Coronavirus Breaking News

The coronavirus disease COVID-19 is currently reaching pandemic levels in various countries.

Mar 10, 2021 • 6:28 pm CST

North Carolina-based EmitBio Inc. announced new evidence demonstrating its proprietary light technology could inactivate variants of the coronavirus that causes COVID-19, including the highly infectious United Kingdom and South Africa variants.

These findings published on March 10, 2021, indicate important effectiveness against potentially more transmissible mutations of COVID-19.

EmitBio™ has developed a novel, hand-held treatment device that directs energy into the upper respiratory tract with 100% of the dose available in the area of need, thereby avoiding the possible side effects of systemic treatments. This non-FDA authorized device has been designed as an at-home treatment for mild-tomoderate COVID-19 in adults testing positive for SARS-CoV-2.

Neal Hunter, Executive Chairman of EmitBio, commented in a press release, “We have clearly demonstrated that EmitBio treatment technology is mutation resistant and resilient. This is an important weapon in the global fight against an enemy that keeps evolving.”

The company recently reported results from a clinical trial with the investigational treatment device, which showed a 99.9% reduction in viral load in adults with COVID-19. The clinical trial results, along with the results from a Phase I safety study in healthy volunteers, have been submitted as part of a comprehensive package to the U.S. FDA requesting Emergency Use Authorization.

EmitBio Inc. is a life science company using the precise delivery of light to stimulate, heal and protect the body.

Mar 10, 2021 • 12:52 pm CST

The European Medicines Agency (EMA) reported today Austrian's national competent authority had suspended using a batch of COVID-19 Vaccine AstraZeneca (batch number ABV5300) after a person was diagnosed with multiple thrombosis and died 10 days after vaccination. Another person was hospitalized with pulmonary embolism after being vaccinated. The latter is now recovering.

As of March 9, 2021, two other reports of thromboembolic event cases had been received by the EMA for this vaccine batch.

Overall, 22 cases of thromboembolic events had been reported among the 3 million people vaccinated with COVID-19 Vaccine AstraZeneca in the European Economic Area during 2021.

However, there is currently no indication that vaccination with the AstraZeneca COVID-19 vaccine has caused these conditions, which are not listed as side effects with this vaccine. Although a quality defect is considered unlikely at this stage, the batch quality is being investigated, stated the EMA in a press release.

Batch ABV5300 was delivered to 17 EU countries and comprised 1 million vaccine doses. Some EU countries have also subsequently suspended this batch as a precautionary measure, while a full investigation is ongoing. The EMA commented the 'information available so far indicates that the number of thromboembolic events in vaccinated people is no higher than that seen in the general population.

And the EMA will continue its assessment of any potential issue with the batch as well as its review of thromboembolic events and related conditions.'

The AstraZeneca COVID-19 vaccine, formerly known as ChAdOx1 nCoV-19, is made from a virus (ChAdOx1), a weakened version of a common cold virus. Genetic material has been added to the ChAdOx1 construct, which is used to make proteins from the SARS-CoV-2 coronavirus called Spike glycoprotein.

Mar 10, 2021 • 9:22 am CST

According to a recent survey, only 3% of Americans received information from government agencies about COVID-19 resources, tools, and information. Overall this survey's results point towards proper and trustworthy notification on local protocols, potential exposure, and verified coronavirus information from an authorized source is an essential part of keeping at-risk communities safe.

Other key survey findings include:

  • 84% would be willing to provide information to help health agencies identify "hotspots" in the community
  • 65% would be willing to provide necessary information to health agencies to reduce restrictions
  • 61% would be willing to download a contact tracing app (with 16.7% willing to receive notifications)
  • 62% prefer their close contacts to be notified about potential exposure through text message or a smartphone app
  • 49% prefer texting as the method of contact (*noting 14.2% approve of contact via email)

Justin Beck, CEO of Contakt World, stated in a press release issued on March 9, 2021, "Without a comprehensive and coordinated federal response, it's often left to local health agencies to fill in the gaps without the proper tools and funding to meet the task at hand."

The survey also sheds light on why contact tracing systems need to be voluntary. Communities are stating they don't want to be forced or pushed to use a contact tracing system; it's most important that the system users are comfortably in control. Further, the option of a subscription-based, non-invasive, daily in-home testing kit that measures one's well-being in fifteen minutes was very well received and deemed necessary and important to help manage the situation.

