Your guide to the pharmaceutical world Volume 8 Issue 6 Clinical trials Progress at an unprecedented pace AI in drug development The future of drug development? Asthma exposé Breathing easy PharmaBUSINESS INTERN ATION AL The total package From development to dispensing The total package From development to dispensing Clinical trials Progress at an unprecedented pace AI in drug development The future of drug development? Asthma exposé Breathing easy www .pbiforum.net 01.qxp_Layout 1 07/12/2020 08:01 Page 1 INTER N Food Food &&& Food Food & N ATI O N &&Drin Drin Drin &&Drin AL nk nk nkk app A r f h hi ts a ews Ingredient spotlight End offline packkaaging For businesses that are serious about reducing their carbon footprint www.blmgroup.co.uk VOLUME 4 ISSUE 1 W W W. R E N E W A B L E S A N D E N V I R O N M E N T. C O M E A S T M I D L A N D S L E A E A D I N G B U S I N E S S M A G A A Z I N E APRIL 2020 0 £3. .50 BUS SUP SINES T PPOR SS TING B THCART HEAL YY FACTOR RE OFF FICE ea Stopping the spr THCAR WW HEAL d thinkin Forwar TT AUTOMA Y AFACTOR ad WW EASTMIDL RE A hea SOL OFF ng factories LANDSBUSINE TION ficef althy of LUTIONS ESSLINK CO U FICE w UK www.blmgroup.co.uk EMPOWER Your Business Focus on T A Pharm rld o our guide to the pharmaceutical w Y B U S I N E S S I N T E R N A L ma olume 8 Issue 1 V T I O N declares g rrld Hea oooW coron F ganisa gg l b l g l h O virus na g gency ti medi Nucle Prev aaccin V The nuclea b f treatment ve The P l t k aage n e t eelopment t vv om de rF w w w di i k . p b i f o r u m . n yorkshire & lincolnsh hire’s leading business ma magazine april 2020 £3.5 50 TO T RES C THE SPOND CRISIS DING S YY FACTOR C TT HEAL OFF THCARE FICE safety Ensuring e TT HEAL e of factories The futur TION T AUTOMA YY AFACTOR fices healthy f Keeping of SOLUTIONS OFFICE employee THCARE V w VOLUME 35 ISSUE 4 .blmgroup.co.uk www Often Imitated - Never Equalled www.blmgroup.co.uk 02.qxp_Layout 1 07/12/2020 08:02 Page 1Contents Volume 8 Issue 6 10 14 22 26 Group Editor: Steve Fisher (s.fisher@blmgroup.co.uk) Editor: Michael Fisher (m.fisher@blmgroup.co.uk) Assistant Editor: Dominic Cuthbert (d.cuthbert@blmgroup.co.uk) Journalist: Tess Egginton (t.egginton@blmgroup.co.uk) Sales Director: Angie Cooper (a.cooper@blmgroup.co.uk) Sales Manager: Sam Trott (s.trott@blmgroup.co.uk) Sales: Vicky Hunt (v.hunt@blmgroup.co.uk) Tel: +44 (0) 1472 310302 Accounts & Subscriptions: Angela Sharman (a.sharman@blmgroup.co.uk) Design & Production: Gary Jorgensen, Mark Casson, (studio@blmgroup.co.uk) Editorial: Tel: +44 (0) 1472 310305, Fax: +44 (0) 1472 310317 Part of BLMGroup: Armstrong House, Armstrong Street, Grimsby, North East Lincolnshire DN31 2QE England All rights reserved. No part of this publication may be reproduced, transmitted, photocopied, recorded or otherwise without express permission of the copyright holder, for which application should be addressed first to the publisher. While every reasonable care is taken, neither the publisher nor its participating agents accept liability for loss or damage to prints, colour transparencies, negatives or other material of whatever nature submitted to this publication. The views expressed in this publication are not necessarily the views of those held by the publisher. News4 Stay up to date with the latest industry updates from the global pharmaceutical technology industry. M&A round-up10 Ordinarily, in the last M&D round-up of the year, Pharma Business International looks back at the biggest deals of the year. However, with a spate of major acquisitions over the last few months, this issue will focus on 2020’s last quarter. Asthma exposé14 In a time of COVID, it can be easy to forget about other widespread killers. One we have all grown used to living with is asthma, and while a vaccine or cure for that may not be on the horizon, research is still being conducted into managing the condition. Antidepressants18 Pharma Business International takes a look at the latest news in the antidepressants industry. AI in drug development22 The best estimates put the time it takes for new drugs to make it from the lab to market between ten and fifteen years. Not only can AI be used to drastically shorten this process, but also reduce the £1.5 billion price tag that comes with it. Repurposing therapies26 Repurposing existing therapies for oncology could help to circumvent many of the time and financial costs involved in developing new treatments, as the innovative ReDO project is discovering. Treating food allergies30 