Pfizer Inc and its partner BioNTech SE on Monday announced that two of their experimental coronavirus vaccines have received the U.S. health agency's so-called "fast track" approval to accelerate the regulatory evaluation process.
The German company's U.S.-listed shares rallied around 10 percent, while the stock of Pfizer soared around 2 percent before the closing bell.
Fast Track is a process to speed up the assessment of new vaccines and facilitate the development of new ones. The pharma groups are in a global competition with AstraZeneca Plc, Moderna, and others to produce a COVID-19 vaccine, the respiratory disease caused by the latest coronavirus that has claimed more than 568,500 lives worldwide, according to a Reuters report.
As Moderna continued to squabble with the government and initiating last-minute protocol revisions to its final phase efforts, Pfizer and BioNTech have quietly made very decent advances on their own as the duo, like Moderna, now prepare for a July start.
The phase 2B/3 clinical tests could commence as soon as later this month, the partners disclosed in a statement on Monday morning, and they are looking at enrolling up to 30,000 participants.
Pfizer sealed an agreement with BioNTech in March. Under the conditions of the deal, the two biotech groups will work to contain COVID-19, a highly contagious respiratory disease discovered last year. If successful, Pfizer and BioNTech will collaborate to market and sell the coronavirus drug outside of China.
The two companies are also looking to produce up to 100 million doses by the end of the year and potentially over 1.2 billion doses by the end of 2021. The test programs are made up of candidate drugs under the BNT162 program.
Pfizer is one of the largest biotech firms in the world. But its sales have dropped each quarter in the last four quarters. In the first three months this year, the company's revenue fell 8 percent to $12.03 billion. Adjusted earnings have retreated for three quarters now, sliding 6 percent to 80 cents per share.
According to Peter Honig, Pfizer Senior Vice President for Global Regulatory Affairs, the FDA's decision to grant the Fast Track designation "signifies a critical milestone in the efforts to develop a safe and effective vaccine against SARS-CoV-2," Tomi Kilgore of MarketWatch wrote.
There is still no approved drug for COVID-19, and the United States and other nations have allocated billions into their own development as they seek to secure a safe and effective treatment.