Pharmaceutical giant Pfizer and German biotech company BioNTech announced that they have filed an application for emergency authorisation of their coronavirus vaccine in the United States this Friday. It is the first prototype produced in the West to submit the data to one of the world's most demanding regulators, the Food and Drug Administration (FDA).
The application comes after the FDA last week reported a maximum efficacy of 95 per cent from the analysis of 170 cases of covid infection in the Phase III trial with more than 41,000 volunteers.
Pfizer and BioNTech have also reported that they are sending their application for emergency use authorisation to other countries around the world, including Australia, Canada, Japan and the European Medicines Agency.
The submission to the FDA is based on "a 95% vaccine efficacy rate demonstrated in the Phase III clinical trial in participants without prior SARS-CoV-2 infection and also in participants with infection. The encouraging data have been obtained in both cases "from seven days after the second dose". The Pfizer vaccine has to be applied in two inoculations three weeks apart.
Documentation sent by the two companies to the US regulator also relies on safety data from a random subset of approximately 8,000 adult participants and "unsolicited data from approximately 38,000 participants. Follow-up has been done for at least two months after the second inoculation.
The submission of the application report also includes safety data "on approximately 100 children aged 12-15 years".
Albert Bourla, President and CEO of Pfizer, said: "Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming increase in the number of covid cases - 19 worldwide. The US launch represents a critical milestone on our journey to deliver a vaccine to the world and we now have a more complete picture of the efficacy and safety profile. It gives us confidence in its potential.
Ugur Sahin, CEO and co-founder of BioNTech, said: "Applying for emergency use authorisation in the US is a critical step in making our vaccine candidate available to the world's population as quickly as possible. We intend to continue working with regulatory agencies around the world to enable rapid distribution of our vaccine globally. As a company located in Germany, in the heart of Europe, our interactions with the European Medicines Agency [EMA] are particularly important to us and we have provided them with data on an ongoing basis as part of our ongoing review process.
The likely timetable would be that in two, at most three weeks, both the United States and the European Medicines Agency, and others, would make their statements. If they agree, the first doses could begin to be distributed by December 15, especially in the United States, where Pfizer says it can produce up to 50 million by 2020.