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EMA recommends Nuvaxovid for authorisation in the EU

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EMA recommends Nuvaxovid for authorisation in the EU

December 20, 2021: “EMA has recommended granting a conditional marketing authorisation for Novavax’s COVID-19 vaccine Nuvaxovid (also known as NVX-CoV2373) to prevent COVID-19 in people from 18 years of age. 

Nuvaxovid is the fifth vaccine recommended in the EU for preventing COVID-19. It is a protein-based vaccine and, together with the already authorised vaccines, will support vaccination campaigns in EU Member States during a crucial phase of the pandemic.

After a thorough evaluation, EMA’s human medicines committee (CHMP) concluded by consensus that the data on the vaccine were robust and met the EU criteria for efficacy, safety and quality.

Results from two main clinical trials found that Nuvaxovid was effective at preventing COVID-19 in people from 18 years of age.

The studies involved over 45,000 people in total. In the first study, around two thirds of participants received the vaccine and the others were given a placebo (dummy) injection; in the other study, participants were equally split between Nuvaxovid and placebo.

People did not know if they had been given Nuvaxovid or placebo.

The first study, conducted in Mexico and the United States, found a 90.4% reduction in the number of symptomatic COVID-19 cases from 7 days after the second dose in people who received Nuvaxovid (14 cases out of 17,312 people) compared with people given placebo (63 out of 8,140 people). This means that the vaccine had a 90.4% efficacy in this study.

The second study conducted in the United Kingdom also showed a similar reduction in the number of symptomatic COVID-19 cases in people who received Nuvaxovid (10 cases out of 7,020 people) compared with people given placebo (96 out of 7,019 people); in this study, the vaccine efficacy was 89.7%.

Taken together, the results of the two studies show a vaccine efficacy for Nuvaxovid of around 90%. The original strain of SARS-CoV-2 and some variants of concern such as Alpha and Beta were the most common viral strains circulating when the studies were ongoing.

There is currently limited data on the efficacy of Nuvaxovid against other variants of concern, including Omicron.

The side effects observed with Nuvaxovid in the studies were usually mild or moderate and cleared within a couple of days after vaccination. The most common ones were tenderness or pain at the injection site, tiredness, muscle pain, headache, a general feeling of being unwell, joint pain, and nausea or vomiting.

The safety and effectiveness of the vaccine will continue to be monitored as it is used across the EU, through the EU pharmacovigilance system and additional studies by the company and European authorities.

Where to find more information

The product information for Nuvaxovid contains information for healthcare professionals, a package leaflet for members of the public and details of conditions of the vaccine’s authorisation.

An assessment report with details of EMA’s evaluation of Nuvaxovid and the full risk management plan will be published shortly. 

Clinical trial data submitted by the company in the application for marketing authorisation will be published on the Agency’s clinical data website in due course.

More information is available in an overview of the vaccine in lay language, including a description of the vaccine’s benefits and risks and why EMA recommended its authorisation in the EU.

How Nuvaxovid works

Nuvaxovid works by preparing the body to defend itself against COVID-19. The vaccine contains a version of a protein found on the surface of SARS-CoV-2 (the spike protein), which has been produced in the laboratory. It also contains an ‘adjuvant’, a substance to help strengthen the immune responses to the vaccine.

When a person is given the vaccine, their immune system will identify the protein as foreign and produce natural defences — antibodies and T cells — against it.

If, later on, the vaccinated person comes into contact with SARS-CoV-2, the immune system will recognise the spike protein on the virus and be prepared to attack it.

The antibodies and immune cells can protect against COVID-19 by working together to kill the virus, prevent its entry into the body’s cells and destroy infected cells.

Nuvaxovid is given as two injections, usually into the muscle of the upper arm, 3 weeks apart.

Conditional marketing authorisation

The European Commission will now fast-track the decision-making process to grant a decision on the conditional marketing authorisation for Nuvaxovid, allowing this vaccine to be included in vaccination programmes rolled out across the EU.

