The Food and Drug Administration has approved Pfizer and BioNTech's coronavirus vaccine for emergency use. This is a monumental turning point in the pandemic that killed nearly 300,000 Americans in less than a year and affected the US economy.
FDA chief scientist Denise Hinton told Pfizer in a letter Friday that she approved the company's emergency use of the vaccine.
President Donald Trump called it a "medical miracle" in a video tweet. "We delivered a safe and effective vaccine in just 9 months," Trump said. "This is one of the greatest scientific achievements in history."
Dr. Peter Marks, director of the FDA Center for Biologics Evaluation and Research, said the decision "promises to change the course of this pandemic in the United States." Data support the approval of the Pfizer-BioNTech COVID-19 vaccine as the known and potential benefits of the vaccine significantly outweigh the known and potential risks, "he said.
FDA approval for the emergency will now boost the federal government's distribution of the potentially life-saving doses to 64 states, territories, and major cities across the country. The government plans to distribute 2.9 million doses of the vaccine within 24 hours, followed by another 2.9 million doses 21 days later, for patients to receive their second shot, General Gustave Perna, who runs the logistics for the Operation Warp vaccination program Speed monitored by President Donald Trump said Wednesday. Pfizer's vaccine requires two doses three weeks apart.
The vaccine couldn't come at a more crucial time. Hospitals in the U.S. already have higher numbers of Covid patients than ever before, and the country's outbreak is poised to break even worse records. According to a CNBC analysis of the Johns Hopkins University data, the US reported 3,124 new Covid-19 deaths on Wednesday, the pandemic's deadliest one-day record to date. The director of the Centers for Disease Control and Prevention, Dr. Robert Redfield, warned earlier this month that the next few months of the pandemic would be "some of the most difficult in the history of this country's public health."
Initial doses of the Pfizer vaccine will be limited as production begins. Officials predict it will be months before everyone in the US who wants to be vaccinated is vaccinated. Pfizer has announced that it will ship 50 million doses of vaccine this year, enough to vaccinate 25 million people. The vaccine is expected to be distributed in phases where the most critical U.S. workers and vulnerable people receive it first. The CDC has given states an outline recommending that priority be given to health workers and nursing homes first. However, states may distribute the vaccine at their own discretion.
An emergency permit, or EEA, is not the same as a full permit, which can typically take months. Pfizer has only submitted safety data for two months, but it typically takes the agency six months for full approval. The vaccine was approved for people aged 16 and over.
On Friday, FDA Commissioner Stephen Hahn said the agency was "working fast" to clear the vaccine in case of emergency. Shortly after Hahn testified, Trump, who has repeatedly said he had urged the FDA to move faster in the vaccine development process, told the agency in a tweet: "Get the dam vaccines out NOW."
The FDA's announcement comes after a key agency advisory body voted 17 to 4, with one abstention, to recommend the vaccine for emergency approval on Thursday. The Advisory Committee on Vaccines and Related Biological Products plays a key role in approving influenza and other vaccines in the United States and verifying that the vaccines are safe for public use. While the FDA does not need to follow the advisory board's recommendation, it often does.
FDA approval marks a record breaking time frame for a process that typically takes about a decade. The fastest vaccine development to date against mumps took more than four years and was licensed in 1967. Pfizer and BioNTech announced plans to develop a coronavirus vaccine in March and filed an emergency clearance application with the FDA in November. Health authorities in Canada, the UK and Bahrain have all approved the Pfizer vaccine for most adults.
Pfizer's vaccine uses messenger RNA or mRNA technology. It's a new approach to vaccines that uses genetic material to trigger an immune response. Moderna, another front runner in the Covid vaccine race, also uses mRNA technology. Late-stage clinical trial data shows Pfizer's vaccine is 95% effective against Covid, safe, and appears to ward off serious illness. For maximum effectiveness, the vaccine requires two doses about 21 days apart.
Pfizer's vaccine requires a storage temperature of minus 94 degrees Fahrenheit, which poses potential logistical challenges for rural areas and inner cities that may not have good health infrastructure. For comparison: According to Moderna, the vaccine can be stored for up to six months at minus 4 degrees Fahrenheit.
FedEx and United Parcel Service on Thursday expressed confidence in their networks to distribute the vaccines across the country in a Senate hearing and outlined plans to monitor the location and temperatures of the shipments.
The Federal Aviation Administration asked the airports late Friday to ensure that they have adequate staff when the vaccines arrive. In a statement hours before the vaccine was approved, the FAA said airports should consider providing areas for trucks for vaccines to be picked up on arrival. The agency has announced that flights with cans and related supplies will be given priority.
U.S. officials plan to continue to monitor for side effects of the Pfizer vaccine among the health care workers and nursing homes who receive it, said Dr. Nancy Messonnier, director of the CDC's National Center for Immunization and Respiratory Diseases, during the agency's meeting on Thursday. The officers will use an SMS system called v-safe, which is designed to provide early warning of possible side effects of the vaccine.
During the meeting, FDA vaccine reviewer Dr. Susan Wollersheim found that the study data showed a "numerical imbalance" in Bell's palsy, a condition that causes temporary weakness or paralysis of the muscles in the face. She said there were four cases in the vaccine group and none in the placebo group. Although the frequency of the cases was inconsistent with the general population, the FDA recommended further monitoring once the vaccine becomes more widely distributed.
Read the full letter from the FDA below: