Sunday, July 12, 2020

THE NEW YORK TIMES VACCINE TRACKER.


PRECLINICAL
PHASE I
PHASE II
PHASE III
APPROVAL
135
14
11
4
1
Vaccines
not yet in
human trials
Vaccines
testing safety
and dosage
Vaccines
in expanded
safety trials
Vaccines
in large-scale
efficacy tests
Vaccine
approved for
limited use
Researchers around the world are developing more than 155 vaccines against the coronavirus, and 22 vaccines are in human trials. Vaccines typically require years of research and testing before reaching the clinic, but scientists are racing to produce a safe and effective vaccine by next year.

Antibody
produced in
response to a
vaccine
SARS-CoV-2
coronavirus
Work began in January with the deciphering of the SARS-CoV-2 genome. The first vaccine safety trials in humans started in March, but the road ahead remains uncertain. Some trials will fail, and others may end without a clear result. But a few may succeed in stimulating the immune system to produce effective antibodies against the virus.
Here is the status of all the vaccines that have reached trials in humans, along with a selection of promising vaccines still being tested in cells or animals.
New additions and recent updates:
•  The Chinese company Anhui Zhifei Longcom began Phase II trials.
•  Maryland-based Novavax announced U.S. government funding.
•  Canada-based Medicago announced a Phase I trial.
•  A vaccine by CanSino Biologics was approved for military use.

The Vaccine Testing Process

The development cycle of a vaccine, from lab to clinic.

PRECLINICAL TESTING: Scientists give the vaccine to animals such as mice or monkeys to see if it produces an immune response.
PHASE I SAFETY TRIALS: Scientists give the vaccine to a small number of people to test safety and dosage as well as to confirm that it stimulates the immune system.
PHASE II EXPANDED TRIALS: Scientists give the vaccine to hundreds of people split into groups, such as children and the elderly, to see if the vaccine acts differently in them. These trials further test the vaccine’s safety and ability to stimulate the immune system.
PHASE III EFFICACY TRIALS: Scientists give the vaccine to thousands of people and wait to see how many become infected, compared with volunteers who received a placebo. These trials can determine if the vaccine protects against the coronavirus.
APPROVAL: Regulators in each country review the trial results and decide whether to approve the vaccine or not. During a pandemic, a vaccine may receive emergency use authorization before getting formal approval.
WARP SPEED: The U.S. government’s Operation Warp Speed program is expected to name five or more vaccine projects to receive billions of dollars in federal funding before there’s proof that the vaccines work. We will update the tracker and label the Warp Speed projects when there is an official announcement.
COMBINED PHASES: Another way to accelerate vaccine development is to combine phases. Some coronavirus vaccines are now in Phase I/II trials, for example, in which they are tested for the first time on hundreds of people. (Note that our tracker would count a combined Phase I/II trial as both Phase I and Phase II.)
Filter the list of vaccines:
     

Genetic Vaccines

Vaccines that use one or more of the coronavirus’s own genes to provoke an immune response.

DNA
RNA

PHASE II

Moderna’s vaccine dazzled the stock market in May with Phase I data on just eight people, only to see its stock price drop when experts had a lukewarm reaction to the results. The vaccine uses messenger RNA (mRNA for short) to produce viral proteins. The American company is eyeing Phase III trials in July and hopes to have vaccine doses ready by early 2021.

PHASE I PHASE II

The German company BioNTech has entered into collaborations with Pfizer, based in New York, and the Chinese drug maker Fosun Pharma to develop their mRNA vaccine. On July 1, they announced that all the volunteers for their Phase I/II trial produced antibodies against SARS-CoV-2, while some experienced moderate side effects such as sleep disturbances and sore arms. In an interview, Pfizer’s CEO said that he hoped his company could begin delivering vaccines in October, providing hundreds of millions of doses by the end of 2020, and then up to a billion by the end of 2021.

PHASE I PHASE II

Imperial College London researchers have developed a “self-amplifying” RNA vaccine, which boosts production of a viral protein to stimulate the immune system. They began Phase I/II trials on June 15 and have partnered with Morningside Ventures to manufacture and distribute the vaccine through a new company called VacEquity Global Health. The researchers expect to know if the vaccine is effective by the end of the year.

PHASE I PHASE II

Indian vaccine-maker Zydus Cadila has created a DNA-based vaccine. On July 3 they announced approval to start human trials, becoming the second company in India to enter the Covid-19 vaccine race after Bharat Biotech.

