Coronavirus Breaking News

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

Mar 3, 2021 • 2:35 pm CST

India-based Bharat Biotech announced on March 3, 2021, the first interim analysis of its BBV152 (COVAXIN®), the whole virion inactivated COVID-19 vaccine candidate. The first interim analysis is based on 43 cases, of which 36 cases of COVID-19 were observed in the placebo group versus 7 cases observed in the BBV152 (COVAXIN) group, resulting in a point estimate of vaccine efficacy of 80.6%.

The interim analysis included a preliminary review of the safety database, which showed that severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups. The trial's conduct and monitoring are as per Good Clinical Practice guidelines and have been outsourced to IQVIA.

Another analysis is planned for 87 cases, and the final analysis is planned for 130 cases.

“With today’s results from our Phase 3 clinical trials, we have now reported data on our COVID-19 vaccine from Phase 1, 2, and 3 trials involving around 27,000 participants. COVAXIN demonstrates a high clinical efficacy trend against COVID-19, but also significant immunogenicity against the rapidly emerging variants,” commented Dr. Krishna Ella, Chairman & Managing Director, Bharat Biotech, in a related press statement.

Bharat Biotech has established an excellent track record of innovation with more than 145 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 123 countries, and the World Health Organization Prequalifications.

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Mar 2, 2021 • 3:06 pm CST

Texas Governor Greg Abbott issued an Executive Order (GA-34) on March 2, 2021, lifting the mask mandate in Texas and increasing the capacity of all businesses and facilities in the state to 100 percent.  

"With the medical advancements of vaccines and antibody therapeutic drugs, Texas now has the tools to protect Texans from the virus,” commented Governor Abbott in a press release. Make no mistake, COVID-19 has not disappeared, but it is clear from the recoveries, vaccinations, reduced hospitalizations, and safe practices that Texans are using that state mandates are no longer needed."

"We must now do more to restore livelihoods and normalcy for Texans by opening Texas 100 percent."

Today's announcement does not abandon safe practices that Texans have mastered over the past year. Instead, it is a reminder that each person has a role to play in their own personal safety and the safety of others. With this executive order, we are ensuring that all businesses and families in Texas have the freedom to determine their own destiny."

This executive order rescinds most of the Texas Governor's earlier executive orders related to COVID-19. Effective next Wednesday, all businesses of any type may open to 100% capacity. Businesses may still limit capacity or implement additional safety protocols at their own discretion. 

However, if COVID-19 hospitalizations in any of the 22 hospital regions in Texas reaches above 15% of the hospital bed capacity in that region for seven straight days, a County Judge in that region may use COVID-19 mitigation strategies. However, County Judges may not impose jail time for not following COVID-19 orders nor may any penalties be imposed for failing to wear a face mask. If restrictions are imposed at a County level, those restrictions may not include reducing capacity to less than 50% for any type of entity. 

 

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Mar 1, 2021 • 8:29 am CST

As a centralized distribution partner for the U.S. government’s COVID vaccine distribution effort, Irving-based McKesson announced today it began distributing the Janssen COVID-19 vaccine received from Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

The Janssen COVID-19 vaccine received Emergency Use Authorization from the U.S. FDA on February 27, 2021, and is the first one-shot COVID-19 vaccine to be authorized for use in the United States.

The U.S. government selected McKesson in August 2020 to operate as the centralized distributor for frozen and refrigerated COVID-19 vaccines and ancillary supply kits needed to administer them.

In December 2020, McKesson began distributing the ancillary supply kits for Pfizer BioNTech’s COVID-19 vaccine. Later that month, the company began distributing Moderna’s COVID-19 vaccine and ancillary supply kits.

McKesson is a global leader in healthcare and supply chain management, is managing different aspects of the distribution efforts in coordination with the U.S. government.

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Feb 28, 2021 • 8:43 pm CST

Sitka, Alaska's civic center, looks different from many in the lower 48 states, wrote Katerine Rose with NPR. There are no lines and no crowds. Patients arrive every few minutes for their COVID-19 vaccination appointments. 

They don't have to wait very long before a nurse directs them to roll up their sleeves.

Dr. Elliot Bruhl, the chief medical officer at the Southeast Alaska Regional Health Consortium in Sitka, says health workers can vaccinate around 750 people each week. The public health goal is vaccinating whole communities, Alaska Native people and non-Native residents alike.

"As these (COVID-19) vaccines came, we saw it as a moral and ethical imperative that we did not leave vaccines sitting in the freezer," says Dr. Bruhl. 

