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CEPI and VBI Vaccines Collaborate to Advance Vaccine Candidates Against COVID-19 Variants

CEPI, the Coalition for Epidemic Preparedness Innovations, and VBI Vaccines Inc. (Nasdaq: VBIV), today announced a partnership to develop VBI’s enveloped virus like particle (eVLP) vaccine candidates against SARS-CoV-2 variants, including the B.1.351 variant, also known as 501Y.V2, first identified in South Africa.

CEPI will provide up to $33m to support the advancement of VBI-2905, a monovalent eVLP candidate expressing the pre-fusion form of the spike protein from the B.1.351 strain, through Phase 1 clinical development. As part of the agreement, this funding will also support preclinical expansion of additional multivalent vaccine candidates designed to evaluate the potential breadth of VBI’s eVLP technology. This preclinical expansion is intended to develop clinic-ready vaccine candidates capable of addressing emerging variants.

Dr Richard Hatchett, CEO of CEPI, said:

“Remarkable progress has been made to develop safe and effective vaccines against COVID-19, but in parallel to the global roll out of vaccines we must now redouble our R&D efforts so we have the tools we need to tackle emerging variants of the virus. I am delighted that CEPI will support the development of VBI’s promising vaccine candidates against variants of concern, which crucially can be made globally accessible through COVAX if proven to be safe and effective.

“Today, CEPI also launches its 5-year plan to substantially reduce, and in the long-term even eliminate, the risk of epidemic and pandemic diseases, including coronaviruses. If we are to achieve this future, we must act now by investing in crucial R&D to optimise our vaccination strategies and technologies.”

Jeff Baxter, President and CEO of VBI, said:

“We are grateful for CEPI’s partnership, support, and confidence in our eVLP approach to vaccine development. We look forward to working with CEPI, who has played a crucial role in the development of COVID-19 vaccines over the last 12 months, and we remain steadfast in our mission to contribute to the end of the ongoing pandemic and the long-term protection against coronaviruses.”

VBI’s eVLP technology has been supported by investment from the Government of Canada, which is a long-standing and vital CEPI supporter and investor.

Karina Gould, Canadian Minister of International Development, said:

“Canada is deeply committed to its vaccine partnerships. The innovative collaboration announced today will help to ensure that millions will have access to safe vaccines against COVID-19 and future infectious disease threats.”

Race against viral mutation

CEPI is investing in the development of vaccines against COVID-19 variants to help the world to stay one step ahead of the virus.

The virus that causes COVID-19 is constantly mutating. Variant B.1.1.7 (first identified in the UK) is up to 70% more transmissible than the virus that emerged in Wuhan and has since been confirmed to be associated with an increased risk of hospitalisation and death. Variants B.1.351 and P.1 (identified in South Africa and Brazil, respectively) are even more concerning. They spread rapidly, can reinfect people who have been infected before, and they are rendering our countermeasures—including our vaccines and monoclonal-antibody treatments—less effective. The increased transmissibility of these variants could result in a reversal in the global downward trends in transmission seen in recent weeks resulting in a renewed burden on health systems, and more deaths.

Equitable access key to ending acute phase of pandemic

The rate of viral mutation is a function of the global spread of the virus, so it is imperative to control transmission everywhere. CEPI is therefore committed to enabling global equitable access to COVID-19 vaccines and, through this agreement, CEPI and VBI have agreed that the vaccine candidates supported by CEPI will be made available to the COVAX Facility for procurement and allocation, if proven to be safe and effective. The COVAX Facility aims to ensure equitable access to COVID-19 vaccines for all countries, at all levels of development, that wish to participate. To date, COVAX has delivered vaccines to over 30 countries, with the aim of distributing 2 billion doses globally in 2021.

VBI’s eVLP Coronavirus Vaccine Candidates

VBI Vaccines is advancing a suite of coronavirus vaccine candidates, under the VBI-2900 program, developed using the Company’s proprietary eVLP platform technology in collaboration with the National Research Council of Canada. Coronaviruses are enveloped by nature which make them a prime target for VBI’s eVLP platform technology. VBI’s eVLP technology is flexible and highly customizable, allowing for expression of multiple protein antigens of interest on the surface of the particles. eVLPs create a close mimic of the natural presentation of viruses and they carry multiple copies of the target protein, designed to trigger a potent immune response.

