partially) cross-over from placebo to… … trial vaccine ‘EUA’ + recommendation for use (in risk groups) + supplies available at country level … other vaccine • Correlates of Protection (CoP) Breakthrough cases Standardised assays allowing comparability across programmes / platforms • Evidence on infection / transmission • Heterologous prime-boost • Clinical trial sites • (Long-term) vaccine safety Pre-licensure Post-licensure • Long COVID • … st nd Manufacturing / supply: cold chain, 2-dose regimen: different formulations for 1 / 2Privilegeddose, …and confidential 12 Placebo groups: Continue or Cross-over? • Continue placebo groups for as long as possible • SWAT Workshop, Oct 28th • WHO consultation, Nov 6th position paper published 2nd December • Some developers may choose to cross-over quickly … • … in countries where EUA has been obtained • … specific risk (=trial) populations with a public health recommendation to get vaccinated (HCW, elderly, underlying medical conditions, …) Privileged and confidential 13 Privileged and confidential 14 Placebo groups: Continue or Cross-over? Points to consider: • Ethical / regulatory aspects • Vaccine-related safety events usually occur within 2-3 months post vaccination • Unrealistic to maintain placebo-group for 12 or even 24 months anyway • Rapid and complete cross-over would … • … facilitate conduct of the trial / data analysis • … simplify maintaining the blinding • … increase the absolute number of breakthrough cases accelerate establishment of a CoP Privileged and confidential 15 Placebo groups: Continue or Cross-over – next steps FDA VRBPACs: - Pfizer / BioNTech 10th December - Moderna 17th December Ongoing Ph3 trials with pivotal results available • BioNTech / Pfizer • Moderna • Astra Zeneca / Oxford (…) • Gamaleya (?) Ph3 data expected soon • China (Sinovac, Cansino, Sinopharm) Pivotal Ph3 trials to start in the next few months (possibly before end of 2020) • Novavax • CureVac • Clover • SP / GSK • BioE Ph3 trials to start after spring 2021 ( alternative trial design / strategy to establish VE / CoP ???) • Merck (IAVI, Themis) Privileged and confidential 16 Conclusion and related to correlates of protection: Workshop on Nov 19th • Strong endorsement of the neutralizing antibody titer • Bob Seder, Chief, Cellular Immunology Section, Vaccine Research Center (NIH/NIAID): “It seems like with the number of antibodies you get with vaccines, which often are well in excess of what you get
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