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COVID Moderna

Moderna COVID-19 vaccine appears safe, shows signs of working in older adults: study – Reuters

CHICAGO (Reuters) – Results from an early safety study of Moderna Inc’s MRNA.O coronavirus vaccine candidate in older adults showed that it produced virus-neutralizing antibodies at levels similar to those seen in younger adults, with side effects roughly on par with high-dose flu shots, researchers said on Tuesday.

The study, published in the New England Journal of Medicine, offers a more complete picture of the vaccine’s safety in older adults, a group at increased risk of severe complications from COVID-19.

The findings are reassuring because immunity tends to weaken with age, Dr. Evan Anderson, one of the study’s lead researchers from Emory University in Atlanta, said in a phone interview.

The study was an extension of Moderna’s Phase I safety trial, first conducted in individuals aged 18-55. It tested two doses of Moderna’s vaccine – 25 micrograms and 100 micrograms – in 40 adults aged 56 to 70 and 71 and older.

Overall, the team found that in older adults who received two injections of the 100 microgram dose 28 days apart, the vaccine produced immune responses roughly in line with those seen in younger adults.

Moderna is already testing the higher dose in a large Phase III trial, the final stage before seeking emergency authorization or approval.

Side effects, which included headache, fatigue, body aches, chills and injection site pain, were deemed mainly mild to moderate.

In at least two cases, however, volunteers had severe reactions.

One developed a grade three fever, which is classified as 102.2 degrees Fahrenheit (39°C) or above, after receiving the lower vaccine dose. Another developed fatigue so severe it temporarily prevented daily activities, Anderson said.

Typically, side effects occurred soon after receiving the vaccine and resolved quickly, he said.

“This is similar to what a lot of older adults are going to experience with the high dose influenza vaccine,” Anderson said. “They might feel off or have a fever.”

Norman Hulme, a 65-year-old senior multimedia developer at Emory who took the lower dose of the vaccine, said he felt compelled to take part in the trial after watching first responders in New York and Washington State fight the virus.

“I really had no side effects at all,” said Hulme, who grew up in the New York area.

Hulme said he was aware Moderna’s vaccine employed a new technology, and that there might be a risk in taking it, but said, “somebody had to do it.”

Reporting by Julie Steenhuysen; Editing by Bill Berkrot

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COVID Moderna

Moderna COVID-19 vaccine appears safe, shows signs of working in older adults: study – Yahoo News

By Julie Steenhuysen

CHICAGO (Reuters) – Results from an early safety study of Moderna Inc’s coronavirus vaccine candidate in older adults showed that it produced virus-neutralizing antibodies at levels similar to those seen in younger adults, with side effects roughly on par with high-dose flu shots, researchers said on Tuesday.

The study, published in the New England Journal of Medicine, offers a more complete picture of the vaccine’s safety in older adults, a group at increased risk of severe complications from COVID-19.

The findings are reassuring because immunity tends to weaken with age, Dr. Evan Anderson, one of the study’s lead researchers from Emory University in Atlanta, said in a phone interview.

The study was an extension of Moderna’s Phase I safety trial, first conducted in individuals aged 18-55. It tested two doses of Moderna’s vaccine – 25 micrograms and 100 micrograms – in 40 adults aged 56 to 70 and 71 and older.

Overall, the team found that in older adults who received two injections of the 100 microgram dose 28 days apart, the vaccine produced immune responses roughly in line with those seen in younger adults.

Moderna is already testing the higher dose in a large Phase III trial, the final stage before seeking emergency authorization or approval.

Side effects, which included headache, fatigue, body aches, chills and injection site pain, were deemed mainly mild to moderate.

In at least two cases, however, volunteers had severe reactions.

One developed a grade three fever, which is classified as 102.2 degrees Fahrenheit (39°C) or above, after receiving the lower vaccine dose. Another developed fatigue so severe it temporarily prevented daily activities, Anderson said.

Typically, side effects occurred soon after receiving the vaccine and resolved quickly, he said.

“This is similar to what a lot of older adults are going to experience with the high dose influenza vaccine,” Anderson said. “They might feel off or have a fever.”

Norman Hulme, a 65-year-old senior multimedia developer at Emory who took the lower dose of the vaccine, said he felt compelled to take part in the trial after watching first responders in New York and Washington State fight the virus.

“I really had no side effects at all,” said Hulme, who grew up in the New York area.

Hulme said he was aware Moderna’s vaccine employed a new technology, and that there might be a risk in taking it, but said, “somebody had to do it.”

