COVID-19 R&D Update: WHO Releases Vaccine Target Product Profiles; Apple and Google Launch Privacy-Preserving Contact Tracing Technology

According to the report released by the World Health Organization (WHO) on April 12, the global number of deaths from coronavirus disease (COVID-19) has exceeded 100,000, with nearly 1.7 million confirmed cases. Saving lives and curbing the continued spread of the COVID-19 pandemic remain significant challenges facing people worldwide.

In countries and regions where the pandemic has been brought under control, how to prevent a resurgence of the outbreak while resuming normal work and daily life is a new challenge facing public health institutions and the general public. Addressing these challenges requires multidimensional solutions, ranging from safe and effective vaccines and therapies to public health measures and technologies tailored to local conditions. Pharmaceutical research and development institutions and high-tech companies worldwide are striving to meet these challenges.

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WHO Releases Target Product Profile for COVID-19 Vaccines

According to a review published in Nature Reviews Drug Discovery on April 9, there are over 100 research and development projects for SARS-CoV-2 vaccines underway globally, with five of these projects having entered the clinical development stage. These vaccine R&D initiatives rely on diverse technological platforms, including mRNA, DNA, adenoviral vectors, and live-attenuated and inactivated viruses. Safe and effective vaccines represent one of the critical measures for preventing SARS-CoV-2 infection, providing long-term protection to the global population, and restoring normal daily life. What characteristics should a successful vaccine against SARS-CoV-2 possess?

At the Coronavirus Innovation Forum convened by the World Health Organization (WHO) this February, experts from around the world were brought together to discuss the desired characteristics of coronavirus vaccine products. On April 9, the WHO released the Target Product Profile for coronavirus vaccines. Based on discussions among experts at the Coronavirus Innovation Forum, this document outlines the preferred and minimum acceptable criteria that WHO hopes coronavirus vaccine products will meet.

The following are the product specifications from the WHO Target Product Profile for COVID-19 vaccines:

The WHO also stated in the document that this guideline aims to assist the industry in optimizing vaccine development. The review of each candidate vaccine will integrate multiple criteria; if a vaccine demonstrates exceptional performance in specific areas, deficiencies in certain other aspects may not preclude it from obtaining WHO prequalification.

Apple and Google Partner to Develop Contact Tracing Technology

On April 10, Apple and Google jointly announced that they would co-develop contact tracing technology based on Bluetooth to help public health agencies reduce the spread of the novel coronavirus.

Given that the spread of COVID-19 is driven by close contact with infected individuals, public health agencies consider contact tracing an effective tool for curbing disease transmission. Numerous public health agencies, universities, and non-profit organizations worldwide have developed opt-in technologies/software to facilitate contact tracing.

Apple and Google will further advance the development of technology in this area. First, in May, the two companies will release software that users can download to assist with contact tracing. These applications, provided by public health agencies, feature interoperability between the Android and Apple operating systems.

Subsequently, Apple and Google will develop a more extensive Bluetooth-based contact tracing platform, with its functionality integrated into the operating systems. It can provide more robust features when users opt in to participate.

In their statements, both Apple and Google emphasized that privacy, transparency, and user informed consent are of paramount importance in the development of this project. The R&D team will consult relevant stakeholders during the development process and publicly release information about this research for third-party analysis.

For Critically Ill Patients, Eli Lilly’s JAK Inhibitor and Ang2 Inhibitor Enter Clinical Trials

On April 10, Eli Lilly and Company announced that it had reached an agreement with the National Institute of Allergy and Infectious Diseases (NIAID) to provide the JAK1/2 inhibitor baricitinib as part of NIAID’s adaptive clinical trial of therapies for COVID-19. The study, conducted by NIAID, is set to launch in the United States this month and is planned to expand to Europe and Asia, aiming to evaluate the efficacy of multiple treatments for patients with COVID-19. Results from this clinical trial are expected within the next two months.

