European Commission approved a fourth contract with pharmaceutical companies BioNTech and Pfizer, which provides for the initial purchase of 200 million doses on behalf of all EU Member States, plus an option to request up to a further 100 million doses, to be supplied once a vaccine has proven to be safe and effective against COVID-19. Member States can decide to donate the vaccine to lower and middle-income countries or to re-direct it to other European countries.
Today’s contract with the BioNTech-Pfizer alliance builds upon the broad portfolio of vaccines to be produced in Europe, including the already signed a contracts with AstraZeneca, Sanofi-GSK and Janssen Pharmaceutica NV, and the concluded successful exploratory talks with CureVac and Moderna. This diversified vaccines portfolio will ensure Europe is well prepared for vaccination, once the vaccines have been proven to be safe and effective.
President of the European Commission, Ursula von der Leyen, said: “In the wake of Monday’s promising announcement by BioNTech and Pfizer on the prospects for their vaccine, I’m very happy to announce today’s agreement with the European company BioNTech and Pfizer to purchase 300 million doses of the vaccine. With this fourth contract we are now consolidating an extremely solid vaccine candidate portfolio, most of them in advanced trials phase. Once authorised, they will be quickly deployed and bring us closer to a sustainable solution of the pandemic.”
Stella Kyriakides, Commissioner for Health and Food Safety, said: “A safe and effective vaccine is the only lasting exit strategy from the pandemic, and is at the centre of our European Vaccine Strategy. Today’s agreement follows the encouraging first indications from the clinical trial results and is further evidence of our commitment to putting more Europe in the area of health. It is a very telling example of what the EU can achieve when working together, as a Union, and a case in point of what a future European Health Union will be able to deliver.”
BioNTech is a German company working with US-based Pfizer to develop a new vaccine based on messenger RNA (mRNA). mRNA plays a fundamental role in biology, transferring instructions from DNA to cells’ protein making machinery. In an mRNA vaccine, these instructions make harmless fragments of the virus which the human body uses to build an immune response to prevent or fight disease.
The Commission has taken a decision to support this vaccine based on a sound scientific assessment, the technology used, the companies’ experience in vaccine development and their production capacity to supply the whole of the EU.
The European Commission presented on 17 June a European strategy to accelerate the development, manufacturing and deployment of effective and safe vaccines against COVID-19. In return for the right to buy a specified number of vaccine doses in a given timeframe, the Commission finances part of the upfront costs faced by vaccines producers in the form of Advance Purchase Agreements. Funding provided is considered as a down-payment on the vaccines that will actually be purchased by Member States.
Since the high cost and high failure rate make investing in a COVID-19 vaccine a high-risk decision for vaccine developers, these agreements will therefore allow investments to be made that otherwise might not happen.
Once vaccines have been proven to be safe and effective and have been granted market authorisation by the European Medicines Agency, they need to be quickly distributed and deployed across Europe. On 15 October, the Commission set out the key steps that Member States need to take to be fully prepared, which includes the development of national vaccination strategies. The Commission is putting in place a common reporting framework and a platform to monitor the effectiveness of national vaccine strategies.
The European Commission is also committed to ensuring that everyone who needs a vaccine gets it, anywhere in the world and not only at home. No one will be safe until everyone is safe. This is why it has raised almost €16 billion since 4 May 2020 under the Coronavirus Global Response, the global action for universal access to tests, treatments and vaccines against coronavirus and for the global recovery and has confirmed its interest to participate in the COVAX Facility for equitable access to affordable COVID-19 vaccines everywhere. As part of a Team Europe effort, the Commission announced is contributing with €400 million in guarantees to support COVAX and its objectives in the context of the Coronavirus Global Response.
Moderna vs. Pfizer: Two Recent Studies Show Moderna to Be The More Effective One
The first study was published by medRxiv “The Preprint Server for Health Sciences” on August 9th, and compared (on 25,589 vaccinated v. 25,589 unvaccinated Minnesotans) “the effectiveness of two full-length Spike protein-encoding mRNA vaccines from Moderna (mRNA-1273) and Pfizer/BioNTech (BNT162b2) in the Mayo Clinic Health System in Minnesota over time from January to July 2021.” Moderna was 86% effective against the infection; Pfizer was 76% effective. In July (when the “Delta” variant first became dominant) Moderna was 91.6% effective against hospitalization; Pfizer was 85%. But during that month, effectiveness against the infection was 76% for Moderna v. 42% for Pfizer. Nationwide (including Mayo in MN, WI, AZ, FL, & IA), Moderna was about twice as effective “against breakthrough infection” v. Pfizer.
The second study was far smaller, published on September 10th by the CDC, and studied only 1,175 hospitalized U.S. veterans (93% male) at V.A. centers nationwide. Moderna was estimated at 91.6% effective, Pfizer at 83.4%. Since no non-hospitalized comparison-sample were studied, “Vaccine effectiveness … to prevent Covid-19-associated hospitalization was estimated by using multivariate logistic regression to compare the odds of full vaccination between case-patients and controls,” and so the reliability of this study was far less than in the Mayo Clinic study.
India Completes First Drone Delivery of Vaccines
Today marks the beginning of the first trials for the delivery of MMR, influenza and COVID-19 vaccines in the southern state of Telangana.
The trials, which have been organized by the World Economic Forum in partnership with the state government of Telangana, Apollo Hospital’s HealthNet Global and NITI Aayog, will be conducted over 28 days in designated air corridors in the district of Vikarabad, Telangana.