PHASE I PHASE II

On June 30, the Japanese biotechnology company AnGes announced they had started safety trials on a DNA-based vaccine, developed in partnership with Osaka University and Takara Bio.

PHASE I

On June 30, the American company Inovio announced they had interim Phase I data on their DNA-based vaccine. They found no serious adverse effects, and measured an immune response in 34 out of 36 volunteers. They plan to start Phase II/III trials this summer.

PHASE I

In March, the Trump administration unsuccessfully tried to entice CureVac to move its research from Germany to the United States. In June, the company launched Phase I trials of its mRNA vaccine. The company said its German facility can make hundreds of millions of vaccine doses a year.

PHASE I

The Korean company Genexine started testing the safety of a DNA-based vaccine in June. They anticipate moving to Phase II trials in the fall.

PHASE I

In June, Chinese researchers at the Academy of Military Medical SciencesSuzhou Abogen Biosciences and Walvax Biotechnology announced they would start their country’s first safety trials on a mRNA-based vaccine, called ARCoV. Earlier studies on monkeys reportedly showed protective effects.

PRECLINICAL

The French pharmaceutical company Sanofi is developing an mRNA vaccine in partnership with Translate Bio. On June 23, they announced they were planning Phase I trials in the fall.

Viral Vector Vaccines

Vaccines that use a virus to deliver coronavirus genes into cells and provoke an immune response.

PHASE II PHASE III

vaccine in development by the British-Swedish company AstraZeneca and the University of Oxford is based on a chimpanzee adenovirus called ChAdOx1. The vaccine is in a Phase II/III trial in England and Phase III trials in Brazil and South Africa. The project may deliver emergency vaccines by October. In June, AstraZeneca said their total manufacturing capacity stands at two billion doses.

PHASE II LIMITED APPROVAL

The Chinese company CanSino Biologics developed a vaccine based on an adenovirus called Ad5, in partnership with the Institute of Biology at the country’s Academy of Military Medical Sciences. In May, they published promising results from a Phase I safety trial. Unpublished data from Phase II trials demonstrated the vaccine produced a strong immune response, leading the Chinese military to approve it on June 25 for a year as a “specially needed drug.” CanSino would not say whether vaccination would be mandatory or optional for soldiers.

PHASE I

The Gamaleya Research Institute, part of Russia’s Ministry of Health, launched a Phase I trial in June of a vaccine they call Gam-Covid-Vac Lyo. It is a combination of two adenoviruses, Ad5 and Ad26, both engineered with a coronavirus gene.

PRECLINICAL

Researchers at Beth Israel Deaconess Medical Center in Boston are testing an adenovirus called Ad26 in monkeys. Johnson & Johnson announced in June that they would start Phase I/II trials in late July.

PRECLINICAL

The Swiss company Novartis will manufacture a vaccine based on a gene therapy treatment developed by the Massachusetts Eye and Ear Hospital. A virus called an adeno-associated virus delivers coronavirus gene fragments into cells. Phase I trials are set to begin in late 2020.

PRECLINICAL

The American company Merck announced in May it would develop a vaccine from vesicular stomatitis viruses, the same approach it successfully used to produce the only approved vaccine for Ebola. The company is partnering with IAVI.

PRECLINICAL

Merck is also working with Themis Bioscience, an Austrian firm it is acquiring, to develop a second vaccine, which will use the measles virus to carry genetic material into patients’ cells.

PRECLINICAL

Vaxart’s vaccine is an oral tablet containing an adenovirus that delivers coronavirus genes. They are preparing for Phase I trials this summer.

Protein-Based Vaccines

Vaccines that use a coronavirus protein or a protein fragment to provoke an immune response.

PHASE II

In July, the Chinese company Anhui Zhifei Longcom began Phase II trials for a vaccine that is a combination of viral proteins and an adjuvant that stimulates the immune system. The company is part of Chongqing Zhifei Biological Products and has partnered with the Chinese Academy of Medical Sciences.

PHASE I PHASE II

Maryland-based Novavax has developed a way to stick proteins onto microscopic particles. They’ve created vaccines for a number of different diseases using this platform, and their flu vaccine finished Phase III trials in March. The company launched trials for a Covid-19 vaccine in May, and the Coalition for Epidemic Preparedness Innovations has invested $384 million in the vaccine. On July 6, Novavax announced a U.S. government award of $1.6 billion to support clinical trials and manufacturing. If the trials succeed, Novavax expects to deliver 100 million doses for use in the United States by the first quarter of 2021. Plants in Europe and Asia would be able to satisfy more of the world’s demand.

