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Fifth person tests positive in B.C. for new coronavirus after return from China – Toronto Star

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VANCOUVER—A fifth case of the novel coronavirus has been presumptively confirmed in British Columbia, bringing the total number of cases in Canada to eight.

Provincial health officer Dr. Bonnie Henry said Friday a woman in her 30s returned from Shanghai in the past week through Vancouver’s airport before travelling by car to her home in the Interior health region.

Henry said the woman wore a mask on the plane and contacted health officials when she had symptoms of an illness before testing positive Tuesday for the virus that the World Health Organization has named COVID-19.

“We are very grateful and thankful that the people who are coming back from Hubei province and all over China are taking the advice seriously to self monitor and to connect with us and make sure that they can be tested, assessed and cared for safely,” she said.

The woman is in isolation at home, as are her close contacts, Henry said, adding that in all cases a further test will be conducted at a national lab in Winnipeg to confirm the results obtained provincially.

Officials will be contacting passengers who sat three rows ahead and behind the woman on the aircraft that arrived from China but the risk to them is “very, very low,” she said.

The first person to be tested for the virus in the province is recovering well and has tested negative in the first of two tests that would indicate the virus no longer exists and isolation is no longer required, she said.

Henry said 715 tests have been done on about 500 people returning from China based on a low threshold for testing of the virus that originated in Hubei province.

Health Minister Adrian Dix said British Columbia has done more testing than any other jurisdiction.

Earlier Friday, Foreign Affairs Minister Francois-Philippe Champagne said health workers from Canada are assisting in Japan after 12 Canadians contracted the virus aboard a cruise ship.

Three cases of the virus have also been confirmed in Ontario.

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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) – Stockhouse

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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.

Media:

Colleen Hussey

Senior Manager, Corporate Communications

617-335-1374

Colleen.Hussey@modernatx.com

Investors:

Lavina Talukdar

Head of Investor Relations

617-209-5834

Lavina.Talukdar@modernatx.com

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Canadian doctors worried about supplies of flu vaccine: Survey – iNFOnews

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A man wears a face mask as he waits outside a COVID-19 testing clinic in Montreal, Sunday, September 27, 2020, as the COVID-19 pandemic continues in Canada and around the world.
Image Credit: THE CANADIAN PRESS/Graham Hughes

September 29, 2020 – 9:00 PM

TORONTO – The Canadian Medical Association says doctors still face hurdles getting personal protective equipment and fear they won’t be able to adequately respond to increased demands for the flu shot.

With COVID-19 cases surging to new highs in parts of Canada, the CMA is calling for government action to bolster the health system so that it can handle the possibility of a devastating “twin epidemic.”

“There’s going to be an increased demand for PPE, probably over and above what the demand was at the beginning of the pandemic,” CMA president Dr. Ann Collins said Tuesday from Fredericton, pointing to the reopening of businesses and schools as compounding pressures.

“It is an issue for protection for frontline workers.”

A CMA survey conducted Aug. 19 to 24 found more than 86 per cent of 1,459 respondents worried influenza season will put additional strain on the health-care system.

Of the 598 doctors who offer the flu vaccine, half said they won’t have enough doses to meet demand and 85 per cent said the system needs more capacity.

The survey also found 54 per cent of respondents still faced challenges trying to acquire personal protective equipment.

Collins said that includes surgical masks, gowns, gloves and shields needed for routine doctor visits. She says that was already an issue back in August, before the current spike in cases, demand for COVID-19 testing and school openings.

“There were areas in the country where community based physicians were having challenges accessing PPE — they either couldn’t get it, it was not a sure-thing that when they ordered it they were going to get it, (or) that they would get it on time,” said Collins, who notes she had trouble supplying her own family practice back in the spring.

The survey found 68 per cent of doctors said they worried suppliers wouldn’t have enough PPE, 62 per cent expected orders to be delayed, and more than half worried global demand will hinder supply.

Nevertheless, three quarters believed the health-care system was better prepared with COVID-19 resurgences than during the first wave.

The Public Health Agency of Canada said Tuesday it was preparing for the potential of simultaneous outbreaks of the flu and COVID-19.

The agency said provincial and territorial governments have ordered more than 13 million doses of vaccine — an increase from last season’s order of 11.2 million doses.

Collins says the CMA has been assured by public health officials there will be enough doses to meet demand but says they cannot predict what the uptake will be. Still, they encourage all Canadians to get the vaccine.

Each province and territorial government decides how much to purchase for their populations, where they are distributed and when to begin the rollout.

While this varies, many start their vaccination programs in October or early November.

In Ontario, Premier Doug Ford stressed multiple investments to bolster the health system as it attempts to address a backlog of surgeries while grappling with COVID-19 and the coming flu season.