In summary, this survey shows that health agencies need to innovate to improve contact tracing, vaccination trust, and general public health education. "Phone calls just aren't cutting it alone," added Beck.

Contakt World is a technology and media company innovating public health agency connections with their community to become the most trustworthy, accessible, and scalable digital public health and safety platform globally - address the needs of a post-pandemic world.

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Mar 9, 2021 • 6:54 pm CST

Researchers from NYU Grossman School of Medicine found people previously infected with the SARS-CoV-2 coronavirus may produce levels of antibodies against COVID-19 after one dose of the Pfizer–BioNTech COVID-19 vaccine that is equal to or higher than people not previously infected have after two vaccine doses.

In the limited study announced on March 9, 2021, people that previously had COVID-19 infection and who received a single dose of mRNA vaccine produced high levels of “neutralizing” antibodies—those capable of defending cells from the virus and of blocking its biological effects at 6 to 14 days after vaccination.

“Our findings support a hypothesis that SARS-CoV-2–experienced people may require only a single dose of mRNA vaccine,” commented Mark J. Mulligan, MD, director of the Division of Infectious Diseases and Immunology and director of the Vaccine Center, in a press release.

“That said, our results would need to be borne out by larger studies before they influenced current policy, which is that patients receive the evidence-based, two-shot regimen."

Researchers say vaccines safely mimic actual infections, which teaches the immune system to be ready for a future encounter. The Pfizer vaccine is based on RNA, or ribonucleic acid, which serves as the primary genetic material instead of DNA for the pandemic coronavirus. The vaccine contains viral mRNA encoding the “spike proteins” used by SARS-CoV-2 to attach to proteins on human cell surfaces, which invade the cells in which it multiplies.

Including the spikes in vaccines has made proteins required for viral ability to infect visible to the human immune system, say the study authors. Once injected into the arm muscle, the spike protein is made. It triggers the production of antibodies, immune proteins that specifically glom onto this viral target protein, disabling it and tagging it for removal from the body.

The Pfizer-BioNTech COVID-19 vaccine was issued the first U.S. Food and Drug Administration (FDA) emergency use authorization for a vaccine to prevent COVID-19 in individuals 16 years of age and older on December 11, 2020. However, the experimental Pfizer-BioNTech COVID-19 vaccine has not been Approved or Licensed by the U.S. FDA.

Mar 9, 2021 • 12:24 pm CST

USA-based VBI Vaccines Inc. announced the enrollment of its Phase 1/2 clinical study of VBI-2902, the Company’s monovalent enveloped virus-like particle (eVLP) COVID-19 vaccine candidate.

VBI-2900 consists of two enveloped virus-like particle (eVLP) vaccine candidates: VBI-2901, a trivalent pan-coronavirus vaccine expressing the SARS-CoV-2, SARS-CoV, and MERS-CoV spike proteins, and VBI-2902, a monovalent COVID-19-specific vaccine expressing the SARS-CoV-2 spike protein.

The execution of this adaptive Phase 1/2 study will be conducted at nine clinical sites in Canada and is supported by funding from the Strategic Innovation Fund of the Government of Canada.

François-Philippe Champagne, Canada’s Minister of Innovation, Science, and Industry, stated in a VBI press statement, “Today’s news is a welcome development, bringing VBI one step closer to delivering a safe and effective COVID-19 vaccine for Canadians. Through this investment, we continue to expand our toolbox to help fight this pandemic as well as future pandemics.”

The Phase 1 portion of the study will evaluate a one- and two-dose regimen of a 5µg dose of VBI-2902 and enroll up to 60 healthy adults age 18-54. Contingent upon enrollment rate, the initial data from Phase 1 of this study are expected by the end of Q2 2021.

The Phase 2 portion of the study is expected to be a dose-escalation extension study, assessing one- and two-dose regimens that will enroll an expanded adult population across three age cohorts: 18-54, 55-65, and 65+.

