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Bayer raises peak sales for Nubeqa to exceed three billion euro amid positive Phase III ARASENS trial data

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Bayer raises peak sales for Nubeqa to exceed three billion euro amid positive Phase III ARASENS trial data

February 17, 2022: “At the 2022 ASCO GU Cancers Symposium Bayer presented results from the Phase III ARASENS trial which demonstrated that the use of the oral androgen receptor inhibitor (ARi) darolutamide plus androgen deprivation therapy (ADT) and docetaxel significantly increased overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to ADT plus docetaxel.

Darolutamide plus ADT and docetaxel significantly reduced the risk of death by 32.5% compared to ADT plus docetaxel (HR=0.68, 95% CI 0.57-0.80; P<0.001).

At the data cutoff date for the primary analysis (October 25, 2021), the median treatment duration was longer for darolutamide plus ADT and docetaxel (41.0 months) versus ADT plus docetaxel (16.7 months).

Amid these positive results Bayer raised peak sales expectation for Nubeqa™ (darolutamide) to exceed €3 billion.

“Subject to regulatory approval, the team at Bayer is excited to be able to offer even more patients suffering from prostate cancer an additional treatment option backed by strong clinical data,” said Stefan Oelrich, Member of the Board of Management of Bayer and President of the Pharmaceuticals Division.

“With the confirmation of darolutamide’s clinical profile and expansion into the metastatic setting as well as the investments that we are making in clinical trials in other potential indications, we feel that Nubeqa has the potential to generate peak sales of more than 3 billion euros”.

Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

Based on results from the pivotal Phase III ARAMIS trial, the compound is already approved for the treatment of patients with nmCRPC, who are at high risk of developing metastatic disease, in more than 60 markets worldwide.

Results from the second Phase III ARASENS trial evaluating darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC) were presented yesterday as an oral presentation at the 2022 ASCO GU Cancer Symposium and simultaneously published in The New England Journal of Medicine. 

Bayer is already in discussions with health authorities worldwide regarding the submission for marketing authorization in this additional indication.

Darolutamide is being investigated in a broad development program with additional three ongoing or planned large clinical studies, to investigate its potential across prostate cancer patients from the early- to the late-stage of this disease.

This includes another Phase III trial in mHSPC (ARANOTE) as well as an ANZUP-led international co-operative group Phase III trial, evaluating darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence (DASL-HiCaP, ANZUP1801).

Information about these trials can be found at www.clinicaltrials.gov. In addition, a study to explore the potential of darolutamide in the early setting for patients who have been treated with surgery or radiation and now see a rise in their prostate specific antigen (PSA) levels is also planned.

About Nubeqa™ (darolutamide)
Darolutamide is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells.

The low potential for blood-brain barrier penetration for darolutamide is supported by preclinical models and neuroimaging data in healthy humans.

A low blood-brain barrier penetration would explain the overall low incidence of central nervous system (CNS)-related adverse events (AEs) compared to placebo as seen in the ARAMIS and ARASENS Phase III trials and the improved verbal learning and memory observed in the darolutamide arm of the Phase II ODENZA trial.

The product is approved under the brand name Nubeqa™ in more than 60 markets around the world, including the U.S., EU, Japan, China, for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.

The compound is also currently being investigated in further studies across various stages of prostate cancer, including another Phase III trial in mHSPC (ARANOTE) as well as an ANZUP-led international co-operative group Phase III trial, evaluating darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence (DASL-HiCaP, ANZUP1801).”

https://media.bayer.com/baynews/baynews.nsf/id/Bayer-raises-sales-Nubeqa-exceed-three-billion-positive-Phase-III-ARASENS-trial?OpenDocument&sessionID=1645371134

Nirsevimab EMA regulatory submission accepted for RSV protection in all infants

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Nirsevimab EMA regulatory submission accepted for RSV protection in all infants

February 17, 2022: “AstraZeneca’s Marketing Authorisation Application (MAA) for nirsevimab has been accepted under an accelerated assessment procedure by the European Medicines Agency (EMA), for the prevention of medically attended lower respiratory tract infections (LRTI) in all infants through their first respiratory syncytial virus (RSV) season.

Nirsevimab is being developed by AstraZeneca in collaboration with Sanofi.

Nirsevimab is the first investigational long-acting antibody designed to provide RSV protection for all infants.

It is being developed as a single dose for infants experiencing their first RSV season and for children at higher risk in their second RSV season.

The MAA is based on positive results from the MELODY Phase III trial, MEDLEY Phase II/III trial, and Phase IIb trial which demonstrated nirsevimab’s safety and efficacy in providing protection against the virus for all infants with a single dose for the RSV season.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) granted nirsevimab accelerated assessment as it was deemed of major interest for public health and therapeutic innovation.

Accelerated assessment aims to reduce the timeframe for the CHMP to review a MAA compared to the standard procedure and follows the EMA granting access to the PRIority MEdicines (PRIME) scheme in 2019.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca said: “Each year, respiratory syncytial virus causes seasonal epidemics of lower respiratory tract infections in infants and preventative options are currently limited to infants at higher-risk .

We are excited that the EMA has accepted this regulatory submission under an accelerated assessment procedure, as nirsevimab has the potential to be the first immunisation to offer protection for all infants against respiratory syncytial virus as shown by the extensive clinical trial programme.”