Bruhl says they received enough supply of the vaccine from both the state and the Indian Health Service (IHS), and the IHS has been extremely efficient in getting vaccines out, reported Rose.

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Feb 28, 2021 • 8:21 pm CST

The Honourable Anita Anand, Minister of Public Services and Procurement, announced on February 26, 2021, that Canada had secured 2 million doses of the AstraZeneca COVID-19 vaccine through an agreement with Verity Pharmaceuticals Canada Inc./Serum Institute of India.

The first 500,000 doses will be delivered to Canada in the coming weeks and will quickly be ready for distribution to the provinces and territories, said the press statement. The remaining 1.5 million doses will arrive by mid-May 2021.

The 2 million doses secured through this agreement are in addition to the 20 million doses already secured through an earlier agreement with AstraZeneca. Health Canada's recent authorization of the AstraZeneca vaccine allows the Government of Canada to advance its work with AstraZeneca to finalize delivery schedules for the 20 million doses.

"We remain fully on track to ensure that there will be a sufficient supply so that every eligible Canadian who wants a vaccine will have access to one by the end of September. I am grateful for the collaboration of our partners in India to finalize this agreement, and I look forward to continuing to work closely together in the weeks ahead," stated the Honourable Anita Anand.

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Feb 28, 2021 • 7:45 am CST

A recent study published by researchers from India's Centre for Cellular and Molecular Biology (CCMB) on February 20, 2021, found 7,569 SARS-CoV-2 coronavirus variants in India alone.

These researchers stated 'the evolution of SARS-CoV-2 can render it more infectious via adaptive mutations that increase affinity or enhance binding to host cells, while escape mutations that can help it evade the immune response have serious implications for vaccines and therapeutics and can adversely impact the severity and mortality of the disease.'

'As multiple vaccines are rolled out in the year ahead, the virus will be subjected to new selection pressures and evolution modes. India has so far not been sequencing SARS-CoV-2 isolates to full capacity, having deposited only about 6,400 genomes of the over 10.4 million recorded cases (0.06%). Exploiting advances in genomic epidemiology by monitoring and increasing sequencing efforts following local spikes will go a long way in staying on top of mutations of concern. At the same time, their biology and effects are studied in greater detail.'

“The novel variants that are worrying many countries globally have been identified with only a low prevalence in India so far. These include variants with immune-escape E484K mutation and the N501Y mutation with a higher transmission rate. However, their apparent low prevalence might be simply because not enough sequencing has been done."

"More coronavirus genomes need to be sequenced across the country to identify the emergence of these and other new variants accurately,” said Dr. Rakesh Mishra, Director, CCMB, in an article by India Times on February 27, 2021.

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Feb 27, 2021 • 6:45 pm CST

The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third experimental vaccine for the prevention of COVID-19. The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.

“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” commented Acting FDA Commissioner Janet Woodcock, M.D., in a press statement.

The FDA had previously issued EUA for the Pfizer-BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine.

Overall, there are eleven COVID-19 vaccines being distributed globally.

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Feb 27, 2021 • 2:21 pm CST

The Canadian Minister of Transport, the Honourable Omar Alghabra, announced new Interim Orders during the COVID-19 pandemic, which prohibit pleasure craft in Canadian Arctic waters and cruise vessels in all Canadian waters until February 28, 2022.

This means adventure-seeking pleasure craft are still prohibited from entering Arctic waters; passenger vessels carrying more than 12 people are still prohibited from entering Arctic coastal waters, including Nunatsiavut, Nunavik, and the Labrador Coast; and cruise vessels carrying more than 100 people are still prohibited from operating in Canadian waters.

Essential passenger vessels, such as ferries and water taxis, should continue to follow local public health guidance and protocols and follow mitigation measures to reduce the spread of COVID-19 and prevent future outbreaks.

“As Canadians continue to do their part to reduce the spread of COVID-19, our government continues to work hard to ensure Canada’s transportation system remains safe. Temporary prohibitions to cruise vessels and pleasure craft are essential to protect the most vulnerable among our communities and avoid overwhelming our health care systems. This is the right and responsible thing to do, stated Honourable Omar Alghabra in a press statement issued on February 4, 2021.

Those who do not comply with the pleasure craft prohibition could be subject to penalties: $5,000 per day for individuals and $25,000 per day for groups or corporations. And those who do not comply with the passenger vessel prohibition could be liable on summary conviction to a fine of up to $1 million or imprisonment for a term of up to 18 months, or both.