Mitch Davis, the President of the National Research Council (NRC), further commented, “The NCR of Canada and VBI Vaccines have a long-standing collaboration in research. Since March 2020, we have been working jointly with their research operations in Ottawa on pre-clinical evaluation, optimization, and manufacturing process development of this COVID-19 vaccine candidate. We are very pleased to see this candidate reach the important milestone of human clinical trials.”

VBI’s coronavirus vaccine program is being developed at the Company’s research facilities in Ottawa, Canada, and with the NRC, a recently expanded collaboration to include additional joint research and development activities for pre-clinical evaluation, optimization of clinical candidates, and manufacturing scale-up.

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Mar 9, 2021 • 9:45 am CST

The Annal of Internal Medicine published the fifth update alert on March 9, 2021, for a living rapid review on the use of masks for the prevention of respiratory virus infections, including SARS-CoV-2, in health care and community settings.

This Alert found the strength of evidence for any mask use versus nonuse in community settings remains low. Other strength-of-evidence ratings related to mask use in community settings were unchanged because of no new evidence.

The comparison of N95 mask only use versus surgical mask use favored the N95, but the difference was not statistically significant (odds ratio, 0.60 [CI, 0.31 to 1.15]). Based on disclosed study limitations and because of inconsistent results across studies, evidence for N95 versus surgical mask use and other comparisons involving mask use and risk for SARS-CoV-2 infection in health care settings remains insufficient.

Furthermore, as with prior updates, there were no new studies on the effectiveness and safety of mask reuse or extended use.

The U.S. CDC announced on March 8, 2021, if you’ve been fully vaccinated with an experimental COVID-19 vaccine, you should still take steps to protect yourself and others in many situations, like wearing a mask, staying at least 6 feet apart from others, and avoiding crowds and poorly ventilated spaces.

Mar 8, 2021 • 2:03 pm CST

New Zealand's Prime Minister Jacinda Ardern and Covid-19 Response Minister Chris Hipkins announced on March 7, 2021, the purchase of 8.5 million doses of the Pfizer-BioNTech Covid vaccine, reported local media. These vaccines are expected to arrive in New Zealand during the second half of 2021.

"This purchase marks a significant milestone in New Zealand's fight against Covid-19. We can all take heart that we have now secured one of the strongest and more effective tools in the Covid-19 toolkit," Ardern said.

On February 3, 2021, the local medicines regulator Medsafe provisionally approve the Pfizer - BioNTech Vaccine (Comirnaty) to be used in New Zealand. In a joint statement, the Director-General of Health, Dr. Ashley Bloomfield, and Medsafe Group Manager Chris James outlined the decision process.

“Medsafe began assessing the clinical data provided by Pfizer-BioNTech in November 2020, working over weekends and through the Christmas break,” said Dr. Bloomfield. “The data was provided on a rolling basis, which streamlined the assessment process and enabled a timely approval without compromising the rigor of the review of the vaccine."

“I want to reinforce that this has been a carefully considered decision every step of the way."

The experimental Pfizer-BioNTech COVID-19 (Comirnaty) Vaccine prevents severe COVID-19 disease caused by the SARS-CoV-2 coronavirus. Comirnaty (the trade name used in Europe) is a nucleoside-modified RNA formulated in lipid nanoparticles and encodes an optimized SARS-CoV-2 full-length spike protein antigen. It was authorized in the USA during December 2020.

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Mar 8, 2021 • 9:55 am CST

Finland-based Rokote Laboratories Finland Ltd. announced it is working to introduce a nasal spray vaccine against COVID. The vaccine candidate uses gene transfer technology developed at the University of Eastern Finland by Academy Professor Seppo Ylä-Herttuala's research group.

The vaccine uses a safe adenovirus carrier that contains a cloned DNA strand, which causes nasopharyngeal cells to produce the virus protein, which, in turn, produces a response to the vaccine. There is no actual SARS-CoV-2 virus in the vaccine.

"Even if we were able to vaccinate the entire population, at least people in medical risk groups will still need new vaccines against new variants in the upcoming years," stated Professor of Virology Kalle Saksela from the University of Helsinki.

According to a press statement issued on March 8, 2021, the technology has already been successfully used in several clinical trials using gene therapy to treat cardiovascular diseases and cancer. Preliminary results show that the vaccine has performed well in animal studies, and clinical testing in humans will start within a few months.

Nasal delivery was chosen as the new vaccine's method of administration because the virus is also naturally transmitted through the airways.