Jean-François Toussaint, Global Head of Research and Development, Sanofi, said: “Respiratory syncytial virus is a leading cause of hospitalisation in all infants, and recent spikes in bronchiolitis and hospitalisations caused by respiratory syncytial virus infection around the globe further demonstrate the need for a preventative option that can help protect all infants.

We are pleased to receive this regulatory filing acceptance and remain confident in nirsevimab’s potential to change the current RSV prevention paradigm as a possible single dose option that may offer sustained protection to all infants for the season”

Data from the MELODY and MEDLEY trials will be published in an upcoming peer-reviewed journal.”

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2022/nirsevimab-ema-regulatory-submission-accepted-under-accelerated-assessment-for-rsv-protection-in-all-infants.html

New gene therapy treatment for patients with relapsed or refractory large B-cell lymphoma

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New gene therapy treatment for patients with relapsed or refractory large B-cell lymphoma

Jan 28, 2022: “EMA has recommended granting a marketing authorisation in the EU for Breyanzi (lisocabtagene maraleucel), a gene therapy for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), whose cancer has come back or who have not responded to treatment after two or more lines of systemic therapy.

DLBCL, PMBCL and FL3B are subtypes of non-Hodgkin lymphoma, a cancer of the lymphatic system that begins in B-cells, a subtype of the white blood cells of the immune system, and can grow into tumours in the lymph nodes or in other places in the body, causing serious problems in the immune system, and in the organ in which they are growing.

Approximately 50% to 60% of patients achieve a long-term response and will be cured of the disease with standard-of-care immune-chemotherapy.

However, the treatment of patients who do not respond to standard therapy or whose cancer has come back after previous treatments remains challenging and they require alternative options to improve their health outlook.

Breyanzi is an advanced therapy medicinal product (ATMP) belonging to a new generation of personalised immune-cell-based-gene-therapies that are based on collecting and genetically modifying a patient’s own immune cells to treat their cancer.

To create each dose of Breyanzi, the patient’s blood is extracted and its T-cells, a type of white blood cell that helps the body fight infection, are collected and genetically engineered to have a specific protein (chimeric antigen receptor, CAR) that helps the body recognise and eliminate cancerous B-cells.

These modified immune cells are then infused back into the patient.

The safety of Breyanzi was studied in four studies involving over three hundred treated patients and the efficacy in two studies pooling about three hundred and fifty enrolled patients.

The efficacy studies concluded that clinical benefit would be expected with a meaningful disease control in a substantial proportion of patients.

Although Breyanzi is overall well tolerated, it can cause severe side effects, particularly cytokine release syndrome (CRS).

This is a systemic response to the activation and proliferation of CAR-T cells causing high fever and flu-like symptoms, infections and encephalopathy, i.e., a brain disorder.

The consequences of CRS can be life threatening and, in some cases, even fatal.

Monitoring and mitigation strategies for these side effects are described in the product information and in the risk management plan that is an integral part of the authorisation.

Breyanzi was supported through EMA’s PRIority MEdicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support for promising medicines with a potential to address unmet medical needs.

In its overall assessment of the available data, the Committee for Advanced Therapies (CAT), EMA’s expert committee for cell- and gene-based medicines, found that the benefits of Breyanzi outweighed the possible risks in patients with relapsed or refractory DLBCL, PMBCL and FL3B.

The CHMP, EMA’s human medicines committee, agreed with the CAT’s assessment and positive opinion, and recommended approval of this medicine.

The opinion adopted by the CHMP is an intermediary step on Breyanzi’s path to patient access.

The CHMP opinion will now be sent to the European Commission for the adoption of a decision on the EU-wide marketing authorisation.

Once a marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each Member State, taking into account the potential role/use of this medicine in the context of the national health system of that country.”

https://www.ema.europa.eu/en/news/new-gene-therapy-treatment-patients-relapsed-refractory-large-b-cell-lymphoma

Crucial changes needed to protect workers’ health while teleworking

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Crucial changes needed to protect workers’ health while teleworking

 February 02, 2022: “The World Health Organization and the International Labour Organization have called for measures to be put in place to protect workers’ health while teleworking.

A new technical brief to healthy and safe teleworking, published by the two UN agencies, outlines the health benefits and risks of teleworking and the changes needed to accommodate the shift towards different forms of remote work arrangements brought on by the COVID-19 pandemic and the digital transformation of work.

Among the benefits, the report says, there can be improved work–life balance, opportunities for flexible working hours and physical activity, reduced traffic, and time spent commuting and a decrease in air pollution — all of which can improve physical and mental health and social wellbeing.

Teleworking can also lead to higher productivity and lower operational costs for many companies.

However, the report warns that without proper planning and organization and without health and safety support, the impact of teleworking on the physical and mental health and social wellbeing of workers can be significant.

It can lead to isolation, burnout, depression, home violence, musculoskeletal and other injuries, eye strain, increase in smoking and alcohol consumption, prolonged sitting and screen time and unhealthy weight gain.

The report outlines the roles that governments, employers, workers and health services at workplaces should play in promoting and protecting health and safety while teleworking.

“The pandemic has led to a surge of teleworking, effectively changing the nature of work practically overnight for many workers”, said Dr Maria Neira, Director, Department of Environment, Climate Change and Health, World Health Organization.

“In the nearly two years since the start of the pandemic, it’s become very clear that teleworking can as easily bring health benefits, and it can also have dire impact.

Which way the pendulum swings depends entirely on whether governments, employers and workers work together and whether there are agile and inventive occupational health services to put in place policies and practices that benefit both workers and the work.”

