Shares of Pfizer rose 4%, and BioNTech 10% after their two candidate vaccines have received a “shortcut” status from the FDA that can help faster to obtain approval to manufacture and sell, after having completed the last survey. After positive results on 24 patients companies are moving to large-scale vaccine testing up to 30 000 participants.
Shares of Pfizer (PFE) and BioNTech (BNTX) rose sharply Monday, at 4% and 10%, respectively, after control for food and drug administration (FDA) has scheduled an “urgent” status of their two candidates for vaccine COVID-19.
Although the company has not yet completed final testing and has not received approval for production and sale of its vaccines, this status gives them a chance at a quick transition to these stages. It is also a chance that their vaccine can obtain the status of a “priority review” by the FDA, which means that the management can make the decision on approval within six months.
In early July it became known that the phase 2 clinical trials of their candidate vaccine BNT162b1 showed that all 24 volunteers who received two injections, observed a “strong immune response” to the virus is stronger than in patients undergoing COVID-19. Read more in the article Marketinfo.pro “Tested vaccine Pfizer and BioNTech against coronavirus were able to form a strong immunity.”
While data on these tests should be published in this months, today, Pfizer and BioNTech are going to test the most promising vaccine candidates to 30,000 participants in the United States and Europe.
“The FDA’s decision to provide the two candidates for vaccine COVID-19 “crash status” is an important milestone in the efforts to develop safe and effective vaccines against SARS-CoV-2″, – said a senior Pfizer Vice President, global regulatory issues Peter Honig. “We look forward to continued close cooperation with the FDA throughout the clinical development of this program Project Lightspeed to assess the safety and effectiveness of these vaccine candidates”.
According to Pfizer, if regulators will ultimately approve the drug, Pfizer and BioNTech plan to produce 100 million doses by the end of the year and at least 1.2 billion by the end of 2021.
Moderna (MRNA), which is developing a potential vaccine using the technology similar to Pfizer and BioNTech, in may received the same “accelerated” status for its candidate vaccine against COVID-19.
Moderna shares jumped by 14.65% on Monday on news that will be added to the Nasdaq-100 index before the market opens on July 20.
Analysts estimate the potential annual revenues from worldwide sales of the vaccine COVID-19 $5 billion – $10 billion For the world’s major contracts a dozen competing companies from different countries to be the first to complete final tests on a large group of people and to obtain regulatory approval.