Through this partnership with CEPI, VBI will develop VBI-2905 through Phase 1, and additional multivalent candidates through preclinical studies. VBI and CEPI expect to initiate Phase 1 studies of VBI-2905 – the first eVLP-based vaccine candidate in the CEPI portfolio – mid-year 2021.

An adaptive Phase 1/2 study of VBI-2902 is already ongoing at nine clinical sites in Canada, having initiated earlier in March 2021, and is supported by a contribution from the Canadian Government’s Strategic Innovation Fund.

(Source: VBIVaccines, 2021)


Johnson & Johnson Single-Shot COVID-19 Vaccine Granted Emergency Use Listing by the World Health Organization

Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the World Health Organization (WHO) has issued Emergency Use Listing (EUL) for its single-shot COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), to prevent COVID-19 in individuals 18 years of age and older.

Data from the Phase 3 ENSEMBLE study showed that the Johnson & Johnson COVID-19 vaccine was well tolerated and demonstrated a 67 percent reduction in symptomatic COVID-19 disease in participants who received the vaccine in comparison to participants given the placebo. The onset of protection was observed from day 14 and was maintained 28 days post-vaccination.

The data also demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death across countries with different variants, beginning 28 days after vaccination.1 Variants observed in an ongoing analysis in the ENSEMBLE study included the B.1.351 variant which was identified in 95 percent of the COVID-19 cases in South Africa.

“From the beginning of the pandemic, we have worked to develop and deliver a vaccine that could protect the health of people everywhere, and today’s milestone represents significant progress toward ensuring global access to our single-shot vaccine,” said Alex Gorsky, Chairman and Chief Executive Officer at Johnson & Johnson. “We are moving forward with urgency and purpose to meet our commitments to the global community as we do all we can to help end the pandemic.”

The EUL procedure streamlines the process by which new or unlicensed products can be assessed for use during public health emergencies by governments and United Nations procurement agencies. The EUL process expedites access to such products in many countries around the world and is also a prerequisite to supply vaccines to the new COVAX Facility, a global mechanism for pooled procurement and distribution of COVID-19 vaccines in 190 participating countries, including 92 lower-income countries.

“The WHO listing of our single-shot COVID-19 vaccine advances our pledge to help stem this pandemic and our unwavering commitment to equitable access,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. “Achieving this important prerequisite for distributing our vaccine through the COVAX Facility which is co-led by Gavi is a major step forward in making our vaccine accessible for all.”

In December 2020, Johnson & Johnson entered into an agreement in principle with Gavi, the Vaccine Alliance (Gavi) in support of the COVAX Facility. Johnson & Johnson and Gavi expect to enter into an Advance Purchase Agreement (APA) that would provide up to 500 million doses of the Company’s vaccine to COVAX through 2022.2

“A single-shot COVID-19 vaccine that can be distributed and stored using established supply chains has the potential to be very meaningful in the face of this global pandemic,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development at Johnson & Johnson. “In addition, the clinical data shared with WHO that informed the Emergency Use Listing demonstrated protection against disease across countries with multiple variants.”

Commitment to Equitable Access
Equitable access is at the center of Johnson & Johnson’s COVID-19 response. The Johnson & Johnson single-shot vaccine candidate and its compatibility with standard vaccine distribution channels align with WHO’s recommendations for medical interventions in a pandemic setting, which emphasize ease of distribution, administration, and compliance.

The Company is committed to ensuring global access to the Johnson & Johnson single-shot COVID-19 vaccine candidate on a not-for-profit basis for emergency pandemic use. In September 2020, Johnson & Johnson joined other life sciences companies and the Bill & Melinda Gates Foundation in signing an unprecedented communiqué which outlined a steadfast commitment to facilitating equitable access to the innovations being developed to fight the pandemic.3

Regulatory Filings
Johnson & Johnson received Emergency Use Authorization (EUA) in the United States on February 274 following a unanimous vote by the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee on February 26, 2021.5 The Company’s single-shot COVID-19 vaccine was also granted Interim Order authorization in Canada on March 5, 20216 and Conditional Marketing Authorization (CMA) in the European Union on March 11, 2021.7