Measures that should be put in place by employers include ensuring that workers receive adequate equipment to complete the tasks of the job; providing relevant information, guidelines and training to reduce the psychosocial and mental health impact of teleworking; training managers in effective risk management, distance leadership and workplace health promotion; and establishing the “right to disconnect” and sufficient rest days.

Occupational health services should be enabled to provide ergonomic, mental health and psychosocial support to teleworkers using digital telehealth technologies, the report says.

“Teleworking and particularly hybrid working are here to stay and will likely increase after the pandemic, as both companies and individuals alike have experienced its feasibility and benefits,” said Vera Paquete-Perdigão, Director of the ILO Governance and Tripartism Department. ‘

As we move away from this ‘holding pattern’ to settle into a new normal, we have the opportunity to embed new supportive policies, practices and norms to ensure millions of teleworkers have healthy, happy, productive and decent work.”

The report offers practical recommendations for the organization of telework that meet the needs of both workers and organizations.

These include discussing and developing individual teleworking work plans and clarifying priorities; being clear about timelines and expected results; agreeing on a common system to signal availability for work; and ensuring that managers and colleagues respect the system.

Enterprises with teleworkers should develop special programmes for teleworking combining measures for the management of work and performance with information and communication technologies and adequate equipment, and occupational health services for general health, ergonomic and psycho-social support.”

https://www.who.int/news/item/02-02-2022-crucial-changes-needed-to-protect-workers-health-while-teleworking

Pfizer and BioNTech Initiate Authorization of COVID-19 Vaccine in Children

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Pfizer and BioNTech Initiate Authorization of COVID-19 Vaccine in Children

 February 01, 2022: “Pfizer Inc. and BioNTech SE announced that following a request from the U.S. FDA the companies have initiated a rolling submission seeking to amend the EUA of the Pfizer-BioNTech COVID-19 Vaccine to include children 6 months through 4 years of age (6 months to <5 years of age), in response to the urgent public health need in this population.

The companies expect to complete the EUA submission in the coming days.

This application is for authorization of the first two 3 µg doses of a planned three-dose primary series in this age group.

Data on a third dose given at least 8 weeks after completion of the second dose are expected in the coming months and will be submitted to the FDA to support a potential expansion of this requested EUA.

Since the pandemic began, more than 10.6 million children have tested positive for COVID-19 in the U.S., with children under 4 accounting for more than 1.6 million of those cases.

Further, reported COVID-19 cases and related hospitalization among children have spiked dramatically across the United States during the Omicron variant surge.

For the week ending January 22, children under 4 accounted for 3.2% of the total hospitalizations due to COVID-19.

If authorization is granted, the Pfizer-BioNTech COVID-19 Vaccine would be the first vaccine available to help protect children under 5 years of age from this disease, potentially including future emerging variants of concern.

“As hospitalizations of children under 5 due to COVID-19 have soared, our mutual goal with the FDA is to prepare for future variant surges and provide parents with an option to help protect their children from this virus,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.

“Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants.

If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose.”

“Our vaccine has already demonstrated a favorable safety, tolerability and efficacy profile in multiple clinical trials and real-world studies for all age groups starting from 5 years old,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.

“If authorized, we are very excited about the prospect of offering parents the opportunity to help protect their children 6 months through 4 years of age from COVID-19 and the potentially severe consequences of infection.”

The request to amend the EUA is based on the totality of data on the safety, tolerability, immunogenicity, and available efficacy of two doses of the Pfizer-BioNTech COVID-19 Vaccine.

The companies also plan to share these data with the European Medicines Agency and other regulatory agencies around the world.

The companies plan to provide ample supply of the 3 µg dose to meet demand should the FDA approve the EUA application.

The companies previously announced planned global supply capacity of approximately four billion doses of the Pfizer-BioNTech COVID-19 Vaccine in 2022.

The companies continue to supply the vaccine under their existing supply agreement with the U.S. government, which continues through April 2022.

About the Phase 1/2/3 Trial in Children

The Phase 1/2/3 trial initially enrolled 4,500 children ages 6 months to under 12 years of age in the United States, Finland, Poland, and Spain from more than 90 clinical trial sites.

Additional children have been enrolled in all age groups following study amendments and the trial currently includes approximately 8,300 children.

It was designed to evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech vaccine on a two-dose schedule (approximately 21 days apart) in three age groups: ages 5 to under 12 years; ages 2 to under 5 years; and ages 6 months to under 2 years.

Based on the Phase 1 dose-escalation portion of the trial, children ages 5 to under 12 years received a two-dose schedule of 10 µg each while children under age 5 received a lower 3 µg dose for each injection in the Phase 2/3 study.

The trial enrolled children with or without prior evidence of SARS-CoV-2 infection. On December 17, 2021, Pfizer and BioNTech announced the companies would test a third 3 µg dose given at least two months after the second dose in children under age 5 and a third dose of the 10 µg formulation in children 5 to under 12 years of age.

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer.

BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.

Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

U.S. Indication & Authorized Use

HOW IS THE VACCINE GIVEN?

The vaccine will be given as an injection into the muscle.

Primary Series:
In individuals 5 years of age and older, the vaccine is administered as a 2-dose series, 3 weeks apart.
In individuals 5 years of age and older, a third primary series dose may be administered at least 28 days after the second dose to individuals who are determined to have certain kinds of immunocompromise.

