Pfizer (PFE) and BioNTech have announced that its COVID-19 vaccine has shown 90% effectiveness at preventing COVID-19 in clinical trials.

The company made the announcement early Monday, saying they planned to submit the COVID-19 vaccine to the U.S. Food and Drug Administration for emergency use authorization after it achieves the required safety milestone of data collection next week.

“Today is a great day for science and humanity,” Dr. Albert Bourla, Pfizer Chairman and CEO, said in a statement.

“The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19. We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen.

“With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks,” he added.

Pfizer and BioNTech began testing the COVID-19 vaccine (BNT162b2) with 43,538 participants on July 27, reporting that no serious safety concerns have been observed. A total of 38,955 patients received a second dose of the vaccine on Nov. 8, with 30% of U.S. participants coming from a racially and ethnically diverse background.

A total of 94 confirmed cases of COVID-19 infections were evaluated during the trial, with noninfected patients split between receiving the vaccine and a placebo. An efficacy rate of over 90% was achieved seven days after the second dose was administered to participants who had no evidence of prior SARS-CoV-2 infection. Data showed that COVID-19 protection occurred 28 days after the initial vaccine through a two-dose inoculation schedule.

Additional safety data still needs to be collected, and the final vaccine efficacy percentage would need to be determined by Pfizer and BioNTech.

The breakthrough with the COVID-19 vaccine comes at a critical time during the pandemic as positive cases of the virus continue to surge in several parts of the U.S. The country has reported over 9.9 million positive cases of the coronavirus and over 237,500 COVID-19 deaths, according to Johns Hopkins University.

“...While we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality,” Professor Ugur Sahin, BioNTech co-founder and CEO, said.

The companies said they are continuing to enroll participants in the study and are expected to continue analyzing up to 164 confirmed COVID-19 cases. The study will also look at the potential of protecting those that have had exposure to the coronavirus and preventing severe COVID-19 disease.

The companies project that they will produce up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses in 2021.

Shares of Pfizer were trading at $41.99 as of premarket open on Monday, up 15.36%.

Pfizer Pfizer, whose Manhattan headquarters is seen here, is among the companies in the race to develop a coronavirus vaccine. Photo: GETTY IMAGES / Drew Angerer