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Three Burnaby residents have died as COVID-19 outbreak escalates – Delta-Optimist

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Burnaby has four active COVID-19 outbreaks, with three people now dead after testing positive at one site.

New Vista Care Home on Rosewood Street has 22 people who have tested positive for the virus, according to an emailed update to the families of residents shared with the NOW.

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Out of the 22 cases, 14 have been residents and eight are staff members, said the email. The outbreak started with one staff member.

“Ten residents with COVID are being cared for by our clinical team in isolation areas,” says the email. “One resident and one staff member have recovered and sadly we’ve had three residents pass away. At the direction of Fraser Health (FHA) we have tested 200+ residents and staff, with the vast majority of tests coming back negative. Based on direction from FHA, all residents are taking meals in their rooms and have been isolated from other residents. Any essential visitations to the Care Home, except in cases where residents are palliative, remain suspended until further notice.”  

The latest positive cases follow three other “outbreaks” – the term used by Fraser Health – at Burnaby care homes. A resident of Burnaby’s George Derby Centre tested positive for COVID-19 recently, and staff at Burnaby’s Derby Manor and Dania Home have also tested positive in the few weeks. One worker at Stay Fresh in Metropolis at Metrotown tested positive and that store was closed temporarily. Read more about that here.

According to an update by provincial health officials on Tuesday, there were 58 new cases identified, including one presumed, or “epi-linked” case, meaning that since the pandemic started, B.C. has discovered 5,242 cases of COVID-19. Of those patients, 4,114 have recovered, and 203 have died. 

Those battling infections who are not in hospital are self-isolating at home. There are also 2,675 people who are under active public-health monitoring as a result of identified exposure to known cases.

The breakdown of all COVID-19 infections in the province by health region is:
• 1,683 in Vancouver Coastal Health (up 32);
• 2,762 in Fraser Health (up 23);
• 168 in Island Health (up two);
• 425 in Interior Health (no change);
• 128 in Northern Health (up one); and
• 76 people who reside outside Canada (no change).

Fraser Health’s interim chief medical health officer Elizabeth Brodkin, on August 25, mentioned two situations where there has been COVID-19 at hospitals.

She said a COVID-19 outbreak has taken place at Langley Memorial Hospital, which involved a single patient who was released and then tested positive for the disease. Brodkin declined to say when the patient was at Langley Memorial Hospital, and released, in order to protect that person’s confidentiality. News of the incident arose on August 25.

She added that at Royal Columbian Hospital one staff person tested positive after having conducted surgery in an operating room. Brodkin said that this case was likely contracted in the community so it is not officially considered an outbreak at the hospital.

  • With files from Glen Korstrom, Glacier Media

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Lonza confident of 2020 target for Moderna COVID-19 vaccine supply – Yahoo Finance

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By John Miller

VISP, Switzerland (Reuters) – Lonza is confident that U.S. and Swiss plants it is building to help make Moderna’s COVID-19 vaccine candidate will be ready for commercial production this year, executives at the Swiss company said on Tuesday.

New production lines at Lonza’s site in Portsmouth, New Hampshire, aim to start making vaccine ingredients in November, while three lines in Visp, deep in a valley in the Swiss Alps – to supply 300 million vaccine doses annually – should begin delivering by December.

There is no approved COVID-19 vaccine yet, but several are in advanced trials, including from Pfizer Inc, Johnson & Johnson and Moderna, whose candidate relies on technology never previously approved that enlists human cells to help trigger an immune response.

Torsten Schmidt, who heads Lonza’s Visp facility, where Moderna’s $210 million production lines are about 50% completed, said he has secured the equipment needed to avoid any last-minute setbacks.

“The delivery of the equipment was critical,” Schmidt said in an interview. “You typically wait 12 months, you’re talking here about 4-5 months. In the end, the CEO has been talking to the CEOs of suppliers, to get the equipment delivered.”

Lonza, whose shares are up 60% this year, has a 10-year contract to supply ingredients to Moderna, including for up to 1 billion doses annually of COVID-19 vaccine.

The ingredients include a synthetic version of messenger RNA (mRNA), genetic material, which is packed inside tiny fat droplets called nanolipids, to instruct human cells to make a non-replicating form of the coronavirus’s spike protein and trigger an immune response in the body.