Conditional marketing authorisation (CMA) is used as the fast-track authorisation procedure to speed up approval of treatments and vaccines during public health emergencies in the EU. CMAs allow authorisation of medicines that fulfil an unmet medical need on the basis of less complete data than normally required.

This happens if the benefit of a medicine or vaccine’s immediate availability to patients outweighs the risk inherent in the fact that not all the data are yet available. 

A CMA guarantees that the approved medicine or vaccine meets rigorous EU standards for efficacy, safety and quality and is manufactured in approved, certified facilities in line with high pharmaceutical standards for large-scale production.

Once a CMA has been granted, companies must provide further data from ongoing or new studies within pre-defined deadlines to confirm that the benefits continue to outweigh the risks.

Monitoring the safety of Nuvaxovid

In line with the EU’s safety monitoring plan for COVID-19 vaccines, Nuvaxovid will be closely monitored and subject to several activities that apply specifically to COVID-19 vaccines.

Although large numbers of people have received COVID-19 vaccines in clinical trials, certain side effects may only emerge when millions of people are vaccinated.

Companies are required to provide monthly safety reports in addition to the regular updates required by legislation and conduct studies to monitor the safety and effectiveness of the vaccines as they are used by the public.

In addition, independent studies of COVID-19 vaccines coordinated by EU authorities will give more information on the vaccine’s long-term safety and benefit in the general population.

These measures will allow regulators to swiftly assess data emerging from a range of different sources and take any necessary regulatory action to protect public health.

Assessment of Nuvaxovid

During the assessment of Nuvaxovid, CHMP had the support of EMA’s safety committee, PRAC, who assessed the risk management plan of Nuvaxovid, and the COVID-19 EMA pandemic task force (COVID-ETF), a group that brings together experts from across the European medicines regulatory network to facilitate rapid and coordinated regulatory action on medicines and vaccines for COVID-19.”

https://www.ema.europa.eu/en/news/ema-recommends-nuvaxovid-authorisation-eu

FDA Approves First Injectable Treatment for HIV Pre-Exposure Prevention

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FDA Approves First Injectable Treatment for HIV Pre-Exposure Prevention

December 20, 2021: “The U.S. FDA approved Apretude (cabotegravir extended-release injectable suspension) for use in at-risk adults and adolescents weighing at least 35 kilograms (77 pounds) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV.

Apretude is given first as two initiation injections administered one month apart, and then every two months thereafter.

Patients can either start their treatment with Apretude or take oral cabotegravir (Vocabria) for four weeks to assess how well they tolerate the drug. 

“Today’s approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill,” said Debra Birnkrant, M.D., director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research.

“This injection, given every two months, will be critical to addressing the HIV epidemic in the U.S., including helping high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option.”

According to the U.S. Centers for Disease Control and Prevention, notable gains have been made in increasing PrEP use for HIV prevention in the U.S. and preliminary data show that in 2020, about 25% of the 1.2 million people for whom PrEP is recommended were prescribed it, compared to only about 3% in 2015.

However, there remains significant room for improvement. 

PrEP requires high levels of adherence to be effective and certain high-risk individuals and groups, such as young men who have sex with men, are less likely to adhere to daily medication.

Other interpersonal factors, such as substance use disorders, depression, poverty and efforts to conceal medication also can impact adherence.

It is hoped that the availability of a long-acting injectable PrEP option will increase PrEP uptake and adherence in these groups.

The safety and efficacy of Apretude to reduce the risk of acquiring HIV were evaluated in two randomized, double-blind trials that compared Apretude to Truvada, a once daily oral medication for HIV PrEP.

Trial 1 included HIV-uninfected men and transgender women who have sex with men and have high-risk behavior for HIV infection.

Trial 2 included uninfected cisgender women at risk of acquiring HIV.

Participants who took Apretude started the trial with cabotegravir (oral, 30 mg tablet) and a placebo daily for up to five weeks, followed by Apretude 600mg injection at months one and two, then every two months thereafter and a daily placebo tablet.

Participants who took Truvada started the trial taking oral Truvada and placebo daily for up to five weeks, followed by oral Truvada daily and placebo intramuscular injection at months one and two and every two months thereafter.

