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.
Vaccines in Clinical Trials
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Vaccines approved in the EU
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:
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 n 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.
Our members are committed to ensure that when new vaccines are approved they are available and affordable. See all our commitments here.
On 12 October 2021, CureVac announced that they are ending the development of their mRNA vaccine (CVnCoV) for COVID-19, to focus on a second-generation vaccine with GSK. CureVac did also withdrew their rolling review from the European Medicines Agency. Read press release here.
On Tuesday 5 October 2021, The European Medicines Agency (EMA) issued a recommendation that an extra dose of the COVID-19 vaccines Comirnaty (BioNTech/Pfizer) and Spikevax (Moderna) may be given to people with severely weakened immune systems, at least 28 days after their second dose. See EMA press briefing here.
On Tuesday 5 October 2021, The European Medicines Agency (EMA) issued a recommendation that an extra dose of the COVID-19 vaccines Comirnaty (BioNTech/Pfizer) and Spikevax (Moderna) may be given to people with severely weakened immune systems, at least 28 days after their second dose. See EMA press briefing here.
On 28 September 2021, Sanofi announced positive phase 1/2 study results for its first mRNA-based vaccine candidate. See press release here.
On 6 September 2021, EMA started to evaluate an application from Pfizer-BioNTech for the use of a booster dose of their COVID-19 vaccine to be given 6 months after the second dose in people aged 16 years and older. The assessment of data includes results from an ongoing clinical trial in which around 300 adults with healthy immune systems received a booster dose. Read press release here.
On 16 August 2021, CureVac and GSK announced the publication of their preclinical study, that showed evidence for improved immune responses with the second-generation Covid-19 vaccine candidate (CV2CoV) compared to first-generation one, even against all variants of concern (Beta, Delta and Lambda). A Phase 1 clinical trial is expected to start in Q4 2021.Read press release here.
On 4 August 2021, Novavax announced that they have reached an agreement with the European Commission for the purchase of up to 200 million doses of NVX-CoV2373, COVID-19 vaccine candidate. The agreement covers the purchase of up to 100 million doses of the vaccine with the option for an additional 100 million doses through 2023. Read press release here.
On 23 July 2021, EMA’s human medicines committee (CHMP) has recommended granting an extension of indication for Moderna's COVID-19 vaccine (Spikevax) to include use in children aged 12 to 17 years. The vaccine is already authorised for use in people aged 18 and above. Read press release here.
On 20 July 2021, EMA’s human medicines committee (CHMP) has started a rolling review of Vidprevtyn, a COVID-19 vaccine developed by Sanofi Pasteur. Read press release here.
On 8 July 2021, Pfizer and BioNTech announced that they will seek authorization to the U.S. Food and Drug Administration (FDA) for a third dose of their COVID-19 vaccine by next month as early data from their ongoing booster trial suggest, that a third vaccine dose may be able to improve protection against the Delta variant. Read press release here.
On 30 June 2021, CureVac announced their final data from phase 2b/3 trial of first-generation COVID-19 vaccine candidate, CVnCoV. The final analysis showed a vaccine efficacy of 48% against COVID-19 of any severity across all age groups and 15 variants, and demonstrated 53% protection in ages between 18 to 60 years. Read press release here.
On 22 June 2021, the European Commission purchased an additional 150 million doses of Moderna’s COVID-19 vaccine for delivery in 2022. The new contract enables EU countries to access updated COVID-19 vaccine booster candidates. Read press release here.
On 16 June 2021, CureVac announced the results of their Phase 2b/3 Trial of their COVID-19 vaccine candidate, CVnCoV. The overall efficacy rate was 47 percent against all COVID-19 cases. Read press release here.
On 14 June 2021, Novavax announced that their COVID-19 vaccine, NVX-CoV2373, proved to be 90.4 percent effective in preventing COVID-19 cases, and additionally proved to be 100 percent effective in preventing moderate and severe disease in phase 3 trials. Read press release here.
On 7 June 2021, Moderna announced their submission for a conditional marketing approval (CMA) for their COVID-19 vaccine with the European Medicines Agency (EMA) in adolescents aged 12 to 18. Read press release here.
On 27 May 2021, Sanofi and GlaxoSmithKline announced the launch of the Phase 3 clinical trial of their COVID-19 vaccine candidate targeting original virus D.614 as well as a variant B.1.351. Pending positive Phase 3 outcomes and regulatory reviews, the vaccine could be approved in Q4 2021. Read press release here.
On 20 May 2021, The European Commission signed a third contract with BioNTech-Pfizer for an additional 1.8 billion COVID-19 vaccine doses on behalf of all EU Member States, between end 2021 to 2023. Read press release here.
On 18 May 2021, Medicago and GSK announced that the Phase 2 results of their novel plant-derived COVID-19 vaccine, showed a strong antibody response. Read press release here.
