Vaccine industry response to COVID-19

As the impact of COVID-19 continues to be felt across the world, the vaccine industry in Europe remains committed to global efforts to care for those affected, contain the outbreak and develop resources to tackle future outbreaks.

At Vaccines Europe our thoughts are with all those affected by the outbreak of the coronavirus (COVID-19). Vaccines Europe, part of the European Federation of Pharmaceutical Industries and Associations (EFPIA), stands in support with the global community and the World Health Organization (WHO) to contain the COVID-19 pandemic.

While governments contend with implementing appropriate public health measures and health systems are treating unprecedented numbers of patients requiring intensive care, our industry is focused on three key areas:

1. Ensuring the supply of existing vaccines to the patients that need them,
2. Supporting governments and health systems on the ground, 
3. The search for vaccines to help in the fight against the coronavirus.

The COVID-19 pandemic is the public health challenge of our time, which requires a concerted effort and new solutions to be found together.  Vaccines Europe, as a representative of innovative research & development vaccine manufacturers, is honoured to be a part of the R&D ecosystem that responds in a spirit of partnership. We participate in an unprecedent exchange of information and dialogue with other stakeholders on how to address this pandemic.

Europe’s collaborative research community has responded to global health crises before. Through efforts such as the Innovative Medicines Initiative and other public-private partnerships1, we advanced new Ebola vaccine candidates, and diagnostics, and developed new identification and compliance tools. Collaborating in this way has the potential to accelerate development of resources to tackle this pandemic. It enables networks of centres of excellence that can deliver real impact and create a preparedness infrastructure which can be mobilized for future outbreaks.

For more information please consult EFPIA and IFPMA websites.

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Worldwide, there are around 80 initiatives focusing on the development of COVID-19 candidate vaccine. The World Health Organization (WHO) regularly updates their report on the research & development landscape of COVID-19 candidate vaccines here.

Vaccines Europe’s company members are actively contributing to research efforts to develop potential COVID-19 vaccine candidates. Below are just a few of many examples of how we are supporting efforts in the prevention of the COVID-19 outbreak.

AstraZeneca

AstraZeneca and the University of Oxford joined forces to be responsible for the development, worldwide manufacturing and distribution of the vaccine, developed by the Jenner Institute and Oxford Vaccine Group, at the University of Oxford, if clinical trials prove successful.

Read the AstraZeneca’s press release

On 21 May 2020, AstraZeneca announced having received support of more than $1bn from the US Biomedical Advanced Research and
Development Authority (BARDA) for the development, production and delivery of the vaccine, starting in the fall. The development programme includes a Phase III clinical trial with 30,000 participants and a paediatric trial.

On 4 June 2020, AstraZeneca announced to have reached a $750m agreement with CEPI and Gavi to support the manufacturing, procurement and distribution of 300 million doses of the vaccine, with delivery starting by the end of the year. In addition, AstraZeneca reached a licensing agreement with the Serum Institute of India (SII) to supply one billion doses for low and middle-income countries, with a commitment to provide 400 million before the end of 2020.

On 13 June 2020, AstraZeneca announced to have reached an agreement with Europe’s Inclusive Vaccines Alliance (IVA), spearheaded by Germany, France, Italy and the Netherlands, to supply up to 400 million doses of the University of Oxford’s COVID-19 vaccine, with deliveries starting by the end of 2020.

On 20 July 2020, AstraZeneca announced interim results from the ongoing Phase I/II trial of their COVID-19 candidate vaccine (AZD1222), led by Oxford University. The interim results showed that the candidate vaccine was tolerated and generated robust immune responses against the virus in all evaluated participants.

On 14 August 2020, AstraZeneca concluded agreement with the European Commission for the supply of up to 400 million doses of AZD1222 COVID-19 vaccine.

CureVac

CureVac is developing a mRNA based prophylactic vaccine against SARS-CoV-2, funded by and in collaboration with CEPI, the Coalition for Epidemic Preparedness Innovations. On 16 March 2020, the EU Commission offered financial support to CureVac, to scale up development and production of a vaccine against the coronavirus in Europe. The support has come in form of an EU guarantee of a currently assessed EIB loan of an identical amount, in the framework of the InnovFin Infectious Disease Finance Facility under Horizon 2020.

On 14 May 2020, CureVac announced positive pre-clinical results at a low dose for its lead vaccine candidate against COVID-19. The data showed a fast induction of a balanced immune response with high levels of virus neutralizing titers (VNTs) and T-cell responses.

