WASHINGTON — From testing to treatment – major advancements are being made in the fight against COVID-19.
Overnight, the Food and Drug Administration (FDA) announced it has approved emergency use authorization of the first all-in-one at-home COVID-19 testing kit.
Meanwhile, vaccine developer Pfizer also announced it will be seeking emergency use authorization within the next few days for its mRNA vaccine.
Both of these are examples of the leaps and bounds that have been made in technology surrounding the coronavirus since its onset earlier this year.
There are other self-testing options out there, but this new one by Lucira Health is the first to also provide results at home. Previously, the swabs needed to be sent in for testing.
Lucira said it’s kit is both easy to use and easy to read – users complete the nasal swab on themselves, swirl it into the test vial, and wait for results which take 30 minutes or less.
According to Lucira Health, the tests have a sensitivity of about 94.1 percent and a specificity of 98%.
FDA Commissioner Dr. Stephen Hahn said in a statement, “This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission.”
Vaccine developers Pfizer and BioNTech report that the vaccine they’ll be bringing in front of the FDA for emergency use authorization within days is 95% effective.
This news comes after last week’s initial claim that their COVID-19 vaccine was believed to be more than 90% effective, which was already a shocking number.
Now, the companies say that after reviewing results from Phase 3 of the trial, the vaccine is showing to be closer to 95% effective and shows no safety concerns.
It’s a similar number to data shared by vaccine developer Moderna earlier this week.
All combined, the companies expect to manufacture more than 2 billion vaccine doses in 2021 – up to 1.3 billion for Pfizer and BioNTech and 1 billion for Moderna.
As for Lucira’s at home test kit, it’s expected to roll out first in California and Florida sometime in the near future. Then, it will become widely available throughout the country by spring of 2021.
The kits will be available by prescription only for people 14 years and older, or in the hospital for all ages.
Each kit is made to be used once and will cost about $50.
As of Wednesday, more than 11.4 million cases of COVID-19 have been recorded in the United States, according to John Hopkins University.