On 17 May 2021, Sanofi and GSK announced that their experimental coronavirus vaccine has shown positive results in a Phase 2 clinical trial. A global Phase 3 study is expected to start in the coming weeks. Read press release here.
On 17 May 2021, Sanofi and GSK announced that their experimental coronavirus vaccine has shown positive results in a Phase 2 clinical trial. A global Phase 3 study is expected to start in the coming weeks. Read press release here.
On 10 May 2021, Novavax announced that they intend to file for the marketing authorisation of their candidate COVID-19 vaccine to the European Medicines Agency (EMA) in the third quarter of 2021. Read press release here.
On 12 March 2021, Sanofi Pasteur and Translate Bio announced the start of the Phase 1/2 clinical trial for MRT5500, an mRNA vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. The Companies expect interim results from this trial in the third quarter of 2021. Read press release here.
On 11 March 2021, Johnson & Johnson announced that the European Commission (EC) has granted a Conditional Marketing Authorization (CMA) for its single-dose COVID-19 vaccine. Read press release here.
On 22 January 2021, Sanofi and GSK initiated new Phase 2 study of their adjuvanted recombinant protein-based COVID-19 vaccine candidate. Read press release here.
On 16 February 2021, the European Medicines Agency has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by Janssen-Cilag International N.V. Read press release here.
On 12 February 2021, the European Medicines Agency has started a rolling review of CVnCoV, a COVID‑19 vaccine being developed by CureVac. Read press release here.
On 3 February 2021, GSK and CureVac announced a new €150m collaboration, building on their existing relationship, to jointly develop next generation mRNA vaccines for COVID-19 with the potential for a multi-valent approach to address multiple emerging variants in one vaccine. Read press release here.
On 3 February 2021, the European Medicines Agency has started a rolling review of NVX-CoV2373, a COVID‑19 vaccine being developed by Novavax. Read press release here.
On 29 January 2021, AstraZeneca’s COVID-19 vaccine has been granted a conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older. Read press release here.
On 29 January 2021, Novavax announced that NVX-CoV2373, its protein-based COVID-19 vaccine candidate, met the primary endpoint, with a vaccine efficacy of 89.3%, in its Phase 3 clinical trial conducted in the United Kingdom (UK). Read press release here.
On 29 January 2021, Johnson & Johnson announced top-line efficacy and safety data from the Phase 3 clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development met all primary and key secondary endpoints. Read press release here.
On 25 January 2021, MSD announced that the company is discontinuing development of its COVID-19 vaccine candidates, V590 and V591, and plans to focus its COVID-19 research strategy and production capabilities on advancing two therapeutic candidates. Read press release here.
On 13 January 2021, Interim Phase 1/2a data were published in the New England Journal of Medicine demonstrating that Johnson&Johnson's single-dose investigational COVID-19 vaccine candidate provided an immune response that lasted for at least 71 days. Read press release here.
On 12 January 2021, the European Medicines Agency received application for conditional marketing authorisation of COVID-19 Vaccine AstraZeneca. Read press release here.
On 7 January 2021, CureVac and Bayer entered into collaboration and services agreement. Under the terms of the agreement, Bayer will support CureVac in numerous areas, including development and supply of Covid-19 vaccines. Read press release here.
On 31 December 2020, the World Health Organization (WHO) listed Pfizer's and BioNTech's COVID-19 vaccine for emergency use. Read press release here.
On 30 December 2020, AstraZeneca’s COVID-19 vaccine has been approved for emergency supply in the UK, with the first doses being released today so that vaccinations may begin early in the New Year. Read press release here.
On 21 December 2020, the European Commission granted a conditional marketing authorization (CMA) to Pfizer and BioNTech for their Covid-19 vaccine - COMIRNATY®. This follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine earlier today. The CMA is valid in all 27 member states of the European Union (EU). Read press release here.
On 17 December 2020, the European Commission concluded exploratory talks with Novavax with a view to purchasing its potential vaccine against COVID-19. The envisaged contract with Novavax would provide for the possibility for all EU Member States to purchase 100 million doses. Read press release here.
On 14 December 2020, CureVac announced that it has enrolled the first participant in the pivotal Phase 2b/3 study of its mRNA vaccine candidate, CVnCoV, against COVID-19. The study is expected to include more than 35,000 participants at sites in Europe and Latin America. Read press release here.
On 11 December 2020, Sanofi and GSK announced a delay in their COVID-19 vaccine programme to improve immune response in the elderly. Vaccine availability is now expected in Q4 2021 pending successful completion of the development plan. Read press release here.
On 11 December 2020, Sanofi and GSK announced a delay in their COVID-19 vaccine programme to improve immune response in the elderly. Vaccine availability is now expected in Q4 2021 pending successful completion of the development plan. Read press release here.
