Fauci: Pfizer vaccine trial findings ‘just extraordinary’

WINDOW ROCK

Pfizer Inc. announced on Monday that its vaccine candidate, in Phase 3 clinical trials, was found to be more than 90% effective in preventing COVID-19 in participants without prior infection.

This is the vaccine that is currently being tested on the Navajo Nation, as well as around the world.

“The data were absolutely striking — the efficacy of the Pfizer mRNA candidate is over 90%, which is just extraordinary and is going to have a major impact on everything that we do with regard to COVID,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, in a press briefing.

The data analysis looked at the first 94 confirmed cases of COVID-19 among 43,538 volunteers in the Pfizer clinical trial where half of the participants were given the vaccine and half received a placebo.

It found that 10% of the 94 participants with COVID-19 infections received the vaccine while more than 90% of the infections appeared in participants who had received a placebo. No serious safety concerns were reported.

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

“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,” he said. “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.”

As of Tuesday, more than 100 people had consented to participate in the Pfizer vaccine trial on the Navajo and White Mountain Apache reservations, according to lead research coordinator Deionna Vigil.

Approximately 30% of the participants in the trial in the United States have racially and ethnically diverse backgrounds, which was a priority for Pfizer and Johns Hopkins.

Fauci said the Pfizer vaccine trial findings are an “important advance.”

“It validates the mRNA platform, and it validates greatly the ‘spike’ protein as the target of the anti-coronavirus response,” he said.

Rather than use live or killed virus, the vaccine synthesizes the protein found on the “spikes” of the virus, prompting the body to launch an immune response.

Fauci said this is important because while the Pfizer results are the “first out of the gate,” virtually every one of the other vaccine candidates in trials use the coronavirus spike protein as the target of the immune response, which could lead to more approved vaccines.

According to Fauci, scientists from both Pfizer and Moderna were able to “pull out the gene” from the coronavirus sequence that codes for the coronavirus spike protein in January.

According to Fauci, when the mRNA is injected into the muscle, it starts coding for and produces the spike protein within the body, which then recognizes it and mounts an immune response to it.

The goal is for the neutralizing antibodies that are created in the process to protect people if they are exposed to COVID-19.

Since the mRNA vaccines do not contain pathogens, it is not possible to infect someone with COVID-19 from the vaccination.

Prior to the 2020 trials, no mRNA vaccine had ever been approved for use in humans.

Pfizer said safety and additional efficacy data will be collected and the clinical trial will continue through to final analysis at 164 confirmed cases of COVID-19 in order to further evaluate the vaccine candidate’s performance.

Once the required two-month safety follow-up (after the second vaccine dose) is completed, which is expected to occur in the third week of November, Pfizer will submit an application to the U.S. Food and Drug Administration for an emergency use authorization.

Additionally, vaccine trial participants will continue to be monitored for long-term immunity and safety for an additional two years.

“I want to thank the thousands of people who volunteered to participate in the clinical trial,” said Bourla. “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.”

Pfizer expects to produce up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.

“It’s a good day for biomedical research,” said Fauci.

---