PHASE I

Clover Biopharmaceuticals has developed a vaccine containing a protein from coronaviruses. To further stimulate the immune system, the vaccine is being given in conjunction with so-called adjuvants made by British drugmaker GSK and the American company DynavaxInvestments from CEPI will support the development of manufacturing that could lead to the production of hundreds of millions of doses a year.

PHASE I

The Australian company Vaxine launched a Phase I trial in July. Their vaccine combines viral proteins with an adjuvant that stimulates immune cells.

PHASE I

Canada-based Medicago uses plants to make vaccines. They inject genes into leaves, causing the plant cells to create protein shells that mimic viruses. In July, Medicago announced they would begin Phase I trials on a plant-based Covid-19 vaccine in combination with adjuvants from drug makers GSK and Dynavax.

PRECLINICAL

After the SARS epidemic in 2002, Baylor College of Medicine researchers began developing a vaccine that could prevent a new outbreak. Despite promising early results, support for the research disappeared. Because the coronaviruses that cause SARS and Covid-19 are very similar, the researchers are reviving the project in partnership with the Texas Children’s Hospital.

PRECLINICAL

A vaccine in development by the University of Pittsburgh, called PittCoVacc, is a skin patch tipped with 400 tiny needles made of sugar. When placed on the skin, the needles dissolve and deliver virus proteins into the body.

PRECLINICAL

A vaccine from Australia’s University of Queensland delivers viral proteins altered to draw a stronger immune response. In June, the university and the company CSL announced a partnership to start Phase I trials, which could lead to millions of doses a year starting in 2021. GSK is providing an adjuvant to further stimulate the immune system.

PRECLINICAL

In addition to their mRNA vaccine, Sanofi is developing a vaccine based on viral proteins. They are producing the proteins with engineered viruses that grow inside insect cells. GSK will supplement these proteins with adjuvants that stimulate the immune system. Sanofi has said it could produce at least 600 million doses a year if the vaccine succeeds in trials.

Whole-Virus Vaccines

Vaccines that use a weakened or inactivated version of the coronavirus to provoke an immune response.

Inactivated
virus

PHASE III

After promising early testing, the state-owned Chinese company Sinopharm announced in June that it would be moving into Phase III trials. They reached an agreement with the United Arab Emirates to start testing the efficacy of an inactivated virus vaccine in the Gulf state.

PHASE III

The private Chinese company Sinovac Biotech is testing an inactivated vaccine called CoronaVac. In June the company announced that Phase I/II trials on 743 volunteers found no severe adverse effects and produced an immune response. Sinovac then launched a Phase III trial in Brazil in July. The company is also building a facility to manufacture up to 100 million doses annually.

PHASE II

Researchers at the Institute of Medical Biology at the Chinese Academy of Medical Sciences, which has invented vaccines for polio and hepatitis A, started a Phase II trial of an inactivated virus vaccine in June.

PHASE I PHASE II

In collaboration with the Indian Council of Medical Research and the National Institute of Virology, the Indian company Bharat Biotech designed a vaccine called Covaxin. It is an inactivated rabies virus engineered to carry proteins from the coronavirus. Phase I/II trials are scheduled to begin this month. The Indian Council of Medical Research reportedly envisions having the vaccine ready for public use on August 15, but this target has been met with skepticism.

Repurposed Vaccines

Vaccines already in use for other diseases that may also protect against Covid-19.

PHASE III

The Bacillus Calmette-Guerin vaccine was developed in the early 1900s as a protection against tuberculosis. The Murdoch Children’s Research Institute in Australia is conducting a Phase III trial, and several other trials are underway to see if the vaccine partly protects against the coronavirus.

Note: Vaccines will be added to the tracker when they reach Phase I, and tracked until they succeed or fail.
Did we miss something? To notify The Times of new developments, send updates to vaccinetracker@nytimes.com.

Tracking the Coronavirus



Additional reporting by Carlos Tejada and Li Cao.

Sources: World Health Organization, National Institute of Allergy and Infectious Diseases, National Center for Biotechnology Information, New England Journal of Medicine

Wednesday, July 8, 2020

A GOOD NEWS MODERNA PRESS RELEASE.