On 10 December 2020, Pfizer and BioNTech announced that the New England Journal of Medicine has published safety and final efficacy results from the pivotal Phase 3 trial of BNT162b2, their mRNA-based COVID-19 vaccine candidate. In the trial of 43,448 participants, the two-dose regimen of 30 μg BNT162b2, was well-tolerated and demonstrated vaccine efficacy of 95% against COVID-19. Read press release here.
On 2 December 2020, Pfizer and BioNTech announced that the Medicines & Healthcare Products Regulatory Agency (MHRA) in the U.K. has granted a temporary authorization for emergency use for their COVID-19 mRNA vaccine (BNT162b2), against COVID-19. This constitutes the first Emergency Use Authorization following a worldwide Phase 3 trial of a vaccine to help fight the pandemic. Read press release here.
On 1 December 2020, Pfizer and BioNTech submitted a formal Application for Conditional Marketing Authorization (CMA) to the European Medicines Agency (EMA) for their mRNA vaccine candidate, BNT162b2, against COVID-19. Read press release here.
On 1 December 2020, the European Medicines Agency started rolling review of Janssen’s COVID-19 vaccine, Ad26.COV2.S. Read press release here.
On 23 November 2020, AstraZeneca announced positive high-level results from an interim analysis of clinical trials of their Covid-19 candidate vaccine (AZD1222) which showed the vaccine was highly effective in preventing COVID-19. One dosing regimen (n=2,741) showed vaccine efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose at least one month apart. Read press release here.
On 18 November 2020, Pfizer and BioNtech concluded Phase 3 study of their COVID-19 vaccine with an efficacy rate of 95% in participants without prior SARS-CoV-2 infection. They will seek EMA from regulators within days. Read press release here.
On 17 November 2020, the European Commission authorized an Advanced Purchase Agreement for CureVac´s COVID-19 vaccine candidate (CVnCoV). Once finalised, the contract will allow EU Member States to buy up to 405 million doses of a vaccine produced by CureVac. Read press release here.
On 15 November 2020, Janssen initiated the two-dose regimen Phase 3 clinical trial of its candidate Covid-19 vaccine. It will run in parallel and in addition to the single-dose regiment Phase 3 clinical trial that started in September 2020. Read more here.
On 11 November 2020, Pfizer and BioNTech announced to have reached an agreement with the European Commission to supply the EU with 200 Million Doses of their vaccine candidate against COVID-19 (BNT162b2). Read press release here.
On 9 November 2020, Pfizer and BioNTech announced their Covid-19 vaccine candidate, BNT162b2, had demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of Covid-19 infection, based on the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study. Read press release here.
On 2 November 2020, CureVac reported positive interim phase 1 data for its COVID-19 vaccine candidate (CVnCoV). Read press release here.
On 16 October 2020, Pfizer published an open letter from CEO Albert Bourla on the timelines of the company's vaccine development programme. Read here.
On 8 October 2020, The European Commission announced it has approved a contract to advance purchase 200 million doses of a coronavirus vaccine developed by Johnson & Johnson. Read press release here.
On 7 October 2020, the European Medicines Agency started a ‘rolling review’ of data on a vaccine for COVID-19 known as BNT162b2, which is being developed by BioNTech in collaboration with Pfizer. Read press release here.
On 1 October 2020, the European Medicines Agency has started the first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. Read press release here.
On 25 September 2020, interim analysis from the ongoing Phase 1/2a clinical trial of the Janssen's COVID-19 vaccine candidate (JNJ-78436735) was posted on the pre-print server medRxiv. Read press release here.
On 24 September 2020, Novavax announced that it has initiated its first Phase 3 study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, Novavax’ COVID-19 vaccine candidate. The trial is being conducted in the United Kingdom (UK), and is expected to enroll and immunize up to 10,000 individuals. Read press release here.
On 23 September 2020, Johnson & Johnson announced the launch of its large-scale, pivotal, multi-country Phase 3 trial for its COVID-19 vaccine candidate, JNJ-7843673. Read press release here.
On 18 September 2020, CureVac started Phase 2 clinical trial of its investigational SARS-CoV-2 mRNA vaccine.
On 18 September 2020, Sanofi and GSK finalised and signed an advanced purchase agreement with the European Commission (EC) for the supply of up to 300 million doses of a COVID-19 vaccine, once the vaccine is approved. Read press release here.
On 18 September 2020, Sanofi and GSK finalized and signed an Advanced purchase agreement with the European Commission (EC) for the supply of up to 300 million doses of a COVID-19 vaccine, once the vaccine is approved. Read press release here.
On 15 September 2020, Novavax announced an amendment to its existing agreement with Serum Institute of India Private Limited (SIIPL) under which SIIPL will also manufacture the antigen component of Novavax’ COVID‑19 vaccine candidate (NVX-CoV2373). With this agreement, Novavax increases its manufacturing capacity of NVX-CoV2373 to over two billion doses annually. Read press release here.