In Trial 1, 4,566 cisgender men and transgender women who have sex with men received either Apretude or Truvada.

The trial measured the rate of HIV infections among trial participants taking daily cabotegravir followed by Apretude injections every two months compared to daily oral Truvada.

The trial showed participants who took Apretude had 69% less risk of getting infected with HIV when compared to participants who took Truvada.

In Trial 2, 3,224 cisgender women received either Apretude or Truvada.

The trial measured the rate of HIV infections in participants who took oral cabotegravir and injections of Apretude compared to those who took Truvada orally.

The trial showed participants who took Apretude had 90% less risk of getting infected with HIV when compared to participants who took Truvada.

Side effects occurring more frequently in participants who received Apretude compared to participants who received Truvada in either trial include injection site reactions, headache, pyrexia (fever), fatigue, back pain, myalgia and rash.

Apretude includes a boxed warning to not use the drug unless a negative HIV test is confirmed.

It must only be prescribed to individuals confirmed to be HIV-negative immediately prior to starting the drug and before each injection to reduce the risk of developing drug resistance.

Drug-resistant HIV variants have been identified in people with undiagnosed HIV when they use Apretude for HIV PrEeP.

Individuals who become infected with HIV while receiving Apretude for PrEP must transition to a complete HIV treatment regimen.

The drug labeling also includes warnings and precautions regarding hypersensitivity reactions, hepatotoxicity (liver damage) and depressive disorders.

Apretude was granted a Priority Review and Breakthrough Therapy designation. The FDA granted the approval of Apretude to Viiv.”

https://www.fda.gov/news-events/press-announcements/fda-approves-first-injectable-treatment-hiv-pre-exposure-prevention

Sandoz submits BLA for proposed biosimilar trastuzumab to US FDA

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Sandoz submits BLA for proposed biosimilar trastuzumab to US FDA

December 20, 2021: “Sandoz, a global leader in generic and biosimilar medicines announced the submission of its BLA for a proposed biosimilar trastuzumab (150 mg, for intravenous use) developed by EirGenix, Inc. to the US FDA.

Trastuzumab is a monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers.

Sandoz is seeking approval for the same indications as the reference medicine, based on a comprehensive package that includes analytical, preclinical and clinical data.

“Approximately 15-20% of all breast cancer patients have tumors that are HER2- positive and, as these tumors tend to grow more quickly than HER2-negative tumors, getting treated swiftly can be live-saving,” said Florian Bieber, Global Head of Biopharmaceuticals Development, Sandoz.

“Trastuzumab is standard of care so, if approved, we will introduce more competition aiming to broaden access to this important therapy and liberate healthcare resources that can be used to fund other innovative medicines in the US.”

Breast cancer is the most commonly diagnosed cancer among women in the US and associated death rates are the second highest of all cancers. It is estimated that about 30% of newly diagnosed cancers in women will be breast cancers in 2021.

As part of the license agreement signed in April 2019, EirGenix, Inc. is responsible for development and manufacturing and Sandoz will have the right to commercialize the medicine upon approval in all markets excluding China and Taiwan.

Sandoz has been developing and providing oncology medicines for over 30 years.

Today, it has well over 50 such medicines, including chemotherapeutics, biologics, hormones and supportive care treatments, for the treatment of a wide range of cancers.

The collaboration with EirGenix will enable Sandoz to build on its leading generic and biosimilar oncology portfolio to further expand patient access, while contributing to the sustainability of healthcare systems.”

https://www.novartis.com/news/media-releases/sandoz-submits-biologics-license-application-proposed-biosimilar-trastuzumab-us-fda

Sanofi to acquire Amunix immuno-oncology pipeline with next generation Conditionally Activated Biologics

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Sanofi to acquire Amunix immuno-oncology pipeline with next generation Conditionally Activated Biologics

December 21, 2021: “Sanofi announced that it has entered into an agreement to acquire Amunix Pharmaceuticals, Inc., an immuno-oncology company leveraging its proprietary, clinically validated XTEN® and innovative universal protease-releasable masking technology platform, Pro-XTENTM, to discover and develop transformative T-cell engagers (TCE) and cytokine therapies for patients with cancer.