“We put a billion dollars into testing and tracing, which is absolutely imperative. We also have the immunization program for the flu vaccine which is 5.1 million doses. That is the largest ever in Canadian history,” Ford said.

While virtual care has reduced in-person appointments, Collins said doctors still need to see some patients face-to-face.

In addition to PPE, she said each visit requires cleaning supplies to sanitize between visits and time and staff to do that work. Collins said that all costs money.

“Doctors need to know … that there’s a concerted effort to co-ordinate (resources) amongst those different bodies and to communicate clearly to physicians what is available and to support those physicians,” she said.

“There are people with all kinds of other health-care conditions that need to be seen, they need to be assessed. And so there needs to be protection for them, protection for the doctor seeing them.

“Because COVID is among us.”

This report by The Canadian Press was first published Sept. 29, 2020.

News from © The Canadian Press, 2020

The Canadian Press

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Survey finds doctors worry supplies of flu vaccine, PPE will lag demand

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TORONTO — The Canadian Medical Association says doctors still face hurdles getting personal protective equipment and fear they won’t be able to adequately respond to increased demands for the flu shot.

With COVID-19 cases surging to new highs in parts of Canada, the CMA is calling for government action to bolster the health system so that it can handle the possibility of a devastating “twin epidemic.”

“There’s going to be an increased demand for PPE, probably over and above what the demand was at the beginning of the pandemic,” CMA president Dr. Ann Collins said Tuesday from Fredericton, pointing to the reopening of businesses and schools as compounding pressures.

“It is an issue for protection for frontline workers.”

A CMA survey conducted Aug. 19 to 24 found more than 86 per cent of 1,459 respondents worried influenza season will put additional strain on the health-care system.

Of the 598 doctors who offer the flu vaccine, half said they won’t have enough doses to meet demand and 85 per cent said the system needs more capacity.

The survey also found 54 per cent of respondents still faced challenges trying to acquire personal protective equipment.

Collins said that includes surgical masks, gowns, gloves and shields needed for routine doctor visits. She says that was already an issue back in August, before the current spike in cases, demand for COVID-19 testing and school openings.

“There were areas in the country where community based physicians were having challenges accessing PPE — they either couldn’t get it, it was not a sure-thing that when they ordered it they were going to get it, (or) that they would get it on time,” said Collins, who notes she had trouble supplying her own family practice back in the spring.

The survey found 68 per cent of doctors said they worried suppliers wouldn’t have enough PPE, 62 per cent expected orders to be delayed, and more than half worried global demand will hinder supply.

Nevertheless, three quarters believed the health-care system was better prepared with COVID-19 resurgences than during the first wave.

The Public Health Agency of Canada said Tuesday it was preparing for the potential of simultaneous outbreaks of the flu and COVID-19.

The agency said provincial and territorial governments have ordered more than 13 million doses of vaccine — an increase from last season’s order of 11.2 million doses.

Collins says the CMA has been assured by public health officials there will be enough doses to meet demand but says they cannot predict what the uptake will be. Still, they encourage all Canadians to get the vaccine.

Each province and territorial government decides how much to purchase for their populations, where they are distributed and when to begin the rollout.

While this varies, many start their vaccination programs in October or early November.

In Ontario, Premier Doug Ford stressed multiple investments to bolster the health system as it attempts to address a backlog of surgeries while grappling with COVID-19 and the coming flu season.

“We put a billion dollars into testing and tracing, which is absolutely imperative. We also have the immunization program for the flu vaccine which is 5.1 million doses. That is the largest ever in Canadian history,” Ford said.

While virtual care has reduced in-person appointments, Collins said doctors still need to see some patients face-to-face.

In addition to PPE, she said each visit requires cleaning supplies to sanitize between visits and time and staff to do that work. Collins said that all costs money.

“Doctors need to know … that there’s a concerted effort to co-ordinate (resources) amongst those different bodies and to communicate clearly to physicians what is available and to support those physicians,” she said.

“There are people with all kinds of other health-care conditions that need to be seen, they need to be assessed. And so there needs to be protection for them, protection for the doctor seeing them.

“Because COVID is among us.”

This report by The Canadian Press was first published Sept. 29, 2020.

Cassandra Szklarski, The Canadian Press

<!– Photo: 2020092912098-5f735c422abff6c972be8b91jpeg.jpg, Caption: A man wears a face mask as he waits outside a COVID-19 testing clinic in Montreal, Sunday, September 27, 2020, as the COVID-19 pandemic continues in Canada and around the world. A new survey finds many doctors fear they won’t have enough of the flu vaccine to meet demand.

The Canadian Medical Association says more than 86 per cent of 1,459 respondents say they worry influenza season will put additional strain on the health-care system. Of those who offer the flu vaccine, half say they won’t have enough doses to meet demand and 85 per cent said the system needs more capacity. THE CANADIAN PRESS/Graham Hughes

–>

Source:- Cochrane Today

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