FDA’s thumbs-up—first for coronavirus vaccine in U.S.—will pave way for shots to be administered within day or two
A Covid-19 vaccine from Pfizer Inc. was the first to gain the U.S federal government’s permission to go into use in the U.S., a landmark step in efforts to beat back the pandemic.
The U.S. Food and Drug Administration’s authorization of the shot on Friday, following its record-setting swift development, sets the stage for the administration of the vaccine to begin within a day or two.
The FDA’s first green light for a Covid-19 vaccine follows a 44,000-person study, which found that the shot was 95% effective at preventing symptomatic Covid-19 and was safe.
Now, the U.S. begins its largest vaccination campaign ever, bringing together governments, small and big hospitals, as well as retail pharmacy chains with the goal of vaccinating hundreds of millions of people swiftly.
The daunting task will include distributing a vaccine that must be stored at extremely cold temperatures, and since inoculation requires two doses three weeks apart, the challenge of ensuring people return for a booster shot.
Initial supplies will be limited. Pfizer plans to distribute about 25 million doses in the U.S. [within 2 weeks], potentially enough for 12.5 million people because the vaccine requires two doses. The people first in line won’t get vaccinated right away, because the shots must be shipped to hospitals and other sites.
If enough people eventually take the shots, schools, businesses and restaurants could start fully reopening. A vaccine’s impact comes not only if it is effective in an individual but also if it is widely taken.
Since Covid-19 swamped hospitals and sank the economy, health authorities, government officials and business leaders have awaited the arrival of vaccines and their potential to stamp out the virus.
Vaccines typically take years to create, test and bring to market. Pfizer and BioNTech were among dozens of drugmakers that raced into action.
The development and authorization of Pfizer and BioNTech’s vaccine advanced faster than any shot has ever progressed, in less than a year. A mumps vaccine previously had been the fastest to market, taking about four years.
Pfizer and BioNTech moved quickly by turning to a promising gene-based technology, known as messenger RNA after the molecules that carry to cells DNA’s instructions for making proteins.
Using the genetic sequence of the coronavirus, BioNTech researchers synthesized mRNA that would teach cells to make a version of the spike protein protruding from the coronavirus. Production of the protein would prompt an immune system to develop defenses that mobilize against the real virus.
The FDA said it still held the vaccine to the high standards it would have demanded if there wasn’t a pandemic.
The U.S. government placed an initial order for 100 million doses of the Pfizer-BioNTech vaccine for nearly $2 billion, with the option to purchase 500 million additional doses.
The federal government decides how much of the vaccine supplies states will get, based on the size of their populations. States and other jurisdictions will initially get 2.9 million doses from Pfizer, with an additional 2.9 million following three weeks later for the second dose. Weekly shipments of doses would follow.
States, as well as some territories, federal health agencies and large cities, will determine where the millions of shots will be delivered, and who should get vaccinated first. Hospitals, health clinics and certain public-health locations will serve as most vaccination sites initially. Pharmacies will be able to give inoculations as more doses are made and more people are able to get access.
The U.S. Centers for Disease Control and Prevention recommended the nation’s 21 million health-care workers and three million nursing-home and other long-term care residents be the first to receive any Covid-19 vaccine doses. States don’t have to follow the CDC’s guidelines.
CVS Health and Walgreens pharmacies will deliver and administer most vaccine doses for the nation’s approximately 15,600 nursing homes and 29,000 assisted-living communities, once states give the go-ahead.
How soon vaccinations with the initial supplies will start is unclear. Once a vaccine gets to a hospital, it could start administering shots within hours, vaccine experts say, though it could also take days as hospital workers learn how to handle the containers storing the shots at ultracold temperatures.