Amunix’s pipeline, which includes lead candidate, AMX-818, a masked HER2-directed TCE, offers a strong strategic fit with Sanofi’s focus on developing potentially transformative cancer therapies in immuno-oncology.

Under the terms of the agreement, Sanofi will acquire Amunix for an upfront payment of approximately $1 billion and up to $225 million upon achievement of certain future development milestones.

The acquisition supports Sanofi’s efforts to accelerate and expand its contributions to innovative medicines for oncology patients, with approximately 20 molecules currently in development. 

“This acquisition demonstrates our ongoing commitment to investing in promising research and discovery platforms,” said John Reed, M.D., Ph.D., Global Head of Research & Development, Sanofi. 

“The Amunix technology platform utilizes a next generation smart biologics approach to precisely tailor-deliver medicines to become active only in tumor tissues while sparing normal tissues, thus bringing the promise of more effective and safer treatment options for cancer patients. 

We are excited to rapidly advance Amunix’s promising pipeline and to combine their innovative candidate medicines with complementary molecules in Sanofi’s immuno-oncology portfolio.”
 
Amunix’s proprietary XTEN® masks and cleavable linkers are a next-generation protein engineering approach that allows biologics to circulate in “stealth” mode, becoming active preferentially in disease specific micro-environments, with the aim to enable safer and more efficacious medicines.

The technology can be applied to a wide range of existing and potentially new pipeline assets.

The molecular design of Amunix’s molecules endows the inactive stealth molecules with long-lasting properties, converting after activation in disease tissues to short half-life agents so that the active molecule is rapidly cleared from the body.

Specifically, in immuno-oncology, Amunix’s technology offers the potential to overcome challenges that have plagued the adoption of T-Cell Engager
bi-specific antibodies for solid tumors, including unwanted immune attack of normal healthy cells and systematic widespread immune system activation that leads to side effects such as Cytokine Release Syndrome. 

“We are very proud of what the extraordinary and diverse Amunix team has accomplished in the development of our Pro-XTEN technology and rapid expansion of our pipeline,” said Angie You, Ph.D., CEO, Amunix. 

“We now look forward to combining forces with Sanofi’s team to leverage its expertise and together serve as a center of excellence in bringing these potentially better and safer drug candidates to patients,” said Volker Schellenberger, Ph.D., Co-Founder, President and Chief Technology Officer, Amunix.
         
The closing of the transaction is subject to expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and other customary closing conditions. Sanofi expects to complete the acquisition in Q1 of 2022.

Weil, Gotshal & Manges LLP is acting as Sanofi’s legal counsel. Centerview Partners LLC is acting as financial advisor to Amunix and Fenwick & West LLP is acting as its legal counsel.

XTEN, XPAT, XPAC and PRO-XTEN are trademarks in the name of Amunix.”

https://www.sanofi.com/en/media-room/press-releases/2021/2021-12-21-05-30-00-2355740

AZ’s Ultomiris approved by FDA for generalised myasthenia gravis

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AZ’s Ultomiris approved by FDA for generalised myasthenia gravis

December 21, 2021: “The sBLA for Ultomiris (ravulizumab-cwvz) in adults with generalised myasthenia gravis (gMG) has been accepted for Priority Review by the US FDA.

The FDA set a Prescription Drug User Fee Act date during the second quarter of 2022, following use of a rare disease priority review voucher by Alexion, AstraZeneca’s Rare Disease group.

gMG is a rare, debilitating, chronic, autoimmune neuromuscular disease that leads to a loss of muscle function and severe weakness.1 The diagnosed prevalence of gMG in the US is estimated at 64,000.2-10

Marc Dunoyer, Chief Executive Officer, Alexion, said: “Soliris was the first new treatment approved for this devastating disease in approximately 60 years, and this filing for Ultomiris demonstrates Alexion’s continued commitment to improve outcomes for patients living with gMG. The Phase III trial shows that Ultomiris may help a broader range of patients including those with milder symptoms or who are earlier in their treatment journey.”