(Reporting by Julie Steenhuysen; Editing by Bill Berkrot)

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Moderna CEO downplays vaccine timeline pressure: ‘We don’t want the first, we want the best’ – Yahoo Finance

Anjalee Khemlani

As the scientific race for an effective coronavirus vaccine becomes embroiled in controversy, Moderna (MRNA) CEO Stéphane Bancel dismissed suggestions about political pressure, telling Yahoo Finance in an interview that his company was not under the gun from the government.

President Donald Trump has insisted the U.S. will approve a vaccine by Election Day, even as his top health officials have contradicted him. In the U.S., Moderna and Pfizer (PFE) are considered the two frontrunners, and the latter has said it can expect the first safety readout by the end of October.

Yet unlike Pfizer, Moderna, has relied on government funding from the Trump administration’s “Operation Warp Speed” initiative. Despite the nearly $1 billion in federal funding, and the urgency to find workable treatments as infections rise worldwide, Bancel insisted the company is not being pressured — and never has been.

“We have had, from no governments, any pressure to go faster,” Bancel told “The Final Round” on Thursday.

In fact, Moderna is riding a wave of momentum around its company’s vaccine candidate, and hopes to translate that into ongoing enthusiasm about the mRNA technology, the CEO added.

Trump’s aggressive expectations of having a vaccine by Election Day have been tempered by scientists and his own public health officials. During Moderna’s investor day on Thursday, chief medical officer Tal Zaks said that getting regulatory approval by November is “a question of getting lucky.”

Despite being slightly behind Pfizer in its development — even as both began clinical trials on the same day— Moderna’s chief insisted he’s not concerned about meeting anyone’s timeline.

“We’re not solving to be the first vaccine, we want to have the best vaccine,” Bancel told Yahoo Finance.

“I would rather be two weeks behind the first vaccine and have the best vaccine, plus from a business standpoint and potential turnover it will have no impact,” he added.

U.S. cases are up over 1src%. (Graphic: David Foster/Yahoo Finance)

U.S. cases are up over 10%. (Graphic: David Foster/Yahoo Finance)

Racing toward the finish line

The company willingly slowed down enrollment of its Phase 3 trial. Moderna has already enrolled 25,000 of the 30,000 required for Phase 3, and 10,000 of those individuals have already received the second required dose.

But in the past few weeks, the company closed down enrollment at sites that were not doing well with diverse populations. That said, Bancel said it wouldn’t affect the company’s ability to file for an emergency use authorization by November, the earliest possible for an efficacy reading.

Moderna’s initial safety readout depends on 53 individuals contracting the virus. If the company reaches that marker, and the infected individuals are in the placebo group, the company can move forward with an emergency use authorization filing.

Like other vaccine makers in the race, Moderna is already manufacturing as much of the vaccine it can — ready to ship out as soon as the FDA gives the green light for the product. That will have no impact on fourth quarter sales, Bancel said.

However, some experts have warned that, with little known about what level of antibody protection a vaccine truly offers, some of the frontrunners could be providing limited protection.

“It is true that there are vaccines behind us that have a higher chance of working,” Bancel said. Yet pre-clinical data that was published in the New England Journal of Medicine showed there could be strong protection that prevents transmission of the virus.

Regardless of the outcome, the company has already benefitted from the race by being closer to commercialization of a product that it was at the start of the year.

A vaccine could “accelerate the company’s transition to a commercial company by 3-4 years,” including a limited emergency use authorization this year and a full license for the product by 2021, Bancel said.

On Thursday, the company also announced ambitions to break into the seasonal flu vaccine market, after having worked for some time on a bird flu vaccine. The company has more products in the pipeline in clinical trials — in keeping with Bancel’s insistence that Moderna is more than just a COVID-19 vaccine maker.

More from Anjalee:

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Moderna updates

Moderna CEO updates timing for COVID-19 vaccine trial results – msnNOW

Moderna, the first pharmaceutical firm to conduct human trials of a coronavirus vaccine in the U.S., said it should know sometime in November whether its vaccine works. Moderna CEO Stephane Bancel told CNBC on Thursday that it could have enough data by October from its late-stage trial to evaluate its efficacy, although he said he viewed that timeline as unlikely, according to the report. 

President Donald Trump has asserted that a vaccine could be ready “during the month of October.” Experts say that is unlikely given the time required to test and evaluate the vaccines for efficacy and safety. U.S. Centers for Disease Control Director Robert Redfield told Congress Wednesday that a vaccine wouldn’t be widely available until the second or third quarter of next year — a projection that Mr. Trump took issue with, saying that Redfield “made a mistake.”