Moderna and ROVI Announce Collaboration for OUS Fill-Finish Manufacturing of Moderna’s COVID-19 Vaccine Candidate

July 9, 2020 at 8:00 AM EDT
CAMBRIDGE, Mass. & MADRID--(BUSINESS WIRE)--Jul. 9, 2020-- Moderna, Inc. (Nasdaq: MRNA), a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines, and Laboratorios Farmacéuticos Rovi, S.A. (BME: ROVI), a pan-European pharmaceutical company specializing and engaging in the research, development, contract manufacturing and marketing of small molecules and biological specialties, today announced a collaboration for large-scale, commercial fill-finish manufacturing of Moderna’s mRNA vaccine candidate against COVID-19 (mRNA-1273) at ROVI’s facility in Madrid, Spain.
As part of the agreement, ROVI will provide vial filling and packaging capacity by procuring a new production line and equipment for compounding, filling, automatic visual inspection and labeling to support production of hundreds of millions of doses of the vaccine candidate intended in principle to supply markets outside of the U.S. starting in early 2021. ROVI will also hire additional staffing required to support manufacturing operations and production.
“Moderna is committed to helping address the COVID-19 crisis. We are pleased to partner with ROVI to potentially supply hundreds of millions of doses of finished mRNA-1273, once approved, and help address the need for a vaccine against COVID-19 around the world,” said Juan Andres, Moderna’s Chief Technology Operations and Quality Officer. “ROVI’s experience as a global manufacturer of drug product and expertise in fill-finish will be an important partnership for us to establish dedicated supply chains that can meet the needs of different countries and regions. I am delighted to be working with ROVI again.”
“We are very happy about the collaboration with Moderna, whose vaccine against COVID-19 is one of the frontrunners in the race to solve this health crisis. We would be thrilled for ROVI to form part of the solution to this pandemic that is affecting all of us and to support Moderna in supplying it on a wide scale. Our proven experience and capabilities as a toll manufacturer of injectables has allowed us to reach this agreement, which would help strengthen our manufacturing area and would, in all probability, provide us with a significant growth opportunity in the area. Likewise, I would like to thank the Ministry of Health and the Spanish Medicines Agency for making themselves available and providing their support, which has been of fundamental importance, during this entire process,” said Juan López-Belmonte, Chief Executive Officer of ROVI.
About mRNA-1273, Moderna’s Vaccine Candidate Against COVID-19
mRNA-1273 is an mRNA vaccine candidate against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH). On July 8, the Company’s Phase 2 study of mRNA-1273 completed enrollment. Moderna’s Phase 3 study of approximately 30,000 participants, is expected to begin in July 2020.
About Moderna
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients and to protect populations from vaccines preventable diseases. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The company’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.
Headquartered in Cambridge, Mass.Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, and Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been named a top biopharmaceutical employer by Science for the past five years. To learn more, visit www.modernatx.com.
About ROVI
ROVI is a pan-European pharmaceutical company specializing and engaging in the research, development, contract manufacturing and marketing of small molecules and biological specialties. The company, in a continuous international expansion process, has subsidiaries in PortugalGermany, the United Kingdom, Italy France and Poland, and has a diversified marketing portfolio of more than 40 products, among which its flagship product, Bemiparin, which is already marketed in 56 countries all over the world, should be highlighted. Likewise, in 2017, ROVI commenced the marketing of its in-house developed enoxaparin biosimilar in Europe. ROVI continues to develop the ISM® Platform technology, a leading-edge line of research in the field of prolonged drug release with proven advantages. For more information, please visit www.rovi.es.
Moderna’s Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding the Company’s development of a potential vaccine against the novel coronavirus, the scope of the Company’s manufacturing collaboration with ROVI, the potential number of doses to be provided under the collaboration, the timing of supply of mRNA-1273 outside of the U.S., and the timing of the planned Phase 3 study of mRNA-1273. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “could”, “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the manufacturing infrastructure required to manufacture mRNA-1273 by Moderna is still being developed and implemented; the fact that the safety and efficacy of mRNA-1273 has not yet been established; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.
ROVI’s Forward-Looking Statements
This news release contains forward-looking statements. Such forward looking statements involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial condition, performance, or achievements of ROVI or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward looking statements. These risks, uncertainties, and other factors include, among others: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the manufacturing infrastructure required to manufacture mRNA-1273 is still being developed and implemented; the fact that the safety and efficacy of mRNA-1273 has not yet been established; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy. The statements in this press release represent ROVI's expectations and beliefs as of the date of this press release. ROVI anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while ROVI may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing ROVI's expectations or beliefs as of any date subsequent to the date of this press release.
Moderna
Media:
Colleen Hussey
Senior Manager, Corporate Communications
203-470-5620
Colleen.Hussey@modernatx.com
Investors:
Lavina Talukdar
Head of Investor Relations
617-209-5834
Lavina.Talukdar@modernatx.com
Rovi
Media:
Beatriz García Suárez
+34 662 570 818
bgarciasuarez@rovi.es
Investors:
Marta Campos Martínez
+34 607 539 780
mcampos@rovi.es
Antonio Marquina Ospina
+34 674 315 715
amarquina@rovi.es
Source: Moderna, Inc.