The sBLA submission in the US is based on results from the Phase III trial of Ultomiris in gMG, which were announced by Alexion in July 2021, and showed efficacy as early as Week 1 and sustained for 52 weeks (26 weeks randomised controlled period + 26 weeks of open-label extension).

In the trial, the safety profile of Ultomiris was consistent with that observed in Phase III trials of Ultomiris in paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS).

Regulatory submissions for Ultomiris for the treatment of gMG are also currently under review with health authorities in the European Union (EU) and Japan.”

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/ultomiris-accepted-for-fda-priority-review-for-gmg.html

Xeris Biopharma’s Ogluo® Available in UK Through Tetris Pharma

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Xeris Biopharma’s Ogluo® Available in UK Through Tetris Pharma

Dec. 16, 2021: ” Xeris Biopharma Holdings, Inc, a biopharmaceutical company developing and commercializing unique therapies for patient populations in endocrinology, neurology, and gastroenterology, today announced that its commercialization partner, Tetris Pharma (Tetris), has launched Ogluo® (glucagon injection) in the United Kingdom and it is now available by prescription for the treatment of severe hypoglycemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus.

In July, Xeris announced a licensing agreement with Tetris for the commercialization of Ogluo (European brand name of Gvoke®) in the European Union area, the UK, and Switzerland (the Territory).

Under the terms of the applicable agreements, Xeris is responsible for product supply and Tetris is responsible for the commercialization of Ogluo in the Territory, starting with the UK.

Tetris aims for Ogluo to be launched in several countries across Europe during 2022.

“Just as Gvoke has the potential to change lives for people in the US with diabetes, we are delighted that Ogluo is now accessible to people in the UK and will be available in other European countries in 2022,” said Paul R. Edick, Chairman and CEO of Xeris.

“Having a product that is ready-to-use will be a real benefit to both people with diabetes and their caregivers in the case of a severe hypoglycemic event.”

Xeris estimates there are approximately five million people with diabetes and at risk of severe hypoglycemia in the UK, with only an estimated 10-20% having a prescription for glucagon.

Healthcare professionals can obtain details about Ogluo® by emailing [email protected].

ABOUT GVOKE® (US) / OGLUO® (EU)

Gvoke® (glucagon injection), the first prescription, ready-to-use, pre-mixed, pre-measured glucagon injection, was approved by the FDA in September 2019 for use in the United States.

Gvoke is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above.

Ogluo® (glucagon injection) received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in December 2020 and the European Commission (EC) granted the marketing authorization on 11 February 2021.

The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) approved Ogluo on April 29, 2021. Ogluo is indicated for the treatment of severe hypoglycemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus.”

https://ir.xerispharma.com/news-releases/news-release-details/xeris-biopharma-announces-availability-ogluor-uk-through-its

Novartis provides an update on Phase III ligelizumab studies in CSU

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Novartis provides an update on Phase III ligelizumab studies in CSU

December 20, 2021: “Novartis announced top-line results from PEARL 1 and PEARL 2 Phase III studies in chronic spontaneous urticaria (CSU), which showed that the studies met their primary endpoints of superiority for ligelizumab versus placebo at Week 12, but not versus omalizumab.

“We are disappointed that we have been unable to demonstrate superior efficacy for ligelizumab versus standard of care in the treatment of CSU,” said John Tsai, M.D., Head of Global Drug Development and Chief Medical Officer, Novartis.

“We will continue to evaluate the potential for ligelizumab to bring benefit to patients in the areas of chronic inducible urticaria (CIndU) and food allergy, where there is significant unmet need.”

Full PEARL 1 and 2 Phase III data will be made publicly available after study completion in the second half of 2022.

CSU is an unpredictable, systemic skin disease, characterized by the spontaneous and recurrent appearance of itchy, painful hives (wheals) on the skin, angioedema or both for at least 6 weeks and affects up to 1% of the population at any one time.

Approximately 60% of patients do not achieve complete control with first-line treatment antihistamines.