They will be frozen at -70 degrees Celsius, then shipped from Visp to Spain’s Laboratorios Farmacéuticos Rovi SA for “fill and finish,” the final stage of manufacture.

STILL HIRING

Lonza is still hiring some of the roughly 200 workers it needs to operate the Moderna production lines in Visp, located where the Alps tip up towards the nearby ski towns of Zermatt, near the famed Matterhorn, and Saas Fe.

In all, Lonza expects to have some 4,000 workers in Visp by January, from 3,500 now, following a hiring spree fueled by its manufacture of drugs for other customers, as well as Moderna. They include Roche, Sanofi and California’s Humanigen, with which it has partnered on another COVID-19 project.

However ready Lonza is, when precisely Moderna’s vaccine becomes available depends on its trials and regulators. The U.S. company has said about 20 million doses should be ready by the year’s end.

Already Lonza’s drugs unit revenue has seen double-digit percentage gains, prompting the Basel-based company earlier this year to seek to offload its $1.8 billion-per-year speciality chemicals business, after sales of products, such as animal feed supplements and resins have stagnated.

Talks with potential buyers are ongoing, Renzo Cicillini, Lonza’s Visp site head, said.

‘A LITTLE PROUD’

In Visp, two hours by train from both Zurich and Milan, Italy, its roughly 8,000 residents are accustomed to Lonza’s taking a behind-the-scenes role in making drugs for better-known companies, the town’s mayor, Niklaus Furger, said.

But the COVID-19 pandemic, which has killed more than 1 million people and wreaked global economic havoc, has left the people of Visp hoping for success that would put it on the map.

“The idea that a vaccine might just be produced in Visp with which we could fight against the pandemic, that would be excellent,” Furger told Reuters at Visp city hall. “For certain, the attention of the world would be trained on Visp along with Lonza, something that admittedly would make us all a little proud.”

(Reporting by John Miller; editing by Barbara Lewis)

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How can I volunteer for a COVID-19 vaccine study?

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AP Illustration/Peter Hamlin;

How can I volunteer for a COVID-19 vaccine study?

Governments and companies are setting up websites where people can sign up.

Enthusiasm is high: More than 400,000 people have signed a registry of possible volunteers that’s part of a vaccine network set up by the U.S. National Institutes of Health.

But before raising your hand, it’s important to understand how the research works.

Initial studies include only a few dozen young, healthy volunteers, since this is the first chance to see if a shot causes a risky reaction in people. Older adults, anyone with a serious underlying illness, and pregnant women are typically excluded from this testing stage.

Mid-stage studies of COVID-19 vaccines recruit a few hundred people, including some older adults. The focus is on comparing how people’s immune systems react to different doses, as well as getting more safety data.

In final-stage studies, scientists need tens of thousands of volunteers who reflect the diversity of the population, including those at high risk of severe illness from the virus. So volunteers can include people who are over age 65 and people with chronic health problems such as diabetes.

Enough study participants have to be exposed to the virus for researchers to be able to tell if the vaccine works. That’s why essential workers, such as grocery or transportation workers who come into frequent contact with others, are especially sought after for the last testing phase. It’s also why researchers are recruiting in places where the virus is spreading, not areas that have it under control — so even if you meet the eligibility criteria, you might not be called back, depending on where you live.

Volunteers won’t know if they’re getting the vaccine or a dummy shot.

The World Health Organization counts 10 vaccines worldwide in this final stage of testing, and dozens more are in earlier stages. A few websites list vaccine studies for people interested in volunteering.

— The website clinicaltrials.gov lets people search for COVID-19 vaccine studies by country.

— Many regions, such as the European Union, also have their own research registries.

— And if local hospitals, clinics or testing labs in your area are looking for volunteers, you’ll likely see advertisements or flyers with a number to call for information.


The AP is answering your questions about the coronavirus in this series. Submit them at: FactCheck@AP.org. Read more here:

Does a face mask protect me, or just the people around me?

Does the coronavirus spread easily among children?

Can I get the coronavirus twice?

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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

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.

 

Source: – Stockhouse

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