"Vaccines injected intramuscularly produce IgG antibodies in the bloodstream, but nasal vaccines also produce an IgA response that protects mucous membranes. We assume that this can also prevent those who have received the vaccine from transmitting the virus," commented Academy Professor Seppo Ylä-Herttuala from the University of Eastern Finland.

The University of Eastern Finland is an international, participatory, and inclusive scientific community.

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Mar 8, 2021 • 5:49 am CST

Moderna announced a supply agreement with the Republic of the Philippines for 13 million doses of the COVID-19 Vaccine Moderna. Under the terms of this agreement, deliveries would begin in mid-2021. The Company stated in its press statement issued on March 6, 2021, 'it will work with local regulators to pursue necessary approvals before distribution.'

A separate agreement with the Philippine Government and the private sector to supply an additional 7 million doses is also anticipated.

Stéphane Bancel, Chief Executive Officer of Moderna, commented, “We appreciate the confidence in Moderna, and our mRNA platform demonstrated by the Government of the Philippines. We remain committed to making our vaccine available on every continent to help end this global pandemic.”

The COVID-19 Vaccine Moderna is not currently approved for use in the Philippines.

The experimental mRNA vaccine prevents COVID-19 by encoding for a prefusion stabilized form of the Spike (S) protein co-developed by Moderna and investigators from NIAID’s Vaccine Research Center. In the USA, the Moderna COVID-19 Vaccine gained emergency authorization from the U.S. FDA in December 2020. There are no FDA-approved vaccines to prevent COVID‑19 as of March 8, 2021.

Massachusetts-based Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA) to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and unprecedented speed.

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Mar 7, 2021 • 12:44 pm CST

The Lancet published a commentary on March 6, 2021, which highlighted the positive impact of the single-dose Oxford–AstraZeneca COVID-19 vaccine followed by a 12-week booster.

Overall, this study provides evidence that a single dose of the ChAdOx1 nCoV-19 vaccine is highly efficacious in the 90 days after vaccination. And that a longer prime-boost interval results in higher vaccine efficacy. Furthermore, the protection against symptomatic COVID-19 is maintained despite a longer dosing interval.

In exploratory analyses, vaccine efficacy after a single standard dose was 76% from day 22 to day 90, and antibody levels were maintained during this period with minimal waning. Supporting a longer-interval immunization strategy, vaccine efficacy was significantly higher at 81% after two standard doses are given at an interval of 12 weeks or longer, compared with 55% when given less than 6 weeks apart.

This analysis offers supporting evidence for the United Kingdom's policies of extending the AstraZeneca COVID-19 vaccine dosing interval to 12 weeks and for rapid mass-immunization campaigns worldwide.

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Mar 6, 2021 • 9:39 am CST

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization for the T-Detect COVID Test developed by Adaptive Biotechnologies. The T-Detect COVID Test is a next-generation sequencing-based test to aid in identifying individuals with an adaptive T cell immune response to SARS-CoV-2, indicating recent or prior infection with SARS-CoV-2.

Chad Robins, CEO of Seattle-based Adaptive Biotechnologies. “The authorization of T-Detect COVID represents a true breakthrough for patients and a pivotal milestone for the diagnostic testing paradigm. We have proven that it is possible to read how T cells detect disease in the blood, and this is just the beginning of a pipeline of tests for many other indications.”

The test analyzes DNA (deoxyribonucleic acid) sequences from T cells (white blood cells) to aid in identifying individuals with an adaptive T cell immune response to SARS-CoV-2, indicating recent or previous SARS-CoV-2 infection. All test results from the test should be used combined with a clinical examination, patient medical history, and other findings said the FDA on March 5, 2021.

Furthermore, the T-Detect COVID Test should not be used to diagnose current SARS-CoV-2 infection.

“Today’s authorization further underscores the FDA’s commitment to innovation in test development,” stated Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health, in a press statement. "The T-Detect COVID Test is a novel technology that assesses the T cell immune response to COVID-19. Information and scientific data that deepen our understanding of SARS-CoV-2 remain important keys to get ahead of this global pandemic.”

The FDA, based in Maryland, is an agency within the U.S. Department of Health and Human Services.