 

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Feb 27, 2021 • 6:34 am CST

The U.S. Food and Drug Administration (FDA) reissued its warning about alcohol-based hand sanitizers packaged in containers that may appear as food or drinks and may put consumers at risk of serious injury or death if ingested.

The FDA stated on February 26, 2021, it had 'discovered that some hand sanitizers are being packaged in beer cans, children’s food pouches, water bottles, juice bottles, and vodka bottles. Additionally, the FDA has found hand sanitizers that contain food flavors, such as chocolate or raspberry.'

“These products could confuse consumers into accidentally ingesting a potentially deadly product. It’s dangerous to add scents with food flavors to hand sanitizers which children could think smells like food, eat and get alcohol poisoning,” commented former FDA Commissioner Stephen M. Hahn, M.D., in a press statement issued in 2020.

“Manufacturers should be vigilant about packaging and marketing their hand sanitizers in food or drink packages to mitigate any potential inadvertent use by consumers. The FDA continues to monitor these products, and we’ll take appropriate actions as needed to protect the health of Americans.”

Furthermore, consumers are reminded to keep hand sanitizers out of the reach of children and, in case of ingestion, to get medical help or contact a Poison Control Center immediately. Very small amounts of hand sanitizer can be toxic, even lethal, to young children, says the FDA.

As part of the FDA's efforts, it published three guidances to help meet the increased demand for hand sanitizers during the COVID-19 public health emergency. During the emergency, entities that are not currently registered drug manufacturers can register as over-the-counter drug manufacturers and make alcohol-based hand sanitizers, pharmacies and registered outsourcing facilities can compound certain alcohol-based hand sanitizers, and alcohol production firms can produce alcohol for making hand sanitizers provided they follow the conditions outlined in the FDA guidance for industry.

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Feb 26, 2021 • 12:32 pm CST

Diagnostic testing analyzes the qualitative detection of nucleic acid from the COVID-19 disease in upper and lower respiratory specimens, says the US Centers for Disease Control and Prevention. The real-time Data Tracker reported about 328 million RT-PCR diagnostic tests, excluding antibody and antigen tests, have been performed to confirm SARS-CoV-2 virus infections as of February 25, 2021.

And, as of February 23, 2021, the U.S. FDA had authorized 331 coronavirus diagnostic tests, including 247 molecular tests, 70 antibody tests, and 14 antigen tests during the COVID-19 pandemic. Furthermore, 35 molecular authorizations can be used with home-collected samples.

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Feb 26, 2021 • 7:15 am CST

Indiana-based Eli Lilly and Company announced on February 26, 2021, the U.S. government has agreed to purchase a minimum of 100,000 doses of bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together for the treatment of recently diagnosed, mild to moderate COVID-19 in patients who are at high risk of progressing to severe COVID-19 and/or hospitalization.

Additionally, the US National Institutes of Health updated the COVID-19 Treatment Guidelines to recommend the use of bamlanivimab plus etesevimab for the treatment of outpatients with mild to moderate COVID-19 who are at high risk of clinical progression.

The U.S. government has said it will provide neutralizing antibodies at no out-of-pocket cost to patients, although healthcare facilities may charge a fee for the product's administration.

This new purchase agreement is for $210 million and doses will be delivered through March 31, 2021. Lilly will begin shipping these additional doses immediately.

The U.S. government has the option to purchase up to an additional 1,100,000 doses through November 25, 2021, under the same terms as the base agreement and subject to agreement from Lilly.

The government has already committed to purchasing a total of 1,450,000 doses of bamlanivimab alone.

"In our clinical trials, Lilly's neutralizing antibody therapies significantly reduced the risk of hospitalizations and death," said David A. Ricks, Lilly's chairman, and CEO, in a press statement.

Bamlanivimab and etesevimab together and bamlanivimab alone are authorized under Emergency Use Authorization only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under Section 564(b)(1) of the Act, 21 U.S.C § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Bamlanivimab and etesevimab together and bamlanivimab alone have not been approved by the FDA for any use. It is not known if bamlanivimab and etesevimab together or bamlanivimab alone are safe and effective for the treatment of COVID-19.

Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world.

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Feb 25, 2021 • 7:33 pm CST

The American Dental Hygienists’ Association recently published a study that estimated the prevalence of COVID-19 among the United States dental hygienists was low.

As of October 8, 2020, a total of 4,776 dental hygienists from all 50 states and Puerto Rico participated in the study. Of the respondents, 3.1% had ever tested positive or been diagnosed with COVID-19.

