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R Brief: Infectious Disease R BRIEF: INFECTIOUS DISEASE COVID-19 Vaccines Update Published October 20, 2020 • Operation Warp Speed (OWS) is a public-private partnership to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics (medical countermeasures). • On June 30, 2020, the FDA issued guidance to COVID-19 vaccine developers, stating that a vaccine must prevent disease or decrease its severity in at least 50% of people who receive it, and that Emergency Use Authorization (EUA) and the Accelerated Approval pathway for vaccine licensure may be considered for vaccines that fulfill these criteria. • On October 5, 2020, the FDA stated it will require vaccine developers to monitor their clinical trial participants for a median of 2 months after administering the last shot. Depending on the data, the FDA could shorten this time frame requirement before considering approval. The 2-month median time is to ensure the safety and efficacy of the vaccine, recognizing the need to balance the urgency of the pandemic with public safety. • This summary includes a selection of current investigational COVID-19 candidates being studied in trials, along with key information about each potential therapy. Current Vaccine Candidates At the time of this publication, there are more than 46 vaccines in human clinical trials (up from 29 reported in August 2020) and at least 91 preclinical vaccines in animal trials. Of the 46 vaccines, 11 are in large-scale Phase 3 clinical trials. Most of these vaccines are summarized in Table 1. Table 1. COVID-19 Vaccines in Phase 3 Clinical Trials (as of October 16, 2020) Vaccine/Developer Platform Other Target Notes Candidates BNT162b2 3 LNP-mRNA • 2-dose schedule of 30 mcg IM vaccine, 21 days apart (BNT162b2 Pfizer/BioNTech/ • July 1, 2020: Preliminary results from Phase 1/2 trials encodes Fosun Pharma in U.S. and Germany found both antibody and optimized (U.S.) T-cell production SARS-CoV-2 • July 13, 2020: Fast Track designation by FDA full-length spike • July 27, 2020: Phase 2/3 trial launched; plans to enroll protein antigen) 30,000 subjects 18–85 years of age in the U.S. and globally (except for China) • September 12, 2020: Trial expanded to 43,000 subjects Questions? Contact us: [email protected] | +1(305) 662-8515 For subscribers of IPD Analytics only. Not for distribution. R BRIEF: INFECTIOUS DISEASE Table 1. COVID-19 Vaccines in Phase 3 Clinical Trials (as of October 16, 2020) Vaccine/Developer Platform Other Target Notes Candidates • Awarded $1.9 billion contract through OWS for 100 million doses by December 2020 with the option to acquire 500 million more doses • September 2020: Per Pfizer CEO, trial results may be ready in October 2020; plans for >1.3 billion doses worldwide by end of 2021 • November 2020: If vaccine is effective, Pfizer expects to seek EUA in third week of November; will have 2 months of safety data on at least half of patients • Needs ultra-cold freezer for storage at –70 °C; Pfizer created temperature-controlled containers that can keep between 1000 and 5000 doses cold for 10 days before requiring more dry ice. Once thawed, vials can be refrigerated for as long as 2 days. • Working on a lyophilized formulation that can be stored at warmer temps, but not ready until end of 2021 mRNA-1273 mRNA Multiple • 2-dose regimen, 28 days apart candidates Moderna/National (lipid nanoparticle • July 27, 2020: Phase 3 trial started; will enroll 30,000 Institute of Allergy [LNP] – healthy volunteers at 89 sites in U.S. (1:1 ratio of and Infectious encapsulated) vaccine: placebo) Diseases (NIAID) • Phase 3 trial expected to last around 6 months (U.S.) • In partnership with the National Institutes of Health (NIH), has funded ~$1 billion in support and on August 1, 2020, was awarded additional $1.5 billion for 100 million doses if the vaccine proves safe and effective • September 17, 2020: Moderna shared its vaccine trial protocol. The design entails waiting until a significant number of volunteers become sick with COVID-19 and then determining the percentage vaccinated. This will likely take until the end of 2020 or early 2021 to reach the required numbers. • Needs ultra-cold freezer for storage at –20 °C. Once thawed, must be kept at between 2 °C and 8 °C and can remain refrigerated for 1 week AZD1222 Nonreplicating MERS, • 2-dose schedule intramuscular (IM) vaccine, viral vector Influenza, TB, AstraZeneca/ 4 weeks apart (ChAdOx1, based Chikungunya, University of • May 2020: Awarded $1.2 billion in support from on chimpanzee Zika, MenB, Oxford (UK) U.S. OWS adenovirus) Plague • July 20, 2020: Phase 1/2 results published demonstrating that a single IM injection of 5× 1010 Questions? Contact us: |2| [email protected] | +1(305) 662-8515 For subscribers