Booster Dose:

  • A single booster dose of the vaccine may be administered at least 5 months after completion of a primary series of the Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) to individuals 12 years of age and older
  • A single booster dose of the vaccine may be administered to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine.
    Individuals should check with their healthcare provider regarding timing of the booster dose

WHAT IS THE INDICATION AND AUTHORIZED USE?

The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide:

  • a 2-dose primary series to individuals 5 years of age and older
  • a third primary series dose to individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise
  • a single booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
  • a single booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine.
    The booster schedule is based on the labeling information of the vaccine used for the primary series

COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.

  • It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older
  • It is also authorized under EUA to provide:
    • a 2-dose primary series to individuals 12 through 15 years of age
    • a third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
    • a single booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
    • a single booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine.
    • The booster schedule is based on the labeling information of the vaccine used for the primary series.”

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-initiate-rolling-submission-emergency

CHMP recommends approval of Dupixent for severe asthma for 6 to 11 yrs

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CHMP recommends approval of Dupixent for severe asthma for 6 to 11 yrs

January 31, 2022: ‘The EMA’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending to extend the approval of Dupixent® (dupilumab) in the EU to include add-on maintenance treatment for children aged 6 to 11 years with severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO) who are inadequately controlled on two maintenance therapies.

The European Commission is expected to announce a final decision on the Dupixent application in the coming months.

The CHMP positive opinion is supported by Phase 3 data recently published in the New England Journal of Medicine showing that Dupixent added to standard of care significantly reduced the rate of severe asthma attacks and rapidly improved lung function within two weeks, with sustained improvement up to 52 weeks, in children with uncontrolled moderate-to-severe asthma.

The safety results from the trial were generally consistent with the known safety profile of Dupixent in patients aged 12 years and older with uncontrolled moderate-to-severe asthma.

Adverse events more commonly observed with Dupixent compared to placebo included injection site reactions, viral upper respiratory tract infections and eosinophilia.

Helminth infections were also more commonly observed with Dupixent compared to placebo in patients aged 6 to11 years.

Asthma is one of the most common chronic diseases in children. Up to 85% of children with asthma may have type 2 inflammation and are more likely to have higher disease burden.

Despite treatment with current standard-of-care inhaled corticosteroids (ICS) and bronchodilators, these children may continue to experience serious symptoms such as coughing, wheezing and difficulty breathing.

Severe asthma may impact children’s developing airways and cause potentially life-threatening exacerbations.

Children with severe asthma also may require the use of multiple courses of systemic corticosteroids that carry significant risks.

Uncontrolled severe asthma can interfere with day-to-day activities, like sleeping, attending school and playing sports.

On October 20, 2021, Dupixent was approved by the FDA as an add-on maintenance treatment for patients aged 6 to 11 years with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma.

The use of Dupixent in children aged 6 to 11 years with uncontrolled severe asthma is investigational in the EU and is not yet approved.

About Dupixent

Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant.

IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP).

Dupixent is currently approved in Europe for adults and adolescents 12 years and older as an add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised FeNO, who are inadequately controlled with high-dose ICS plus another medicinal product for maintenance treatment.

It is also approved in the U.S., Japan and other countries around the world for use in certain patients with asthma, specific patients with moderate-to-severe atopic dermatitis as well as CRSwNP in different age populations.

Dupixent is also approved in one or more of these indications in more than 60 countries around the world, and more than 350,000 patients have been treated globally.

Dupilumab Development Program

Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.

To date, dupilumab has been studied across 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.

In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes including chronic obstructive pulmonary disease with evidence of type 2 inflammation (Phase 3), pediatric atopic dermatitis (6 months to 5 years of age, Phase 3), eosinophilic esophagitis (Phase 3), bullous pemphigoid (Phase 3), prurigo nodularis (Phase 3), chronic spontaneous urticaria (Phase 3), chronic inducible urticaria-cold (Phase 3), chronic rhinosinusitis without nasal polyposis (Phase 3), allergic fungal rhinosinusitis (Phase 3), allergic bronchopulmonary aspergillosis (Phase 3) and peanut allergy (Phase 2).

These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority.

About Regeneron

Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories.

Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases.

Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune®, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.”

https://www.sanofi.com/en/media-room/press-releases/2022/2022-01-31-07-00-00-2375371

Tonnes of COVID-19 health care waste expose urgent need to improve waste management systems

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Tonnes of COVID-19 health care waste expose urgent need to improve waste management systems

February 01, 2022: “Tens of thousands of tonnes of extra medical waste from the response to the COVID-19 pandemic has put tremendous strain on health care waste management systems around the world, threatening human and environmental health and exposing a dire need to improve waste management practices, according to a new WHO report.

The WHO Global analysis of health care waste in the context of COVID-19: status, impacts and recommendations bases its estimates on the approximately 87,000 tonnes of personal protective equipment (PPE) that was procured between March 2020- November 2021 and shipped to support countries’ urgent COVID-19 response needs through a joint UN emergency initiative.

Most of this equipment is expected to have ended up as waste.

The authors note that this just provides an initial indication of the scale of the COVID-19 waste problem.

It does not take into account any of the COVID-19 commodities procured outside of the initiative, nor waste generated by the public like disposable medical masks.

They point out that over 140 million test kits, with a potential to generate 2,600 tonnes of non-infectious waste (mainly plastic) and 731,000 litres of chemical waste (equivalent to one-third of an Olympic-size swimming pool) have been shipped, while over 8 billion doses of vaccine have been administered globally producing 144,000 tonnes of additional waste in the form of syringes, needles, and safety boxes.

