Milestones :: Perspectives :: Research
COVID-19 Vaccines – Regulatory/Licensing
IFPMA [to 29 Aug 2020]
Selected Press Releases, Statements, Publications
Innovative vaccine industry strongly committed to rigorous regulatory standards for approval of COVID-19 vaccines
Geneva, 28 August 2020 – In the face of an unprecedented public health and economic crisis, the world’s leading innovative vaccine companies are working in partnership with international organizations, governments, academia and many others across the world in answering the call to develop novel vaccines against SARS-CoV-2. Our goal is to provide vaccines to people once national regulatory agencies (NRAs) have approved them, on the basis of solid validation of the vaccines’ quality, safety and effectiveness. Nothing is more important to us than the health and safety of those receiving a vaccine, and that hasn’t changed during the COVID-19 pandemic.
:: We strongly support the rigorous and objective scientific review of safety and efficacy data for the approval of COVID-19 vaccines. We call on regional and national regulatory agencies (NRAs) to work as fast as science and regulatory compliance allow AND at the appropriate pace needed to ensure delivery of safe and effective vaccines.
:: No matter how urgently action is needed against the coronavirus public health emergency, it is imperative that the highest standards of quality, safety and efficacy are upheld everywhere. We are fully committed to transparency in clinical trial results whether their results are good or bad, and support the need to inform the public of what we know, as well as what we don’t know about the vaccines in development.
:: We believe that ensuring appropriate engagement with society whilst assessing and approving vaccines will be key to gaining public’s trust in COVID-19 vaccines and helping end the coronavirus pandemic.
:: Rigorous application of regulatory science and openness in the process will ensure that everybody, starting with healthcare workers, have confidence in COVID-19 vaccines once they have been approved by NRAs based on their quality, safety, and efficacy.
Thomas B. Cueni, Director General, International Federation of Pharmaceutical Manufacturers (IFPMA)