Selected Publications

Moderna is proud to be among the many groups working to respond to this continuing global health emergency. This page summarizes key milestones in our work to advance our vaccine candidate (mRNA-1273) and responds to frequently asked questions.

Timeline of our response through March 27, 2020

  • On January 11, 2020, the Chinese authorities shared the genetic sequence of the novel coronavirus.
  • On January 13, 2020, the U.S. National Institutes of Health (NIH) and Moderna’s infectious disease research team finalized the sequence for mRNA-1273, the Company’s vaccine against the novel coronavirus. At that time, the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, disclosed their intent to run a Phase 1 study using the mRNA-1273 vaccine in response to the coronavirus threat and Moderna mobilized toward clinical manufacture. Manufacture of this batch was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).
  • On February 7, 2020, the first clinical batch, including fill and finishing of vials, was completed, a total of 25 days from sequence selection to vaccine manufacture. The batch then proceeded to analytical testing for release.
  • On February 24, 2020, the clinical batch was shipped from Moderna to the NIH for use in their Phase 1 clinical study.
  • On March 4, 2020, the U.S. Food and Drug Administration (FDA) completed its review of the Investigational New Drug (IND) application filed by the NIH for mRNA-1273 and allowed to the study to proceed to begin clinical trials.
  • On March 16, 2020, the NIH announced that the first participant in its Phase 1 study for mRNA-1273 was dosed, a total of 63 days from sequence selection to first human dosing. This Phase 1 study will provide important data on the safety and immunogenicity of mRNA-1273. Immunogenicity means the ability of the vaccine to induce an immune response in participants. The open-label trial is expected to enroll 45 healthy adult volunteers ages 18 to 55 years over approximately six weeks.
  • On March 23, 2020, Moderna filed a Current Report on Form 8-K which included, among other things, information regarding the potential timing of the availability of a vaccine against COVID-19. The Company reported that the Phase 1 study is proceeding in accordance with the protocol under the direction of NIAID. The Company further reported that while a commercially-available vaccine is not likely to be available for at least 12-18 months, it is possible that under emergency use, a vaccine could be available to some people, possibly including healthcare professionals, in the fall of 2020. Any emergency use would be subject to authorization by the appropriate regulatory agencies, based on the emergence of clinical data for mRNA-1273 that would support use of the vaccine prior to licensure. In addition, the Company confirmed that it is scaling up manufacturing capacity toward the production of millions of doses per month, in the potential form of individual or multi-dose vials. As has previously been disclosed, the ability of the Company to make millions of doses per month is contingent on investments in the scale up and further buildout of the Company’s existing manufacturing infrastructure.
  • On March 27, 2020, the NIH announced that Emory University in Atlanta will begin enrolling healthy adult volunteers ages 18 to 55 years in the NIH-led Phase 1 study of mRNA-1273. 

Frequently asked questions about our technology & platform

How well validated is your mRNA platform? 

mRNA is an emerging platform. Over the past few years, we have demonstrated its potential in vaccines across more than 1,000 subjects in our clinical trials. This includes successful early-stage (Phase 1) clinical trials against five other respiratory viruses (two pandemic influenza strains, RSV, hMPV, and PIV3). Over the last four years, we have started 9 clinical trials for mRNA vaccines.

However, it is important to emphasize that we are still early in the story. Our most advanced vaccine program (CMV) is in Phase 2 clinical testing and we have no approved drugs to date.

Despite this, we are doing everything we can to help in the current emergency by working to develop a safe and effective vaccine for this novel coronavirus. 

Have you ever worked on other coronaviruses?     

We had previously collaborated with the NIH on a vaccine for MERS-CoV, which is a different type of coronavirus than the current pandemic. While the program was only at the research stage, it provided significant insights as we launched our efforts for mRNA-1273. Before the Phase 1 study for mRNA-1273, we had not previously tested a coronavirus vaccine in humans.

How was mRNA-1273 able to move so quickly?    

mRNA is an information molecule and we design our mRNA vaccines using the sequence of the virus, not by working on the virus itself. Our mRNA platform provides significant advantages in speed and efficiency, across basic science, manufacturing, and clinical development. 

Moderna currently has 9 development candidates in its prophylactic vaccines modality. To date, Moderna has demonstrated positive Phase 1 data readouts for 6 prophylactic vaccines (H10N8, H7N9, RSV, chikungunya virus, hMPV/PIV3 and CMV).

For mRNA-1273, we were able to leverage our experience in vaccines to move rapidly on design and manufacture of material for the Phase 1 clinical trial. This included our broad understanding of the safety of our platform to date across more than 1,000 subjects. We also benefited from the use of our well-established manufacturing capabilities, which produced over 100 batches of mRNA medicines for use in human clinical trials in just the last two years.