On 3 September 2020, AstraZeneca announced that the development of the potential COVID-19 vaccine has expanded into a Phase III clinical trial in the US to assess the safety, efficacy and immunogenicity of the potential vaccine for the prevention of COVID-19. Read press release here.
On 3 September 2020, Sanofi and GSK announced the start of the Phase 1/2 clinical trial for their adjuvanted COVID-19 vaccine. Read press release here.
On 3 September 2020, Sanofi and GSK started the Phase 1/2 clinical trial for their adjuvanted COVID-19 vaccine. Read press release here.
On 2 September 2020, Novavax announced the publication in The New England Journal of Medicine of Phase 1 data from its Phase 1/2 clinical trial of NVX‑CoV2373, its COVID‑19 vaccine candidate adjuvanted with Matrix‑M™. The publication offers further detail on the previously announced results. Read press release here.
On 24 August 2020, MSD together with Dohme Corp. initiated the phase 1 clinical trial of their candidate Covid-19 vaccine (V590). Read more here.
On 24 August 2020, Novavax announced that the first volunteers have been enrolled in the Phase 2 portion of its ongoing clinical trial to evaluate the immunogenicity and safety of NVX-CoV2373, Novavax’ COVID-19 vaccine candidate. Read press release here.
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.
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.
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.
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.
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.
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.
On 30 July 2020, Johnson & Johnson announced that its lead vaccine candidate protected against infection with SARS-CoV-2, the virus that causes COVID-19, in pre-clinical studies. Based on the strength of the data, a Phase 1/2a first-in-human clinical trial of the vaccine candidate, Ad26.COV2.S, in healthy volunteers, has now commenced in the United States and Belgium. Read press release here.
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.
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.
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).
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.
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 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 press release here.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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. Read press release here.
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 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.
On 29 January 2021, AstraZeneca’s COVID-19 vaccine has been granted a conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older. Read press release here.
On 12 January 2021, the European Medicines Agency received application for conditional marketing authorisation of COVID-19 Vaccine AstraZeneca. Read press release here.
On 30 December 2020, AstraZeneca’s COVID-19 vaccine has been approved for emergency supply in the UK, with the first doses being released today so that vaccinations may begin early in the New Year. Read press release here.
On 23 November 2020, AstraZeneca announced positive high-level results from an interim analysis of clinical trials of their Covid-19 candidate vaccine (AZD1222) which showed the vaccine was highly effective in preventing COVID-19. One dosing regimen (n=2,741) showed vaccine efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose at least one month apart. Read press release here.
On 1 October 2020, the European Medicines Agency has started the first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. Read press release here.
On 3 September 2020, AstraZeneca announced that the development of the potential COVID-19 vaccine has expanded into a Phase III clinical trial in the US to assess the safety, efficacy and immunogenicity of the potential vaccine for the prevention of COVID-19. Read press release here.
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.
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.
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.
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.
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.
CSL 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.
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 7 January 2021, CureVac and Bayer entered into collaboration and services agreement. Under the terms of the agreement, Bayer will support CureVac in numerous areas, including development and supply of Covid-19 vaccines. Read press release here.
On 14 December 2020, CureVac announced that it has enrolled the first participant in the pivotal Phase 2b/3 study of its mRNA vaccine candidate, CVnCoV, against COVID-19. The study is expected to include more than 35,000 participants at sites in Europe and Latin America. Read press release here.
On 17 November 2020, the European Commission authorized an Advanced Purchase Agreement for CureVac´s COVID-19 vaccine candidate (CVnCoV). Once finalised, the contract will allow EU Member States to buy up to 405 million doses of a vaccine produced by CureVac. Read press release here.
On 2 November 2020, CureVac reported positive interim phase 1 data for its COVID-19 vaccine candidate (CVnCoV). Read press release here.
On 18 September 2020, CureVac started Phase 2 clinical trial of its investigational SARS-CoV-2 mRNA vaccine.
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.
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.
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 12 February 2021, the European Medicines Agency has started a rolling review of CVnCoV, a COVID‑19 vaccine being developed by CureVac. Read press release here.
On 16 June 2021, CureVac announced the results of their Phase 2b/3 Trial of their COVID-19 vaccine candidate, CVnCoV. The overall efficacy rate was 47 percent against all COVID-19 cases. Read press release here.
On 30 June 2021, CureVac announced their final data from phase 2b/3 trial of first-generation COVID-19 vaccine candidate, CVnCoV. The final analysis showed a vaccine efficacy of 48% against COVID-19 of any severity across all age groups and 15 variants, and demonstrated 53% protection in ages between 18 to 60 years. Read press release here.
On 16 August 2021, CureVac and GSK announced the publication of their preclinical study, that showed evidence for improved immune responses with the second-generation Covid-19 vaccine candidate (CV2CoV) compared to first-generation one, even against all variants of concern (Beta, Delta and Lambda). A Phase 1 clinical trial is expected to start in Q4 2021.Read press release here.