As the number of people with food allergies continues to grow, the need for novel treatments is clear. Clinical trials 34 Pharma Business International investigates recent developments in clinical trials for COVID-19 vaccines, as well as the impact the pandemic has had on trials. @pbiforum www.pbiforum.net company/pharma-business- international Cover photo courtesy: Shutterstock / myboys.me 03.qxp_Layout 1 07/12/2020 10:32 Page 1Lead Pharma & Roche to develop oral small molecules for immune mediated diseases Lead Pharma has entered into a collaboration and license agreement with Roche to develop oral small molecules to treat a broad range of immune mediated diseases. In this single target research collaboration, the two companies will collaborate in research activities up to the selection of a pre-clinical candidate after which Roche will be responsible for further development and global commercialisation. Lead Pharma will receive an upfront payment of €10 million, and will be eligible to receive research funding and pre-clinical milestone payments; total potential payments including research, development, regulatory and sales milestones may add up to an aggregate of €260 million, plus royalties on worldwide sales. Arthur Oubrie, Chief Scientific Officer of Lead Pharma, said: “This is the second project we partner with one of the largest pharmaceutical companies under our Discover, Design and Deliver platform… We are keen to collaborate with our colleagues at Roche to bring this novel approach to patients.” 4 Pharma Business International www.pbiforum.net Latest news Takeda & Arrowhead to co- develop RNAi therapy for AATLD Takeda and Arrowhead Pharmaceuticals will collaborate to develop ARO-AAT, a Phase 2 investigational RNA interference (RNAi) therapy in development to treat alpha-1 antitrypsin-associated liver disease (AATLD). ARO-AAT is a potential first-in-class therapy designed to reduce the production of mutant alpha-1 antitrypsin protein, the cause of AATLD progression. If approved, ARO-AAT will be co-commercialised in the United States under a 50/50 profit-sharing structure. Outside the US, Takeda will lead the global commercialization strategy and receive an exclusive license to commercialize ARO-AAT with Arrowhead eligible to receive tiered royalties of 20-25% on net sales. Arrowhead will receive an upfront payment of $300 million and is eligible to receive potential development, regulatory and commercial milestones up to $740 million. Closing of the transaction is contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the US. Boehringer & Click to develop digital therapeutic for schizophrenia Boehringer Ingelheim and Click Therapeutics will together develop and commercialise of a prescription-based digital therapeutic for schizophrenia. It will utilise cognitive and neurobehavioral mechanisms delivered through Click’s proprietary engagement platform with the goal of reducing cognitive deficits and impaired social functioning in patients with schizophrenia. Together the two companies will combine their expertise to develop a novel mobile application – CT-155 – which combines multiple clinically validated therapeutic interventions to help schizophrenia patients modify their behaviour to achieve positive clinical outcomes alone and in combination with pharmaceutical therapy options. The partnership aims to provide better tools and resources to those living with schizophrenia, where there remains a huge unmet need due to lack of access to psychosocial intervention therapies. Click Therapeutics will receive an upfront payment and funding for R&D activities as well as clinical, regulatory and commercial milestones representing a total deal value of over $500 million. Additionally, it will receive tiered royalties on annual net sales of CT-155 worldwide. © Shutterstock/Natali_ Mis © Shutterstock / PopTika © Shutterstock/Explode 04-07.qxp_Layout 1 07/12/2020 10:47 Page 1Moderna and Vertex to treat cystic fibrosis using gene editing Moderna and Vertex Pharmaceuticals will discover and develop lipid nanoparticles (LNPs) and mRNAs for the delivery of gene-editing therapies for the treatment of cystic fibrosis (CF). The three-year research collaboration initially will focus on the discovery and optimisation of novel LNPs and mRNAs that can deliver gene-editing therapies to cells in the lungs, enabling functional cystic fibrosis transmembrane conductance regulator (CFTR) protein to be produced. Moderna will conduct research activities