Frequently asked questions about the next steps for mRNA-1273

What happens after the Phase 1?    

Phase 1 safety and immunogenicity data from the trial being run by the NIH is expected to guide our next steps. Given the pandemic, we have started to work in parallel to responsibly accelerate further development. 

The Company is actively preparing for a potential Phase 2 study under its own Investigational New Drug (IND) filing to build on data from the ongoing Phase 1 study being conducted by the NIH. To continue to progress this potential vaccine during the ongoing global public health emergency, Moderna intends to work with the FDA and other government and non-government organizations to be ready for a Phase 2 and any subsequent trials, which are anticipated to include a larger number of subjects and which will seek to generate additional safety and immunogenicity data. Manufacture of the mRNA-1273 material for the potential Phase 2 trial, which could begin in a few months, is underway. Moderna continues to prepare for rapid acceleration of its manufacturing capabilities that could allow for the future manufacture of millions of doses should mRNA-1273 prove to be safe and effective.

Our goal is to generate data that will demonstrate the safety and effectiveness of mRNA-1273 against infection caused by SARS-CoV-2.

Are you working on further supply of the vaccine?    

Moderna has already started to prepare for rapid acceleration of its manufacturing capabilities that could allow for the future manufacture of millions of doses should mRNA-1273 prove to be safe and of expected benefit. We are working around-the-clock to make sure a vaccine is available as quickly and as broadly as possible. We will continue to work together, with government, industry and other third parties to enable the best chance for success.

About mRNA-1273, Moderna’s Potential Vaccine Against COVID-19

Related Resources

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 conduct and timing of the Phase I study of mRNA-1273, the planning, conduct and timing of a potential Phase 2 and any subsequent trials of mRNA-1273, and potential manufacturing capabilities. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “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 summary and FAQ 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; and those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Annual Report on Form 10-K 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 summary and FAQ 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.

The medical community stands in solidarity with the world against COVID19. We are willing to risk our lives to save lives. But we need ADEQUATE PERSONAL PROTECTIVE EQUIPMENT (PPE). We need #PPE! Thank you! Use the popwer of social media to spread the message.

It is a rather surprising that the president of the United States Donald Trump, recommended two drugs as covid-19 treatments tweeting the following. Please understand the treatments vary from case to case, and also these drugs are not vaccines.

Note:- Please don't take hydroxychloroquine (Plaquenil) plus Azithromycin for COVID19 UNLESS your doctor prescribes it. Both drugs affect the QT interval of your heart and can lead to arrhythmias and sudden death, especially if you are taking other meds or have a heart condition.

People need to understand these meds are used by sick people for other infections and autoimmune diseases. If you start buying & hoarding them "just in case" then there will be none left for those who need them NOW. Please act responsibly. There will be enough if we all work together.

The 1st clinical trial of a potential vaccine for coronavirus has actually started in Seattle. Although it may take 12-18 months to “fully validate” a vaccine, medical community is looking to manufacture doses of our best options NOW, so we can vaccinate SOONER.

While it's true that treatments like chloroquine or hydroxychloroquine (a cheap malarial drug) seem to work, it's only because coronavirus or covid-19 affects red blood cell production, kicking out the iron from blood cells, thereby influencing the oxygen carrying capacity. New work out of China says COVID-19 might also involve abnormal blood production. CoV genes 1 & 8 are predicted to interfere with heme, the red compound in blood, by kicking out the iron. This would explain why chloroquine seems effective as a treatment, but it's not the vaccine, nor the cure!

Other treatments that seem to work are Gilliad's remdesivir with interferon-beta (in clinical trials from COV-19), plasma from recovered patients, and a steroid (methylprednisilone). Doctors in US are now using remdesivir off-label.

What to do when there is no vaccine yet?

The best line of defense against coronavirus right now is social distancing , as mentioned in the WHO advisory.

Another line of defense is working on your own immunity. There are some supplements which can enhace immuity & defence power. The below recommended supplements are NOT the cure of covid-19(coronavirus). They are best taken as proactive measures to build up your immune power:-

Human Growth Hormone supplement:- This product recommended by Dr. Lamm, has the potential to enhance immune system. This clinical study demonstrated the positive effects of HGH administration on immune system. (Effect of 1 year of growth hormone treatment on thymus mass, naive and total T cells.) Thymus gland is the most crucial organ in the body, related to the immune system and HGH has been demonstrated to influence this. For best results, it's recommended to take HGH supplement for at least 3 months or so. It's a comprehensive anti-aging supplement as well, and can be taken by both men and women. HGH is also recommended line of treatment against HIV virus.

