Filenews 20 November 2020
Us pharmaceutical company Pfizer filed on Friday, as expected, the application to the US Food and Drug Administration (FDA) for urgent licensing of the vaccine against the new coronavirus it is developing jointly with German BioNTech.
The two companies are the first to make such a request in the US. After that, a rapid regulatory process is in place that could allow for early vaccinations.
Pfizer had earlier announced that production of the vaccine is expected to reach 50 million doses this year and 1.3 billion doses in 2021. The company has committed to delivering 100m euros to the company. and reached an agreement with the EU on Friday on 300 million doses.
The company has not yet applied for marketing authorisation in Europe, but has started the planned procedures with the European Medicines Agency.
Pfizer chief executive Albert Burla, in a videotaped message on Twitter, announced that the request had been filed, took a brief look back at the 248 days it took to prepare the vaccine and thanked in particular the volunteers involved in the clinical trials and partners of the two companies around the world.
In the US, the meeting of the FDA Advisory Committee for Marketing Approval is scheduled for early December, US media report.
The request by us Pfizer, which is in charge of marketing the vaccine of the German BioNTech, comes two days after the announcement of the final efficacy data, according to which the vaccine prevents 95% of Cases of Covid-19 without being accompanied by serious side effects.
The announcements by Pfizer/BioNTech and Moderna, whose vaccine is based on the same mRNA technology, brought the first wave of optimism to tackle an uncontrolled pandemic that has affected more than 51 million people and disrupted the lives of the entire world's population.
"Making a request to the U.S. represents a critical milestone in our effort to offer the world a vaccine against Covid-19. We now have a fuller picture of both the effectiveness and safety profile of our vaccine," Albert Burla, Pfizer's chief executive, said in a company statement.
Burla: Historic day for science
"With great pride and joy and still with some relief, I announce to you that our request for Urgent Approval of Use (of the Covid-19 vaccine) is now in the hands of the FDA," Burla said in his videotaped message and continued.
"It is a historic day, a historic day for science and for all of us. It took just 248 days to get there, from the day we announced our plan to work with BioNTech, to submit the request to the FDA. We operated at an unusual speed in the clinical development program, from capturing the idea to submitting the request to regulators, always focusing on safety. So many things have contributed to this happening: advances in technology, amazing collaboration, thousands of courageous test volunteers around the world and, of course, partners led by the same motivation in both companies.
Today, we were able to submit a very robust data package, which we believe meets, and in many cases exceeds, the fda's high standards. Our candidate vaccine has demonstrated 95% efficacy against Covid-19, with no serious concerns for its safety observed so far.
Of course, the journey is not yet complete. In addition to today's submission (of the request) to the FDA, we have already started making requests in Australia, Canada, Europe, Japan and the United Kingdom and intend to submit (requests) to other regulators around the world. We are also looking forward to the next debate in December at the US Advisory Committee on Vaccines and Related Biological Products (VRBPAC).
Finally, we will continue the work that is already under way to ensure that we can start sending the vaccine as soon as it is approved. Based on current forecasts, we expect to produce up to 50 million doses worldwide in 2020 and up to 1.3 billion doses by the end of 2021.
I want to thank all those who volunteered for the clinical trial, our university colleagues and our colleagues and colleagues around the world who work night and night to help ensure that science wins."
Production has started in the US and EU
Production has already begun at Pfizer's factories in St. Louis, Missouri, Kalamazoo, Michigan and Andover, Massachusetts, as well as in the Belgian city of Pierce.
"BioNTech's facilities in Germany will also be used in production," the companies say.
Pfizer is also trying to allay concerns that the vaccine should be kept at -70 degrees, which creates a requirement for "cold chain" infrastructure that is missing even from developed nations. As he says, it has developed special containers that use dry ice (solid carbon dioxide) to transport vaccines to its large distribution network. The containers are equipped with GPS transmitters and sensors that monitor temperature on an ongoing basis.
New technology vaccine
Like all vaccines, Pfizer's BNT162b2 was designed to cause the production of antibodies that recognize specific virus proteins and target the immune system.
Unlike other vaccines, however, Pfizer's experimental formulation does not contain parts of the virus itself, or antigens, but mRNA molecules in which the instructions for the production of antigens are encoded. In other words, the candidate vaccine was designed to instruct human cells to make up molecular parts of the coronae on their own.
To date no mRNA vaccine has been approved for human use, although the new technology is already in use in some veterinary vaccines.
MRNA technology is expected to be widely exploited in the future as it significantly accelerates the production process and reduces costs.
Source: in.gr
