COVID-19 vaccine

Learning from COVID-19: The global health emergency has ended. Here's what is needed to prepare for the next one

Retrieved on: 
Sunday, May 14, 2023
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However, it would be a mistake to assume that this is a mere formality.

Key Points: 
  • However, it would be a mistake to assume that this is a mere formality.
  • A PHEIC, like the one adopted for COVID-19 on Jan. 30, 2020, is declared if a public health event is determined to constitute:
  • A PHEIC means the WHO is sounding the loudest possible alarm to national governments to act together with urgency.
  • However, the heightened state of emergency under a PHEIC is not meant to be sustained indefinitely.

Significance of the end of the COVID-19 PHEIC

    • Moreover, the phrase “no one is safe until everyone is safe” may have become a familiar tagline during the pandemic.
    • Yet, many people, mostly in low- and middle-income countries, still struggle to access COVID-19 vaccines, diagnostics and treatments.
    • Second, the standing down of the PHEIC declaration is accompanied by an understandable desire — and necessity — to “move on” from COVID-19 after three difficult years.
    • The lack of real-world authority by the WHO to enforce the legally binding IHR has become abundantly clear.

Global co-ordination fell short

    • Still, what ensued fell far short of a co-ordinated global effort.
    • Read more:
      COVID-19 vaccine inequity allowed Omicron to emerge

      The need for collective action during global public health emergencies like COVID-19 has only been reinforced by the past three years.

    • Additionally, travel measures implemented in response to COVID-19, and in previous PHEICs, fell inequitably upon different population groups.
    • Meanwhile, a new pandemic may already be on the horizon as the global and interspecies spread of highly pathogenic avian influenza is raising growing alarm.

Invivyd Reports First Quarter 2023 Financial Results and Business Highlights

Retrieved on: 
Thursday, May 11, 2023
Well, Research and development, SG, Conference call, SARS-CoV-2, Hook effect, CMC, COVID-19, Clinical trial, Pharmacokinetics, Research, Interest, Chemistry, Phase-gate process, COVID-19 vaccine, Retirement, Administration, Risk, Engineering, Science Translational Medicine, Webcast, R, Immunodeficiency, FDA, General Administration of Sport of China, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Conference, Food, Safety, Vaccine, Pharmaceutical industry, Cryptocurrency

ET

Key Points: 
  • ET
    WALTHAM, Mass., May 11, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced financial results for the quarter ended March 31, 2023, and recent business highlights.
  • In May 2023, the company announced the conclusion of Fred Driscoll’s service as interim chief financial officer and his planned retirement, effective May 31, 2023.
  • Selling, General & Administrative (SG&A) Expenses: SG&A expenses were $11.0 million for the quarter ended March 31, 2023, compared to $8.7 million for the comparable period of 2022.
  • Basic and diluted net loss per share was $0.32 for the quarter ended March 31, 2023, compared to $0.93 for the comparable period in 2022.

Dyadic Announces First Quarter 2023 Financial Results and Highlights Recent Company Progress

Retrieved on: 
Wednesday, May 10, 2023
Phibro, RBD, Marketing, Public, Enzyme, Biomedical Advanced Research and Development Authority, Fungus, Influenza, Science, Development, Pandemic, Protein, COVID-19 vaccine, Patent, WNV, Rubic Ghasemi-Nobakht, TBEV, Antigen, University of California, Davis, Albumin, Therapy, Fermentation, Research, Infection, Gene expression, Consultant, RVFV, CGMP, Manuscript, Recombinant, Growth, FDA, BARDA, ACE2, Safety, D, Vaccine, DNA, COVID-19, Antibody, CSR, Government, Animal, UC, Webcast, Food, Omicron, Education, SARS-CoV-2, Clinical trial, CHO, Sale, NIIMBL, Health, Pharmaceutical industry, Financial adviser, Cryptocurrency, Fine chemical, Rare-earth element, Video game, EU, African, C1, Dyadic

Top 5 Pharma – In April 2023, the Company entered a new research collaboration with a top 5 pharmaceutical company to express a vaccine antigen from C1 for human health.