Redfield also said a mask could be even more effective in fighting the virus than a vaccine for someone who fails to build an immunity response from the vaccine. 

“This face mask is more guaranteed to protect me against COVID than when I take a COVID vaccine,” Redfield said while showing his mask. “… If I don’t get an immune response, the vaccine’s not going to protect me. This face mask will.”

So far, there are seven vaccines, including Moderna’s product, in final Phase 3 testing, which involves large-scale tests on people.

“If the infection rate in the country were to slow down in the next weeks, it could potentially be pushed out in a worst-case scenario in December,” Bancel told CNBC.


Final clinical trials on COVID-19 vaccines

03:20

During a presentation on Thursday about Moderna’s research and development efforts, the company said it has enrolled more than 25,000 people in the Phase 3 trial. The company had reported promising results in a smaller-scale test earlier this year.

The company also said it was scaling manufacturing to produce between 500 million to 1 billion doses of the vaccine. 

Moderna’s vaccine, which uses messenger RNA, or mRNA, to trick the body into producing viral proteins to fight disease, could require two shots to provide protection from the coronavirus. About 10,000 volunteers have received a second shot in the Phase 3 trial, Moderna said on Thursday.  

However, no mRNA vaccine has so far been approved for an infectious disease, and Moderna has yet to bring a product to market, according to Deutsche Bank analysts. 

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Moderna talks

Moderna in talks to supply Japan with 40 million doses of COVID-19 vaccine – MarketWatch

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CDC now says people without symptoms who have been exposed to COVID-19 don’t need to get tested

The Centers for Disease Control and Prevention on Monday updated guidance to say that Americans who have recently been exposed to someone with COVID-19 for more than 15 minutes and do not have symptoms do not need to get tested. “You do not necessarily need a test unless you are a vulnerable individual or your health care provider or state or local public health officials recommend you take one,” the CDC said. This is a change from previous guidance that said people who had spent more than 15 minutes with an individual who has tested positive for the virus should also get tested, regardless of symptoms. The U.S. has conducted more than 73 million tests this year, and about 6 million of them have come back positive. The CDC’s decision has been criticized by some in the medical community. “Our work on the ‘silent’ spread underscores the importance of testing people who have been exposed to COVID-19 regardless of symptoms,” Alison Galvani, an epidemiologist and director of the Center for Infectious Disease Modeling and Analysis, tweeted. “This change in policy will kill.” It is estimated that up to 40% of people who have COVID-19 are asymptomatic, meaning they do not demonstrate common symptoms of an infection like coughing or muscle aches, according to one research letter published in May in JAMA Network.

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COVID Moderna

Moderna COVID-19 vaccine appears to work as well in older adults in early study – Reuters

(Reuters) – Moderna Inc (MRNA.O) said on Wednesday its experimental COVID-19 vaccine induced immune responses in older adults similar to those in younger participants, offering hope that it will be effective in people considered to be at high risk for severe complications from the coronavirus.

FILE PHOTO: A sign marks the headquarters of Moderna Therapeutics, which is developing a vaccine against the coronavirus disease (COVID-19), in Cambridge, Massachusetts, U.S., May 18, 2020. REUTERS/Brian Snyder/File Photo

The company is one of the leading contenders in the race to develop a vaccine against the virus that has killed more than 820,000 people worldwide. Its candidate, mRNA-1273, is already in late-stage human trials testing its ability to safely prevent infection.

The latest data from an early Phase I study includes an analysis from 20 additional people detailing how the vaccine performed in older adults.

The analysis looked at subjects given the 100-microgram dose being tested in the much larger Phase III trial. Moderna said the immune responses in those aged between ages 56 and 70, above age 70 and those 18 to 55-years-old were similar.

Health officials have been concerned about whether vaccine candidates would work in older people, whose immune systems typically do not respond as strongly to vaccines.

Moderna shares, which have more than tripled in value this year, rose about 6% after the data’s release.

The company has so far enrolled over 13,000 participants in its late-stage study. About 18% of the total participants are Black, Latino, Native American or Alaska Native, groups that have been particularly hard hit by the pandemic, and are often under represented in clinical trials.

Dr. Jacqueline Miller, Moderna’s head of infectious disease development, told a U.S. Centers for Disease Control and Prevention (CDC) panel the company plans to post weekly updates on enrollment of Black and Latino trial subjects on its website.