The majority of study respondents (99.1%) who practiced dental hygiene reported their primary dental practice had enhanced infection prevention or control efforts in response to the pandemic.

Most dental practices disinfected between patient visits (97.9%), asked staff to use masks (97.8%), screening patients before treatment (96.7%), and (96.8%) of dental hygienists reported at least five infection-control measures at their primary practice.

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Feb 25, 2021 • 7:11 pm CST

London-based GlaxoSmithKline plc (GSK) announced results from the phase 2 proof of concept OSCAR study with otilimab (GSK3196165), an investigational anti-granulocyte macrophage colony-stimulating factor (anti-GM-CSF) monoclonal antibody.

The primary endpoint of the OSCAR study was the proportion of COVID-19 patients who were alive and free of respiratory failure 28 days after treatment with a single dose of otilimab in addition to standard of care (including anti-viral treatments and corticosteroids), compared to patients being treated with standard of care alone.

A pre-planned efficacy analysis by age in patients 70 years and older showed that 65.1% of patients were alive and free of respiratory failure 28 days after treatment with otilimab plus standard of care, compared to 45.9% of patients who received the standard of care alone.

In a mortality analysis up to day 60, a treatment difference of 14.4% favoring otilimab was seen with rates of 40.4% on the standard of care vs. 26% on otilimab plus standard of care in patients 70 years and older.

Given these data suggest a potentially important clinical benefit in a pre-defined subgroup of high-risk patients and the public health need, GSK has decided to amend the OSCAR study to expand this cohort to confirm these potentially significant findings.

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. 

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Feb 25, 2021 • 9:00 am CST

California-based AIVITA Biomedical, Inc.,  announced the completion of a Phase 1 clinical study in Indonesia of its personalized vaccine candidate, AV-COVID-19, for the SARS-CoV-2 virus. The 27-participant Phase 1 study showed the treatment was well-tolerated, with no serious adverse events, and that treated individuals produced antibodies.

The clinical program is being conducted by PT AIVITA Biomedika Indonesia, a joint venture established between AIVITA and local partners with support from the government of Indonesia. AV-COVID-19 is being manufactured locally by AIVITA.

AIVITA is in discussions with regulatory authorities for a Phase 2 study in Indonesia, as well as a clinical investigation of AV-COVID-19 in the USA in early 2021.

“We continue to see an unprecedented global need for preventative vaccines that can be rapidly scaled and adapted to provide protection against all COVID-19 viral variants,” said Hans Keirstead, Ph.D., chief executive officer of AIVITA, in a press release.

“Our personalized vaccine can be created locally to support regional economic stimulation, using a kit that can be produced rapidly at scale. In addition, our materials can be adapted to quickly create new vaccines against mutations of the virus. With this decentralized model, we can conduct studies in Indonesia and prepare for worldwide distribution.”

AIVITA Biomedical, Inc. is a personalized vaccine company evaluating vaccines for the prevention of COVID-19 infection and treatment of cancer.

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Feb 24, 2021 • 2:57 pm CST

The European Medicines Agency human medicines committee announced on February 24, 2021, it had started a ‘rolling review’ of data on the monoclonal antibody regdanvimab (CT-P59) for the treatment of COVID-19, which South Korea-based Celltrion is developing.

The decision to start the rolling review is based on preliminary results from an ongoing study looking at the ability of the medicine to treat COVID-19.  A monoclonal antibody is a type of protein that has been designed to attach to a specific structure (called an antigen).

The Korea Disease Control and Prevention Agency (KDCA) announced that it had assessed on February 11, 2021. It independently confirmed that CT-P59 successfully neutralizes the SARS-CoV-2 variants first identified in the UK (B.1.1.7) in addition to the previously identified six variant genome mutations of SARS-CoV-2 (variants S·L·V·G·GH·GR).

The KDCA also added that cocktail therapy of CT-P59 with another monoclonal antibody candidate demonstrated neutralizing capability against the UK (B.1.1.7) and South African (B.1.351) variants.

Regdanvimab has been designed to attach to the spike protein of SARS-CoV-2, the virus that causes COVID-19. When it attaches to the spike protein, the ability of the virus to enter the body’s cells is reduced. This is expected to reduce the need for hospitalization in patients with mild to moderate COVID-19.

The Korean pharmaceutical company Celltrion has pioneered numerous uncharted areas to stellar success, which it plans to follow up by continuing its growth as a global biopharmaceutical company with unique approaches to small-molecule pharmaceuticals.