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Moderna Announces Publication in The New England Journal of Medicine of Interim Results From Older Adult Age Cohorts in Phase 1 Study of its mRNA Vaccine Against COVID-19 (mRNA-1273)

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mRNA-1273 induced consistently high levels of pseudovirus neutralization antibody titers in all participants in the 56-70 (n=10) and 71+ (n=10) age cohorts

Potent neturalization responses were confirmed by 3 different live virus assays

mRNA-1273 elicited Th1-biased CD4 T cell responses in the 56-70 and 71+ age cohorts

Neutralizing antibody titers and T cell responses in the 56-70 and 71+ age cohorts were consistent with those reported in younger adults

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At the 25 µg and 100 µg dose levels, mRNA-1273 was generally well-tolerated in all age cohorts

Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the publication of the second interim analysis of the open-label Phase 1 study of mRNA-1273, its vaccine candidate against COVID-19, in The New England Journal of Medicine . This interim analysis evaluated a two-dose vaccination schedule of mRNA-1273 given 28 days apart in 40 healthy adult participants across two dose levels (25 and 100 µg) in two age cohorts (ages 56-70 and ages 71+), and reports results through Day 57 (1 month after the second dose). This analysis found that both the 25 µg and 100 µg dose levels were generally well-tolerated in both age cohorts. Immune responses were dose-dependent with the 100 µg dose eliciting higher binding and neutralizing antibody titers, supporting the selection of the 100 µg dose for further study in the Phase 3 trial. The study was led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

“These interim Phase 1 data suggests that mRNA-1273, our vaccine candidate for the prevention of COVID-19, can generate neutralizing antibodies in older and elderly adults at levels comparable to those in younger adults,” said Tal Zaks, M.D., Ph.D., Chief Medical Officer of Moderna. “Given the increased morbidity and mortality of COVID-19 in older and elderly adults, these data give us optimism in demonstrating mRNA-1273’s protection in this population, which is being evaluated in the Phase 3 COVE study.”

Both the 25 µg and 100 µg dose levels of mRNA-1273 were generally well-tolerated, with no serious adverse events reported through Day 57. The most common solicited adverse events were headache, fatigue, myalgia, chills, and pain at the injection site, the majority of which were mild-to-moderate in severity and of self-limited duration. Local and systemic reactogenicity were more common and more frequently moderate in severity after the second dose. Two severe solicited systemic adverse events occurred following the second vaccination: fever in one participant in the ages 56-70 cohort who received the 25 µg dose and fatigue in one participant in the ages 71+ cohort who received the 100 µg dose. Clinical laboratory values of Grade 2 or higher revealed no pattern of concern. Participants will continue to be followed through 13-months to allow for a longer assessment of vaccine-related adverse events.

At both the 25 µg and 100 µg dose levels, after two vaccinations, mRNA-1273 induced dose-dependent binding antibody responses reaching the upper quartile of the distribution of convalescent sera. At Day 57 (1 month post-dose 2), geometric mean titers (GMT) exceeded the median of those seen in convalescent sera from 41 individuals with confirmed COVID-19 diagnosis.

Neutralizing activity was assessed with multiple assays, including a pseudovirus neutralization assay (pseudotyped lentivirus reporter single-round-of-infection neutralization assay [PsVNA]) against the two most common SARS-CoV-2 variants (614D and 614G) and three live-virus neutralization assays (SARS-CoV-2 nanoluciferase high-throughput neutralization assay [nLUC HTNA], focus reduction neutralization test mNeonGreen [FRNT-mNG] and classical plaque-reduction neutralization test [PRNT]). No participants had detectable neutralizing responses by any assay prior to vaccination, and robust neutralizing activity was observed in all participants 14 days after the second vaccination.

Psuedovirus neutralization responses were observed as early as seven days after the second vaccination and were dose-dependent across all age groups (18-55, 56-70 and 71+). At Day 43 at the 100 µg dose level, PsVNA ID 50 titers in the older adult cohorts ages 56-70 (GMT 402) and 71+ (GMT 317) were comparable to those seen in the age 18-55 cohort (GMT 360), and 3- to 4-fold higher than those seen in convalescent sera (GMT 106). Titers remained high through four weeks after the second dose in all age cohorts. Neutralizing activity against the 614G variant was also observed at the 100 µg dose in all age cohorts.

Results were consistent using 3 live virus assays. Neutralizing antibody titers as measured by nLUC HTNA and FRNT-mNG were similar across all age groups (18-55, 56-70 and 71+). At Day 43, PRNT 80 GMT in the 100 ug dose groups was 878 in the 56-70 and 317 in the 71+ age cohort, representing 5.5 and 2.0-fold above convalescent sera respectively, and 4.1-fold above convalescent sera in the 18-55 age group (GMT 654).

The 25 µg dose in the 56-70 age cohort and the 100 µg dose level across all age groups (18-55, 56-70 and 71+) elicited a strong Th1-biased CD4 T cell response.

The U.S. government has purchased 100 million doses of mRNA-1273, with an option to purchase an additional 400 million doses.