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Mar 5, 2021 • 1:52 pm CST

The US Centers for Disease Control and Prevention (CDC) published its weekly COVID-19 report today, showing various trends on the decline. This good news from the CDC on March 5, 2021, includes declines in cases, hospitalization, and mortality related to COVID-19 in the USA.

In recent weeks during 2021, there has been an overall decline of 43.1% of the COVID-19 fatality 7-day moving average since January 13th. The current 7-day average of related deaths is a 6.7% decrease from the previous 7-day average of 2,060 daily deaths.

Hospital admissions of patients with confirmed COVID-19 decreased 67% from the national 7-day average peak on January 9, 2021, to a 7-day average of 5,490 admissions on March 2, 2021.

The percent of COVID-19 RT-PCR tests that were positive continued to decline as well. The 7-day average of percent positivity from tests is now 4.5%. In January 2021, the SARS-CoV-2 virus positivity rate exceeded 10%.

The one metric that significantly increased is the number of COVID-19 vaccinations, which began in the USA on December 14, 2020. As of March 4th, 82.6 million vaccine doses have been administered.

The CDC says, 'As we enter spring, we need to stay focused on reducing spread in our communities. This means we need to continue to practice proven prevention strategies, including wearing a well-fitted mask, staying six feet apart from people we don’t live with, avoiding gatherings, washing hands often, staying home when sick, and getting vaccinated when the vaccine is available to you.'

Mar 5, 2021 • 9:36 am CST

Health Canada officials held a technical briefing on COVID-19 vaccines in Ottawa, ON. During this meeting, Health Canada announced the approval of Johnson & Johnson's Janssen COVID-19 vaccine for use in Canada.

Additionally, Canada ordered 10 million doses with options for up to 28 million more. The expected arrival of the Janssen COVID-19 vaccine order is by the end of September 2021.

The Janssen COVID-19 (Ad26.COV2-S) single-shot experimental vaccine leverages Janssen's AdVac and PER.C6® technologies. Janssen’s AdVac® vectors are based on a specific type of adenovirus, which has been genetically modified so that it can no longer replicate in humans and cause disease. Adenoviruses are a group of viruses that can cause the common cold.

This vaccine is authorized in the USA and South Africa.

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Mar 4, 2021 • 2:42 pm CST

South Korea-based GC Pharma announced that it would support Moderna Inc. and the Republic of Korea's government to distribute 40 million doses of COVID-19 Vaccine Moderna.

Under the terms of its agreement with Moderna, GC pharma is responsible for local regulatory activities. Under the terms of its agreement with the Korean government, GC Pharma, with the Korean government authorities' support, is responsible for distribution activities in South Korea.

“We are proud to be partnering with the government and Moderna to support the distribution of crucial vaccines to the South Korean public,” said EC Huh, Ph.D., President of GC Pharma, in a press statement. “At GC pharma, with using our industry know-how, we are also exploring multiple ways to specifically help those impacted by COVID-19 and ensure preparedness for future public health emergencies.”

The Korea Diseases Control and Prevention Agency previously announced that it would import 40 million doses of COVID-19 Vaccine Moderna from the second quarter of 2021.

Headquartered in Yongin, South Korea, GC Pharma (formerly known as Green Cross Corporation) is a biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines.

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Mar 4, 2021 • 5:54 am CST

The European Medicines Agency (EMA) announced on March 4, 2021, the latest safety data for the Comirnaty Vaccine (Pfizer-BioNTech) are in line with the known benefit-risk profile, and the outcomes of the related assessments are presented in this update.

The benefits of Comirnaty in preventing COVID19 continue to outweigh any risks, and there are no recommended changes regarding the use of this vaccine, says the EMA.

Safety updates provide the outcomes of the assessment of emerging data since marketing authorization for COVID-19 vaccines. Diarrhea and vomiting after vaccination have been identified as new side effects.

The EMA’s Pharmacovigilance Risk Assessment Committee carries out the assessments based on all available data.

Comirnaty was authorized in the European Union on December 21, 2020, for use in people aged 16 years and older to prevent the development of COVID-19 when infected with the coronavirus SARS-CoV-2. Comirnaty contains a molecule called mRNA, which the body uses to produce the SARS-CoV-2 spike protein temporarily.

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