On 17 June 2020, CureVac announced that the German Health Authority Paul-Ehrlich-Institute (PEI) and the Belgian Federal Agency for Medicines and Health Products (FAMHP) have approved the Phase 1 clinical trial for its vaccine program to prevent SARS-CoV-2 infection. The trial will be conducted in Germany and Belgium.

On 20 August 2020, the European Commission concluded exploratory talks with CureVac to purchase a potential vaccine against COVID-19. The envisaged contract with CureVac would provide for the possibility for all EU Member States to purchase the vaccine. It is anticipated that the Commission will have a contractual framework in place for the initial purchase of 225 million doses. 

GSK

GSK is supporting vaccine development by providing access to its pandemic vaccine adjuvant platform to selected institutions and companies with promising vaccine candidates.  In doing this it is contributing to a coordinated effort, focusing on the most promising approaches to enable development of strong candidate vaccines for COVID-19.  Access to its adjuvant technology is being provided through CEPI, the Coalition for Epidemic Preparedness Innovations or directly, in bilateral agreements (see below).

In the pandemic flu setting, GSK’s adjuvant system has been shown to be antigen-sparing, i.e. less of the antigen is needed per dose to protect an individual than would be needed in a vaccine without the adjuvant included. If this is shown to be the case with its adjuvant system for COVID-19 vaccines, the company would be able to protect more people, as less antigen would be needed per person, a crucial advantage in the case of a pandemic where high numbers of doses are needed for broad protection and manufacturing capacity is limited.

Sanofi and GSK have also signed a letter of intent to develop an adjuvanted vaccine for COVID-19, using innovative technology from both companies: Sanofi will contribute its S-protein COVID-19 antigen, which is based on recombinant DNA technology; and GSK will contribute its proven pandemic adjuvant technology. They plan to initiate phase I clinical trials in the second half of 2020 and, if successful and subject to regulatory considerations, aim to complete the development required for licensure in the second half of 2021. Considering the extraordinary humanitarian and financial challenge of the pandemic, both companies believe that global access to COVID-19 vaccines is a priority and are committed to making any vaccine that is developed through the collaboration affordable to the public and through mechanisms that offer fair access for people in all countries.

In addition to Sanofi, GSK is also collaborating with the University of Queensland, Clover Biopharmaceuticals and Xiamen Innovax Biotech Co., Ltd. 

Read the GSK’s press release

More information: https://www.gsk.com/en-gb/media/resource-centre/our-contribution-to-the-fight-against-2019-ncov/

The Janssen Pharmaceutical Companies of Johnson & Johnson

Since the early days of the outbreak, Johnson & Johnson has been working with industry partners, governments and health authorities to help end the fast-moving COVID-19 pandemic. Johnson & Johnson has mobilised resources in response to the outbreak to develop a preventive vaccine candidate against this coronavirus, leveraging Janssen’s AdVac® and PER.C6® technology, that provide the ability to rapidly upscale production of the optimal vaccine candidate. These are the same technologies that are used in the development and manufacturing of Janssen’s investigational Ebola vaccine and are also used to construct the Company’s Zika, RSV and HIV vaccine candidates.

Johnson & Johnson’s efforts to expedite development and production of a vaccine are enhanced by the existing COVID-19 vaccine collaborations between Janssen and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health & Human Services. On March 13, 2020, a new collaboration was announced with the Beth Israel Deaconess Medical Center (BIDMC) to support the development of a preventive vaccine candidate for COVID-19.

On 30 March 2020, Johnson & Johnson announced the selection of a lead COVID-19 vaccine candidate from constructs it has been working on since January 2020; the significant expansion of the existing partnership between the Janssen Pharmaceutical Companies of Johnson & Johnson and the Biomedical Advanced Research and Development Authority (BARDA); and the rapid scaling of the Company’s manufacturing capacity with the goal of providing global supply of more than one billion doses of a vaccine. The company expects to initiate human clinical studies of its lead vaccine candidate at the latest by September 2020 and anticipates the first batches of a COVID-19 vaccine could be available for emergency use authorization in early 2021, a substantially accelerated timeframe in comparison to the typical vaccine development process.

Read the J&J’s press release

On 10 June, Johnson & Johnson announced that through its Janssen Pharmaceutical Companies (Janssen) it has accelerated the initiation of the Phase 1/2a first-in-human clinical trial of its investigational COVID-19 vaccine. Initially scheduled to begin in September, the trial is now expected to commence in the second half of July.

Read the J&J press release

More information: https://www.jnj.com/coronavirus

MSD

As a company dedicated to saving and improving lives for more than 100 years, MSD has a special responsibility to help in the fight against COVID-19.

