FOLLOW US

Pfizer (NYSE: PFE) and BioNTech (Nasdaq: BNTX) are one step closer to developing a COVID-19 vaccine, which the companies tout has an effectiveness rate of 90% based on preliminary data.

According to the companies, their mRNA-based vaccine candidate, BNT162b2 showed a more than 90% efficacy rate in preventing COVID-19 in trial participants.

Pfizer and BioNTech enrolled 43,538 participants in Phase 3 clinical study of BNT162b2. Forty-two percent (42%) of the participants have diverse backgrounds and have no serious safety concerns.

An independent Data Monitoring Committee (DMC) evaluated 94 cases of COVID-19 in trial participants from the Phase 3 clinical study. Half of the participants received placebo and half were vaccinated. The participants took two doses. The DMC found that the efficacy rate was over 90% at 7 days after the second dose, which means the protection is achieved 28 days after the vaccination. The DMC hasn't reported any serious safety concerns.

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

On the other hand, BioNTech co-founder and CEO Prof. Ugur Sahin said, “The first interim analysis of our global Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19. This is a victory for innovation, science and a global collaborative effort...We will continue to collect further data as the trial continues to enroll for a final analysis planned when a total of 164 confirmed COVID-19 cases have accrued.”

While the preliminary data on the vaccine's effectiveness looks promising, the U.S. Food and Drug Administration (FDA) must declare it to be 'safe' for mass consumption. Before approving a COVID-19 vaccine, the FDA requires safety outcomes for two months for half of the participants.

Pfizer and BioNTech to initially produce 50 million doses of COVID-19 vaccine

BioNTech and Pfizer have confirmed that they will produce the COVID-19 vaccine this year, but only in limited numbers. Both companies estimate they will be able to produce up to 50 million doses globally with the majority of them going to frontline workers particularly healthcare professionals and first responders.

Looking at 2021, Pfizer claims it can produce up to 1.3 million doses. A challenging element of the vaccine is the fact that two dosages are required to be protected from COVID-19. The company expected preliminary data on vaccine safety right around this time.

Pfizer and BioNTech did not receive funding from Operation Warp Speed

Pfizer and BioNTech are not part of President Donald Trump's Operation Warp Speed, a program that provided funding for pharmaceutical companies to accelerate the development and production of a COVID-19 vaccine. BioNTech received $445 million in funding from the German government. It has a history working with Pfizer on influenza vaccines. In March, both companies agreed to partner in developing a vaccine to prevent COVID-19.