About mRNA-1273

mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from the National Institute of Allergy and Infectious Disease’s (NIAID) Vaccine Research Center. 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 the National Institutes of Health (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. On May 29, the first participants in each age cohort: healthy adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300) were dosed in the Phase 2 study of mRNA-1273. On July 8, the Phase 2 study completed enrollment.

The Phase 3 COVE study of mRNA-1273, being conducted in collaboration with the NIH and BARDA, began on July 27. Results from a non-human primate preclinical viral challenge study evaluating mRNA-1273 were recently published in The New England Journal of Medicine. On July 14, an interim analysis of the original cohorts in the NIH-led Phase 1 study of mRNA-1273 was published in The New England Journal of Medicine . A summary of the company’s work to date on COVID-19 can be found here .

The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), is supporting the continued research and development of mRNA-1273 with $955 million in federal funding under Contract no. 75A50120C00034. BARDA is reimbursing Moderna for 100 percent of the allowable costs incurred by the company for conducting the program described in the BARDA contract. The U.S. government has committed $1.525 billion to purchase supply of mRNA-1273 under U.S. Department of Defense Contract No. W911QY-20-C-0100.

About Moderna’s Prophylactic Vaccines Modality

Moderna scientists designed the company’s prophylactic vaccines modality to prevent infectious diseases. More than 1,900 participants, prior to enrolling the Phase 3 study of mRNA-1273, 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)
  • COVID-19 vaccine (mRNA-1273)
  • Influenza H7N9 vaccine (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 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.

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. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company 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; 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) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been named a top biopharmaceutical employer by Science for the past five years. To learn more, visit www.modernatx.com .

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, but not limited to, statements concerning the potential for mRNA-1273 to generate binding and neutralizing antibodies in older adults, the potential for adverse side effects from mRNA-1273, and the timing for the completion of enrollment for the Phase 3 COVE study of mRNA-1273.. 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 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: preclinical and clinical development is lengthy and uncertain, especially for a new class of medicines such as mRNA, and therefore our preclinical programs or development candidates may be delayed, terminated, or may never advance to or in the clinic; no commercial product using mRNA technology has been approved, and may never be approved; mRNA drug development has substantial clinical development and regulatory risks due to the novel and unprecedented nature of this new class of medicines; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with the Company’s regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; 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 clinical trials, preclinical work, overall operations, regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those 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.

 

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Measles case reported locally turns out to be negative: health unit

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NEWS RELEASE
SIMCOE MUSKOKA DISTRICT HEALTH UNIT
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On March 26, the Simcoe Muskoka District Health Unit (SMDHU) was notified by Public Health Ontario’s (PHO) laboratory that due to laboratory error, the case of measles that had been lab-confirmed positive on March 12, based on symptoms and a positive urine measles laboratory result by PHO’s laboratory, is in fact negative for the measles virus.

“With this new information of the negative lab result, we believe that that individual was not infected with measles and that there has not been any public exposure to measles resulting from this individual’s illness,” said Dr. Charles Gardner, medical officer of health. “We recognize that notifying the public of what we believed to be a positive measles case in our area created worry, anxiety and disruption for some, and we regret this.

“We do know that, despite best efforts, on rare occasions laboratory errors can occur. We are working closely with the PHO’s laboratory to do all that we can to ensure that such an incident does not occur again.”

Measles is a highly contagious viral infection that spreads very easily through airborne transmission. The measles virus can live in the air or on surfaces for up to two hours.

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Symptoms of measles begin seven to 21 days after exposure and include fever, runny nose, cough, drowsiness, and red eyes. Small white spots appear on the inside of the mouth and throat but are not always present. Three to seven days after symptoms begin, a red, blotchy rash appears on the face and then progresses down the body.

The risk of transmission to those vaccinated with two doses is low, and when it does occur tends to show a reduction in the severity of these symptoms.

“Although we are relieved for the individual involved, and for all Simcoe-Muskoka residents, that this case has now been confirmed as negative, we know that measles is still active in Ontario at this time and the potential remains for new cases to arise, especially given the increase in Ontarians travelling to areas in the world that have higher numbers of measles cases,” said Dr. Gardner. “This is why we continue to advise individuals to keep up to date with their routine immunizations, including measles, mumps and rubella (MMR) vaccination.”

The risk of measles is low for people who have been fully immunized with two doses of measles vaccine or those born before 1970; however, many children have been delayed in receiving their routine childhood immunizations and people who have not had two doses of measles vaccine are at higher risk of contracting the disease.

People who do get sick usually recover without treatment, but measles can be more severe for infants, pregnant women, and those with compromised immune systems. Possible complications include middle-ear infections, pneumonia, diarrhea, or encephalitis (swelling of the brain) and occasionally death in the very young. Even individuals who are up to date with the measles vaccine should watch for symptoms of measles for 21 days after exposure.

For more information about measles, please visit smdhu.org or call Health Connection at 705-721-7520 or 1-877-721-7520, Monday to Friday between 8:30 a.m. and 4:30 p.m. to speak with a public health professional.

