Pfizer is among the companies that applied for COVID-19 vaccine in the US, with a difference, this one is seeking emergency approval.
The companies filed the COVID-19 vaccine approval application with the FDA on Friday. At best, vaccinations can start in December – possibly soon in Europe and the rest of the world as well.
Two days after the detailed presentation of very good test results for their COVID-19 vaccine BNT162b2, Biontech from Mainz and its US partner Pfizer have applied for emergency approval for the COVID-19 vaccine at the US Food and Drug Administration (FDA). Pfizer confirmed this on Twitter in the afternoon. Pfizer and Biontech are thus on track to become the first suppliers worldwide to bring a vaccine to market.
The vaccine could potentially be used from mid to late December in high-risk populations, i.e. people at particularly high risk for severe corona disease. Biontech and Pfizer announced that they are prepared to deliver it within hours of approval.
The two partners confirmed their plan to produce up to 50 million units this year and up to 1.3 billion units next year. Since two vaccinations at four-week intervals are required for immunization, these quantities are sufficient to vaccinate around 25 million people this year and 750 million next year.
This is currently also benefiting the German company: the Biontech share was traded more than six percent up in midday trading in Frankfurt on Friday. In the current year, the share price has risen by around 160 percent despite recent fluctuations.
The COVID-19 vaccine, which is based on the novel mRNA technology, is already in so-called rolling approval procedures with the European Medicines Agency (EMA) and the British Medicines & Healthcare Products Regulatory Agency (MHRA). In addition, the company plans to submit applications for approval to other authorities worldwide.
“The application for emergency approval in the USA is a critical step on the way to making our vaccine candidate available to the global population as quickly as possible,” explained Biontech CEO Ugur Sahin.
The FDA has scheduled the hearing of an Advisory Committee for December 8-10. The COVID-19 vaccine is expected to be approved immediately after these consultations on December 10. Some observers had previously expected approval before that date.
A timetable for approval in Europe is still unclear, as larger data volumes have to be submitted for the rolling approval procedures than for the “Emergency Use Authorization” in the U.S. However, the states and authorities in Europe are also likely to be very interested in obtaining approval as soon as possible.
In addition, Biontech has already submitted data to the authorities during the ongoing Phase 3 trial. For Biontech as a company based in the heart of Europe, the interaction with the European Medicines Agency is of particular importance, Sahin confirmed.
Extensive supply agreements
In recent weeks, Biontech and Pfizer have already signed contracts for larger deliveries with both the EU and the USA. The EU has secured 200 million vaccine doses and an option for a further 100 million units. The US has pre-ordered 100 million doses with an option to purchase a further 500 million doses.
In addition, Japan, Canada, Great Britain and ten other countries have also ordered larger quantities of vaccine. The companies are also in talks with the international organization Covax, which is responsible for the vaccine supply of numerous emerging and developing countries.
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Biontech and Pfizer published final data from their large Phase 3 study on Wednesday, which indicate that the vaccine is very effective with good safety. According to the study, it should reduce the risk of infection by 95 percent and showed this effect in all age groups.
The study involved about 44,000 subjects, about half of whom received the COVID-19 vaccine, the other half a placebo. Of the 170 sars-CoV-2 infections that occurred in the study participants, 162 were in the placebo group and only eight in the vaccinated group.
The vaccine also appears to be able to significantly reduce the risk of serious disease progression. Of ten severe Covid 19 cases, nine were in the unvaccinated group. The side effects of the vaccine were minor and within the range of normal vaccination reactions. The conditions for approval of the vaccine are therefore considered extremely good.
Moderna on course for COVID-19 vaccine approval
Similar positive results were reported by the U.S. biotech company Moderna after an interim evaluation of its Phase 3 study with a comparable vaccine candidate. Moderna reported an efficacy of 94.5 percent, but observed a slightly higher rate of side effects than Biontech. The U.S. company’s vaccine also consists of mRNA, which is specially prepared and triggers an immune response against the Sars-CoV-2 virus in the body.
Moderna had announced that it would submit an application for emergency approval of its COVID-19 vaccine in the coming weeks, once the safety data required by the FDA were also available.
The U.S. FDA requires that for emergency approval, at least half of the study participants were observed for at least two months after the second vaccination. Biontech and Pfizer have met this criterion for several days. Moderna is also expected to meet this requirement in the near future.
It is therefore considered likely that the FDA will also discuss the Moderna vaccine at the expert hearing and that this vaccine could also receive initial approval this year. This could result in two Covid 19 vaccines being available in December. Moderna plans to produce 20 million doses of its vaccine by then and up to one billion units next year. Here, too, the share price is rising sharply: on a monthly basis, the share price has risen by more than 30 percent; in the current year, the increase is currently more than 370 percent.