to discover and optimise novel LNPs for the delivery of gene-editing therapies to lung cells for the treatment of CF. Moderna will receive $75 million upfront and will be eligible to receive up to $380 million in development, regulatory and commercial milestones, plus tiered royalties on any products that result from the collaboration. This new collaboration adds to the existing relationship between Moderna and Vertex in their recently extended collaboration aimed at the discovery and development of mRNA therapeutics for the treatment of CF. Pharma Business International 5 www.pbiforum.net Latest news Collaboration to develop next-generation CAR-T cell therapies PhoreMost, the UK-based biopharma dedicated to developing drugs against intractable disease targets, and Oxford Biomedica, a gene and cell therapy group, have entered into a discovery collaboration to develop next-generation CAR-T cell therapies. PhoreMost will deploy its in-house expertise and next-generation phenotypic screening platform, SITESEEKER, to identify therapeutic candidates for Oxford Biomedica’s LentiVector gene therapy delivery system. The programme will initially focus on CAR-T therapy and aims to develop next- generation cell therapies with significantly improved efficacy and durability. Dr Chris Torrance, CEO, PhoreMost, said: “This collaboration with Oxford Biomedica, a global pioneer in cell and gene therapies, is further recognition of the power of SITESEEKER, offering an exciting opportunity to discover and accelerate the development of clinical stage products. The natural complementarity between SITESEEKER and LentiVector offers great promise for this and future collaborations between the two companies.” Financial details of the agreement are not disclosed. Samsung Biologics & Lilly partnership to accelerate delivery of COVID antibody treatments Samsung Biologics’ strategic manufacturing partnership with Eli Lilly is expected to greatly accelerate the global supply for Lilly’s COVID-19 antibody therapies through a long-term manufacturing agreement. The ultimate goal of the partnership is to make antibody treatments more globally accessible for patients. Lilly’s success in developing neutralising antibodies against COVID- 19 – augmented with Samsung Biologics’ manufacturing scale – signals a major move forward in delivering important treatments to patients suffering from the deadly pandemic. “Neutralising antibodies are proving to be a potentially important tool in the fight against COVID-19, and the biopharmaceutical industry is collaborating quickly and effectively to increase the global manufacturing supply,” said David A. Ricks, Lilly’s Chairman and CEO. “This agreement with Samsung supplements Lilly’s own internal manufacturing capacity and greatly expands our ability to deliver Lilly antibody therapies to patients around the world.” Lilly and Samsung Biologics entered into the manufacturing partnership agreement in May of 2020 to address the increasingly urgent demand for COVID-19 treatments worldwide. © Shutterstock / Kateryna Kon © Shutterstock / Andrey_Popov © Shutterstock / Meletios V erras 04-07.qxp_Layout 1 07/12/2020 10:47 Page 26 Pharma Business International www.pbiforum.net Latest news Life sciences accelerator creates seventy new companies since inception MediCity Glasgow, a multi-agency supported incubator & accelerator project, has helped create seventy new life sciences and med-tech companies in the last five years, according to new figures. The project’s success includes 201 new jobs generated within Scotland’s thriving life sciences sector, coupled with over £26 million raised in private investment, against a project goal of just £5 million at its outset. The MediCity approach focuses on coaching evidence-based entrepreneurship, allowing scientists to test hypotheses about the commercial viability of their ideas without the need for significant investment. It also develops the skills and mindset required to accelerate the commercialisation of scientific research from lab to market. “The MediCity project and its accelerator programme has provided a supportive and exciting environment for companies to commercialise opportunities in MedTech, HealthTech, Digital Health, Healthcare and Wellness since its launch in 2015,” said Colin Roberts, Venture Development Director of BioCity Group, pioneers of the MediCity project. The Native Antigen Company launches range of SARS-CoV-2 specific antibodies The Native Antigen Company (now part of LGC’s Clinical