Pfizer will request the authorization of the vaccine from the third week of November

Pfizer’s late-stage coronavirus vaccine trial is near complete

Pfizer’s late-stage coronavirus vaccine trial is near complete.

The countdown to the arrival of the Covid vaccine has begun. Pfizer is one of the best placed to be the first company to offer a solution. Its general manager in Spain tells what point the antigen is. The full interview can be read in the monthly health magazine of elEconomista.

Pfizer, in its alliance with BioNTech, is one of the companies that is most advanced to obtain the vaccine against the coronavirus. When will the first doses be seen, if the clinical trials are successful?

We are working at the speed set by science. There are three key areas in which we must demonstrate success to get the vaccine approved for use. First, the vaccine must prove effective, which means that it can help prevent Covid-19 in at least the majority of vaccinated patients. Second, the vaccine must be shown to be safe. And finally, we must demonstrate that the vaccine can be consistently manufactured to the highest quality standards. Assuming all data is positive, Pfizer will request the use of emergency authorization in the United States shortly after the safety milestone is reached in the third week of November. If regulatory approval or clearance is obtained, we expect to globally manufacture up to 100 million doses by the end of 2020 and potentially 1.3 billion doses by the end of 2021.

What immunity capacity does it generate and for how long?

This is a question that we continue to explore. The duration of immunity after Covid requires observing a large number of people who have already had the disease until some contract it a second time. Because the first known cases occurred in December, there has not been enough time to observe a significant number of second illnesses to know the duration of natural protection. Similarly, determining the duration of immunity after immunization will require looking at a large number of people who have been immunized with an effective vaccine to see when their Covid rates start to rise relative to the time of immunization.

In an agreement with the United States, we saw that the price was around 17 euros. Will it be the same price in Europe?

Rather than using a traditional profitability approach, we will price in a way that can help governments ensure there is little or no spending for their people. Ensuring broad access is key and speed, security and availability drive us. Our pricing strategy is based on principles of volume, upfront commitments, fairness and affordability. It is important to note that our development and manufacturing costs have been fully self-funded and we have already invested billions of dollars, and we are prepared to continue to bear development and manufacturing costs.

How are the negotiations with the European Commission going?

We from Pfizer and BioNTech announced in September that they had concluded exploratory talks with the European Commission for a proposed supply of 200 million doses to the Member States of the European Union, with the option of supplying an additional 100 million doses. Deliveries would begin in late 2020, subject to clinical success and regulatory clearance. We are currently in contractual negotiations with the European Commission.

How do you meet the challenge of producing millions of doses?

Pfizer has 40 of its own centers and more than 200 suppliers around the world. We are activating our extensive supply chain and investing at risk with the goal of doing whatever it takes to carry as many doses as possible. In addition, we plan to make other capital investments over time. In Europe, our manufacturing program is currently using BioNTech’s facilities in Germany and Pfizer’s in Puurs, Belgium.

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