Key Points: 
  • Top 5 Pharma – In April 2023, the Company entered a new research collaboration with a top 5 pharmaceutical company to express a vaccine antigen from C1 for human health.
  • In the first quarter of 2023, the Company entered into a new research collaboration with a biotech company for a fully funded proof-of-concept project to express an enzyme for pharmaceutical applications.
  • G&A Expenses: General and administrative expenses for the quarter ended March 31, 2023, decreased by 10.6% to approximately $1,480,000 compared to $1,656,000 for the quarter ended March 31, 2022.
  • Other Income: Other income for the quarter ended March 31, 2023 was from the sale of the equity interest in Alphazyme, LLC.

What does ending the emergency status of the COVID-19 pandemic in the US mean in practice? 4 questions answered

Retrieved on: 
Wednesday, May 10, 2023
Vaccine, White House, Telehealth, Communication, PHEIC, Conversation, Therapy, Pharmacy, Contract, Public, COVID-19, Trump, Infection, World, Public Health Service Act, COVID-19 Response (Vaccinations) Legislation Act 2021, Research, COVID, Title 42 of the United States Code, Appetite, United States Public Health Service, Former, White, CDC, Organization, Medicare, Congress, COVID-19 vaccine, Patient, Income, Emergency medical services, Health, Federation, WHO, World Health Organization, Disease, Pharmaceutical industry, Health insurance, Medicaid

The COVID-19 pandemic’s public health emergency status in the U.S. expires on May 11, 2023.

Key Points: 
  • The COVID-19 pandemic’s public health emergency status in the U.S. expires on May 11, 2023.
  • And on May 5, the World Health Organization declared an end to the COVID-19 public health emergency of international concern, or PHEIC, designation that had been in place since Jan. 30, 2020.
  • While the global emergency status has ended, COVID-19 is still an “established and ongoing health issue,” he said.

1. What does ending the national emergency phase of the pandemic mean?

    • Ending the federal emergency reflects both a scientific and political judgment that the acute phase of the COVID-19 pandemic crisis has ended and that special federal resources are no longer needed to prevent disease transmission across borders.
    • In practical terms, it means that two declarations – the federal Public Health Emergency, first declared on Jan. 31, 2020, and the COVID-19 national emergency that former President Donald Trump announced on March 13, 2020, are expiring.
    • Declaring those emergencies enabled the federal government to cut through mountains of red tape to respond to the pandemic more efficiently.

2. What domestic policies are changing?

    • Another analysis projected that as many as 24 million people will be kicked off the Medicaid rolls.
    • Before the pandemic, states required people to prove every year that they met income and other eligibility requirements.
    • In March 2020, Congress enacted a continuous enrollment provision in Medicaid that prevented states from removing anyone from their rolls during the pandemic.
    • In a December 2022 appropriations bill, Congress passed a provision that ended continuous enrollment on March 31, 2023.
    • The array of telehealth services that Medicare began covering during the pandemic will continue to be covered through December 2024.

3. What does this mean for the status of the pandemic?

    • But declaring an end to the emergency doesn’t mean a return to business as usual.
    • She called for more federally funded research into therapeutics and durable vaccines that protect against many variants.
    • With the end of the emergency, the CDC is also changing the way it presents its COVID-19 data to a “sustainable national COVID-19 surveillance” model.

4. How will state and local pandemic measures be affected?

    • Most U.S. states, however, have ended their own public health emergency declarations.
    • Marian Moser Jones receives funding from the National Endowment for the Humanities and The American Public Health Association.
    • In the past she has received funding from the National Institutes of Health and the American Association for the History of Nursing, as well as the State of Maryland.

Health Canada should be transparent about how it's monitoring drug safety

Retrieved on: 
Thursday, May 4, 2023
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Regulatory bodies like Health Canada are intended to ensure that approved drugs go through a rigorous multi-stage process.

Key Points: 
  • Regulatory bodies like Health Canada are intended to ensure that approved drugs go through a rigorous multi-stage process.
  • Once new drugs are approved for marketing in Canada, Health Canada continues to monitor them.

Clinical trials

    • Potential new drugs are assessed in clinical trials before they can be authorized for sale in Canada.
    • In addition, clinical trials often leave out children, the elderly, women, minority groups, people with disabilities and multiple other groups.
    • Usually only 3,000 to 5,000 people are exposed to an experimental drug in clinical trials.

Drug safety programs

    • That’s why when regulatory agencies like Health Canada approve a drug, they require the drug company to monitor post-market safety.
    • These programs go by various names; in Canada and Europe they are Risk Management Plans (RMP) and in the United States they are Risk Evaluation and Mitigation Strategies (REM).
    • Under these plans companies may have to conduct additional safety studies, set up registries to identify patients who are taking the drug, develop educational materials for health care professionals and/or patients, restrict access to the drug and commit to undertaking a number of other measures.