Diagnostics Division), suppliers of reagents that enable research into vaccines and diagnostics for emerging and endemic infectious diseases, has announced the introduction of ten new monoclonal antibodies recognising SARS-CoV-2, the causative agent of COVID-19. These ten antibodies recognise different epitopes of the SARS-CoV-2 Spike glycoprotein, nine of which are SARS-CoV-2-specific and do not cross-react with other human coronaviruses. The introduction of these new antibodies extends The Native Antigen Company’s existing range and offers researchers a source of high-quality reagents for the research and development of in vitro diagnostics, therapeutics and vaccines for COVID-19. These SARS-CoV-2 antibodies were raised using the Company’s own S1 and S2 recombinant Spike proteins as immunogens. Produced in the Company’s proprietary mammalian expression system, these antigens exhibit full glycosylation and proper folding to ensure that antibodies raised against them are highly specific. The antibodies have been screened against the Company’s other coronavirus proteins, including SARS, MERS, NL63, OC43, 229E and HKU1 to demonstrate specificity. Three of the antibodies have been shown to be specific for the receptor-binding domain (RBD) of Spike, the region responsible for binding to the cellular ACE2 receptor. Dr Andy Lane, Commercial Director, The Native Antigen Company, said: “There is a real need for commercially available antibodies that are specific for SARS-CoV-2, as many reagents that are currently in use were originally raised against SARS-CoV and only cross-react with SARS-CoV-2. “The Native Antigen Company was one of the first recognised suppliers to release SARS-CoV-2 antigens in February of this year, and we have since continued to expand our offering. These ten new antibodies represent a significant advancement in the availability of defined reagents for CoV-2 studies, including immunoassay development for antigen detection.” Samsung Biologics breaks ground on ‘world’s largest’ biopharma manufacturing facility Samsung Biologics has officially begun construction of its Plant 4 in Incheon, South Korea. Dubbed the “Super Plant”, the new, multi-story 238,000-square-meter construction will be the world’s largest biopharmaceutical manufacturing facility of its kind boasting 256,000 litres total manufacturing capacity. In a joint event with the Korean government and the Incheon City, Samsung Biologics showcased a virtual groundbreaking ceremony in light of COVID-19 protocols and announced an investment plan to build the “Future of Biopharma.” Upon completion of Plant 4, Samsung Biologics is expected to be accountable for a third of the total global bio-CMO manufacturing capacity, offering a combined sum of 620,000 litres from a single site. Plant 4 also features a modular design that will allow flexibility for certain parts of the plant to begin manufacturing activities by the end of 2022, with the goal to commence full operations in 2023. 04-07.qxp_Layout 1 07/12/2020 10:47 Page 3Eye on approvals Roche’s Xofluza approved for post-exposure influenza prophylaxis A supplemental New Drug Application (sNDA) for Roche’s Xofluza (baloxavir marboxil) as a treatment to prevent influenza has been approved in the US. Xofluza is the first single-dose influenza medicine approved for post-exposure prophylaxis. Post-exposure prophylaxis with single-dose Xofluza was evaluated in the phase III BLOCKSTONE study, which was recently published in The New England Journal of Medicine. Regeneron’s antibody cocktail granted Emergency Use Authorisation The FDA has granted Emergency Use Authorisation (EUA) to Regeneron’s antibody cocktail for COVID-19. The cocktail combines casirivimab and imdevimab administered together is the first combination therapy to receive this designation. Casirivimab and imdevimab administered together are authorised for the treatment of mild to moderate COVID-19 in adults, as well as in paediatric patients at least 12 years of age who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalisation. European approval for Tecentriq-Avastin combo for HCC The European Commission has approved Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. The approval is based on results from the Phase III IMbrave150 study, which showed that Tecentriq in combination with Avastin reduced the risk of death by 42% and reduced the risk of disease worsening or death by 41% compared with sorafenib. In total, the combination is now approved in 59 countries