Skip to main content

FDA authorizes first COVID-19 vaccine in US

FDA authorizes first COVID-19 vaccine in US


Health care workers will start receiving shots within days

Share this story

Coronavirus - Wed Dec 9, 2020
A nurse in Belfast prepares a dose of the vaccine.
Photo by Liam McBurney / PA Images via Getty Images

The Food and Drug Administration has authorized the use of a COVID-19 vaccine developed by Pfizer and BioNTech, a landmark moment in the fight to suppress a virus that has killed nearly 300,000 people in the United States and sickened tens of millions around the world. 

“Today’s emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine holds the promise to alter the course of this pandemic in the United States,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release.

The vaccine is authorized in the US for people over the age of 16. It was found to be 95 percent effective at preventing symptomatic COVID-19 in clinical trials. “That is extraordinary,” Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, said in a press conference at the end of November. It’s far better than experts had dared hope for. The FDA was prepared to authorize a vaccine as long as it was at least 50 percent effective. “We were shocked,” Pfizer’s chief executive officer, Albert Bourla, told The New York Times. “We couldn’t believe it.”

The shot appears to protect people against the most severe forms of the disease. It is also highly effective in people over the age of 65, who are particularly vulnerable to COVID-19. Scientists will continue to monitor the vaccine after it’s deployed to see how well it works in the real world.

Scientists will continue to monitor the vaccine after it’s deployed

The news of the clearance comes at the same time that the FDA has faced public pressure from the White House to authorize the vaccine. Chief of Staff Mark Meadows told Stephen Hahn, the commissioner of the FDA, to resign if the vaccine was not cleared by Friday, the Washington Post reported. The agency had originally planned to complete the authorization by Saturday. On Thursday, an independent committee said it recommended authorization.

The Pfizer and BioNTech vaccine has already been authorized by regulatory authorities in the United Kingdom, Canada, and Bahrain.

The authorizations of this vaccine, which have come less than a year after development began, shatter the record for the fastest vaccine developed. The record was previously held by the mumps vaccine, which took four years.

Researchers were able to condense the normally years-long vaccine development process into months by, among other steps, shortening the time between clinical trial phases and scaling up manufacturing of potential candidates as trials were ongoing. Companies did not skip steps in the safety testing process, though. The FDA said that it needed to see two full months of safety data on any COVID-19 vaccine because that’s the window when most dangerous side effects could occur. 

The vaccine will be made available under an Emergency Use Authorization, a designation that lets the FDA make products available during an emergency situation when there are no other options available. The process lets the agency sidestep some of the more lengthy regulatory steps it usually needs to formally approve or license a pharmaceutical. It typically takes the FDA a full year to review vaccine data once it’s submitted by companies. For this emergency authorization, that was condensed to a few weeks; Pfizer and BioNTech submitted their data on November 20th. 

The Pfizer and BioNTech vaccine is made from a gene-based technology that’s never been used before in an authorized vaccine for people. It contains a tiny bit of the genetic material for the coronavirus spike protein, which the virus uses to enter cells. The body builds that spike protein from the genetic instructions and then generates defenses against it. The Moderna vaccine, which the FDA’s vaccine advisory committee will review on December 17th, also uses this technology. The platform is another reason why the vaccine was developed so quickly — once researchers have the genetic sequence of a virus, it’s relatively easy to design a gene-based vaccine to attack it. 

Now starts an equally daunting task: distributing the vaccine and vaccinating people.

Now starts an equally daunting task: distributing the vaccine and vaccinating people. Pfizer’s vaccine has to stay at ultracold temperatures, which makes shipping it around the country and the world more challenging. Doses of the vaccine will also be limited through the start of 2021. 

Health care workers and residents in long-term care facilities will be the first to receive the vaccine, and doses could be administered within days. Other high-risk groups, including older adults and people with underlying health conditions, will likely be next in line. On the most optimistic timeline, vaccinations for the general population could start in March or April, but hospitals say that some of those timelines seem unrealistic

The US has purchased 100 million doses of the Pfizer and BioNTech vaccine, enough to vaccinate 50 million people. The Trump administration reportedly declined an offer to secure an additional 100 million doses this summer. Although the US can acquire up to 500 million more doses, the rejected offer means they may not be available until the summer. 