Pfizer Inc (PFE.N) told Reuters last week that 19% of the 11,000 subjects already enrolled in its vaccine trial are Black or Latino.

Miller said the demographic makeup of Moderna’s trial is a frequent topic at meetings with U.S. officials heading the White House program aimed at accelerating development of COVID-19 vaccines and treatments.

DEEP FREEZE

Companies and health officials also are working on ways to distribute COVID-19 vaccines, some of which must be shipped and stored at extremely cold temperatures.

Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, questioned Pfizer’s plans after the company said its vaccine must be stored at ultra-low temperatures for up to 6 months or in specially designed shipping containers for up to 10 days.

Once removed from the containers, the vaccine can be kept for up to a day at a temperatures between 2 and 8 degrees Celsius (36-46°F) – roughly the temperature of a normal refrigerator – or 2 hours at room temperature.

“The complexities of this plan for vaccine storage and handling will have major impact in our ability to efficiently deliver the vaccine,” Messonnier said.

Pfizer told the CDC panel it is working on making the vaccine stable at higher temperatures. Pfizer shares were down about 1.5%.

Moderna’s vaccine has to be kept at minus 20 degrees Celsius for shipping and longer-term storage of up to six months, but it can be kept at regular refrigeration temperatures for up to 10 days. The vaccine will be distributed in 10-dose vials with no preservatives, the company said.

Moderna is also working to make the vaccine stable at higher temperatures, Miller said.

Moderna, which has never brought a vaccine to market, has received nearly $1 billion from the U.S. government under its Operation Warp Speed program. It has also struck a $1.5 billion supply agreement with the United States.

Reporting by Manojna Maddipatla in Bengaluru; Additional reporting by Ankur Banerjee and Michael Erman; Editing by Jonathan Oatis, Peter Henderson and Bill Berkrot

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Moderna CEO: I am aligned with shareholders even though I am selling stock – Yahoo Finance

Moderna CEO Stéphane Bancel joins Yahoo Finance’s Alexis Christoforous, Brian Sozzi, and Anjalee Khemlani to discuss the company’s entry into the Phase 3 trial of its COVID-19 vaccine, and what to expect.

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Moderna Announces Expansion of BARDA Agreement to Support Larger Phase 3 Program for Vaccine (mRNA-1273) Against COVID-19 – Yahoo Finance

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 a modification to its contract with the Biomedical Advanced Research and Development Authority (BARDA) for an additional commitment of up to $472 million to support late stage clinical development including the expanded Phase 3 study of the Company’s mRNA vaccine candidate (mRNA-1273) against COVID-19.

An earlier award from BARDA for up to $483 million was entered into to support the scale up of mRNA-1273 and clinical development, originally with a smaller anticipated number of participants in the Phase 3 clinical trial. Following discussions with the U.S. Food and Drug Administration (FDA) and consultations with Operation Warp Speed over the past several months, the Company has decided to conduct a significantly larger Phase 3 clinical trial, leaving a gap in BARDA funding that will be closed by this contract modification. Under the terms of the revised contract, BARDA is expanding their support of the Company’s late stage clinical development of mRNA-1273, including the execution of a 30,000 participant Phase 3 study in the U.S. The total value of the award is now approximately $955 million.

“We thank BARDA for this continued commitment to mRNA-1273, our vaccine candidate against COVID-19.” said Stéphane Bancel, Moderna’s Chief Executive Officer. “Encouraged by the Phase 1 data, we believe that our mRNA vaccine may aid in addressing the COVID-19 pandemic and preventing future outbreaks.”

ClinicalTrials.gov identifier is NCT04470427.” data-reactid=”27″ type=”text”>The Phase 3 COVE study is being conducted in collaboration with National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and is expected to begin tomorrow, July 27. The Phase 3 study protocol has been reviewed by the U.S. Food and Drug Administration (FDA) and is aligned to recent FDA guidance on clinical trial design for COVID-19 vaccine studies. The randomized, 1:1 placebo-controlled trial is expected to include approximately 30,000 participants at the 100 µg dose level in the U.S. The primary endpoint will be the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease (as defined by the need for hospitalization) and prevention of infection by SARS-CoV-2. The ClinicalTrials.gov identifier is NCT04470427.