In May 2020, MSD announced two COVID-19 vaccine development efforts – a collaboration with IAVI and plans to acquire Themis Bioscience, a company focused on vaccines and immune-modulation therapies for infectious diseases, including COVID-19.

In a joint effort with IAVI, a nonprofit scientific research organization, MSD collaborates to develop an investigational SARS-CoV-2 vaccine. This vaccine candidate will use the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for MSD’s Ebola Zaire virus vaccine, which was the first rVSV vaccine approved for use in humans. The vaccine candidate is in preclinical development, and clinical studies are planned to start later in 2020.

Through the acquisition of Themis, an Austrian company, MSD plans to accelerate the development of a SARS-CoV-2 vaccine based on a measles virus platform.

In addition to the collaborations with IAVI and the acquisition of Themis, MSD is participating in a research collaboration with the Institute for Systems Biology to investigate and define the molecular mechanisms of SARS-CoV-2 infection and COVID-19 and identify targets for medicines and vaccines, as well as the NIH-led Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV consortium). ACTIV is a partnership that aims to develop a collaborative framework for prioritizing vaccine and drug candidates, streamlining clinical trials and regulatory processes, and/or leveraging assets among all partners to rapidly respond to the COVID-19 and future pandemics.

Alongside other pharmaceutical companies MSD is collaborating with the Bill & Melinda Gates Foundation. This initiative aims to accelerate the development, manufacturing, and delivery of vaccines, diagnostics and treatments for COVID-19.

More information

Novavax

Novavax advances the development of novel COVID-19 vaccine, with the vaccine candidate derived from coronavirus spike (S) protein. Matrix-M™ adjuvant is expected to boost immune responses. On 10 March 2020, Novavax announced that CEPI, the Coalition for Epidemic Preparedness Innovations awarded an initial funding of $4 million to support Novavax’ efforts to develop a COVID-19 vaccine. CEPI and Novavax are having ongoing discussions on additional funding from CEPI to address Novavax’ costs through Phase 1.

On 8 April 2020, Novavax announced that it has identified a coronavirus vaccine candidate, NVX-CoV2373, a stable, prefusion protein made using Novavax’ proprietary nanoparticle technology, and will initiate a first-in-human trial in mid-May. 

On 11 May 2020, Novavax announced that the CEPI will invest up to $384 million of additional funding, on top of $4 million it invested in March, to advance clinical development of its COVID-19 vaccine candidate. In addition, the CEPI funding will allow Novavax to dramatically increase its large-scale manufacturing capacity for both antigen and adjuvant in multiple locations.

On 25 May 2020, Novavax announced enrollment of the first participants in a Phase 1/2 clinical trial of its coronavirus vaccine candidate in Australia. Preliminary immunogenicity and safety results from the Phase 1 portion of the trial are expected in July 2020.

On 27 May 2020, Novavax announced the acquisition of Praha Vaccines a.s., part of the Cyrus Poonawalla Group, in an all cash transaction of approximately $167 million. The acquisition includes a biologics manufacturing facility and associated assets in Bohumil, Czech Republic. The facility is expected to provide an annual capacity of over 1 billion doses of antigen starting in 2021 for NVX‑CoV2373, Novavax’ COVID-19 vaccine candidate.

On 7 July 2020, Novavax announced that it has been selected to participate in Operation Warp Speed (OWS), a U.S. government program that aims to begin delivering millions of doses of a safe, effective vaccine for COVID-19 in 2021. Novavax has been awarded $1.6 billion by the federal government to complete late-stage clinical development, including a pivotal Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100 million doses of NVX‑CoV2373, Novavax’ COVID-19 vaccine candidate, as early as late 2020.

On 4 August 2020, Novavax announced positive data from its Phase 1/2 clinical trial of its COVID‑19 vaccine in healthy adults 18-59 years of age. The vaccine was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera.

On 6 August 2020, Novavax announced a license agreement with Serum Institute of India Private Limited (SIIPL) for the development and commercialization of Novavax’ COVID‑19 vaccine candidate. The agreement is expected to support minimum of 1 billion doses of this vaccine for India and low- and middle-income countries.

On 17 August 2020, Novavax announced the beginning of a Phase 2b clinical trial in South Africa to evaluate the efficacy of NVX-CoV2373, Novavax’ COVID-19 vaccine candidate. The company intends to initiate the Phase 2 portion of this trial in the U.S. and Australia in the near future. This trial will include approximately 1,500 subjects and will include older adults.

Pfizer

Pfizer is working to advance their own potential antiviral therapies and is engaged with BioNTech, German biotech company, on a potential mRNA coronavirus vaccine. The companies are scaling up production to potentially produce millions of vaccine doses by the end of the year — and hundreds of millions in 2021 — depending on how well their vaccine works and the course of regulatory approval.  BioNTech is working on a number of vaccine candidates using mRNA platforms, and hopes to begin human trials this month.