On 12 October 2021, CureVac announced that they are ending the development of their mRNA vaccine (CVnCoV) for COVID-19, to focus on a second-generation vaccine with GSK. CureVac did also withdrew their rolling review from the European Medicines Agency. Read press release here.
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.
More information: https://www.gsk.com/en-gb/media/resource-centre/our-contribution-to-the-fight-against-2019-ncov/
On 17 May 2021, Sanofi and GSK announced that their experimental coronavirus vaccine has shown positive results in a Phase 2 clinical trial. A global Phase 3 study is expected to start in the coming weeks. Read press release here.
On 16 March 2021, Medicago and GlaxoSmithKline (GSK) announced the start of Phase 3 clinical testing of Medicago’s plant-derived COVID-19 vaccine candidate in combination with GSK’s pandemic adjuvant, as part of the ongoing Phase 2/3 study. Read press release here.
On 3 February 2021, GSK and CureVac announced a new €150m collaboration, building on their existing relationship, to jointly develop next generation mRNA vaccines for COVID-19 with the potential for a multi-valent approach to address multiple emerging variants in one vaccine. Read press release here.
On 18 September 2020, Sanofi and GSK finalised and signed an advanced purchase agreement with the European Commission (EC) for the supply of up to 300 million doses of a COVID-19 vaccine, once the vaccine is approved. Read press release here.
On 3 September 2020, Sanofi and GSK announced the start of the Phase 1/2 clinical trial for their adjuvanted COVID-19 vaccine. Read press release here.
On 11 December 2020, Sanofi and GSK announced a delay in their COVID-19 vaccine programme to improve immune response in the elderly. Vaccine availability is now expected in Q4 2021 pending successful completion of the development plan. Read press release here.
On 18 May 2021, Medicago and GSK announced that the Phase 2 results of their novel plant-derived COVID-19 vaccine, showed a strong antibody response. Read press release here.
In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics. Most recently, Moderna’s capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.
On Tuesday 5 October 2021, The European Medicines Agency (EMA) issued a recommendation that an extra dose of the COVID-19 vaccines Comirnaty (BioNTech/Pfizer) and Spikevax (Moderna) may be given to people with severely weakened immune systems, at least 28 days after their second dose. See EMA press briefing here.
On 23 July 2021, EMA’s human medicines committee (CHMP) has recommended granting an extension of indication for Moderna's COVID-19 vaccine (Spikevax) to include use in children aged 12 to 17 years. The vaccine is already authorised for use in people aged 18 and above. Read press release here.
On 22 June 2021, the European Commission purchased an additional 150 million doses of Moderna’s COVID-19 vaccine for delivery in 2022. The new contract enables EU countries to access updated COVID-19 vaccine booster candidates. Read press release here.
On 7 June 2021, Moderna announced their submission for a conditional marketing approval (CMA) for their COVID-19 vaccine with the European Medicines Agency (EMA) in adolescents aged 12 to 18. Read press release here.
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
On 25 January 2021, MSD announced that the company is discontinuing development of its COVID-19 vaccine candidates, V590 and V591, and plans to focus its COVID-19 research strategy and production capabilities on advancing two therapeutic candidates. Read press release here.
On 24 August 2020, MSD together with Dohme Corp. initiated the phase 1 clinical trial of their candidate Covid-19 vaccine (V590). Read more here.
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 4 August 2021, Novavax announced that they have reached an agreement with the European Commission for the purchase of up to 200 million doses of NVX-CoV2373, COVID-19 vaccine candidate. The agreement covers the purchase of up to 100 million doses of the vaccine with the option for an additional 100 million doses through 2023. Read press release here.
On 14 June 2021, Novavax announced that their COVID-19 vaccine, NVX-CoV2373, proved to be 90.4 percent effective in preventing COVID-19 cases, and additionally proved to be 100 percent effective in preventing moderate and severe disease in phase 3 trials. Read press release here.
On 10 May 2021, Novavax announced that they intend to file for the marketing authorisation of their candidate COVID-19 vaccine to the European Medicines Agency (EMA) in the third quarter of 2021. Read press release here.
On 3 February 2021, the European Medicines Agency has started a rolling review of NVX-CoV2373, a COVID‑19 vaccine being developed by Novavax. Read press release here.
On 29 January 2021, Novavax announced that NVX-CoV2373, its protein-based COVID-19 vaccine candidate, met the primary endpoint, with a vaccine efficacy of 89.3%, in its Phase 3 clinical trial conducted in the United Kingdom (UK). Read press release here.
On 17 December 2020, the European Commission concluded exploratory talks with Novavax with a view to purchasing its potential vaccine against COVID-19. The envisaged contract with Novavax would provide for the possibility for all EU Member States to purchase 100 million doses. Read press release here.