May 18, 2020 at 7:30 AM EDT
After two doses all participants evaluated to date across the 25 µg and 100 µg dose cohorts seroconverted with binding antibody levels at or above levels seen in convalescent sera
mRNA-1273 elicited neutralizing antibody titer levels in all eight initial participants across the 25 µg and 100 µg dose cohorts, reaching or exceeding neutralizing antibody titers generally seen in convalescent sera
mRNA-1273 was generally safe and well tolerated
mRNA-1273 provided full protection against viral replication in the lungs in a mouse challenge model
Anticipated dose for Phase 3 study between 25 µg and 100 µg; expected to start in July
Conference call to be held on Monday, May 18 at 8:30 a.m. ET
CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 18, 2020-- Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced positive interim clinical data of mRNA-1273, its vaccine candidate against novel coronavirus (SARS-CoV-2), from the Phase 1 study led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
Immunogenicity data are currently available for the 25 µg and 100 µg dose level (ages 18-55) after two doses (day 43) and at the 250 µg level (ages 18-55) after one dose (day 29). Dose dependent increases in immunogenicity were seen across the three dose levels, and between prime and boost within the 25 µg and 100 µg dose levels. All participants ages 18-55 (n=15 per cohort) across all three dose levels seroconverted by day 15 after a single dose. At day 43, two weeks following the second dose, at the 25 µg dose level (n=15), levels of binding antibodies were at the levels seen in convalescent sera (blood samples from people who have recovered from COVID-19) tested in the same assay. At day 43, at the 100 µg dose level (n=10), levels of binding antibodies significantly exceeded the levels seen in convalescent sera. Samples are not yet available for remaining participants.
At this time, neutralizing antibody data are available only for the first four participants in each of the 25 µg and 100 µg dose level cohorts. Consistent with the binding antibody data, mRNA-1273 vaccination elicited neutralizing antibodies in all eight of these participants, as measured by plaque reduction neutralization (PRNT) assays against live SARS-CoV-2. The levels of neutralizing antibodies at day 43 were at or above levels generally seen in convalescent sera.
mRNA-1273 was generally safe and well tolerated, with a safety profile consistent with that seen in prior Moderna infectious disease vaccine clinical studies. The sole incidence of a grade 3 adverse event in the 25 µg and 100 µg dose cohorts was a single participant at 100 µg who experienced grade 3 erythema (redness) around the injection site. To date, the most notable adverse events were seen at the 250 µg dose level, comprising three participants with grade 3 systemic symptoms, only following the second dose. All adverse events have been transient and self-resolving. No grade 4 adverse events or serious adverse events have been reported.
Preclinical results from a viral challenge study in mice conducted in collaboration with NIAID and its academic partners are also available. In this study, vaccination with mRNA-1273 prevented viral replication in the lungs of animals challenged with SARS-CoV-2. Neutralizing titers in Phase 1 clinical trial participants at the 25 µg and 100 µg dose levels were consistent with neutralizing titers that were protective in the mouse challenge model.
Based on the interim Phase 1 data, the Moderna-led Phase 2 study will be amended to study two dose levels, 50 µg and 100 µg, with the aim of selecting a dose for pivotal studies. The NIAID-led Phase 1 study is being amended to include a 50 µg dose level cohort across each of the three age groups. Moderna anticipates the dose for the Phase 3 study to be between 25 µg and 100 µg and expects Phase 3 trial initiation in July, subject to finalization of the clinical trial protocol.
“These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 µg,” said Tal Zaks, M.D., Ph.D., Chief Medical Officer at Moderna. “When combined with the success in preventing viral replication in the lungs of a pre-clinical challenge model at a dose that elicited similar levels of neutralizing antibodies, these data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials.”
“With today’s positive interim Phase 1 data and the positive data in the mouse challenge model, the Moderna team continues to focus on moving as fast as safely possible to start our pivotal Phase 3 study in July and, if successful, file a BLA,” said Stéphane Bancel, Chief Executive Officer at Moderna. “We are investing to scale up manufacturing so we can maximize the number of doses we can produce to help protect as many people as we can from SARS-CoV-2.”