On 22 April 2020, Pfizer and BioNTech announced that they have received regulatory approval from German authority, Paul Ehrlich Institute, to commence first phase 1/2 clinical trial of our COVID 19 vaccines.  The trial is the first clinical trial of a COVID-19 vaccine candidate to start in Germany, and is part of a global development program. On 29 April 2020, the first cohort has been dosed in the BNT162 Phase 1/2 clinical trial in Germany. On 5 May 2020, Pfizer and BioNTech further announced that the first U.S. participants in the COVID-19 vaccine trial  have been dosed in the U.S.

On 11 June 2020, the European Investment Bank (EIB) and BioNTech concluded a €100 million debt financing agreement to support the development of COVID-19 vaccine programme. The deal will also allow to expand a manufacturing capacity to supply the vaccine fast worldwide in response to the pandemic.

On 1 July 2020, Pfizer and BioNTech announced early positive data from an ongoing phase 1/2 study of vaccine candidate against COVID-19. Further data from this trial of four vaccine candidates will enable selection of a lead candidate and dose level for a large, global Phase 2b/3 safety and efficacy study that may begin as early as July 2020.

On 13 July 2020, Pfizer and BioNTech announced that two of the companies’ four investigational vaccine candidates againts Covid-19 (BNT162b1 and BNT162b2) received Fast Track designation from the U.S. Food and Drug Administration (FDA). 

On 27 July 2020, Pfizer and BioNTech announced the start of a global (except for China) Phase 2/3 safety and efficacy clinical study to evaluate a candidate from their BNT162 mRNA-based vaccine program against Covid-19. This late-stage global study will include up to 30,000 participants. Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review as early as October 2020 and, if regulatory authorisation or approval is obtained, plan to supply up to 100 million doses by the end of 2020 and approximately 1.3 billion doses by the end of 2021.

Sanofi

In February 2020, Sanofi announced a collaboration with the Biomedical Advanced Research and Development Authority (BARDA) to advance a novel COVID-19 vaccine candidate. Work is underway to leverage previous development of a SARS vaccine candidate using Sanofi’s recombinant DNA technology. COVID-19 belongs to the same family of coronaviruses as SARS. Research materials can be produced relatively quickly for clinical testing because Sanofi has a licensed influenza vaccine based on this platform. Further, this technology has the advantage of being highly scalable, allowing Sanofi to potentially rapidly produce large quantities of the coronavirus antigen. Sanofi is also coordinating with the Coalition for Epidemic Preparedness Innovations (CEPI), sharing its vaccine R&D experience and expertise to advance vaccine solution. Sanofi Pasteur and Translate Bio, a clinical-stage messenger RNA (mRNA) therapeutics company, will also collaborate to develop a novel mRNA vaccine for COVID-19. 

Sanofi and GSK have also signed a letter of intent to develop an adjuvanted vaccine for COVID-19, using innovative technology from both companies: Sanofi will contribute its S-protein COVID-19 antigen, which is based on recombinant DNA technology; and GSK will contribute its proven pandemic adjuvant technology. They plan to initiate phase I clinical trials in the second half of 2020 and, if successful and subject to regulatory considerations, aim to complete the development required for licensure in the second half of 2021. Considering the extraordinary humanitarian and financial challenge of the pandemic, both companies believe that global access to COVID-19 vaccines is a priority and are committed to making any vaccine that is developed through the collaboration affordable to the public and through mechanisms that offer fair access for people in all countries.

On 23 June 2020, Sanofi Pasteur and Translate Bio, a clinical-stage messenger RNA (mRNA) therapeutics company, have agreed to expand their existing 2018 collaboration and license agreement to develop mRNA vaccines for infectious diseases. The expansion of this agreement will further unite Translate Bio’s expertise and knowledge from more than 10 years of mRNA research and development with Sanofi’s leadership in vaccine research and development. 

On 31 July 2020, Sanofi and GSK announced to be in advanced discussions, with the European Commission (EC) for the supply of up to 300 million doses of a COVID-19 vaccine. The doses would be manufactured in European countries including France, Belgium, Germany and Italy.

More information

Seqirus

Seqirus is providing scientific and technical expertise and its well-established MF59 adjuvant technology to the University of Queensland in Australia to help fast-track the development of their CEPI-funded n-COV19 vaccine candidate using novel molecular-clamp technology.

More information


1. https://www.weforum.org/agenda/2020/01/global-health-ebola-cooperation

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