Access to drug monitoring information

    • In the U.S., people can turn to a Food and Drug Administration website that lists all the drugs with REMS.
    • Click on a hyperlink and it takes you to a summary of the RMP for the drug in question.
    • Two of Health Canada’s stated goals in implementing a system of RMPs are to “support Canadians’ timely access to safe, efficacious and high quality drugs and support ongoing evaluation of information that could have an impact on the benefit-risk profile of health products.” But without access to current information on specific drugs, Canadians cannot assess those risks for themselves, nor can they evaluate the monitoring program.
    • But Health Canada does not need to wait until then to make this information available to Canadians.

Use of Medicines in the U.S. Continued to Grow in 2022 while Patient Out-of-Pocket Costs Remain Low, Says IQVIA Institute

Retrieved on: 
Tuesday, May 2, 2023
Other Health, Radiology, Pharmaceutical, Oncology, Mental Health, Neurology, Medical Devices, Infectious Diseases, Hospitals, Genetics, COVID-19, Clinical Trials, Cardiology, Biotechnology, Practice Management, Alternative Medicine, Physical Therapy, Managed Care, Health, General Health, Healthcare Reform, Public Policy, Government, Insurance, Science, Veterinary, Medical Supplies, Diabetes, Professional Services, Health Technology, Vitamins, Supplements, Health Insurance, Other Science, Research, Surgery, Telemedicine, Virtual Medicine, Obesity, Telehealth, Use, Therapy, Data science, Policy, Infection, ADHD, Prescription, Woman, Medicine, American Rescue Plan Act of 2021, Inflation, Health care, COVID-19 vaccine, Patient, Growth, PBM, Ageing, Biosimilar, Inflation Reduction Act of 2022, Legislation, Pharmaceutical industry

“This is the tale of a balanced market in the U.S.,” said Murray Aitken, Executive Director of the IQVIA Institute for Human Data Science.

Key Points: 
  • “This is the tale of a balanced market in the U.S.,” said Murray Aitken, Executive Director of the IQVIA Institute for Human Data Science.
  • Over the next five years we can expect significant growth from oncology, obesity and neuroscience medicines.
  • Medicines use: Use of medicines continues to grow but with patterns reflecting a new normal in a post-COVID-19 world.
  • Manufacturer copay assistance brought down patient costs by nearly $19Bn in 2022 and nearly $80Bn over the last five years.

Transatlantic Bridge Awards Honor Dr. Anthony Fauci, Senator Rob Portman, PBS's Judy Woodruff

Retrieved on: 
Thursday, April 27, 2023
Europe Day, EU, Freedom, Democracy, Senate, Dan Sullivan (U.S. senator), Speech, Public, Politics, Schuman Declaration, COVID-19, World Trade Organization, House of Sweden, Woman, Multimedia, Mentorship, Science, Natural Resources, Senate Ukraine Caucus, COVID-19 vaccine, Representative, European, News Hour, Delegation of the European Union to the United States, NIAID, Louisiana House of Representatives, Delegation, International Women's Media Foundation, Media Foundation, House, PBS, Infection, Female, Atlantic Ocean

This year's honorees — Dr. Anthony Fauci, Senator Rob Portman, and journalist Judy Woodruff — will each receive the award for their achievements in fostering closer ties, cooperation, and mutual understanding between Europe and the United States, in a ceremony at the House of Sweden.

Key Points: 
  • This year's honorees — Dr. Anthony Fauci, Senator Rob Portman, and journalist Judy Woodruff — will each receive the award for their achievements in fostering closer ties, cooperation, and mutual understanding between Europe and the United States, in a ceremony at the House of Sweden.
  • In so doing, they have fostered deeper public understanding of the challenges and opportunities facing Europe and the United States in an increasingly turbulent world.
  • During the COVID-19 pandemic, Dr. Anthony Fauci became a household name in Europe and the U.S. for his rigorous, rational response, and his spirit of service.
  • Throughout her long and distinguished career, Judy Woodruff has embodied the best of American journalism.