SuperGreens antioxidants supplement:- This supplement is the best antioxidants supplement in the USA right now, with world class ingredients. Athletic Greens is a greens powder that was brought out especially for use by athletes and fitness enthusiasts, offering them a premium superfood cocktail, with a well balanced list of ingredients that contains most of what athletes need for peak performance. A single serving of Athletic Greens will give the athlete the requisite daily dose of zinc, almost the whole daily Vitamin A requirement, together with the complete complement of Vitamin C, E and biotin, as well as the necessary assortment of B vitamins needed. These include the herbs and greens that are incorporated for their nutrients and alkalinity. Alkalinity is necessary for all athletes to keep the Ph of their bodies maintained, especially those athletes who neglect the eating of enough green vegetables in their normal diets. The Superfoods group includes supplements like spirulina, wheat grass and chlorella - ALL superfoods loaded with antioxidants. Read more on Physiological role of antioxidants in the immune system.

Other tips to enhance immune system & prevent covid-19

Having a weak immune system may make you feel run down and fatigued most of the time, also you catch colds and viruses often, and you're constantly sick. Have you ever noticed how some people catch everything that everyone else has and others are never sick and always full with energy? Different people have different immune systems. Our immune is how we fight off infections, germs and cancer. Some people's immune systems are weaker and don't work properly, as with immunodeficiency disorders. These people are at a big risk to infection and cancer.

The immune function consists of white blood cells, amino acids and some bigger organs. The immune system is multifaceted and important to our healthy being. A strong and balanced immune is necessary for health maintenance. The immune system is composed of many mutually dependent cell types that together protect the body from bacterial, parasitic, fungal and viral infections like HIV or covid-19, as well as from the growth of tumor cells. Many of these cell types have particular functions. The cells of the immune can defeat bacteria, kill parasites or tumor cells, or kill virus infected cells.

  • Excessive fat, alcohol or refined sugar consumption or not enough of protein, calorie, vitamins, mineral or water intake furthers decreased immune performance as well. Monitor your diet closely.
  • Nutrition and dietary choices are always the most important and natural way we can obtain the most essential immune system vitamins our bodies need to remain strong and healthy. We must examine what we eat, such as whether we get enough whole fruits and veggies, proteins, legumes and grains which are good for immunity, before we can consider how any immune system supplements or immune boosters can benefit the unique functioning and genetic makeup of our individual bodies and metabolisms.
  • The second most important thing we must examine to determine if we can make changes that can enhance our immune health is our everyday activities and lifestyle choices. It is important to consider that exercise, emotional well-being, stress levels, and everyday habits all play a part in the functioning of our immune functioning. What you do everyday can either cause harm to your body, or naturally act as immune boosters to improve your overall health and well-being and protect against viral infections.
  • Getting exercise, even a thirty minute indoor walk daily while you are locked downn, finding quite time for yourself, having fun or just relaxing if you are going through a time of stress, and quitting bad habits like excessive sugar or caffeine intake, or smoking are some of the most important things you can do for your immune system to help protect yourself from coronavirus.
  • Beta sitosterol increases natural killer cell activity, thus their depletion leaves the cells under-active. This contributes to an overall degradation of the innate immune system. Hence, a diet rich in sterols can 'quieten' auto-immune responses and improve immune response generally. Beta glucans are derived from the cell walls of plants like shiitake mushrooms and from baker's yeast. WellmuneTM is a highly purified and patented beta glucan ingredient backed by over £120 million worth of clinical research. WellmuneTM 1,3 1,6 beta glucans, like HGH primes the immune system to increase both the numbers and activity levels of vital immune cells called neutrophils, macrophages and Natural Killer cells. This not only improves your resistance to infection and illness, but also helps your body to heal and recover from disease like a viral infection more quickly.

More updates on Coronavirus vaccine & cure

Interesting -- Johns Hopkins Bloomberg School of Public Health organizing national effort to use antibodies from recovered COVID-19 patients for protection and treatments until a vaccine and antiviral medications are available.

https://www.globalhealthnow.org/2020-03/covid-19s-stop-gap-solution-until-vaccines-and-antivirals-are-ready

Following is a typical course of severe Covid-19 and what doctors are trying & not trying. There are 2 phases: mild symptoms then rapid onset of acute respiratory distress syndrome (ARDS) with a potentially fatal inflammation storm, even though viruses seem to be controlled.

Steroids that suppress inflammation are not recommended for Covid-19, but when the body turns on itself with a hyperinflammation storm, then doctors have weapons to unleash.

A trustworthy clinical trial of tocilizumab (Actemra) showed promising results and is now being used around the world. Actemra blocks the action of the inflammatory protein called Interleukin 6 (IL-6). In China, this drug is now approved for coronavirus. IL-6 is one of hundreds of “cytokines.” But this one plays an especially important role in the immune response & promotes many diseases: autoimmunity, multiple myeloma and prostate cancer. It was developed by Japanese company Chugai and Swiss Hoffmann–La Roche in 2000s.