for people with unresectable HCC. Regeneron’s antibody cleared to treat Ebola in US US regulators have approved Regeneron’s Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in adult and paediatric patients, including newborns of mothers who have tested positive for the infection. The safety and efficacy of Inmazeb was established through the 681-patient PALM Trial, a randomized, multicenter, controlled trial initiated in 2018 in the DRC. Nucala approved as first and only biologic treatment for Hypereosinophilic Syndrome GlaxoSmithKline (GSK) has secured FDA approval for Nucala (mepolizumab) for the treatment of adult and paediatric patients aged 12 years and older with Hypereosinophilic Syndrome (HES). The approval makes Nucala the first and only targeted biologic treatment to be approved for patients with this eosinophil-driven disease in the US. The approval follows a priority review of data from a clinical development programme that included positive results from a pivotal phase 3 study, recently published in the Journal of Allergy and Clinical Immunology. FDA approves additional doses of Trulicity for type 2 diabetes The US FDA has approved two additional doses of Eli Lilly’s Trulicity (dulaglutide) for the treatment of type 2 diabetes. The approval expands the label of once-weekly Trulicity to include 3.0 mg and 4.5 mg doses based on data from AWARD-11. The phase 3 trial showed the additional doses led to further benefits in A1C and body weight reduction when compared to Trulicity 1.5 mg in people with type 2 diabetes. Spravato approved for use to treat MDD in Scotland The Scottish Medicines Consortium (SMC) have accepted Spravato (esketamine) nasal spray for use within NHS Scotland less than a week after NICE ruled not to recommend the drug for use on the NHS in England. Specifically, the nasal spray is approved in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI), for adults with treatment-resistant Major Depressive Disorder (TRD), who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode. EU approves Imfinzi for ES-SCLC AstraZeneca’s Imfinzi (durvalumab) has been approved in the European Union for the 1st-line treatment of adults with extensive-stage small cell lung cancer (ES- SCLC) in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin. The approval was based on positive results from the Phase III CASPIAN trial showing Imfinzi plus chemotherapy demonstrated a statistically significant and clinically meaningful overall survival benefit for the 1st-line treatment of patients with ES-SCLC. www.pbiforum.net Pharma Business International 7 04-07.qxp_Layout 1 07/12/2020 10:47 Page 4COVID VACCINE 8 Pharma Business International www.pbiforum.net © Shutterstock /NicoElNino Encouraging results for Moderna’s vaccine candidate Moderna’s COVID-19 vaccine candidate has achieved efficiency of almost 95% in a Phase 3 study. This COVE study enrolled more than 30,000 participants in the US and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID). The primary endpoint of the study is based on the analysis of COVID- 19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. This first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus 5 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.5%. A secondary endpoint analysed severe cases of COVID-19 and included 11 severe cases (as defined in the study protocol) in this first interim analysis. All 11 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group. Against severe COVID-19, the candidate achieved 100% efficacy. The 95 COVID-19 cases included 15 older adults (ages 65+) and 20 participants identifying as being from diverse communities (including 12 Hispanic or LatinX, 4 Black or African Americans, 3 Asian Americans and 1 multiracial). As more cases accrue leading up to the final analysis, Moderna said it expects the point estimate for vaccine efficacy may change. The Company plans to submit data from the full Phase 3 COVE study to a peer-reviewed publication. “This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease,” said Stéphane Bancel, CEO of Moderna. “This milestone is only possible because of the hard work and sacrifices of so many. I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, and the staff at our clinical trial sites who have been on the front lines of the fight against the virus.” Moderna will now submit for an EUA with the U.S. FDA and an application for Conditional Marketing Authorization (CMA) with the European Medicines Agency. The Company has