Coronavirus Vaccine Gets Emergency Use Authorization By FDA

WASHINGTON, DC — The U.S. Food and Drug Administration on Friday night issued an emergency use authorization for the coronavirus vaccine developed by pharmaceutical company Pfizer and its German partner BioNTech, according to an announcement by the agency.

While not an official approval, the emergency use authorization will allow people 16 years of age and older to receive the vaccine in the United States.

An initial shipment of about 2.9 million doses of the vaccine will be sent around the United States over the next week, sources told The New York Times.

FDA chief Stephen Hahn called the authorization a "significant milestone" in fighting the coronavirus pandemic.

President Donald Trump, who has remained relatively silent as the coronavirus ravaged the country in recent weeks, was also quick to weigh in. Trump posted a three-minute video to Twitter declaring that the United States has achieved a "medical miracle."

"We have delivered a safe and effective vaccine in just nine months," the president said. "This is one of the greatest scientific accomplishments in history."

The FDA's decision marks the start of an unprecedented effort to stop the coronavirus pandemic, which has ravaged the United States for nearly 10 months.

In recent weeks, the country has seen a surge in cases and deaths related to COVID-19, the disease caused by the coronavirus. As of Friday night, more than 15.8 million cases had been reported and nearly 295,000 people have died.

On Thursday, an FDA advisory committed voted 17-4 in favor of approving the Pfizer vaccine. The vote followed several hours of discussion.

Dr. Paul Offit of the Children's Hospital of Philadelphia was among the committee members who concluded the shot's potential benefits outweigh its risks.

In an emergency, "the question is whether you know enough," Offit said.

Pfizer said that clinical trials have shown its vaccine, which has already been approved for use in the United Kingdom and Canada, is about 95 percent effective.

On Friday, the White House placed additional pressure on FDA chief Hahn to approve the virus.

In fact, White House chief of staff Mark Meadows reportedly told Hahn to grant an emergency use authorization for the vaccine by the end of Friday or face possible firing, according to the Associated Press.

Regulators had been planning to authorize emergency use early Saturday. On Friday morning, however, Hahn told officials at the agency’s Center for Biologics Evaluation and Research to act by the end of Friday, the Times also reported.

The Centers for Disease Control and Prevention issued official guidance recently stating that U.S. health care workers and people in nursing homes should be among the first to receive the vaccine. It will be up to states, however, to decide how to distribute the first doses.