BIAL Award in Biomedicine worth 300,000 Euros

Retrieved on: 
Wednesday, April 26, 2023
BioNTech, The New England Journal of Medicine, European Medical Association, The BMJ, European Research Council, Medical journal, COVID-19 vaccine, Perelman School of Medicine at the University of Pennsylvania, Medicina, Jury, University, Nature (journal), Medical Faculty Associates, Messenger, Bangladesh Technical Education Board, Harvard Medical School, Panel, Biology, COVID-19, Council, Saint Andrew's Society, Bial, Medical device, Nursing, Pharmaceutical industry, California Institute of Technology, Biomedicine, Psychology, Neuroscience

TROFA, Portugal, April 26, 2023 /PRNewswire/ -- The third edition of the BIAL Foundation's international award, the BIAL Award in Biomedicine, is now underway, with nominations open until 30 June. With the amount of 300 thousand Euros, this award aims to recognise a work of a broad biomedical nature with exceptional quality and scientific relevance results published within the last ten years.

Key Points: 
  • TROFA, Portugal, April 26, 2023 /PRNewswire/ -- The third edition of the BIAL Foundation's international award, the BIAL Award in Biomedicine, is now underway, with nominations open until 30 June.
  • With the amount of 300 thousand Euros, this award aims to recognise a work of a broad biomedical nature with exceptional quality and scientific relevance results published within the last ten years.
  • Candidates for this international award may be nominated by members of the Jury, members of the Scientific Board of the BIAL Foundation, previous BIAL Award winners, Scientific Societies, Boards or Deans of Medical Faculties, Heads of leading research institutes, and Boards or Heads of prestigious Academies.
  • The BIAL Award in Biomedicine takes place biannually, in odd-numbered years, alternating with the Prémio BIAL de Medicina Clínica.

GeoVax Announces Expansion of Next-Generation COVID-19 Vaccine Rights to Include Omicron Variants and Use Against Orthopoxviruses

Retrieved on: 
Monday, April 17, 2023
Vaccine, Human, GeoVax, HIV, SARS-CoV-2, Public, Biotechnology, COVID-19, Ageing, Smallpox, Infection, Research, COH, Messenger, Dialysis, Orthopoxvirus, Malignancy, COVID-19 vaccine, City, Patient, Cancer, Immunodeficiency, Immunization, Virus, Disease, MVA, Pharmaceutical industry, Mpox

ATLANTA, GA, April 17, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire -- GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the expansion of its rights under its exclusive license agreement with City of Hope (COH), a world-renowned cancer research and treatment organization, to include development and commercialization rights against orthopoxviruses in addition to SARS-CoV-2.

Key Points: 
  • Orthopoxviruses include Mpox (monkeypox), smallpox, and other viruses that cause disease in humans.
  • GeoVax previously demonstrated that an experimental HIV vaccine, utilizing MVA as the vaccine vector, protected non-human primates challenged with a lethal dose of the Mpox virus (publication accessible here ).
  • Such a vaccine may offer a simplified vaccine regimen for protection against diseases associated with SARS-CoV-2 and orthopoxviruses.
  • GeoVax is focusing on the clinical development of this vaccine for use in patients with special medical limitations or needs, specifically the immunocompromised populations.

Albertsons Companies, Inc. Reports Fourth Quarter and Full Year Results

Retrieved on: 
Tuesday, April 11, 2023
Retail, Supermarket, Food, Beverage, Acceleration, Net, Common stock, Advertising, Plan, Vaccination, Tripura Merger Agreement, COVID-19, Pharmacy, Special dividend, Public expenditure, EBITDA, COVID-19 vaccine, Investment, Growth, ESG, Pharmaceutical industry, Video game, Security (finance), Kroger, Mergers and acquisitions, Adjustment

Gross margin rate decreased to 27.8% during the fourth quarter of fiscal 2022 compared to 28.7% during the fourth quarter of fiscal 2021.

Key Points: 
  • Gross margin rate decreased to 27.8% during the fourth quarter of fiscal 2022 compared to 28.7% during the fourth quarter of fiscal 2021.
  • We administered 0.4 million COVID-19 vaccinations during the fourth quarter of fiscal 2022, compared to 2.3 million during the fourth quarter of fiscal 2021.
  • Interest expense, net was $91.6 million during the fourth quarter of fiscal 2022 compared to $108.0 million during the fourth quarter of fiscal 2021.
  • Adjusted EBITDA was $1,050.2 million during the fourth quarter of fiscal 2022 compared to $1,073.7 million during the fourth quarter of fiscal 2021.