Novartis recently began Phase III studies for remibrutinib (LOU064), a highly selective, potent oral BTK inhibitor that has previously shown rapid and effective CSU disease control.

Novartis in chronic spontaneous urticaria (CSU)
Novartis is dedicated to reimagining the care of patients with diseases that can severely limit quality of life such as CSU, psoriasis, acne and atopic dermatitis.

Novartis is committed to developing medicines that will advance the treatment of CSU, so patients are able to live their lives without the distressing and unpredictable symptoms of this debilitating disease.

These include ligelizumab (QGE031) a high-affinity monoclonal anti-immunoglobulin E antibody and remibrutinib (LOU064), a highly selective, potent oral Bruton’s tyrosine kinase (BTK) inhibitor with a potential best-in-class profile for the treatment of autoimmune disorders.

Any new therapies will add to our portfolio of medicines that already includes Xolair® (omalizumab), our existing approved therapy for CSU.”

https://www.novartis.com/news/media-releases/novartis-provides-update-phase-iii-ligelizumab-qge031-studies-chronic-spontaneous-urticaria-csu

FDA Approves New Treatment for Myasthenia Gravis –

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FDA Approves New Treatment for Myasthenia Gravis –

December 17, 2021: “The U.S. FDA approved Vyvgart (efgartigimod) for the treatment of generalized myasthenia gravis (gMG) in adults who test positive for the anti-acetylcholine receptor (AChR) antibody. 

Myasthenia gravis is a chronic autoimmune, neuromuscular disease that causes weakness in the skeletal muscles (also called voluntary muscles) that worsens after periods of activity and improves after periods of rest.

Myasthenia gravis affects voluntary muscles, especially those that are responsible for controlling the eyes, face, mouth, throat, and limbs.

In myasthenia gravis, the immune system produces AChR antibodies that interfere with communication between nerves and muscles, resulting in weakness.

Severe attacks of weakness can cause breathing and swallowing problems that can be life-threatening.

“There are significant unmet medical needs for people living with myasthenia gravis, as with many other rare diseases,” said Billy Dunn, M.D., director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research.

“Today’s approval is an important step in providing a novel therapy option for patients and underscores the agency’s commitment to help make new treatment options available for people living with rare diseases.”

Vyvgart is the first approval of a new class of medication. It is an antibody fragment that binds to the neonatal Fc receptor (FcRn), preventing FcRn from recycling immunoglobulin G (IgG) back into the blood.

The medication causes a reduction in overall levels of IgG, including the abnormal AChR antibodies that are present in myasthenia gravis.

The safety and efficacy of Vyvgart were evaluated in a 26-week clinical study of 167 patients with myasthenia gravis who were randomized to receive either Vyvgart or placebo.

The study showed that more patients with myasthenia gravis with antibodies responded to treatment during the first cycle of Vyvgart (68%) compared to those who received placebo (30%) on a measure that assesses the impact of myasthenia gravis on daily function.

More patients receiving Vyvgart also demonstrated response on a measure of muscle weakness compared to placebo. 

The most common side effects associated with the use of Vyvgart include respiratory tract infections, headache, and urinary tract infections.

As Vyvgart causes a reduction in IgG levels, the risk of infections may increase. Hypersensitivity reactions such as eyelid swelling, shortness of breath, and rash have occurred.

If a hypersensitivity reaction occurs, discontinue the infusion and institute appropriate therapy. Patients using Vyvgart should monitor for signs and symptoms of infections during treatment.

Health care professionals should administer appropriate treatment and consider delaying administration of Vyvgart to patients with an active infection until the infection is resolved.

The FDA granted this application Fast Track and Orphan Drug designations. The FDA granted the approval of Vyvgart to argenx BV.”

—https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-myasthenia-gravis

WHO lists 9th COVID-19 vaccine for emergency use

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WHO lists 9th COVID-19 vaccine for emergency use

December 17, 2021: “The World Health Organization issued an emergency use listing (EUL) for NVX-CoV2373, expanding the basket of WHO-validated vaccines against the SARS-CoV-2 virus.