Starting off with the first ever drone delivery of a vaccine in India, the trials are focused on laying the groundwork for a more elaborate drone delivery network that will improve access to vital healthcare supplies for remote and vulnerable communities. This is also the first drone programme since India recently liberalized its drone policy.
“The Forum is pleased to support Indian government and industry in demonstrating how emerging technologies can be used to improve access to healthcare for its most vulnerable populations,” says Timothy Reuter, Head of Aerospace and Drones, World Economic Forum. “The project has set into motion the adoption of drones to deliver lifesaving services across the country. We believe that India’s work with drones can serve as a model for other countries in the region and beyond.”
“Ever since Telangana issued the expression of interest in expanded drone use in March 2020, the industry has witnessed an acceleration around policy decisions,” said Vignesh Santhanam, Lead, Aerospace and Drones, World Economic Forum. “With the latest liberalization of India’s drone economy the Medicine from the Sky initiative has made efforts to invigorate the drone sector in India by demonstrating the essence of cooperative federalism and creating a template for the region.”
“Being at the forefront of leveraging emerging technologies, Telangana has always acted as a testbed for innovative solutions to support scaling across the nation,” said K.T. Rama Rao, Minister of Information Technology, Industries, Municipal Administration and Urban Development of Telangana, India. “The COVID-19 pandemic has highlighted that healthcare supply chains can be further strengthened and drones offer a robust value proposition especially when it comes to remote areas and emergencies. The Medicine from the Sky is the first of its kind initiative in the country to generate insights that shall benefit the entire ecosystem. The enthusiasm and support by all the partners is deeply appreciated.”
With the support of the Vikarabad municipality, India’s Ministry of Civil Aviation, the Directorate-General of Civil Aviation and the Airports Authority of India, this will be the first drone-delivered COVID-19 vaccine in Asia. After extended trials with MMR and influenza vaccines, COVID-19 vaccines will also be transported beyond the visual line of sight.
“This pilot has been enabled through a series of collaborations between India’s regulatory agencies state government, the World Economic Forum, international organizations, healthcare experts and drone companies,” said Anna Roy, Senior Adviser, Frontier Technologies, NITI Aayog, Government of India. “The Medicine from the Sky community has acted as an important platform providing advice and insight that has translated the extensive academic groundwork into action on ground. Through a highly collaborative effort, the pilot programme also demonstrates the importance of localized inputs and micro planning for healthcare in remote parts of the world.”
This initiative aims to improve equity in healthcare while enabling healthcare access for isolated populations and hazard-prone areas. The project has eight participating partners, including drone operators and experts in healthcare and airspace management among others. Together, these partners will demonstrate short and long-range drone-based deliveries to assess the efficacy of low-altitude aerial logistics in healthcare.
“Drone use provides the opportunity to support our traditional approaches to healthcare delivery especially in underserved or remote regions of the country,” said Dr. Sangita Reddy, Joint Managing Director, Apollo Hospitals Group. “Our healthcare sector could potentially witness large-scale deliveries of long-tail medicines, vaccines, blood and vital organs throughout the country across terrains with drones in action. As clinical partners in the Medicine from the Sky initiative, Apollo Hospital’s HealthNet Global will be responsible for enabling vaccine and medicine availability and properly monitoring the adherence of clinical protocols throughout the project.”
An industry core group was commissioned in June 2021 to help scale the effort to bolster last-mile mobility in healthcare. The outcomes from the trials will be analysed and used to scale up the effort to additional states with the support of the Medicine from the Sky community and key stakeholders. The project is expected to be expanded to six states in the coming months.
Pandemic increasing risk factors for suicide
Suicide prevention must be prioritized after 18 months of the COVID-19 pandemic, the Americas office of the World Health Organization (WHO) warned ahead of World Suicide Prevention Day, commemorated annually on 10 September.
Studies show that the global crisis has exacerbated risk factors associated with suicidal behaviours, such as job loss, trauma or abuse, mental health disorders and barriers to accessing health care.
‘Urgent public health problem’
“Suicide is an urgent public health problem and its prevention must be a national priority,” said Renato Oliveira e Souza, head of the Mental Health Unit at the Pan American Health Organization (PAHO).
“We need concrete action from all elements of society to put an end to these deaths, and for governments to create and invest in a comprehensive national strategy to improve suicide prevention and care,” he added.
Globally, one in 100 deaths is by suicide, making it among the leading causes of death worldwide and the fourth leading cause of death among 15- to 29-year-olds, after road traffic accidents, tuberculosis and interpersonal violence.
More people die each year from suicide than from HIV, malaria, or breast cancer, or from war and homicide, according to WHO.
Some of the verbal or behavioural warning signs for suicide include talking about wanting to die, feeling immense guilt or shame, or feeling like a burden to others. Other signs are feeling empty, hopeless or trapped, or having no reason to live, or feeling extremely sad, anxious, agitated, or full of anger.
Among behavioural changes that can also be warning signs, are researching ways to die, staying away from friends, giving away important items, showing extreme mood swings, eating or sleeping too much or too little, and using drugs or alcohol more often.
Anyone who detects warning signs of suicide, whether in themselves or in someone they know, should seek help from a health care professional as soon as possible.
Hope through action
World Suicide Prevention Day is organized by the International Association for Suicide Prevention (IASP) and endorsed by WHO.
This year’s theme ‘Creating hope through action’, focuses on the need for collective action to address the issue.
Key prevention measures include limiting access to means of suicide, such as firearms and pesticide, as well as early identification, assessment, management and follow-up of people affected by suicidal thoughts and behaviours.
Other actions include fostering adolescent social-emotional skills, and educating the media in responsible reporting on suicide
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