Funding from the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), supported the planning for the Phase 2 and Phase 3 studies of mRNA-1273 and will also support the execution of these studies, as well as the scale-up of mRNA-1273 manufacturing both at the Company’s facilities and that of its strategic collaborator, Lonza Ltd.
Conference Call and Webcast Information
Moderna will host a live conference call and webcast at 8:30 a.m. ET on Monday, May 18, 2020. To access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international) and refer to conference ID 2186342. A webcast of the call will also be available under “Events and Presentations” in the Investors section of the Moderna website at investors.modernatx.com. The archived webcast will be available on Moderna’s website approximately two hours after the conference call.
About mRNA-1273
mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), a part of the NIH. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to NIH on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of mRNA-1273 was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing.
On May 6, the U.S. Food and Drug Administration (FDA) completed its review of the Company’s Investigational New Drug (IND) application for mRNA-1273 allowing it to proceed to a Phase 2 study, which is expected to begin shortly. On May 12, the FDA granted mRNA-1273 Fast Track designation. Moderna is finalizing the protocol for a Phase 3 study, expected to begin in July 2020A summary of the company’s work to date on SARS-CoV-2 can be found here.
About Moderna’s Prophylactic Vaccines Modality
Moderna scientists designed the company’s prophylactic vaccines modality to prevent infectious diseases. More than 1,400 participants have been enrolled in Moderna’s infectious disease vaccine clinical studies under health authorities in the U.S.Europe and Australia. Clinical data demonstrate that Moderna’s proprietary vaccine technology has been generally well-tolerated and can elicit durable immune responses to viral antigens. Based on clinical experience across Phase 1 studies, the company designated prophylactic vaccines a core modality and is working to accelerate the development of its vaccine pipeline.
The potential advantages of an mRNA approach to prophylactic vaccines include the ability to combine multiple mRNAs into a single vaccine, rapid discovery to respond to emerging pandemic threats and manufacturing agility derived from the platform nature of mRNA vaccine design and production. Moderna has built a fully integrated manufacturing plant which enables the promise of the technology platform.
Moderna currently has nine development candidates in its prophylactic vaccines modality, including:
Vaccines against respiratory infections
  • Respiratory syncytial virus (RSV) vaccine for older adults (mRNA-1777 and mRNA-1172 or V172 with Merck)
  • RSV vaccine for young children (mRNA-1345)
  • Human metapneumovirus (hMPV) and parainfluenza virus type 3 (PIV3) vaccine (mRNA-1653)
  • Novel coronavirus (SARS-CoV-2) vaccine (mRNA-1273)
  • Influenza H7N9 (mRNA-1851)
Vaccines against infections transmitted from mother to baby
  • Cytomegalovirus (CMV) vaccine (mRNA-1647)
  • Zika vaccine (mRNA-1893 with BARDA)
Vaccines against highly prevalent viral infections
  • Epstein-Barr virus (EBV) vaccine (mRNA-1189)
To date, Moderna has demonstrated positive Phase 1 data readouts for seven prophylactic vaccines (H10N8, H7N9, RSV, chikungunya virus, hMPV/PIV3, CMV and Zika). Moderna’s CMV vaccine is currently in a Phase 2 dose-confirmation study. Moderna’s investigational Zika vaccine (mRNA-1893), currently in a Phase 1 study, was granted FDA Fast Track designation in August 2019.
About Moderna
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The company’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.
Headquartered in Cambridge, Mass.Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been named a top biopharmaceutical employer by Science for the past five years. To learn more, visit www.modernatx.com.
Forward Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding the Company’s development of a potential vaccine against the novel coronavirus, the parameters and timing of the Phase 1 and planned Phase 2 and 3 studies of mRNA-1273, the Company’s investment in manufacturing, and the Company’s intentions regarding vaccine dose production. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “could”, “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the fact that the safety and efficacy of mRNA-1273 has not yet been established; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.
Moderna
Media:
Colleen Hussey
Senior Manager, Corporate Communications
203-470-5620
Colleen.Hussey@modernatx.com
Dan Budwick
1AB
973-271-6085
Dan@1abmedia.com
Investors:
Lavina Talukdar
Head of Investor Relations
617-209-5834
Lavina.Talukdar@modernatx.com
Source: Moderna, Inc.

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