The vaccine, named CovovaxTM, is produced by the Serum Institute of India under licence from Novavax and is part of the COVAX facility portfolio, giving a much-needed boost to ongoing efforts to vaccinate more people in lower-income countries.

WHO’s EUL procedure assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX vaccine supply.

It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.

“Even with new variants emerging, vaccines remain one of the most effective tools to protect people against serious illness and death from SARS-COV-2,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products.

‘This listing aims to increase access particularly in lower-income countries, 41 of which have still not been able to vaccinate 10% of their populations, while 98 countries have not reached 40%.”

CovovaxTM was assessed under the WHO EUL procedure based on the review of data on quality, safety and efficacy, a risk management plan, programmatic suitability, and manufacturing site inspections carried out by the Drugs Controller General of India.

The Technical Advisory Group for Emergency Use Listing (TAG-EUL), convened by WHO and made up of experts from around the world, has determined that the vaccine meets WHO standards for protection against COVID-19, that the benefit of the vaccine far outweighs any risks, and that the vaccine can be used globally.

CovovaxTM is a subunit of the vaccine developed by Novavax and the Coalition for Epidemic Preparedness Innovations (CEPI).

It requires two doses and is stable at 2 to 8 °C refrigerated temperatures.

The vaccine uses a novel platform and is produced by creating an engineered baculovirus containing a gene for a modified SARS-CoV-2 spike protein.

The originator product produced by Novavax, named NuvaxovidTM, is currently under assessment by the European Medicines Agency (EMA). WHO will complete its own assessment of this vaccine once the EMA has issued its recommendation.

A meeting of WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) this week also reviewed the vaccine. SAGE formulates specific policies and recommendations for vaccines’ use in populations (i.e. recommended age groups, intervals between doses, specific groups such as pregnant and lactating women) and will issue recommendations for NuvaxovidTM/CovovaxTM in the coming days.

WHO emergency use listing

The emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies.

-The objective is to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency while adhering to stringent criteria of safety, efficacy and quality.

The assessment weighs the threat posed by the emergency as well as the benefit that would accrue from the use of the product against any potential risks.

The EUL pathway involves a rigorous assessment of late phase II and phase III clinical trial data, as well as substantial additional data on safety, efficacy, quality and a risk management plan. 

These data are reviewed by independent experts and– WHO teams who consider the current body of evidence on the vaccine under consideration, the plans for monitoring its use, and plans for further studies.

As part of the EUL process, the company producing the vaccine must commit to continue to generate data to enable full licensure and WHO prequalification of the vaccine.

The WHO prequalification process will assess additional clinical data generated from vaccine trials and deployment on a rolling basis to ensure the vaccine meets the necessary standards of quality, safety and efficacy for broader availability.”

https://www.who.int/news/item/17-12-2021-who-lists-9th-covid-19-vaccine-for-emergency-use-with-aim-to-increase-access-to-vaccination-in-lower-income-countries

Saphnelo recommended for approval by CHMP for systemic lupus erythematosus

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Saphnelo recommended for approval by CHMP for systemic lupus erythematosus

December 2021: “AstraZeneca’s Saphnelo (anifrolumab) has been recommended for marketing authorisation in the European Union (EU) as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite receiving standard therapy.

SLE is a complex autoimmune condition that can affect any organ, and people often experience inadequate disease control, long-term organ damage and poor health-related quality of life.

If approved, Saphnelo would be the first new treatment for SLE in Europe in more than a decade.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the Saphnelo clinical development programme, including the TULIP Phase III trials and the MUSE Phase II trial.

In these trials, more patients treated with Saphnelo experienced a reduction in overall disease activity across organ systems and achieved sustained reduction in oral corticosteroid (OCS) use compared to placebo, with both groups receiving standard therapy.

Ian Bruce, Professor of Rheumatology at the University of Manchester, UK, and steering committee chair for the Saphnelo SLE clinical development programme, said, “Systemic lupus erythematosus is a complex and heterogeneous disease that can have a debilitating impact on a person’s quality of life.