Baricitinib is an approved oral JAK1/2 inhibitor indicated for the treatment of moderate rheumatoid arthritis. The inflammatory cascade observed in patients with COVID-19 is a significant contributor to lung and other organ damage. The anti-inflammatory activity of baricitinib may offer potential benefits to patients with COVID-19.

Furthermore, Eli Lilly announced the initiation of a Phase 2 clinical trial to evaluate the efficacy of its investigational angiopoietin-2 (Ang2) monoclonal antibody, LY3127804, in high-risk patients with acute respiratory distress syndrome (ARDS). Given that Ang2 levels are elevated in ARDS patients, Eli Lilly will assess whether inhibiting Ang2 activity with this monoclonal antibody therapy can slow the progression of ARDS and reduce the need for mechanical ventilation in patients with COVID-19.

CanSino Biologics’ COVID-19 Vaccine to Launch Phase II Clinical Trials

Recently, CanSino Biologics stated in its submitted regulatory filings that, based on preliminary safety data obtained from Phase I clinical trials, the company and the Institute of Biotechnology, Academy of Military Medical Sciences, Chinese Academy of Military Sciences, plan to initiate Phase II clinical trials for their jointly developed recombinant novel coronavirus vaccine, Ad5-nCoV, in the near future.

Ad5-nCoV is a recombinant candidate vaccine that utilizes replication-defective adenovirus type 5 (Ad5) as a vector to express the spike protein of the novel coronavirus. The spike protein is essential for the virus to enter host cells. This vaccine aims to elicit an immune response against the spike protein, thereby preventing infection and transmission of the novel coronavirus. CanSino Biologics’ adenovirus vector vaccine technology has been applied in the development of multiple vaccines; the company’s innovative Ebola virus vaccine, developed based on this technology platform, is an approved vaccine product in China.

According to the information on the Chinese Clinical Trial Registry, this randomized, double-blind, placebo-controlled Phase II clinical trial will enroll 500 healthy volunteers, who will be divided into three groups: 250 participants will receive a single dose of medium-dose vaccine, 125 will receive a low-dose vaccine, and 125 will receive a placebo.

The three primary endpoints of the trial were: adverse reactions occurring within 14 days after vaccination, the titer of specific antibodies against the SARS-CoV-2 S protein detected by ELISA on Day 28 post-vaccination, and the titer of SARS-CoV-2-specific neutralizing antibodies on Day 28 post-vaccination.

References:

[1] China's CanSino Bio advances COVID-19 vaccine into phase 2 on preliminary safety data. Retrieved April 10, 2020, from https://www.fiercepharma.com/vaccines/china-s-cansino-bio-advances-covid-19-vaccine-into-phase-2-preliminary-safety-data

[2] PHASE II CLINICAL TRIAL PLAN FOR RECOMBINANT NOVEL CORONAVIRUS VACCINE (ADENOVIRUS TYPE 5 VECTOR). Retrieved April 10, 2020, from http://www.cansinotech.com/uploads/article/attachment/2020/04/20200409/t4LVBMCvEI.pdf

[3] WHO Target Product Profiles for COVID-19 Vaccines. Retrieved April 10, 2020, from https://www.who.int/blueprint/priority-diseases/key-action/WHO_Target_Product_Profiles_for_COVID-19_web.pdf?ua=1

[4] A Phase II, randomized, double-blind, placebo-controlled clinical trial of the recombinant novel coronavirus (2019-nCoV) vaccine (adenovirus vector). Retrieved April 10, 2020, from http://www.chictr.org.cn/showproj.aspx?proj=52006

[5] Lilly Begins Clinical Testing of Therapies for COVID-19. Retrieved April 12, 2020, from https://investor.lilly.com/news-releases/news-release-details/lilly-begins-clinical-testing-therapies-covid-19

[6] Apple and Google partner on COVID-19 contact tracing technology. Retrieved April 12, 2020, from https://www.apple.com/newsroom/2020/04/apple-and-google-partner-on-covid-19-contact-tracing-technology/

Note: The original text has been abridged.

Original Title: COVID-19 R&D Updates: WHO Releases Vaccine Product Standards, Apple/Google Jointly Develop Contact Tracing Technology

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