Actemra is usually used to treat moderate to severe rheumatoid arthritis or to stop inflammation of the lining of blood vessels. The drug is usually given IV but can be given under the skin too.

In the UK, patients with low viral load are being given Actemra. The drug is made of an antibody that sticks to the interleukin-6 (IL-6) receptor which blocks the inflammatory signal. This stems the coronavirus-induced cytokine storm. Other promising approaches to COVID include blocking of another protein called IL-1 using the drug Anakinra from Swedish company Biovitrum, initially developed for sepsis. It showed significant survival benefit in patients with hyperinflammation, without serious side-effects.

Janus kinase (JAK) inhibition I shows promise reducing inflammation and cellular viral entry in COVID-19. Professionals see this reference:

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30628-0/fulltext

Thoughts: Paper from CELL that calls for trials with an availableand reasonably safe Japanese drug that may very well prevent infection. Research from superb German science and medical institutions

https://www.cell.com/cell/pdf/S0092-8674(20)30229-4.pdf

In India this drug is sold as CAMOPAN and manufactured by Sun Pharmaceuticals Ltd.

Camostat mesylate, a serine protease inhibitor, partially blocked CoV-2 entry into human cells, and even better when combined with E-64d, a protease inhibitor. Camostat is approved in Japan and "could be considered for off-label use."

https://sph.nus.edu.sg/wp-content/uploads/2020/03/COVID-19-Science-Report-Therapeutics-13-Mar.pdf

More updates

False claim: Coronavirus vaccine approved in Israel, set for mass production and distribution. An image circulated on social media makes the claim that a vaccine for coronavirus (COVID-19) has been approved in Israel. The image, posted on Facebook on March 14, 2020, makes the further claim that the vaccine is already being mass produced and should soon be available in the U.S. for distribution

What follows is a thread of information, our interpretation, links to sources & predictions. Let's start with what you need to know.

Treatments that seem to work are chloroquine (a cheap malarial drug), Gilliad's remdesivir with interferon-beta (in clinical trials from COV-19), plasma from recovered patients, and a steroid (methylprednisilone). Doctors in US are now using remdesivir off-label.

SARS-CoV2 attacks pneumocytes in lung, intestine, heart & cells lining blood vessels. In lung, CoV2 prevents cells from making biological detergents to keep lung passages open. Acute respiratory distress follows. O2 levels fall..but there's may be a dangerous underlying process.

New work out of China yesterday says COVID-19 might also involve abnormal blood production. CoV genes 1 & 8 are predicted to interfere with heme, the red compound in blood, by kicking out the iron. Would explain why chloroquine seems effective as a treatment.

Chloroquine is predicted to prevent orf1ab, ORF3a and ORF10 from attacking heme (red in red blood cells) and inhibit the binding of ORF8 to heme. Although 99% of the virus is seemingly stable, what's disturbing is ORF 1 and 8 are mutating the fastest. It may explain why diabetics and elderly are more susceptible. Blood sugar levels usually increase as we get older, increasing the amount of glycated hemoglobin (HbA1c) (I've tweeted about this before). The authors suggest these people would be more susceptible because the virus could more easily disrupt the heme in red blood cells. If so, the virus is very smart: it destroys the lung so patients can't take up oxygen AND reduces the body's ability to carry oxygen. (For this & other reasons, you should eat healthily the next 2 years).

These ideas are testable. COVID-19 should correlate with HbA1c levels (seems true). Patients should have abnormalities in heme/porphyrin & they might have higher levels of free iron in tissues & blood. I will update with more info as it comes in. Stay safe.

Below are links...

Blood, HbA1c, and chloroquine

https://chemrxiv.org/articles/COVID-19_Disease_ORF8_and_Surface_Glycoprotein_Inhibit_Heme_Metabolism_by_Binding_to_Porphyrin/11938173

CoV2 mutations

https://www.ncbi.nlm.nih.gov/pubmed/32167180

Symptoms

https://www.ncbi.nlm.nih.gov/pubmed/32167181

Susceptibility/Risk

https://www.ncbi.nlm.nih.gov/pubmed/32167524

Fatality

https://www.ncbi.nlm.nih.gov/pubmed/32168463

Therapies

https://www.ncbi.nlm.nih.gov/pubmed/32023685

Remdesivir

I'm sharing might help shape up solution slow down virus,so metformin+HuperzineA & created accidently in nov2019,took dosage since,found too fast to increase oxygen,remove fever,inflamation,HupA protect cell against cytotoxicity,attenuate stress& protect mitochondria.

Some experte believe that nutraceuticals which reduce HbA1c might help. VD3 (normally good for fighting flus) and its ability to increase ACE2 (which SARS-Cov-2 uses to profilerate); some believe this can be problematic.

Resvereatrol reduces HbA1c

https://www.ncbi.nlm.nih.gov/pubmed/24899709

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