already initiated the rolling review process with the EMA, Health Canada, SwissMedic, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA), Ministry of Health in Israel, and Health Sciences Authority in Singapore and intends to seek Prequalification (PQ) and/or Emergency Use Listing (EUL) with the World Health Organization (WHO). Additionally, Moderna announced that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the safety and efficacy data package for mRNA-1273 will likely be scheduled for Thursday, December 17. The Company expects that the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) will make a recommendation on immunisation priorities. The Company anticipates that the shipping of mRNA-1273 to designated distribution points throughout the US will occur shortly after an Emergency Use Authorization is granted. 08-09.qxp_Layout 1 07/12/2020 10:48 Page 1Pharma Business International 9 www.pbiforum.net COVID VACCINE Pfizer and BioNTech’s mRNA-based COVID-19 vaccine candidate – BNT162b2 – has achieved an efficiency rate of 95% after hitting all primary endpoints in a Phase 3 study. Analysis of the data indicates a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. The first primary objective analysis is based on 170 cases of COVID-19, as specified in the study protocol, of which 162 cases of COVID-19 were observed in the placebo group versus 8 cases in the BNT162b2 group. Efficacy was consistent across age, gender, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94%. There were 10 severe cases of COVID-19 observed in the trial, with nine of the cases occurring in the placebo group and one in the BNT162b2 vaccinated group. To date, the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine. In addition, the companies announced that the safety milestone required by the US FDA for Emergency Use Authorization (EUA) has been achieved. Pfizer and BioNTech plan to submit a request within days to the FDA for an EUA based on the totality of safety and efficacy data collected to date, as well as manufacturing data relating to the quality and consistency of the vaccine. “We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world,” said Dr Albert Bourla, Pfizer Chairman and CEO. Pfizer and BioNTech plan to submit the efficacy and safety data from the study for peer-review in a scientific journal once analysis of the data is completed. AstraZeneca’s COVID candidate achieves 90% efficiency at certain dosage AstraZeneca’s COVID-19 vaccine candidate achieved 90% efficiency in results from an interim analysis of clinical trials in the UK and Brazil. One dosing regimen of AZD1222 showed vaccine efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose at least one month apart, and another dosing regimen showed 62% efficacy when given as two full doses at least one month apart. The combined analysis from both dosing regimens resulted in an average efficacy of 70%. An independent Data Safety Monitoring Board determined that the analysis met its primary endpoint showing protection from COVID-19 occurring 14 days or more after receiving two doses of the vaccine. No serious safety events related to the vaccine have been confirmed. AZD1222 was well tolerated across both dosing regimens. AstraZeneca will now immediately prepare regulatory submission of the data to authorities around the world that have a framework in place for conditional or early approval. It will seek an Emergency Use Listing from the World Health Organization for an accelerated pathway to vaccine availability in low-income countries. In parallel, the full analysis of the interim results is being submitted for publication in a peer-reviewed journal. Professor Andrew Pollard, Chief Investigator of the Oxford Vaccine Trial at Oxford, said: “Excitingly, we’ve found that one of our dosing regimens may be around 90% effective and if this dosing regime is used, more people could be vaccinated with planned vaccine supply.” AZ CEO Pascal Soriot said: “This vaccine’s efficacy and safety confirm that it will be highly effective against COVID-19 and will have an immediate impact on this public health emergency. “Furthermore, the vaccine’s simple supply chain and our no-profit pledge and commitment to broad, equitable and timely access means it will be affordable and globally available, supplying hundreds of millions of doses on approval.” 95% efficiency for Pfizer & BioNTech’s mRNA-based COVID vaccine candidate © Shutterstock /siam.pukkato 08-09.qxp_Layout 1 07/12/2020 10:48 Page 2Next >