Distribution of vaccination is expected from the end of 2020.
Pfizer and BioNTech have sent a request for their vaccine registration to the U.S. Food and Drug Administration (FDA). This is reported on the website of the U.S. pharmaceutical giant.
Manufacturers have also applied to other countries, including Australia, Canada, Europe, Japan and the United Kingdom.
Companies said protection plus good safety performance means the vaccine must meet the requirements for authorization for use in an emergency, such as the current pandemic. Recall that the vaccine from Pfizer and BioNTech proved to be 95% effective in preventing light and heavy forms of COVID-19.
According to current projections, companies expect to produce up to 50 million doses of the vaccine in 2020 and up to 1.3 billion by the end of 2021.
What does COVID-19 vaccine emergency use mean?
It is when regulators allow certain people to get vaccinated, while safety and efficacy studies continue. Usually, the regulatory approval process for a new vaccine can take about 10 years. However, during the mass spread of the disease, it is significantly accelerated.
The first coronavirus vaccines that will receive green light in the United States are almost certainly available through this process, known as emergency approval. Instead of the usual requirement of “essential evidence” of safety and effectiveness for approval, the FDA may allow products to enter the market if their benefits may outweigh their risks.
We remind that on January 30 WHO recognized Coronavirus as a problem of global scale. Later the EU authorities launched the innovation program Horizon-2020 for coronavirus research.