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Coronavirus – your questions answered

What is a coronavirus?

Coronaviruses are a large family of viruses which may cause illness in animals or humans.  In humans, several coronaviruses are known to cause respiratory infections ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). 
 
COVID-19 is the infectious disease caused by the most recently discovered coronavirus. This new virus and disease were unknown before the outbreak began in Wuhan, China, in December 2019.[1]

What is the industry in Europe doing to help in the fight against the coronavirus?

As an industry #WeWontRest in fighting the COVID-19 pandemic and preventing future outbreaks. Our first thoughts are with all those affected by the coronavirus pandemic. As an industry we are committed to working collaboratively across the research and healthcare communities, utilising our world-leading science, people and resources to tackle this outbreak. Our aims in this time of public health crisis are to ensure the safe supply of medicines to the patients that need them, research and develop new vaccines, diagnostics and treatments for use in the fight against COVID-19 and partner and support organisations on the ground to fight against COVID-19.

Where do I find accurate information on the coronavirus outbreak?

There are a number of sources of accurate and up-to-date information on the coronavirus outbreak such as the World Health Organisation and the European Centre for Disease Prevention and Control. Health advice should be accessed from national authorities or your health provider.

With the volume of COVID-19 content on social media, always remember to check the source(s) for reliable information.
 
Are there any vaccines for citizens or treatment options for patients with COVID-19?
There are no currently approved vaccines or therapeutics to prevent transmission of, or treat, the COVID-19 virus. However, approved treatments have been used to alleviate symptoms and address complications of patients. EFPIA members are working around the clock to find vaccines, diagnostics and treatments to use in the fight against coronavirus
There are several ongoing clinical trials ongoing worldwide, with 114 already planned or pending in the European Union (database consulted on 22 April 2020).


What is a vaccine? And how do they work?
A vaccine is a biological preparation used to produce or improve immunity against a particular disease like COVID-19. By inoculating killed or weakened disease-causing microorganisms (or crucial fragments, products or derivatives) the production of antibodies is stimulated. If and when the immune system encounters the disease-causing microorganism, it then itself prevents the disease through reacting rapidly and effectively.

The human immune system is a system of biological structures and processes that protects us against diseases by recognising germs that enter the body as foreign invaders (a.k.a. pathogens). These are referred to as antigens, a term which stands for “antibody generator”. When antigens invade the human body, the immune system responds by producing protein substances called antibodies and highly specific cells that can fight the invading germs.
 
Immunity is the body’s successful defence against a pathogen. When a sufficient number of antibodies has been produced by the body to fight the disease, immunity results, providing protection against the disease for many months, for years or even for a lifetime. If a person later comes into contact with that same pathogen again, the immune system will be able to quickly produce the same type of antibodies preventing the disease from developing or decreasing its severity and eliminating the pathogen from the body. Through “immunological memory”, it is estimated that the immune system can remember or recognise and effectively combat hundreds of thousands, possibly millions, of different foreign organisms.
 
Vaccination involves the introduction of a limited quantity of a specific disease antigen into the human body stimulating the immune system just enough to produce the amount of antibodies needed while not causing the disease.

How are vaccines developed?

Vaccine development is a complex and time-consuming process that differs from the development of conventional medicines. Indeed, vaccines are intended for use in healthy individuals as a preventive measure whereas conventional drugs are aimed at the treatment of a condition.  Vaccine clinical trials focus on demonstrating efficacy and safety which implies that a higher number of subjects will be required than for traditional drug trials.

Before a vaccine is licensed and brought to the market, it undergoes a long and rigorous process of research, followed by many years of testing to comply with stringent regulatory requirements.

How long does it take to develop a vaccines?

Normally, the period for vaccine development is 12 to 15 years.

Why are some media stories reporting that vaccines could be available in around 1 year?