Moderna is working closely with Operation Warp Speed and the NIH, including NIAID’s COVID-19 Prevention Trials Network (CoVPN), to conduct the Phase 3 COVE study. Working together with collaborators like NIH, the Company hopes to achieve a shared goal that the participants in the COVE study are representative of the communities at highest risk for COVID-19 and of our diverse society.

strategic collaboration with Lonza. In addition, Moderna recently announced a collaboration with Catalent for large-scale, commercial fill-finish manufacturing of mRNA-1273 at Catalent’s biologics facility in Indiana. Initial funding of $1.3 billion for Moderna to begin producing mRNA-1273 supply at-risk was secured from investors in the Company’s most recent public equity offering in May 2020.” data-reactid=”29″ type=”text”>The Company remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021 from the Company’s internal U.S. manufacturing site and strategic collaboration with Lonza. In addition, Moderna recently announced a collaboration with Catalent for large-scale, commercial fill-finish manufacturing of mRNA-1273 at Catalent’s biologics facility in Indiana. Initial funding of $1.3 billion for Moderna to begin producing mRNA-1273 supply at-risk was secured from investors in the Company’s most recent public equity offering in May 2020.

BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50120C00034.

prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from the VRC. 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 12, the FDA granted mRNA-1273 Fast Track designation. Both cohorts, healthy adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300), in the Company’s Phase 2 study of mRNA-1273 are fully enrolled. A summary of the company’s work to date on COVID-19 can be found here.” data-reactid=”32″ type=”text”>mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from the VRC. 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 12, the FDA granted mRNA-1273 Fast Track designation. Both cohorts, healthy adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300), in the Company’s Phase 2 study of mRNA-1273 are fully enrolled. A summary of the company’s work to date on COVID-19 can be found here.

Moderna scientists designed the company’s prophylactic vaccines modality to prevent infectious diseases. More than 1,900 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.

nine development candidates in its prophylactic vaccines modality, including:” data-reactid=”40″ type=”text”>Moderna currently has nine development candidates in its prophylactic vaccines modality, including:

  • 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)
  • COVID-19 vaccine (mRNA-1273)
  • Influenza H7N9 (mRNA-1851)
  • Cytomegalovirus (CMV) vaccine (mRNA-1647)
  • Zika vaccine (mRNA-1893 with BARDA)
  • Epstein-Barr virus (EBV) vaccine (mRNA-1189)
  • To date, Moderna has demonstrated positive Phase 1 data readouts for eight prophylactic vaccines (H10N8, H7N9, RSV, chikungunya virus, hMPV/PIV3, CMV, Zika and COVID-19). 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.

    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.

    www.modernatx.com.” data-reactid=”58″ type=”text”>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 ranked in the top ten of Science’s list of top biopharma industry employers for the past five years. To learn more, visit www.modernatx.com.

    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.” data-reactid=”60″ type=”text”>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 P

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    Moderna Downgraded to Neutral by J.P. Morgan on Valuation Concerns – TheStreet

    Drugmaker Moderna  (MRNA) – Get Report, one of the front-runners to producing a viable coronavirus vaccine, fell on Monday after Oxford University and AstraZeneca  (AZN) – Get Report published promising data from an early stage trial of a key coronavirus vaccine study and the stock received a downgrade from J.P. Morgan.

    In a study published on Monday, Oxford and AstraZeneca’s coronavirus vaccine trial showed “potent” cellular and humoral immunogenicity in all 1,077 participants in a Phase 1/Phase II study.

    That, combined with an unrelated downgrade from J.P. Morgan analyst Cory Kasimov to neutral from overweight, pushed shares of Moderna lower. The stock was down 10.12% at $85.25 in trading on Monday. 

    Moderna stock has surged in recent months as various studies of its coronavirus vaccine candidate,  mRNA-1273, have shown promising results in various clinical trials. 

    Moderna’s vaccine has shown to produce coronavirus antibodies in trials, federal researchers said last week, something National Institute of Allergy and Infectious Diseases’ head Dr. Anthony Fauci has called “really quite promising.”

    At the same time, Moderna is one of hundreds of companies seeking an effective vaccine, with no resolute proof that it has the recipe for success. More than 20 vaccine hopefuls are in human testing, and another 130 are in earlier phases of development, according to the World Health Organization.

    Moderna, which is applying similar technology as Pfizer  (PFE) – Get Report and BioNTech  (BNTX) – Get Report to develop a vaccine, received fast-track approval from the Food and Drug Administration for its Covid-19 vaccine candidate in May.