Today’s Storystream

Feed refreshed Sep 25 Not just you

Emma RothSep 25
Rihanna’s headlining the Super Bowl Halftime Show.

Apple Music’s set to sponsor the Halftime Show next February, and it’s starting out strong with a performance from Rihanna. I honestly can’t remember which company sponsored the Halftime Show before Pepsi, so it’ll be nice to see how Apple handles the show for Super Bowl LVII.

Emma RothSep 25
Starlink is growing.

The Elon Musk-owned satellite internet service, which covers all seven continents including Antarctica, has now made over 1 million user terminals. Musk has big plans for the service, which he hopes to expand to cruise ships, planes, and even school buses.

Musk recently said he’ll sidestep sanctions to activate the service in Iran, where the government put restrictions on communications due to mass protests. He followed through on his promise to bring Starlink to Ukraine at the start of Russia’s invasion, so we’ll have to wait and see if he manages to bring the service to Iran as well.

External Link
Emma RothSep 25
We might not get another Apple event this year.

While Apple was initially expected to hold an event to launch its rumored M2-equipped Macs and iPads in October, Bloomberg’s Mark Gurman predicts Apple will announce its new devices in a series of press releases, website updates, and media briefings instead.

I know that it probably takes a lot of work to put these polished events together, but if Apple does pass on it this year, I will kind of miss vibing to the livestream’s music and seeing all the new products get presented.

External Link
Emma RothSep 24
California Governor Gavin Newsom vetoes the state’s “BitLicense” law.

The bill, called the Digital Financial Assets Law, would establish a regulatory framework for companies that transact with cryptocurrency in the state, similar to New York’s BitLicense system. In a statement, Newsom says it’s “premature to lock a licensing structure” and that implementing such a program is a “costly undertaking:”

A more flexible approach is needed to ensure regulatory oversight can keep up with rapidly evolving technology and use cases, and is tailored with the proper tools to address trends and mitigate consumer harm.

Welcome to the new Verge

Revolutionizing the media with blog posts

Nilay PatelSep 13
The Verge
Andrew WebsterSep 24
Get ready for some Netflix news.

At 1PM ET today Netflix is streaming its second annual Tudum event, where you can expect to hear news about and see trailers from its biggest franchises, including The Witcher and Bridgerton. I’ll be covering the event live alongside my colleague Charles Pulliam-Moore, and you can also watch along at the link below. There will be lots of expected names during the stream, but I have my fingers crossed for a new season of Hemlock Grove.

Andrew WebsterSep 24
Looking for something to do this weekend?

Why not hang out on the couch playing video games and watching TV. It’s a good time for it, with intriguing recent releases like Return to Monkey Island, Session: Skate Sim, and the Star Wars spinoff Andor. Or you could check out some of the new anime on Netflix, including Thermae Romae Novae (pictured below), which is my personal favorite time-traveling story about bathing.

A screenshot from the Netflix anime Thermae Romae Novae.
Thermae Romae Novae.
Image: Netflix
Jay PetersSep 23
Twitch’s creators SVP is leaving the company.

Constance Knight, Twitch’s senior vice president of global creators, is leaving for a new opportunity, according to Bloomberg’s Cecilia D’Anastasio. Knight shared her departure with staff on the same day Twitch announced impending cuts to how much its biggest streamers will earn from subscriptions.

Tom WarrenSep 23
Has the Windows 11 2022 Update made your gaming PC stutter?

Nvidia GPU owners have been complaining of stuttering and poor frame rates with the latest Windows 11 update, but thankfully there’s a fix. Nvidia has identified an issue with its GeForce Experience overlay and the Windows 11 2022 Update (22H2). A fix is available in beta from Nvidia’s website.