President Hails ‘Medical Miracle’ as FDA Gives Green Light to Pfizer COVID-19 Vaccine

'Free for all Americans'

President Donald Trump speaks at the Operation Warp Speed Vaccine Summit in Washington on Dec. 8, 2020. Tasos Katopodis/Getty Images

President Donald Trump hailed a “medical miracle” after the Food and Drug Administration (FDA) late on Friday authorized a vaccine from Pfizer and its German partner BioNTech for emergency use in efforts to end the pandemic caused by the CCP virus.

“Today our nation has achieved a medical miracle. We have delivered a safe and effective vaccine in just nine months,” Trump announced in a three-minute address to the nation.

“This is one of the greatest scientific accomplishments in history. It will save millions of lives and soon end the pandemic once and for all. ... On behalf of the American people I’d like to thank all of the brilliant scientists, technicians, doctors, and workers who made this all possible.”

“The United States is the first nation in the world to produce a verifiably safe and effective vaccine,” the president said, adding that the first vaccine will be administered in less than 24 hours, and that doses are being shipped to all U.S. states. State governors are expected to decide who can receive the vaccine first, he noted.

The president said that his administration had provided some $14 billion through Operation Warp Speed—a public-private effort to fast-track the development and manufacturing of all of the top COVID-19 vaccine candidates in advance.

“This included a nearly $2 billion investment in Pfizer to produce 100 million doses of their vaccine with an option to produce 500 million additional doses, and I’m proud to say we have made sure that this vaccine will be free for all Americans,” he said.

The U.S. government has pledged to distribute 2.9 million doses of the vaccine to the public within 24 hours of FDA approval.

“We want our senior citizens, health care workers, and first responders to be first in line. This will quickly and dramatically reduce deaths and hospitalizations,” Trump said. “When the China virus invaded our shores, I promised that we would proceed a vaccine in record time before the end of the year. They said it couldn’t be done, but with today’s announcement, we have now achieved that goal.”

Health care workers take part in a rehearsal for the administration of the Pfizer COVID-19 vaccine at Indiana University Health in Indianapolis, Indiana, on Dec. 11, 2020 Bryan Woolston/Reuters

“A vaccine will vanquish the virus and return life back to normal,” he added. “The pandemic may have begun in China but we are ending it right here in America.”

FDA Commissioner Stephen M. Hahn said in a statement that the FDA emergency use authorization (EUA) of the first COVID-19 vaccine marks a “significant milestone.” He said it came after the vaccine met the federal agency’s “rigorous scientific standards for safety, effectiveness, and manufacturing quality” needed to support the EUA.

The FDA has jurisdiction to approve a new product under an EUA if a “chemical, biological, radiological, or nuclear agent can cause a serious or life-threatening disease or condition.” A 23-member panel of independent medical advisers on Thursday voted 18-4, with one abstention, in support of the FDA’s green light.

A vial of the Pfizer-BioNTech COVID-19 vaccine in a file photo. Liam McBurney/Pool via Reuters/File Photo

The Vaccine

The vaccine is purported to immunize against COVID-19, which is the symptomatic disease caused by the virus SARS-CoV-2, also referred to as the CCP (Chinese Communist Party) virus. The likely regimen is for individuals to receive two doses, administered 21 days apart.

According to the FDA, the Pfizer-BioNTech COVID-19 vaccine contains messenger RNA (mRNA), which is genetic material. This is the first time a vaccine has been developed for a coronavirus as well as the first time the FDA has approved a product that uses messenger RNA (mRNA) technology.

“The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive ’spike' protein,” the FDA announcement reads. “When a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.”

A nurse prepares to administer the Pfizer-BioNTech COVID-19 vaccine at Guy's Hospital in London on Dec. 8, 2020. Frank Augstein/Pool via Reuters

The United Kingdom approved Pfizer’s vaccine last week and began administering doses on Dec. 8. Since then, at least two people have had anaphylactic reactions to the vaccine, while a third reported a possible allergic reaction.

Vaccine providers are required to report any serious adverse effects or vaccination administration errors to the Vaccine Adverse Event Reporting System, hosted by Health and Human Services. Vaccine manufacturers are immune from liability for any adverse reactions.

A report on Pfizer’s clinical trials (pdf) showed that four vaccine participants had suffered Bell’s palsy, which is the temporary paralysis of one side of the face, caused by a neurological reaction.

The FDA will consider granting an EUA to Moderna’s vaccine for the CCP virus on Dec. 17.

Charlotte Cuthbertson and Tom Ozimek contributed to this report.