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Kate Middleton Not Alone. Cancer On Rise For People Under 50, Say Experts

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Kate Middleton revealed on Friday that her cancer was discovered after she received abdominal surgery

London:

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When Catherine, Princess of Wales, revealed she was being treated for cancer last week, part of the shock was that an otherwise healthy 42-year-old has a disease that mostly plagues older people.

However, researchers have been increasingly sounding the alarm that more and more people under 50 are getting cancer — and no one knows why.

Across the world, the rate of under-50s diagnosed with 29 common cancers surged by nearly 80 percent between 1990 and 2019, a large study in BMJ Oncology found last year.

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The researchers predicted the number of new cancer cases among younger adults will rise another 30 percent by the end of this decade, with wealthy countries particularly affected.

The increase in cases — and soaring global population — means that the number of deaths among under 50s from cancer has risen by nearly 28 percent over the last 30 years.

This occurred even as the odds of people of all ages surviving cancer have roughly doubled over the last half century.

Shivan Sivakumar, a cancer researcher at the UK’s University of Birmingham, called it an “epidemic” of young adult cancer.

Since Kate Middleton revealed on Friday that her cancer was discovered after she received abdominal surgery earlier this year, Sivakumar and other doctors have spoken out about the uptick in younger cancer patients they have been seeing at their clinics.

While breast cancer remains the most common for people under 50, the researchers expressed particular concern about the rise of gastrointestinal cancers — such as of the colon, pancreas, liver and oesophagus — in younger adults.

Colon cancer is now the leading cause of cancer deaths in men under 50 in the United States, according to the American Cancer Society. For women, it is number two — behind only breast cancer.

One high profile case of colorectal cancer was “Black Panther” actor Chadwick Boseman, who died at the age of 43 in 2020.

Why is this happening?

“We just don’t have the evidence yet” to say exactly what is causing this rise, Sivakumar told AFP, adding it was likely a combination of factors.

Helen Coleman, a cancer epidemiology professor at Queen’s University Belfast who has studied early onset cancer in Northern Ireland, told AFP there were two potential explanations.

One is that people in their 40s were exposed to factors known to cause cancer — such tobacco smoke, alcohol or being obese — at an earlier age than previous generations.

She pointed out that the “obesity epidemic” did not start until the 1980s.

Sivakumar felt that at least part of the puzzle could be explained by obesity.

However, there is “another wave” of under-50 patients who are neither obese nor genetically predisposed still getting cancer, he emphasised, adding that this could not be put down to “statistical chance”.

The other theory, Coleman said, is that “something different” has been going on with her generation.

Fingers have been pointed out a range of possible culprits — including chemicals, new drugs and microplastics — but none have been proven.

Some have suggested that so-called ultra-processed foods could be to blame. “But there’s very little data to back any of that up,” Coleman said.

Another theory is that the food we eat could be changing our gut microbiome.

While there is nothing conclusive yet, Coleman said her own research suggested that cancer causes changes to the microbiome, not the other way around.

Anti-vaxx conspiracy theorists have even tried to blame Covid-19 vaccines.

This is easily disproven, because the rise in young adult cancer has taken place over decades, but the vaccines have only been around for a few years.

What can be done?

To address the rise in younger colorectal cancer, in 2021 the US lowered the recommended age for screening to 45. Other countries have yet to follow suit.

But the researchers hoped that Catherine’s experience would remind people at home that they should consult their doctor if they sense anything is wrong.

“People know their bodies really well,” Sivakumar said.

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“If you really feel that something isn’t right, don’t delay — just get yourself checked out.”

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Almost 3,000 students suspended in Waterloo Region over immunization issues

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Close to 3,000 children attending elementary school across Waterloo Region were suspended from school on Wednesday morning for not having up-to-date immunization records.

The region says Waterloo Public Health suspended 2,969 students under the Immunization of School Pupils Act (ISPA).

For several months, the region has been campaigning for people to get their children’s vaccinations up to date, including sending letters home to parents on a couple of occasions, warning that students’ records needed to be up to date or they would be suspended.

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It announced in January that 32,000 students did not have up-to-date records: 22,000 elementary students and 10,000 high school students.


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“We have made remarkable progress from the original 27,567 immunization notices we sent to parents in November and December 2023,” Dr. Hsiu-Li Wang, medical officer of health, stated.

“Since that time, we have resolved more than 24,500 outdated vaccination records, providing students with valuable protection against these serious and preventable diseases.”

The high school students still have a few weeks to get their records up to date or else face suspension.

The ISPA requires students to have proof-of-vaccination records for diphtheria, polio, tetanus, pertussis, measles, mumps, rubella, varicella (chickenpox) and meningitis, which must be on file with public health.

Public health says caregivers whose children are suspended will need to book an appointment at regionofwaterloo.ca/vaccines for clinics, which will be held in Cambridge and Waterloo on weekdays.

“Given the high number of suspensions, it may take several days before you can be seen at an appointment and return your child to school,” a release from the region warns.

“Record submission and questions must be done in person to ensure immediate resolution.”

The last time suspensions over immunizations were issued was in 2019, when 1,032 students were suspended.

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