On 24 September 2020, Novavax announced that it has initiated its first Phase 3 study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, Novavax’ COVID-19 vaccine candidate. The trial is being conducted in the United Kingdom (UK), and is expected to enroll and immunize up to 10,000 individuals. Read press release here.
On 15 September 2020, Novavax announced an amendment to its existing agreement with Serum Institute of India Private Limited (SIIPL) under which SIIPL will also manufacture the antigen component of Novavax’ COVID‑19 vaccine candidate (NVX-CoV2373). With this agreement, Novavax increases its manufacturing capacity of NVX-CoV2373 to over two billion doses annually. Read press release here.
On 2 September 2020, Novavax announced the publication in The New England Journal of Medicine of Phase 1 data from its Phase 1/2 clinical trial of NVX‑CoV2373, its COVID‑19 vaccine candidate adjuvanted with Matrix‑M™. The publication offers further detail on the previously announced results. Read press release here.
On 24 August 2020, Novavax announced that the first volunteers have been enrolled in the Phase 2 portion of its ongoing clinical trial to evaluate the immunogenicity and safety of NVX-CoV2373, Novavax’ COVID-19 vaccine candidate. Read press release here.
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.
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.
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.
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.
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.
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.
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.
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.
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 Tuesday 5 October 2021, The European Medicines Agency (EMA) issued a recommendation that an extra dose of the COVID-19 vaccines Comirnaty (BioNTech/Pfizer) and Spikevax (Moderna) may be given to people with severely weakened immune systems, at least 28 days after their second dose. See EMA press briefing here.
On 6 September 2021, EMA started to evaluate an application from Pfizer-BioNTech for the use of a booster dose of their COVID-19 vaccine to be given 6 months after the second dose in people aged 16 years and older. The assessment of data includes results from an ongoing clinical trial in which around 300 adults with healthy immune systems received a booster dose. Read press release here.
On 8 July 2021, Pfizer and BioNTech announced that they will seek authorization to the U.S. Food and Drug Administration (FDA) for a third dose of their COVID-19 vaccine by next month as early data from their ongoing booster trial suggest, that a third vaccine dose may be able to improve protection against the Delta variant. Read press release here.
On 20 May 2021, The European Commission signed a third contract with BioNTech-Pfizer for an additional 1.8 billion COVID-19 vaccine doses on behalf of all EU Member States, between end 2021 to 2023. Read press release here.
On 31 December 2020, the World Health Organization (WHO) listed Pfizer's and BioNTech's COVID-19 vaccine for emergency use. Read press release here.
On 21 December 2020, the European Commission granted a conditional marketing authorization (CMA) to Pfizer and BioNTech for their Covid-19 vaccine - COMIRNATY®. This follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine earlier today. The CMA is valid in all 27 member states of the European Union (EU). Read press release here.
On 10 December 2020, Pfizer and BioNTech announced that the New England Journal of Medicine has published safety and final efficacy results from the pivotal Phase 3 trial of BNT162b2, their mRNA-based COVID-19 vaccine candidate. In the trial of 43,448 participants, the two-dose regimen of 30 μg BNT162b2, was well-tolerated and demonstrated vaccine efficacy of 95% against COVID-19. Read press release here.
On 2 December 2020, Pfizer and BioNTech announced that the Medicines & Healthcare Products Regulatory Agency (MHRA) in the U.K. has granted a temporary authorization for emergency use for their COVID-19 mRNA vaccine (BNT162b2), against COVID-19. This constitutes the first Emergency Use Authorization following a worldwide Phase 3 trial of a vaccine to help fight the pandemic. Read press release here.
On 1 December 2020, Pfizer and BioNTech submitted a formal Application for Conditional Marketing Authorization (CMA) to the European Medicines Agency (EMA) for their mRNA vaccine candidate, BNT162b2, against COVID-19. Read press release here.
On 20 November 2020, Pfizer and BioNTech submitted a request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their Covid-19 vaccine candidate (BNT162b2), which will potentially enable use of the vaccine in high-risk populations in the U.S. by the middle to end of December 2020. Read press release here.
On 18 November 2020, Pfizer and BioNtech concluded Phase 3 study of their COVID-19 vaccine with an efficacy rate of 95% in participants without prior SARS-CoV-2 infection. They will seek EMA from regulators within days. Read press release here.
On 11 November 2020, Pfizer and BioNTech announced to have reached an agreement with the European Commission to supply the EU with 200 Million Doses of their vaccine candidate against COVID-19 (BNT162b2). Read press release here.
On 9 November 2020, Pfizer and BioNTech announced their Covid-19 vaccine candidate, BNT162b2, had demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of Covid-19 infection, based on the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study. Read press release here.
On 16 October 2020, Pfizer published an open letter from CEO Albert Bourla on the timelines of the company's vaccine development programme. Read here.
On 7 October 2020, the European Medicines Agency started a ‘rolling review’ of data on a vaccine for COVID-19 known as BNT162b2, which is being developed by BioNTech in collaboration with Pfizer. Read press release here.