of IPD Analytics only. Not for distribution. R BRIEF: INFECTIOUS DISEASE Table 1. COVID-19 Vaccines in Phase 3 Clinical Trials (as of October 16, 2020) Vaccine/Developer Platform Other Target Notes Candidates viral particles provided neutralizing antibody responses in 91% of patients after a single dose and in 100% of patients after a booster dose. Detection of T-cell response was also reported. (Lancet, 2020) • September 2020: Trial protocol made public • September 6, 2020: Phase 3 trials halted due to a serious adverse reaction (transverse myelitis) in one UK-based participant who received vaccine; other countries have resumed trials; U.S. trial still on hold • Standard refrigeration required for storage JNJ-78436735 Ad26CoVS1 Ebola • Single-dose IM vaccine (nonreplicating Johnson & • Demonstrated protection in monkeys viral vector) Johnson/Beth Israel • March 2020: Received $456 million from OWS Deaconess Medical • Phase 1/2 trials launched in July 2020 Center • August 2020: U.S. OWS agreed to pay $1 billion for 100 million doses if the vaccine is approved • July 2020: Phase 3 trials planned for September 2020 • J&J plans to produce at least 1 billion doses in 2021 • October 2020: Trial halted to investigate adverse reaction of “unexplained illness” in one volunteer, although not known whether they received vaccine or placebo NVX-CoV2373 Protein subunit RSV, CCHF, • 2-dose IM regimen, 21 days apart (full-length HPV, VZV, Novavax (U.S.) • May 2020: Phase 1/2 human studies began recombinant Ebola in Australia SARS-COV-2 • May 2020: Coalition for Epidemic Preparedness glycoprotein Innovations (CEPI) invested $384 million nanoparticle vaccine • July 2020: Awarded $1.6 billion from OWS adjuvanted with • September 2020: Phase 3 trial in 10,000 volunteers Matrix M) launched in UK; Phase 2b trial ongoing in South Africa • October 2020: Larger Phase 3 trial to launch in U.S. • If successful, Novavax to produce 100 million doses for use in U.S. by 1Q 2021 • Stored under standard refrigeration Questions? Contact us: |3| [email protected] | +1(305) 662-8515 For subscribers of IPD Analytics only. Not for distribution. R BRIEF: INFECTIOUS DISEASE Table 1. COVID-19 Vaccines in Phase 3 Clinical Trials (as of October 16, 2020) Vaccine/Developer Platform Other Target Notes Candidates Ad5-nCoV Nonreplicating Ebola • Single-dose IM vaccine viral vector CanSino • June 25, 2020: Approved for use in the Chinese (adenovirus type 5 Biologics/Beijing military for 1 year vector) Institute of • July 20, 2020: Phase 2 trial results published Biotechnology demonstrating that the Ad5-vectored vaccine 10 (China) given at 5×10 viral particles is safe and induced rapid immune responses within 14 days and significant humoral and cellular immune responses within 28 days after a single immunization (Lancet, 2020) • August 2020: Phase 3 trials started in several countries including Saudi Arabia, Pakistan, and Russia Sputnik V Combination MERS • August 11, 2020: Approved for early use in Russia, of 2 adenoviruses: The Gamaleya but later stated authorization is “conditional Ad5 and Ad26 Research Institute registration certificate” (Russia) • Phase 3 trials started after “approval” in 40,000 volunteers in Russia, Belarus, United Arab Emirates, Venezuela • September 26, 2020: Phase 1/2 trial in 40 volunteers (Lancet, 2020) concluded it produced good antibody levels in all volunteers (Name TBD) Inactivated • 2-dose IM vaccine, 14 or 21 days apart Wuhan Institute of • July 2020: Phase 3 trials launched in United Arab Biological Emirates with 5000 people receiving Wuhan Institute Products/ version; separate cohort of 5000 people are receiving Sinopharm (China) the Beijing Institute version • September 14, 2020: United Arab Emirates gives emergency approval for use in healthcare workers even though Phase 3 trial is not completed (Name TBD) Inactivated • 2-dose IM vaccine, 14 or 21 days apart Beijing Institute of • Phase 3 trials in United Arab Emirates: 5000 people Biological are receiving the Wuhan Institute version, while Products/ another 5000 people are receiving the Beijing Sinopharm (China) Institute version • September 14, 2020: United Arab Emirates gives emergency approval for use on healthcare workers, even though Phase 3 trial is not completed Questions? Contact us: |4| [email protected] | +1(305) 662-8515 For subscribers of IPD Analytics only. Not for distribution. R BRIEF: INFECTIOUS DISEASE Table 1. COVID-19 Vaccines in Phase 3 Clinical Trials (as of October 16, 2020) Vaccine/Developer Platform Other Target Notes Candidates CoronaVac Inactivated + alum SARS • 2-dose IM vaccine, 14 days apart adjuvant Sinovac (China) • June 2020: Phase 1/2 trials in 743 volunteers found no severe adverse effects and produced
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