The Food and Drug Administration has approved Pfizer and BioNTech’s coronavirus vaccine for emergency use, a monumental turning point in the once-in-a-century pandemic that has taken nearly 300,000 American lives in less than a year and wreaked havoc on the U.S. economy.
FDA Chief Scientist Denise Hinton told Pfizer in a letter Friday that she was authorizing the emergency use of the company’s vaccine.
President Donald Trump called it a “medical miracle” in a video tweet. “We’ve delivered a safe and effective vaccine in just 9 months,” Trump said. “This is one of the greatest scientific accomplishments in history.”
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said the decision “holds the promise to alter the course of this pandemic in the United States.”With science guiding our decision-making, the available safety and effectiveness data support the authorization of the Pfizer-BioNTech COVID-19 Vaccine because the vaccine’s known and potential benefits clearly outweigh its known and potential risks,” he said.
The FDA’s emergency use authorization will now kick-start the federal government’s distribution of the potentially lifesaving doses to 64 states, territories, and major cities across the nation. The government plans to distribute 2.9 million doses of the vaccine within 24 hours, followed by an additional 2.9 million doses 21 days later for patients to get their second shot, Gen. Gustave Perna, who oversees logistics for President Donald Trump’s vaccine program Operation Warp Speed, said Wednesday. Pfizer’s vaccine requires two doses administered three weeks apart.
The vaccine could not come at a more crucial time. Hospitals across the U.S. already have a higher load of Covid patients than ever before, and the country’s outbreak is primed to set even more grim records. The U.S. reported 3,124 new Covid-19 deaths on Wednesday, the deadliest single-day tally of the pandemic so far, according to a CNBC analysis of Johns Hopkins University data. 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 among “the most difficult in the public health history of this nation.”
Initial doses of Pfizer’s vaccine will be limited as manufacturing ramps up, with officials predicting it will take months to immunize everyone in the U.S. who wants to be vaccinated. Pfizer has said it plans to ship 50 million vaccine doses this year, enough to inoculate 25 million people. The vaccine is expected to be distributed in phases with the most critical U.S. workers and vulnerable people getting it first. The CDC has provided states with an outline that recommends prioritizing health-care workers and nursing homes first, but states can distribute the vaccine as they see fit.
An emergency use authorization, or EUA, isn’t the same as a full approval, which can typically take months. Pfizer has only submitted two months of follow-up safety data, but the agency usually requires six months for full approval. The vaccine was authorized for people 16 and older.
On Friday, FDA Commissioner Stephen Hahn said the agency was “rapidly” working toward clearing the vaccine for emergency use. Shortly after Hahn’s statement, Trump, who has repeatedly said that he pushed the FDA to move more quickly in the vaccine development process, told the agency in a tweet to “Get the dam vaccines out NOW.”
The FDA’s announcement comes after a key agency advisory panel on Thursday voted 17 to 4 with one abstention to recommend the vaccine for emergency authorization. The Vaccines and Related Biological Products Advisory Committee plays a key role in approving flu and other vaccines in the U.S., verifying the shots are safe for public use. While the FDA doesn’t have to follow the advisory committee’s recommendation, it often does.
The FDA clearance marks a record-breaking time frame for a process that normally takes about a decade. The fastest-ever vaccine development, for mumps, took more than four years and was licensed in 1967. Pfizer and BioNTech announced plans to develop a coronavirus vaccine in March and submitted an application to the FDA for emergency authorization in November. Health regulators in Canada, the U.K., and Bahrain have all cleared Pfizer’s vaccine for use by most adults.
Pfizer’s vaccine uses messenger RNA, or mRNA, technology. It’s a new approach to vaccines that uses genetic material to provoke an immune response. Moderna, another front-runner in the Covid vaccine race, is also using mRNA technology. Late-stage clinical trial data shows Pfizer’s vaccine is 95% effective in preventing Covid, is safe, and appears to fend off severe disease. To achieve maximum effectiveness, the vaccine requires two doses taken about 21 days apart.
Pfizer’s vaccine requires a storage temperature of minus 94 degrees Fahrenheit, presenting potential logistical challenges for rural areas and inner cities that may not have the good health-care infrastructure. By comparison, Moderna has said its vaccine can be stored for up to six months at minus 4 degrees Fahrenheit.
FedEx and United Parcel Service on Thursday in a Senate panel hearing expressed confidence in their networks to distribute the vaccines around the country, outlining plans to monitor shipments’ location and temperatures.
The Federal Aviation Administration late Friday urged airports to ensure they have enough staffing as vaccines arrive. In a statement hours before the vaccine was approved, the FAA said airports should consider staging areas for trucks to pick up vaccines upon arrival. The agency has said flights carrying doses and related supplies will get priority treatment.
U.S. officials plan to continue watching for any adverse reactions to Pfizer’s vaccine in the health-care workers and nursing home residents who receive it, Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Disease, said during the agency’s meeting Thursday. Officials will use a text messaging system, called v-safe, which is intended to provide early indications about possible adverse reactions from the vaccine.
During the meeting, FDA vaccine reviewer Dr. Susan Wollersheim noted the trial data showed a “numerical imbalance” in cases of Bell’s palsy, a condition that causes a 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. While the frequency of cases was not out of line with the general population, the FDA recommended further surveillance once the vaccine is more broadly distributed.