As the UN and countries grappled with the immediate task of securing and quality-assuring supplies of PPE, less attention and resources were devoted to the safe and sustainable management of COVID-19 related health care waste.

“It is absolutely vital to provide health workers with the right PPE, “said Dr Michael Ryan, Executive Director, WHO Health Emergencies Programme.

“But it is also vital to ensure that it can be used safely without impacting on the surrounding environment.”

This means having effective management systems in place, including guidance for health workers on what to do with PPE and health commodities after they have been used.

Today, 30% of healthcare facilities (60% in the least developed countries) are not equipped to handle existing waste loads, let alone the additional COVID-19 load.

This potentially exposes health workers to needle stick injuries, burns and pathogenic microorganisms, while also impacting communities living near poorly managed landfills and waste disposal sites through contaminated air from burning waste, poor water quality or disease carrying pests.

“COVID-19 has forced the world to reckon with the gaps and neglected aspects of the waste stream and how we produce, use and discard of our health care resources, from cradle to grave,” said Dr Maria Neira, Director, Environment, Climate Change and Health at WHO.

“Significant change at all levels, from the global to the hospital floor, in how we manage the health care waste stream is a basic requirement of climate-smart health care systems, which many countries committed to at the recent UN Climate Change Conference, and, of course, a healthy recovery from COVID-19 and preparedness for other health emergencies in the future.”

The report lays out a set of recommendations for integrating better, safer, and more environmentally sustainable waste practices into the current COVID-19 response and future pandemic preparedness efforts and highlights stories from countries and organizations that have put into practice in the spirit of “building back better”.

Recommendations include using eco-friendly packaging and shipping, safe and reusable PPE (e.g., gloves and medical masks), recyclable or biodegradable materials; investment in non-burn waste treatment technologies, such as autoclaves; reverse logistics to support centralized treatment and investments in the recycling sector to ensure materials, like plastics, can have a second life.

The COVID-19 waste challenge and increasing urgency to address environmental sustainability offer an opportunity to strengthen systems to safely and sustainably reduce and manage health care waste.

This can be through strong national policies and regulations, regular monitoring and reporting and increased accountability, behaviour change support and workforce development, and increased budgets and financing.

“A systemic change in how health care manages its waste would include greater and systematic scrutiny and better procurement practices,” said Dr Anne Woolridge, Chair of the Health Care Waste Working Group, International Solid Waste Association (ISWA).

“There is growing appreciation that health investments must consider environmental and climate implications, as well as a greater awareness of co-benefits of action.

For example, safe and rational use of PPE will not only reduce environmental harm from waste, it will also save money, reduce potential supply shortages and further support infection prevention by changing behaviours.”

The analysis comes at a time when the health sector is under increasing pressure to reduce its carbon footprint and minimize the amount of waste being sent to landfill — in part because of the great concern about the proliferation of plastic waste and its impacts on water, food systems and human and ecosystem health.”

https://www.who.int/news/item/01-02-2022-tonnes-of-covid-19-health-care-waste-expose-urgent-need-to-improve-waste-management-systems

FDA Takes Key Action by Approving Second COVID-19 Vaccine

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FDA Takes Key Action by Approving Second COVID-19 Vaccine

January 31, 2022: “The U.S. FDA approved a second COVID-19 vaccine.

The vaccine has been known as the Moderna COVID-19 Vaccine; the approved vaccine will be marketed as Spikevax for the prevention of COVID-19 in individuals 18 years of age and older. 

Key points:

  • Spikevax meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality required for approval.
  • Moderna COVID-19 Vaccine has been available under emergency use authorization (EUA) for individuals 18 years of age and older since Dec. 18, 2020.

“The FDA’s approval of Spikevax is a significant step in the fight against the COVID-19 pandemic, marking the second vaccine approved to prevent COVID-19.

The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States,” said Acting FDA Commissioner Janet Woodcock, M.D.

“While hundreds of millions of doses of Moderna COVID-19 Vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated.” 

Spikevax has the same formulation as the EUA Moderna COVID-19 Vaccine and is administered as a primary series of two doses, one month apart. Spikevax can be used interchangeably with the EUA Moderna COVID-19 Vaccine to provide the COVID-19 vaccination series.

Moderna COVID-19 Vaccine remains available under EUA as a two-dose primary series for individuals 18 years of age and older, as a third primary series dose for individuals 18 years of age and older who have been determined to have certain kinds of immunocompromise, and as a single booster dose for individuals 18 years of age and older at least five months after completing a primary series of the vaccine.

It is also authorized for use as a heterologous (or “mix and match”) single booster dose for individuals 18 years of age and older following completion of primary vaccination with a different available COVID-19 vaccine. 

“The FDA’s medical and scientific experts conducted a thorough evaluation of the scientific data and information included in the application pertaining to the safety, effectiveness, and manufacturing quality of Spikevax.

This includes the agency’s independent verification of analyses submitted by the company, our own analyses of the data, along with a detailed assessment of the manufacturing processes, test methods and manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

“Safe and effective vaccines are our best defense against the COVID-19 pandemic, including currently circulating variants.

The public can be assured that this vaccine was approved in keeping with the FDA’s rigorous scientific standards.” 

FDA Evaluation of Effectiveness Data for Approval for Individuals 18 Years of Age and Older

The Spikevax BLA builds upon the data and information that supported the EUA, such as preclinical and clinical data, as well as details of the manufacturing process and the sites where the vaccine is made.

The FDA evaluates and conducts its own analyses of the data to determine whether the safety and effectiveness of the vaccine has been demonstrated and meets the standard for approval, and whether the manufacturing and facility information assure vaccine quality and consistency.  

The approval of Spikevax is based on the FDA’s evaluation and analysis of follow-up safety and effectiveness data from the ongoing randomized, placebo-controlled, blinded clinical trial that supported the December 2020 EUA for the Moderna COVID-19 Vaccine and information from post EUA experience to further inform safety and effectiveness.  

The updated analyses to determine effectiveness of Spikevax included 14,287 vaccine recipients and 14,164 placebo recipients 18 years of age and older who did not have evidence of SARS-CoV-2 infection prior to receiving the first dose.

The data used for the analyses were accrued before the Omicron variant emerged.  

These data demonstrated that Spikevax was 93% effective in preventing COVID-19, with 55 cases of COVID-19 occurring in the vaccine group and 744 COVID-19 cases in the placebo group. The vaccine was also 98% effective in preventing severe disease.

FDA Evaluation of Safety Data for Approval for Individuals 18 Years of Age and Older

The FDA’s safety analysis of Spikevax included approximately 15,184 vaccine recipients and 15,162 placebo recipients 18 years of age and older, more than half of these participants were followed for safety outcomes for at least four months after the second dose.

Approximately 7,500 participants originally assigned to receive Spikevax in the blinded phase of the clinical trial completed safety follow-up for at least 6 months after the second dose.

The most commonly reported side effects by clinical trial participants were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, nausea/vomiting, swollen lymph nodes under the arm and fever. 

Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of tissue surrounding the heart) following vaccination with the Moderna COVID-19 Vaccine and has determined that the data demonstrate increased risks particularly within seven days following the second dose, with the observed risk highest in males 18 through 24 years of age.

Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support.

Information is not yet available about potential long-term health outcomes.

The Spikevax Prescribing Information includes a warning about these risks.

The FDA conducted its own benefit-risk assessment using modeling to predict how many symptomatic COVID-19 cases, hospitalizations, intensive care unit (ICU) admissions and deaths from COVID-19 the vaccine in individuals 18 years of age and older would prevent versus the number of potential myocarditis/pericarditis cases, hospitalizations, ICU admissions and deaths that might be associated with the vaccine.

FDA has determined that the benefits of the vaccine outweigh the risk of myocarditis and pericarditis in individuals 18 years of age and older.

The FDA is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Spikevax.

These studies will include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination with Spikevax.

In addition, although not FDA requirements, the company has committed to conducting additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Spikevax during pregnancy.

The FDA granted this application Priority Review. The approval was granted to ModernaTX, Inc.”

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-key-action-approving-second-covid-19-vaccine

Voxelotor gains positive opinion for Treatment of Haemolytic Anaemia

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Voxelotor gains positive opinion for Treatment of Haemolytic Anaemia

Jan. 27, 2022: “Global Blood Therapeutics announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has awarded a positive scientific opinion under the Early Access to Medicines Scheme (EAMS) for voxelotor, an oral once-daily tablet under review by the MHRA for the treatment of haemolytic anaemia due to sickle cell disease (SCD) in adults and paediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide.

This positive opinion means that those patients living with SCD and meeting the eligibility criteria can gain early, pre-license access to voxelotor, while the MHRA completes its review of the Marketing Authorisation Application (MAA).

The aim of EAMS is to grant early access to medicines that have received Promising Innovative Medicine (PIM) designation for patients in the UK with life-threatening or seriously debilitating conditions prior to marketing authorisation when there is a clear unmet medical need.

Medicines under EAMS that receive marketing authorisation by the MHRA as well as a positive assessment by the National Institute of Health and Care Excellence (NICE) also benefit from accelerated NHS England commissioning.

Following a positive opinion from the Committee for Medicine Products for Human Use (CHMP) recommending the approval of voxelotor in the EU, GBT submitted an application to the MHRA for a Great Britain Marketing Authorisation using the European Commission (EC) Decision Reliance Procedure.

If approved, voxelotor would be the first medicine in Great Britain and Europe that directly inhibits sickle haemoglobin polymerisation, the molecular cause of sickling and destruction of red blood cells in SCD.

SCD is a rare genetic condition that affects approximately 15,000 people in the UK.

People living with SCD and those closest to them experience a lifelong journey with the disease that touches every aspect of their lives.

Patients experience progressive, serious complications and morbidities, including end-organ damage, which lead to decreased quality of life and early mortality.

Furthermore, economic disadvantages and health inequalities experienced by many patients with SCD can have negative societal impacts in areas such as access to healthcare, education and employment.

“This decision marks a significant milestone for the sickle cell community in the UK,” said Arvind Agrawal, UK Medical Director at GBT.

“The EAMS positive scientific opinion is a key step forward to meeting our goal of providing patients in the UK with the first oral treatment option that inhibits red blood cell sickling and has the potential to reduce acute and chronic complications of sickle cell disease.

GBT is delighted with the progress to help eligible patients have access to this innovation as soon as possible.”

Voxelotor is currently approved in the United States, under the brand name Oxbryta®, for the treatment of SCD in adults and children 4 years of age and older.

The Ministry of Health and Prevention (MOHAP) in the United Arab Emirates (UAE) has granted marketing authorisation for voxelotor as an oral treatment for SCD in adults and children 12 years of age and older.

For more information on the GBT Early Access to Medicines Scheme please contact [email protected].

About Sickle Cell Disease
Sickle cell disease (SCD) affects approximately 15,000 people in the UK, an estimated 52,000 people in Europe, and millions of people throughout the world, particularly among those whose ancestors are from sub-Saharan Africa.

It also affects people of Hispanic, South Asian, Southern European and Middle Eastern ancestry.

SCD is a lifelong inherited rare blood disorder that impacts haemoglobin, a protein carried by red blood cells that delivers oxygen to tissues and organs throughout the body.

Due to a genetic mutation, individuals with SCD form abnormal haemoglobin known as sickle haemoglobin.

Through a process called haemoglobin polymerisation, red blood cells become sickled, crescent-shaped and rigid.

The recurrent sickling process causes destruction of the red blood cells and haemolytic anaemia (low haemoglobin due to red blood cell destruction) and blockages in capillaries and small blood vessels, which impede the flow of blood and oxygen delivery throughout the body.

The diminished oxygen delivery to tissues and organs can lead to life-threatening complications, including stroke and irreversible organ damage.

Complications of SCD begin in early childhood and can include neurocognitive impairment, acute chest syndrome, and overt stroke, among other serious issues.

About Voxelotor Tablets
Voxelotor is an oral, once-daily therapy that works by increasing haemoglobin’s affinity for oxygen.

Since oxygenated sickle haemoglobin does not polymerise, voxelotor inhibits sickle haemoglobin polymerisation and the resultant sickling and destruction of red blood cells leading to haemolysis and haemolytic anaemia, which are pathologies faced by every single person living with sickle cell disease (SCD).

Through addressing haemolytic anaemia and improving oxygen delivery throughout the body, GBT believes that voxelotor has the potential to modify the course of SCD.

In November 2019, the U.S. FDA granted accelerated approval for Oxbryta (voxelotor) tablets for the treatment of SCD in adults and children 12 years of age and older, and in December 2021, the U.S.

FDA expanded the approved use of Oxbryta for the treatment of SCD in patients 4 years of age and older.10

In recognition of the critical need for new SCD treatments, voxelotor has been granted Priority Medicines (PRIME) designation from the EMA.

Voxelotor was designated by the EC as an orphan medicinal product for the treatment of patients with SCD.

In addition, the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK granted voxelotor a Promising Innovative Medicine (PIM) designation.

About Global Blood Therapeutics
Global Blood Therapeutics, Inc. (GBT) is a biopharmaceutical company dedicated to the discovery, development and delivery of life-changing treatments that provide hope to underserved patient communities.

Founded in 2011, GBT is delivering on its goal to transform the treatment and care of sickle cell disease (SCD), a lifelong, devastating inherited blood disorder.

The company has introduced Oxbryta (voxelotor) tablets and tablets for oral suspension, the first FDA-approved medicine that directly inhibits sickle haemoglobin (HbS) polymerisation, the root cause of red blood cell sickling in SCD.”

https://ir.gbt.com/news-releases/news-release-details/positive-early-access-medicines-scheme-eams-scientific-opinion

Pfizer Receives CHMP Positive Opinion for Novel COVID-19 Oral Treatment

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Pfizer Receives CHMP Positive Opinion for Novel COVID-19 Oral Treatment

January 27, 2022: “Pfizer Inc. announced that the CHMP of the EMA issued a positive opinion recommending the conditional marketing authorization (CMA) of Pfizer’s PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk for progressing to severe COVID-19.

“This expression of confidence in PAXLOVID comes at a critical moment as Europe addresses the ongoing challenges of the pandemic and as infection rates are on the rise in many countries across the globe,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.

“We are proud to have a strong manufacturing footprint in Europe, which will help support the production of up to 120 million courses of PAXLOVID globally.

Pending conditional marketing authorization from the European Commission, we will continue working closely with EU Member State governments to ensure this important treatment can be made available to patients across Europe as quickly as possible.”

The CHMP based its positive opinion on the scientific evidence supporting PAXLOVID, including data from the Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) trial, which enrolled non-hospitalized adults aged 18 and older with confirmed COVID-19 who are at increased risk of progressing to severe illness.

The data showed that PAXLOVID reduced the risk of hospitalization or death by 89% (within three days of symptom onset) and 88% (within five days of symptom onset) compared to placebo, with no deaths observed in the treatment group.

Treatment-emergent adverse events were comparable between PAXLOVID (23%) and placebo (24%), most of which were mild in intensity.

The data have been submitted to a peer-reviewed publication.

Additional Phase 2/3 clinical trials are ongoing in adults at standard risk (i.e., low risk of hospitalization or death) of progressing to severe illness, and in those who have been exposed to the virus through household contacts.

PAXLOVID is currently approved or authorized for emergency use in more than 10 countries across the globe.

In December, the CHMP issued advice under Article 5(3) of Regulation 726/2004 to support authorities of European Union (EU) Member States regarding the potential supply and use of PAXLOVID prior to EU conditional marketing authorization.

Our Commitment to Equitable Access

Pfizer is committed to working toward equitable access to PAXLOVID for all people, aiming to deliver safe and effective antiviral therapeutics as soon as possible and at an affordable price.

