FDA OKs second vaccine in pandemic milestone
WASHINGTON — A second coronavirus vaccine received emergency authorization Friday, an unprecedented scientific feat that gives the United States two powerful tools to fight a pandemic that emerged almost exactly a year ago, sparked by a few cases of mysterious pneumonia that exploded into the biggest global public health crisis in a century.
The Food and Drug Administration’s decision to clear the vaccine, developed by Massachusetts biotechnology company Moderna in partnership with the National Institute of Allergy and Infectious Diseases, arrives at the end of a historic week in medicine — as health care workers began receiving inoculations of the first coronavirus vaccine, developed by Pfizer and BioNTech, which was cleared by the agency Dec. 12.
The first shots in a national mass vaccination campaign this week delivered great hope but also exposed the distribution and supply challenges that will now move to the forefront, as companies, the federal government and states attempt to work in concert to maintain ambitious timelines. Four reports of treatable allergic reactions following vaccination in the United States and United Kingdom drew widespread attention and government investigations, highlighting the challenges that could lie ahead as public health experts work to build trust in the vaccines.
“To get another very important vaccine into play is just, yet again, another step toward what the ultimate goal is: to get enough people vaccinated so you could essentially end the epidemic as we know it in this country,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said. “I believe that’s possible.”
The authorization of a second vaccine — which came as the death toll from the virus in the United States surpassed 312,000 — will have an immediate practical impact that may begin to ease some of the logistical challenges, doubling to roughly 20 million the number of people government officials say they can vaccinate with a first shot before the end of the year. It will free the country from the precarious position of being reliant on a single manufacturer as production ramps up of a type of vaccine that has never been made on a massive scale. And it adds a vaccine that can be stored in a regular freezer, making it easier to distribute to large swaths of the country, in contrast to the specialized ultracold freezers and dry ice coolers needed for the Pfizer-BioNTech vaccine.
The successes also represent a decisive moment in scientific history. Scientists took a novel technology and leveled it against a new virus, developing and deploying in under a year two vaccines that are 94 to 95 percent effective in clinical trials, rivaling some of the most effective vaccines in the world’s medicine cabinet.
“It’s astonishing. Not in our wildest dreams would we imagine the results that we received,” said Lisa Jackson, a senior investigator at Kaiser Permanente Washington Health Research Institute who has worked on more than 60 vaccine trials. In mid-March, she launched what could be the most consequential one — a small safety test of the Moderna vaccine in 45 healthy, young volunteers. “To have two such vaccines — it’s just amazing.”
The development of the vaccines is a testament to a single-minded focus by private industry and the government, which built on decades of basic research to accomplish an urgent goal.