MEPS from the Committee on the Environment, Public Health and Food Safety (ENVI) and from the Committee on Industry, Research and Energy (ITRE) hold a public hearing with researchers and representatives from pharmaceutical companies and civil society organisations on how to secure access to COVID-19 vaccines for all, including challenges linked to clinical trials, production and distribution in the European Parliament in Brussels.

Brussels

public hearing

healthcare safety (T)

WÖLKEN, Tiemo (S&D, DE)

TRILLET-LENOIR, Véronique (Renew, FR)

Coronavirus outbreak (T)

How to secure access to COVID-19 vaccines for EU citizens; clinical trials, production and distribution challenges: extracts from the joint public hearing

Title: How to secure access to COVID-19 vaccines for EU citizens; clinical trials, production and distribution challenges: extracts from the joint public hearing (I-195351)

SOUNDBITE (English), Dr Fergus SWEENEY , Head of Clinical Studies and Manufacturing Task Force, European Medicines Agency, This decision to approve vaccines must be based on the strength of the scientific evidence on vaccine safety, quality and efficacy and nothing else. COVID19 vaccines will be given to millions of people. Large, well-designed, randomized clinical trials in phase three with stringent success criteria and rolling, thousands of people will be needed to demonstrate the efficacy and safety of the vaccines. We expect data on up to 30000 people per vaccine, focusing on adults, including some with preexisting comorbidities and those over 65 who are most susceptible to severe disease. Authorization will be granted when the evidence shows convincingly that the benefits of vaccination are greater than any risks of the vaccine.

SOUNDBITE (English), Dr Fergus SWEENEY, Head of Clinical Studies and Manufacturing Task Force, European Medicines Agency, This transparency is key to reinforcing trust in regulatory decisions and in new medicines placed on the European markets. And it's important in supporting further research and in enabling public scrutiny and independent review. Once the European Commission decision has been granted for a marketing authorization or refused or if the application is withdrawn, EMI will publish all technical data submitted as part of that application as soon as personal data has been anonymized, uncertain, commercially confidential information redacted. As for EMI policy, we will publish the European public assessment reports within three days of the EU marketing authorization being granted by the Commission. And the full risk management plans for COVID19 related products will be made public.

SOUNDBITE (English), Professor Robin SHATTOCK, Department of Infectious Disease, Imperial College London, We are committed to the development of our COVID 19 vaccine, recognizing that we are all in a race against the virus and not each other, a race where the more vaccines that can pass the finishing line, the greater choice we have for global access. Virus is not the first global pandemic, and it certainly won't be the last. The COVID 19 pandemic has demonstrated the importance of international cooperation in dealing with global health emergencies and the role of supranational bodies in funding vaccines and treatment technology.

SOUNDBITE (English), Magdalena RODRIGUEZ DE AZERO, Vaccines Europe, European Federation of Pharmaceutical Industries and Associations, Vaccine confidence is fragile in many countries in Europe, and no medical intervention is entirely risk free. For COVID we will be embarking on a vaccination campaign of unprecedented scale. And there may be adverse events either related to the vaccine itself or events that would have occurred in any case, even if vaccination had not taken place. How we collectively handle those adverse event reports will be key to building or reducing confidence in COVID vaccination and probably for vaccination more generally in the future.

SOUNDBITE (English), Tiemo W&#214;LKEN (S&amp;D, DE), The public interest is of utmost importance for us also when it comes to publishing results from clinical trials. And it's without transparency. This might view vaccine skepticism, and we simply can't afford that. Moreover, I would like to ask the companies present on how they are planning to globally distribute the possible vaccine and not just to wealthier countries. Is there any plan in place to ensure the crisis affects populations will have access to treatments?

SOUNDBITE (French), V&#233;ronique TRILLET-LENOIR (RE, FR), A recent report from Oxfam says that a country, rather, a group of countries representing 13 percent, 13 percent of the population of the world, had brought up half of the vaccines to be supplied by the pharmaceutical industry to UK, US, Switzerland, Israel, Japan, Hong Kong, Australia and the European Union have apparently signed contracts in order to preserve five point three billion vaccines from five manufacturers in phase three. So I would address those of you who are representing the pharmaceutical industries. Can you confirm the reports from Oxfam? And if so, is it not your responsibility to let the international and European institutions know about this dangerous imbalance in global distribution?