During the pandemic, Pfizer will offer its oral therapy through a tiered pricing approach, pending country authorization or approval, based on the income level of each country to promote equity of access across the globe.

High and upper-middle income countries will pay more than lower income countries.

Pfizer continues to invest to support the manufacturing and distribution of PAXLOVID, including exploring potential contract manufacturing options.

As a result of these efforts, Pfizer has raised its production projections, with the potential ability to produce up to 120 million courses of treatment by the end of 2022.

The company has entered into agreements with multiple countries and has initiated bilateral outreach to more than 100 countries around the world.

Additionally, Pfizer has signed a voluntary license agreement with the Medicines Patent Pool (MPP) for its oral treatment to help expand access, pending country regulatory authorization or approval, in 95 low- and middle-income countries that account for approximately 53% of the world’s population.

About PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets)

PAXLOVID is a SARS-CoV-2 main protease (Mpro) inhibitor (also known as SARS-CoV2 3CL protease inhibitor) therapy.

It was developed to be administered orally so that it can be prescribed at the first sign of infection or, pending clinical success of the rest of the EPIC development program and subject to regulatory authorization, at first awareness of an exposure – potentially helping patients avoid severe illness (which can lead to hospitalization and death) or avoid disease development following contact with a household member who contracts COVID-19.

Nirmatrelvir [PF-07321332], which originated in Pfizer laboratories, is designed to block the activity of the Mpro, an enzyme that the coronavirus needs to replicate.

Co-administration with a low dose of ritonavir helps slow the metabolism, or breakdown, of nirmatrelvir in order for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus.

Nirmatrelvir is designed to inhibit viral replication at a stage known as proteolysis, which occurs before viral RNA replication.

In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions.

Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus.

PAXLOVID, however, works intracellularly by binding to the highly conserved Mpro of the SARS-CoV-2 virus to inhibit viral replication.

Nirmatrelvir has shown consistent in vitro antiviral activity against earlier and current variants of concern (i.e., Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron).

PAXLOVID is administered at a dose of 300 mg (two 150 mg tablets) of nirmatrelvir with one 100 mg tablet of ritonavir, given twice-daily for five days.

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course.”

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-receives-chmp-positive-opinion-novel-covid-19-oral

FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant

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FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant

January 24, 2022: “As we have throughout the COVID-19 pandemic, the U.S. FDA has used the best available science as the virus has evolved to make informed decisions with the health and safety of the American public in mind.

Ensuring that healthcare providers on the frontlines have the best tools available to treat patients is a top priority for the agency. 

In light of the most recent information and data available, today, the FDA revised the authorizations for two monoclonal antibody treatments – bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) – to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments. 

Because data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time.

In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions.  

Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses, like SARS-CoV-2.

And like other infectious organisms, SARS-CoV-2 can mutate over time, resulting in certain treatments not working against certain variants such as omicron. This is the case with these two treatments for which we’re making changes today. 

Based on Centers for Disease Control and Prevention data, the omicron variant of SARS-CoV-2 is estimated to account for more than 99% of cases in the United States as of Jan. 15.

Therefore, it’s highly unlikely that COVID-19 patients seeking care in the U.S. at this time are infected with a variant other than omicron, and these treatments are not authorized to be used at this time.

This avoids exposing patients to side effects, such as injection site reactions or allergic reactions, which can be potentially serious, from specific treatment agents that are not expected to provide benefit to patients who have been infected with or exposed to the omicron variant.    

The NIH COVID-19 Treatment Guidelines Panel, an independent panel of national experts, recently recommended against the use of bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) because of markedly reduced activity against the omicron variant and because real-time testing to identify rare, non-omicron variants is not routinely available.  

Importantly, there are several other therapies – Paxlovid, sotrovimab, Veklury (remdesivir), and molnupiravir – that are expected to work against the omicron variant, and that are authorized or approved to treat patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death.

Healthcare providers should consult the NIH panel’s COVID-19 treatment guidelines and assess whether these treatments are right for their patients.

While it’s critical that we have ways to treat those who contract COVID-19, the authorized treatments are not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended.

Data has clearly demonstrated that the available, safe and effective vaccines can lower your risk of developing COVID-19 and experiencing the potential associated serious disease progression, including hospitalization and death.

The FDA is committed to continuing to review emerging data on all COVID-19 therapies related to the potential impact of variants and revise the authorizations further as appropriate to ensure healthcare providers have an effective arsenal of treatments for patients.”

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-certain-monoclonal-antibodies-treat-covid-19-due-omicron

WHO SAGE Roadmap for prioritizing uses of COVID-19 vaccines

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WHO SAGE Roadmap for prioritizing uses of COVID-19 vaccines

January 21, 2022: “This revised Roadmap takes into account increasing vaccine availability, vaccine coverage rates, and the evolving epidemiological situation including COVID-19 variants of concern.

Scenarios in which vaccination coverage exceeds 50% of the population are considered, as are topics such as vaccine use in children and adolescents and prioritization of additional and booster doses in relation to vaccination coverage rates.

To assist countries in developing recommendations for optimized use of vaccines against COVID-19,priority-use groups for vaccination (both primary series and booster doses) are identified based on epidemiological scenarios, public health goals, and vaccine coverage scenarios.

This Roadmap builds on the WHO SAGE values framework for the allocation and prioritization of COVID-19 vaccination.”

https://www.who.int/publications/i/item/who-sage-roadmap-for-prioritizing-uses-of-covid-19-vaccines

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