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.
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).
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.
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.
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.
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 28 September 2021, Sanofi announced positive phase 1/2 study results for its first mRNA-based vaccine candidate. See press release here.
On 27 May 2021, Sanofi and GlaxoSmithKline announced the launch of the Phase 3 clinical trial of their COVID-19 vaccine candidate targeting original virus D.614 as well as a variant B.1.351. Pending positive Phase 3 outcomes and regulatory reviews, the vaccine could be approved in Q4 2021. Read press release here.
On 17 May 2021, Sanofi and GSK announced that their experimental coronavirus vaccine has shown positive results in a Phase 2 clinical trial. A global Phase 3 study is expected to start in the coming weeks. Read press release here.
On 12 March 2021, Sanofi Pasteur and Translate Bio announced the start of the Phase 1/2 clinical trial for MRT5500, an mRNA vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. The Companies expect interim results from this trial in the third quarter of 2021. Read press release here.
On 22 January 2021, Sanofi and GSK initiated new Phase 2 study of their adjuvanted recombinant protein-based COVID-19 vaccine candidate. Read press release here.
On 11 December 2020, Sanofi and GSK announced a delay in their COVID-19 vaccine programme to improve immune response in the elderly. Vaccine availability is now expected in Q4 2021 pending successful completion of the development plan. Read press release here.
On 18 September 2020, Sanofi and GSK finalized and signed an Advanced purchase agreement with the European Commission (EC) for the supply of up to 300 million doses of a COVID-19 vaccine, once the vaccine is approved. Read press release here.
On 3 September 2020, Sanofi and GSK started the Phase 1/2 clinical trial for their adjuvanted COVID-19 vaccine. Read press release here.
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.
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 20 July 2021, EMA’s human medicines committee (CHMP) has started a rolling review of Vidprevtyn, a COVID-19 vaccine developed by Sanofi Pasteur. Read press release here.
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.
More information: https://www.jnj.com/coronavirus
On 11 March 2021, Johnson & Johnson announced that the European Commission (EC) has granted a Conditional Marketing Authorization (CMA) for its single-dose COVID-19 vaccine. Read press release here.
On 29 January 2021, Johnson & Johnson announced top-line efficacy and safety data from the Phase 3 clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development met all primary and key secondary endpoints. Read press release here.
On 13 January 2021, Interim Phase 1/2a data were published in the New England Journal of Medicine demonstrating that Johnson&Johnson's single-dose investigational COVID-19 vaccine candidate provided an immune response that lasted for at least 71 days. Read press release here.
On 15 November 2020, Janssen initiated the two-dose regimen Phase 3 clinical trial of its candidate Covid-19 vaccine. It will run in parallel and in addition to the single-dose regiment Phase 3 clinical trial that started in September 2020. Read more here.
On 8 October 2020, The European Commission announced it has approved a contract to advance purchase 200 million doses of a coronavirus vaccine developed by Johnson & Johnson. Read press release here.
On 25 September 2020, interim analysis from the ongoing Phase 1/2a clinical trial of the Janssen's COVID-19 vaccine candidate (JNJ-78436735) was posted on the pre-print server medRxiv. Read press release here.
On 23 September 2020, Johnson & Johnson announced the launch of its large-scale, pivotal, multi-country Phase 3 trial for its COVID-19 vaccine candidate, JNJ-7843673. Read press release here.
On 30 July 2020, Johnson & Johnson announced that its lead vaccine candidate protected against infection with SARS-CoV-2, the virus that causes COVID-19, in pre-clinical studies. Based on the strength of the data, a Phase 1/2a first-in-human clinical trial of the vaccine candidate, Ad26.COV2.S, in healthy volunteers, has now commenced in the United States and Belgium. Read press release here.
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 press release here.
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. Read press release here.
On 1 December 2020, the European Medicines Agency started rolling review of Janssen’s COVID-19 vaccine, Ad26.COV2.S. Read press release here.
On 16 February 2021, the European Medicines Agency has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by Janssen-Cilag International N.V. Read press release here.
How much will a Covid-19 vaccine cost?
How will COVID-19 vaccines reach people who need them?
How are vaccine companies contributing to the development of vaccines against COVID-19?
When will a COVID-19 vaccine be available?
Will Covid-19 vaccines be safe?
What types of COVID-19 vaccines are currently in development?
How long does it take to develop a vaccine?
What does the pipeline for a COVID-19 vaccine look like?
What is a vaccine? And how does it work?
Vaccines Europe’s member companies are committed to work with governments, payers and other stakeholders to ensure that when new vaccines are approved, they will be available and affordable around the world.
Read our commitments to tackling coronavirus pandemic here.
The global pharmaceutical industry has made the commitment to ensure vaccines against covid-19 will be accessible to everyone that needs them. We are expanding our manufacturing capabilities and sharing available capacity to ramp up production to help meet high demand worldwide.