EFPIA medicine companies and vaccine developers have deep scientific knowledge gained from decades of experience with similar viruses such as MERS, SARS, influenza, HIV and Hepatitis C. This knowledge dramatically improves our likelihood of success in developing an effective vaccine and identifying existing treatments for those infected. EFPIA member companies are now working around the clock to use this knowledge and any likely vaccines or medicines in development can be used in the fight against COVID-19.

Are biopharmaceutical companies developing treatments or vaccines to address the crisis?
Yes, there are significant efforts underway to diagnose, treat and prevent infections from the virus. Companies have donated compounds with the potential to treat coronavirus for emergency use and clinical trials, including compounds formerly tested on other viral pathogens such as Ebola and HIV.

Others are researching vaccine candidates and undertaking inventories of research portfolio libraries to identify additional potential treatments for R&D. Companies are also exploring ways to leverage existing technologies that provide the ability to rapidly upscale production once a potential vaccine candidate is identified.

A practical example of this radical research collaboration in action is the Innovative Medicines Initiative’s Call 21. It brings together world-leading scientists and researchers from industry and academia to accelerate the production of diagnostics and therapies for use in the fight against coronavirus.
 
What other ways are companies supporting the fight against COVID-19?
EFPIA member Companies are committing millions of euros in direct monetary and in-kind contributions to support organizations at the heart of the crisis who are able to have an immediate impact for infected patients and communities.
 
A variety of crucial supplies including advanced surgical equipment, antibiotics, disinfection equipment, vitamins, protective clothing, goggles, masks, gloves and more have also been donated. In addition, antibacterial medicines that are approved to treat secondary infections such as pneumonia are being donated. You can find a host of examples here.

Is biopharmaceutical industry collaborating or coordinating with government agencies?
Companies are collaborating with EU and global public health authorities including the European Commission, the European Medicines Agency, the Innovative Medicines Initiative, Member States and their authorities.

What is EFPIA doing to tackle risks of drug shortages caused by the coronavirus?
As many countries in Europe near the peak of the COVID-19 pandemic, EFPIA member companies are continuing to work around the clock to increase capacity and ensure the supply of critical medicines to patients across Europe. In fact, increases in capacity was one of the first actions undertaken by pharmaceutical manufacturers, as part of their pandemic preparedness plans, activated back in January. However, we are witnessing a significant increase in demand in some European countries, that in some cases can reach many times the normal levels.  

On one recent call with the European Commission, EFPIA welcomed the Commission’s guidance to member states on the optimisation of supply of medicines for COVID-19, as well as underlining the need to continue to address stockpiling and exports bans, provide more information from Member States to forecast demand for medicines in line with their patients’ needs and ensure optimal and timely supply of medicines to all Member States and to work collaboratively to support the continuation of clinical trials across Europe.
 
Export bans restrictions and requisitioning of medicines continue to exist across the EU. Such export bans are particularly challenging for companies who have their multi-market distribution warehouses in those countries, from which they serve all of Europe, or even parts of Africa. We understand each Member State’s desire to ensure the availability of necessary medicines for their population. However, the supply chain is designed to work across borders. No one country can meet all its needs on its own, and through restrictions, countries risk isolating themselves and their citizens from the global supply network. COVID-19 is a global pandemic and requires a global response.

Critical to our efforts to meet the needs of patients is accurate forecasting data on the patient demand for medicines. We urgently need detailed modelling data from the European Centre for Disease Control. COVID-19 has put immense strain on Europe’s intensive care units, including the demand for medicines used in critical care. As these are mainly generic medicines, EFPIA supports the project initiated by Medicines for Europe and its members to try to assess the total demand for ICU medication needed in hospitals across the EU as well as to gather supply and capacity data from manufacturers of these medicines under close supervision by European Commission Directorates General for Competition (DG COMP) and Health (DG SANTE).

 
EFPIA members will continue to liaise with the Commission, the European Medicines Agency, Member States and their Competent Authorities to address issues as they arise with pragmatic approaches that put patient needs first. 
 
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