Pfizer Coronavirus Vaccines Trials Entering Phase 3 Very Soon

• Last stage before regulatory review

• Large trials (30,000 people) to assess safety, efficacy

• Half receive vaccine, half receive placebo

• Success: half as many (or fewer) infections for those on vaccine

U.S, drugmaker and German Biotech BioNTech announced on Monday that they had begun their late-stage human vaccine trial, as they continue in the race for developing potential coronavirus vaccine alongside other pharmaceutical companies.

Following the announcement on Monday, Pfizer shares rose more than 3% after trading on Monday. While BioNTech rose more than 2%.

This late-stage trial will include 30,000 participants, from 18 – 85 years old, across 120 locations globally with the inclusion of 39 U.S. states. If the results of this vaccine trial turn out as expected, both companies will proceed to submit their vaccine for the final regulatory review by October. Once it has been approved, they intend to supply 100 million doses by the end of 2020, and a total of 1.3 billion doses by the end of 2021.

BioNTech CEO Ugur Sahin said the primary goal of developing a vaccine is to “bring a well-tolerated, highly effective vaccine to the market as quickly as possible, while we will continue to evaluate our other vaccine candidates as part of a differentiated COVID-19 vaccine portfolio.”

“Many steps have been taken towards this important milestone and we would like to thank all those involved for their extraordinary commitment,” Sahin said in a press release.

Pfizer and BioNTech’s experimental vaccines can candidate makes use of messenger ribonucleic acid, or mRNA molecules, to stir up an immune response to fight the virus. Using RNA, scientists hope that relaying genetic instructions from DNA can be used to effectively train the immune system to identify and fight the virus.

Pfizer/BioNTech Phase 2/3 Vaccine Candidate

• Favorable viral antigen T cell responses, high levels of neutralizing antibodies

• Favorable tolerability: mild to moderate symptoms of fever, fatigue, and chills

• Immune responses in older adults (65-85 years)

In an announcement last week, the U.S. government said it would pay Pfizer and BioNTech $1.95 billion to produce and deliver 100 million doses of their vaccine if its safety and efficacy prove to be a success. The deal was signed under the Operation Warp Speed, an initiative of Trump’s administration to accelerate the development and production of coronavirus vaccines and treatments.

Pfizer and BioNTech are among the several pharmaceutical companies in the race to develop a coronavirus vaccine or treatment, which has killed at least 660,000 people and infected more than 16 million people worldwide. Currently. There are over 150 coronavirus vaccines being developed globally, with 25 already in human trials phase, according to the World Health Organization.

Moderna also made its announcement the same day as Pfizer and BioNTech. The pharmaceutical company announced that its leading vaccine candidate will begin late-stage trials which will also include 30,000 participants. The company also said that it plans to deliver between 500 million to 1 billion doses every year, starting next year.

Other competitors include pharmaceutical giants like Johnson & Johnson and AstraZeneca. Both companies have announced that they will soon enter late-stage human trials.