Allocation of new vaccines is determined by the regulatory authorities in each country that review and decide to license vaccines for recommended populations and under specific pricing, reimbursement or public funding programs, in part based on submissions from the manufacturers and in consultation with public health experts.
Read our commitments to tackling coronavirus pandemic here.
Currently there are around 27 different companies, large as well as small and medium enterprises, working to develop vaccines against COVID-19, including members of Vaccines Europe. Some are working on more than one approach to develop a vaccine, utilizing different technologies, partnerships and close collaborations with others.
The pharmaceutical industry continues to research and invest in finding new vaccines for COVID-19.
No one company can address this problem alone. This requires a global collaborative effort, and the more approaches that move forward, the more we will increase our chances of success.
Vaccine development has historically required 10 to 15 years from the first research and development steps to making a vaccine available to populations. Then, on average, it takes between 12-36 months to manufacture a vaccine before it is ready for distribution.
Today, the world calls on vaccine manufacturers and researchers to find, develop and manufacture COVID-19 vaccines to be made available in 12 to 18 months.
Our researchers are working around the clock to answer these calls and to discover, develop and deliver vaccines for use in the fight against COVID-19 in record time. Vaccine development is a long, complex process. After the initial development steps, vaccines must generally complete three phases of clinical trials to get approved. The regulatory authorities perform a vital role to ensure quality, safety and efficacy of future vaccines. The challenges for the development of COVID-19 vaccine candidates are twofold: for clinical trials to test widely enough to ensure the safety and effectiveness of the vaccine, and to establish sufficient manufacturing capacity to ensure the many doses of vaccines needed can actually be produced and made available when it is successful.
We have made extraordinary progress already, developing vaccine candidates for COVID-19, however there are still many hurdles on the way to the deployment of a licensed vaccine that can be used in a mass vaccination campaign.
You can find more information on how vaccines are developed and produced here.
In response to the devastating human and economic cost of the COVID-19 crisis, our members are working in collaboration with academic institutions, European and international organisations as well as across the life sciences sector to find vaccines that can stop the coronavirus pandemic in its tracks.
These vaccines will be assessed by the European Medicines Agency (EMA) and other regulators around the world. They will only be approved based on rigorous and objective scientific review of safety and efficacy data based on large-scale, high quality, randomised and observer-blinded clinical trials. The health and safety of people receiving any vaccine is our first priority, and that applies equally to recipients of a COVID-19 vaccine.
Read our full statement on the safety of Covid-19 vaccines here.
Multiple vaccines are currently in different development stages, and it is premature to assess which vaccine candidates have the highest probability of being safe and effective, as all are in early stages of their respective development.
Stakeholders recognize the need to pursue many different avenues as vaccine development holds multiple uncertainties and having multiple vaccine projects moving at the same time increases probability of success in the future. By progressing different types of vaccine technologies in parallel, we increase chances of ensuring manufacturing of enough doses to address the demands for potentially billions of doses across the world.
Here you can find an overview of all the COVID-19 vaccine candidates currently in the development.
This depends on the complexity of the pathogen and how it interacts with the body to cause disease, and subsequently how a vaccine may need to be designed to help prevent the infection. Vaccine development has historically required 10 to 15 years from the first research and development steps to making a vaccine available to populations. Timelines have been drastically reduced in the initial development processes for COVID-19 vaccine projects, but companies working on these vaccines are of course still required to follow international and individual national public health guidelines and regulations to ensure safety and efficacy of the vaccine candidates.
You can find more information on how vaccines are developed and produced here.
Worldwide, there are more than 160 initiatives focusing on the development of a COVID-19 vaccine[1]. The majority of these vaccines are still in early stage pre-clinical evaluations. However, currently, at least 42 COVID-19 vaccine candidates are in clinical evaluation[2] – i.e being trialed on healthy volunteers. The World Health Organization (WHO) regularly updates the report on the research & development landscape of COVID-19 candidate vaccines[3].
Vaccines Europe’s member companies are actively contributing to research efforts to develop COVID-19 vaccine candidates. Pharmaceutical companies, biotech firms, academic researchers, public health institutes, governments, regulatory agencies, and NGOs, are joining forces to accelerate vaccine development, share data, knowhow and ideas.
We will need multiple successful vaccines produced at large scale in order to address the need for potentially billions of doses across the world.
For an overview on the latest updates from our members, please visit our webpage.
[1] https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines.
[2] As of September 2020.
[3] https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines.
Vaccines teach our bodies’ defenses – the immune system, how to protect the body against an invading microorganism and the particular disease it causes.
Vaccination is considered one of the greatest healthcare interventions of our time, having saved millions of lives each year for roughly a century and greatly reduced disease, disability and inequity worldwide. Only clean water, which is also considered to be a basic human right, has performed better
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