We need new treatments that are effective in reducing underlying disease activity for patients, particularly those who require higher doses of oral corticosteroids, which themselves can be damaging in the long-term.

The anifrolumab clinical programme has provided compelling evidence that this medicine has the potential to be an important new option for patients.”

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “Saphnelo isa ground-breaking first-in-class medicine and offers physicians and patients a new way of treating systemic lupus erythematosus by targeting the type I interferon receptor, which is known to play a central role in lupus disease pathophysiology.

This positive recommendation from the CHMP brings us one step closer to providing a much-needed new treatment option to improve outcomes for patients in Europe.”

The adverse reactions that occurred more frequently in patients who received Saphnelo in the three clinical trials included upper respiratory tract infection, bronchitis, infusion-related reactions and herpes zoster.

Saphnelo was recently approved in the US, Japan and Canada for the treatment of SLE, and regulatory reviews are ongoing in additional countries.

The Phase III trial in SLE using subcutaneous delivery has been initiated and additional Phase III trials are planned for lupus nephritis, cutaneous lupus erythematosus and myositis.”

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/saphnelo-recommended-for-eu-approval-for-sle.html

CDC endorses ACIP’s updated COVID-19 vaccine recommendations

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CDC endorses ACIP’s updated COVID-19 vaccine recommendations

December 16, 2021: “CDC is endorsing updated recommendations made by the Advisory Committee on Immunization Practices (ACIP) for the prevention of COVID-19, expressing a clinical preference for individuals to receive an mRNA COVID-19 vaccine over Johnson & Johnson’s COVID-19 vaccine.

ACIP’s unanimous recommendation followed a robust discussion of the latest evidence on vaccine effectiveness, vaccine safety and rare adverse events, and consideration of the U.S. vaccine supply.

The U.S. supply of mRNA vaccines is abundant – with nearly 100 million doses in the field for immediate use.

This updated CDC recommendation follows similar recommendations from other countries, including Canada and the United Kingdom.

Given the current state of the pandemic both here and around the world, the ACIP reaffirmed that receiving any vaccine is better than being unvaccinated.

Individuals who are unable or unwilling to receive an mRNA vaccine will continue to have access to Johnson & Johnson’s COVID-19 vaccine.

The following is attributable to CDC Director, Dr. Rochelle Walensky 

“We have made important strides in the year since the COVID-19 vaccination program started.

More than 200 million Americans have completed their primary vaccine series, providing protection against COVID-19, preventing millions of cases and hospitalizations, and saving over a million lives.

Today’s updated recommendation emphasizes CDC’s commitment to provide real-time scientific information to the American public. I continue to encourage all Americans to get vaccinated and boost.”

https://www.cdc.gov/media/releases/2021/s1216-covid-19-vaccines.html

Launch of UN Group of Friends on Neglected Tropical Diseases and on Support of Water

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Launch of UN Group of Friends on Neglected Tropical Diseases and on Support of Water

December 17, 2021: “On 30 November and 10 December respectively, WUN teamed up with the Ambassadors of Brazil, India, Indonesia and Senegal to launch the UN Group of Friends on Defeating Neglected Tropical Diseases and with the Ambassadors of Hungary and the Philippines, to launch the UN Group of Friends in Support of Water, Sanitation and Hygiene in Healthcare Facilities.

The objective of the Groups is to raise awareness, exchange information, build coalitions and political momentum, support initiatives and mobilize resources directed towards addressing both issues.

They will also seek to build coalitions among Member States, Civil Society Organizations, research institutions and academia, and other relevant actors to collaborate as well as serve as an informal platform at the UN to exchange information, share best practices, support initiatives and mobilize resources. During both events, other UN Member States expressed cooperation and support for the initiatives.

Watch the launch of the Group of Friends on Support of Water, Sanitation and Hygiene in Healthcare Facilities here: 

https://www.who.int/news/item/17-12-2021-launch-of-un-group-of-friends-on-neglected-tropical-diseases-and-on-support-of-water-sanitation-and-hygiene-in-healthcare-facilities

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