    For its part, Moderna will begin a Phase 3 trial on July 27 that is expected to include some 30,000 participants. The participants will help compare its vaccine with placebo injections of the vaccine and determine whether it continues to show a buildup of antibodies needed to fend off the coronavirus.

    Moderna has been focused on testing a vaccine that will not only prevent infection from SARS-CoV-2, the virus that causes Covid-19, but also prevent severe cases of the disease that require hospitalization.

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    Is Moderna Close to Winning the Coronavirus Vaccine Race? – Motley Fool

    Moderna’s phase 1 data looks positive, but the company’s investigational coronavirus vaccine has a lot more to prove in late-stage trials.

    Moderna (NASDAQ:MRNA) has taken another step closer to making its dream of commercializing a coronavirus vaccine a reality. The company just released more detailed interim results from its phase 1 trial — and they are enough for Moderna and investors to cheer about.

    What’s so encouraging about the results? And do they really bring Moderna close to victory? Let’s take a look.

    A researcher draws a dose of vaccine from a vial.

    Image source: Getty Images.

    Moderna’s trial included 45 healthy volunteers ranging from 18 to 55 years old. Each participant was given two doses of mRNA-1273 28 days apart in one of three dosage levels. Based on the results, Moderna chose to pursue the 100-microgram dose — the mid-range dose — in late-stage trials.

    Neutralizing antibody levels

    The key positive in the phase 1 data has to do with neutralizing antibodies. These are the antibodies that actually block infection, so the ability of a vaccine to stimulate their production is crucial. Moderna, in a publication in The New England Journal of Medicine, reported that all evaluated trial participants showed neutralizing antibody production. And in the 100-microgram dosage group, levels were four times higher than those seen in recovered COVID-19 patients.

    Initial data released in May only showed neutralizing antibody data for eight trial participants. While the neutralizing antibody levels came in at or above those of patients who had suffered from COVID-19, the sample wasn’t big enough to demonstrate a clear trend. This latest report of neutralizing antibody production in all participants is a big step forward. Results also showed T-cell responses following the second dose in the lower-dosage group and in the 100-microgram dose. T cells are another important piece of the puzzle as they are an immune system tool to detect and fight infection.

    Moderna will aim to replicate that positive data in as many as 30,000 people when the company begins phase 3 studies on July 27.

    A step closer to the finish line

    All of this is good news for Moderna. The biotech company has taken a step closer to the finish line. But others have been catching up. Moderna isn’t as far ahead as it was several weeks ago.

    AstraZeneca (NYSE:AZN) is conducting a phase 2/3 trial now. The U.S. Food and Drug Administration recently granted the Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) team Fast Track designation for two vaccine candidates. Pfizer and BioNTech, like Moderna, are developing a vaccine using messenger RNA. They aim to begin a phase 2b/phase 3 trial in 30,000 participants later this month. Moderna, AstraZeneca, and the Pfizer and BioNTech team are among a handful of drugmakers closest to the finish line right now. 

    Inovio Pharmaceuticals (NASDAQ:INO) and Novavax (NASDAQ:NVAX) are close behind. Inovio plans to begin a phase 2/3 study this summer, and Novavax expects to release phase 1/2 interim data at the end of this month and then begin the phase 2 part of the study shortly thereafter.

    Of course, that list of “who is ahead” is all from a timeline perspective. What, ultimately, is most important — and will determine the winner or winners — is the safety and efficacy of the vaccine candidate. Though Moderna’s results are encouraging, we still should rein in excitement.

    Here’s why: First there’s the question of neutralizing antibodies. It’s still not clear how long neutralizing antibodies will remain in the body and what level of antibodies is needed to prevent infection. Another question is the vaccine’s performance in the elderly, a group heavily hit by COVID-19. A successful vaccine must be safe and effective in this population. Moderna is testing the vaccine in older and elderly volunteers in phase 2 and will also include these groups in phase 3.

    What does this mean for investors?

    Moderna shares have climbed 315% since the start of the year. The company doesn’t yet have products on the market. Besides the COVID-19 vaccine, Moderna’s most advanced candidate is in phase 2 studies. That means if Moderna’s vaccine fails, the company is still years away from commercializing a product.

    In the near term, with any good news, this biotech stock likely has more to gain. And if Moderna’s vaccine is successful, the shares may skyrocket. But if the company loses this race or produces a vaccine that isn’t as strong as a rival’s, the result may be devastating for the shares. That’s why, for now, long-term investors may want to watch Moderna’s final sprint to the finish from the sidelines.


    Adria Cimino has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

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