Manufacturing and Supply Chain Information
The Johnson & Johnson COVID-19 single-shot vaccine is compatible with standard vaccine storage and distribution channels enabling delivery to remote areas.4 The vaccine is estimated to remain stable for two years at -25 to -15°C, and a maximum of three months of which can be at routine refrigeration at temperatures of 2°-8°C.4,8 This enables the vaccine to be shipped using the same cold chain technologies used to transport other medicines and vaccines in routine use.4,9

Johnson & Johnson’s COVID-19 Vaccine
The Johnson & Johnson COVID-19 vaccine uses the AdVac® vaccine platform, a proprietary technology that was also used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen and construct its investigational Zika, RSV, and HIV vaccines.6

Phase 3 ENSEMBLE Study Design
The Phase 3 ENSEMBLE study is a randomized, double-blind, placebo-controlled clinical trial in individuals 18 years of age and older.10 The study was designed to evaluate the safety and efficacy of the Company’s vaccine candidate in protecting against both moderate and severe COVID-19 disease, with assessment of efficacy as of day 14 and as of day 28 as co-primary endpoints.11 The study enrolled a total of 43,783 participants.

The trial, conducted in eight countries across three continents,10 includes a diverse and broad population of which 34 percent of participants were over age 60.1 Forty-one percent of participants in the study had comorbidities associated with an increased risk for progression to severe COVID-19.1

For more information on the Company’s multi-pronged approach to helping combat the pandemic, visit: www.jnj.com/coronavirus.

(Source: J&J, 2021)


REAL-WORLD EVIDENCE CONFIRMS HIGH EFFECTIVENESS OF PFIZER-BIONTECH COVID-19 VACCINE AND PROFOUND PUBLIC HEALTH IMPACT OF VACCINATION ONE YEAR AFTER PANDEMIC DECLARED

The Israel Ministry of Health (MoH), Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced real-world evidence demonstrating dramatically lower incidence rates of COVID-19 disease in individuals fully vaccinated with the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2), underscoring the observed substantial public health impact of Israel’s nationwide immunization program. These new data build upon and confirm previously released data from the MoH demonstrating the vaccine’s effectiveness in preventing symptomatic SARS-CoV-2 infections, COVID-19 cases, hospitalizations, severe and critical hospitalizations, and deaths. The latest analysis from the MoH proves that two weeks after the second vaccine dose protection is even stronger – vaccine effectiveness was at least 97% in preventing symptomatic disease, severe/critical disease and death. This comprehensive real-world evidence can be of importance to countries around the world as they advance their own vaccination campaigns one year after the World Health Organization (WHO) declared COVID-19 a pandemic.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210311005482/en/

Findings from the analysis were derived from de-identified aggregate Israel MoH surveillance data collected between January 17 and March 6, 2021, when the Pfizer-BioNTech COVID-19 Vaccine was the only vaccine available in the country and when the more transmissible B.1.1.7 variant of SARS-CoV-2 (formerly referred to as the U.K. variant) was the dominant strain. Vaccine effectiveness was at least 97% against symptomatic COVID-19 cases, hospitalizations, severe and critical hospitalizations, and deaths. Furthermore, the analysis found a vaccine effectiveness of 94% against asymptomatic SARS-CoV-2 infections. For all outcomes, vaccine effectiveness was measured from two weeks after the second dose.

“Israel’s strong health system and an unprecedented societal mobilization and awareness allowed us to achieve high national uptake of the COVID-19 vaccine in a short period of time. Thanks to our comprehensive public health surveillance program, we have been able to document the remarkable success of the nationwide vaccination campaign with the COVID-19 vaccine. Incidence rates in the fully vaccinated population have massively dropped compared to the unvaccinated population, showing a marked decline in hospitalized cases due to COVID-19,” said Professor Yeheskel Levy, Israel Ministry of Health Director. “This clearly demonstrates the power of the COVID-19 vaccine to fight this virus and encourages us to continue even more intensively with our vaccination campaign. We aim to achieve even higher uptake in people of all ages, which gives us hope of regaining normal economic and social function in the not so distant future.”

