Biopharma industry commits to working with regulatory agencies on COVID-19 vaccines

A joint statement from a range of biopharmaceutical industry groups has said they recognise that with the first COVID-19 vaccines authorised by regulatory authorities and administered to the public, a critical new phase of the pandemic has begun. The statement was released by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), Pharmaceutical Research and Manufacturers of America (PhRMA), European Federation of Pharmaceutical Industries and Associations (EFPIA), Vaccines Europe, Biotechnology Innovation Organization (BIO) and International Council of Biotechnology Associations (ICBA).

The groups say that collaboration among the global community has resulted in safe and efficacious vaccines being authorised by stringent regulatory agencies, which are already being manufactured and distributed. Additional vaccines are expected to follow.

The biopharmaceutical industry acknowledges the considerable challenges governments are facing to urgently address the enormous strain the pandemic is placing on healthcare systems, societies and economies. In light of the urgent need to reach as many people as possible with COVID-19 vaccines, there are emerging discussions regarding dosing strategies that may not be supported by the authorised labelling or published clinical data.

The groups say that the biopharmaceutical industry commits to work in partnership with regulatory agencies and recommending bodies to gather further clinical data on several ongoing scientific questions with regard to COVID-19 vaccines. The industry believes that vaccine deployment strategies should be based on the outcome of these continuing clinical studies and the evolving knowledge. Therefore, the biopharmaceutical industry supports adhering to the dosing that has been assessed in clinical trials and urges that any changes from the tested and approved vaccine dosing and vaccination schedules for COVID-19 vaccines should follow the science and be based on a transparent deliberation of the available data.

“The biopharmaceutical industry will continue to develop and test vaccine candidates for COVID-19 through a sound, scientific and deliberative process,” the groups say in their statement. They also highlight that vaccine manufacturers have pledged to only submit vaccine candidates for approval or emergency use authorisation after demonstrating safety and efficacy in clinical trials that are designed and conducted to meet the requirements of regulatory authorities.