News

Company Announces Impressive COVID Vaccine Success, Will Seek Emergency FDA Authorization

Pfizer says that more interim results from its ongoing coronavirus vaccine study suggest the shots are 95 percent effective and that the vaccine protects older people most at risk of dying from COVID-19.

Wednesday’s announcement from Pfizer and its German partner BioNTech, just a week after revealing the first promising preliminary results, comes as the team is preparing within days to formally ask U.S. regulators to allow emergency use of the vaccine.

They also have begun “rolling submissions” for the vaccine with regulators in Europe, the United Kingdom and Canada and soon will add this new data.

Pfizer and BioNTech had initially estimated the vaccine was more than 90 percent effective after 94 infections had been counted in a study that included 44,000 people.

With the new announcement, the company now has accumulated 170 infections in the study — and said only eight of them occurred in volunteers who got the actual vaccine rather than a dummy shot. One of those eight developed severe disease, the company said.

Trending:
Tragedy in Alabama: Nine Young Children, One Adult Dead After 'Most Horrific Accident' in County History

“This is an extraordinarily strong protection,” Dr. Ugur Sahin, BioNTech’s CEO and co-founder, told The Associated Press.

The companies have not yet released detailed data on their study, and results have not been analyzed by independent experts.

They said the vaccine was more than 94 percent effective in adults over age 65, though it is not clear exactly how that was determined with only eight infections in the vaccinated group to analyze and no breakdown provided of those people’s ages.

But Sahin said there were enough older adults enrolled in the study and among the placebo recipients who became infected that he is confident “this vaccine appears to work in the higher-risk population.”

Do you want to be among the first to take a COVID-19 vaccine?

In May, President Donald Trump announced “Operation Warp Speed,” a public-private partnership aiming to develop a vaccine by the end of the year.

“That means big and it means fast — a massive scientific, industrial and logistical endeavor unlike anything our country has seen since the Manhattan Project,” Trump said at the time.

Earlier this week, Moderna Inc. — which received $1 billion from the U.S. government — announced that its experimental vaccine appears to be 94.5 percent effective after an interim analysis of its late-stage study.

Pfizer and BioNTech also say now have the required data on the vaccine’s safety needed to seek emergency authorization from the Food and Drug Administration.

The companies didn’t disclose safety details but said no serious vaccine side effects have been reported, with the most common problem being fatigue after the second vaccine dose, affecting about 4 percent of participants.

Related:
Nine More States to End Pandemic Unemployment Bonuses on Saturday

The study has enrolled nearly 44,000 people in the U.S. and five other countries. The trial will continue to collect safety and efficacy data on volunteers for two more years.

Pfizer and BioNTech said they expect to produce up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses in 2021.

U.S. officials have said they hope to have about 20 million vaccine doses each from Moderna and Pfizer available for distribution in late December.

The first shots are expected to be offered to vulnerable groups like medical and nursing home workers, and people with serious health conditions.

Truth and Accuracy

Submit a Correction →



loading

We are committed to truth and accuracy in all of our journalism. Read our editorial standards.

Tags:
, , , , , , , ,
The Associated Press is an independent, not-for-profit news cooperative headquartered in New York City. Their teams in over 100 countries tell the world’s stories, from breaking news to investigative reporting. They provide content and services to help engage audiences worldwide, working with companies of all types, from broadcasters to brands.
The Associated Press was the first private sector organization in the U.S. to operate on a national scale. Over the past 170 years, they have been first to inform the world of many of history's most important moments, from the assassination of Abraham Lincoln and the bombing of Pearl Harbor to the fall of the Shah of Iran and the death of Pope John Paul.

Today, they operate in 263 locations in more than 100 countries relaying breaking news, covering war and conflict and producing enterprise reports that tell the world's stories.
Location
New York City




loading

Conversation