“We are extremely encouraged that the real-world effectiveness data coming from Israel are confirming the high efficacy demonstrated in our Phase 3 clinical trial and showing the significant impact of the vaccine in preventing severe disease and deaths due to COVID-19,” said Luis Jodar, Ph.D., Senior Vice President & Chief Medical Officer, Pfizer Vaccines. “The findings which suggest that the vaccine may also provide protection against asymptomatic SARS-CoV-2 infections are particularly meaningful as we look to disrupt the spread of the virus around the globe. Altogether, these data are critical to understanding the role of vaccination in combatting the pandemic and provide hope to other countries dealing with this devastating disease, which has now afflicted the world for more than a year.”

“When we started our development last year in January, our aim was to make a difference for people worldwide and to help end this pandemic. One year after the declaration of a pandemic by the WHO, we now see that we are on the right track to accomplish our goals,” said Ugur Sahin, M.D., Co-Founder and CEO of BioNTech. “The real-world data reported from Israel demonstrate that BNT162b2 is exceptionally effective in fighting SARS-CoV-2. Our vaccine has been effective in preventing COVID-19 cases, as well as profoundly reducing the rate of COVID-19 related severe diseases, hospitalizations and deaths. These findings are also important, as the data were generated at a time when the SARS-CoV-2 variant B.1.1.7 was the dominant strain.”

In January, Pfizer and the Israel MoH entered into a collaboration agreement to monitor the real-world impact of the Pfizer-BioNTech COVID-19 Vaccine. Detailed findings from this collaboration also will be submitted to a peer-reviewed journal.

About the Israel MoH Vaccination Program and Analysis

Following the authorization for emergency use of the Pfizer-BioNTech COVID-19 Vaccine in Israel on December 6, 2020, the Israel MoH launched a national vaccination program targeting individuals age 16 years or older – a total of 6.4 million people, representing 71% of the population. The vaccination program started at the beginning of a large surge of SARS-CoV-2 infections in Israel, which later resulted in a national lockdown starting on January 8, 2021.

This MoH analysis uses de-identified aggregate Israel MoH public health surveillance data from January 17 through March 6, 2021 (analysis period); the start of the analysis period corresponds to seven days after individuals began receiving second doses of the Pfizer-BioNTech COVID-19 Vaccine. MoH regularly collects comprehensive, real-time data on SARS-CoV-2 testing, COVID-19 cases including date of symptom onset, and vaccination history through a nationally notifiable disease registry and the national medical record database.

Vaccine effectiveness estimates – adjusted to account for variances in age, gender and the week specimens were collected – were determined for the prevention of six laboratory-confirmed SARS-CoV-2 outcomes comparing unvaccinated and fully-vaccinated individuals: SARS-CoV-2 infections (includes symptomatic and asymptomatic infections); asymptomatic SARS-CoV-2 infections; COVID-19 cases (symptomatic only); COVID-19 hospitalizations; severe (respiratory distress, including >30 breaths per minute, oxygen saturation on room air <94%, and/or ratio of arterial partial pressure of oxygen to fraction of inspired oxygen <300mm mercury) and critical (mechanical ventilation, shock, and/or heart, liver or kidney failure) COVID-19 hospitalizations; and COVID-19 deaths.

The MoH analysis was conducted when more than 80% of tested specimens in Israel were variant B.1.1.7, providing real-world evidence of the effectiveness of BNT162b2 for prevention of COVID-19 infections, hospitalizations, and deaths due to variant B.1.1.7. However, this analysis was not able to evaluate vaccine effectiveness against B.1.351 (formerly referred to as the South African variant) due to the limited number of infections caused by this strain in Israel at the time the analysis was conducted.

The vaccine effectiveness estimates align with the 95% vaccine efficacy of BNT162b2 against COVID-19 demonstrated in the pivotal Randomized Clinical Trial (RCT) of BNT162b2. However, this observational analysis differs from the RCT in several aspects. Vaccine effectiveness estimates may be affected by differences between vaccinated and unvaccinated persons (i.e., different test-seeking behaviors or levels of adherence to preventive measures). In the RCT, randomization minimized the impact of differences between vaccinated and unvaccinated. Despite efforts to adjust for these effects in the available dataset, the possibility remains of unmeasured distortions. For example, findings from the Maccabi HMO indicate that neighborhood may be an important factor. Further vaccine effectiveness analyses investigating the effect of additional covariates such as location, comorbidities, race/ethnicity, and likelihood of seeking SARS-CoV-2 testing are warranted.

(Source: Pfizer, 2021)