Solving COVID

Solving COVID: November 18, 2020

Pfizer to seek FDA authorization for vaccine, FDA approves new at-home rapid COVID test, and more

1

Pfizer aims to seek COVID-19 vaccine authorization 'within days'

Pfizer plans to seek emergency use authorization from the Food and Drug Administration for its COVID-19 vaccine candidate "within days," the company and its partner BioNTech announced Wednesday. Pfizer said a final analysis of its coronavirus vaccine candidate's phase three trial showed that it was 95 percent effective, as of the 170 coronavirus cases reported in the trial, only eight were among those who received the vaccine. Pfizer and BioNTech also said "efficacy was consistent across age, race, and ethnicity demographics," and the "observed efficacy in adults over 65 years of age was over 94 percent." Pfizer said there have not been "any serious safety concerns related to the vaccine" reported. On Monday, drug maker Moderna also announced that preliminary phase-three trial data showed its coronavirus vaccine candidate was more than 94 percent effective.

2

FDA approves first complete at-home rapid COVID-19 test

The Food and Drug Administration on Tuesday approved the first rapid coronavirus test for complete use at home. The test, developed by California-based company Lucira Health, requires a prescription, and is expected to cost $50 or less. It relies on a nasal swab, and can provide results in half an hour. Other at-home tests that have already received FDA approval require samples to be shipped to a lab for analysis. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said the authorization of a complete at-home test marks "a significant step" for the FDA's COVID-19 response. "Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them," Shuren said.

3

Regular mouthwashes may help destroy coronavirus, study suggests

Regular, over-the-counter mouthwashes have shown "promising signs" of killing the coronavirus in saliva, scientists at Cardiff University in Wales have found. The study discovered that mouthwashes containing at least 0.07 percent cetypyridinium chloride destroyed the virus within 30 seconds of being exposed to it in a lab. The report hasn't been peer reviewed, and the next step is to see if mouthwashes are as effective in patients as they were in the lab setting. Results from a clinical trial are expected next year. While the news is encouraging, it seems likely mouthwashing would be an addition to preventative measures like hand washing, social distancing, and mask-wearing, as opposed to a treatment since the liquid would not be able to reach the respiratory tract or the lungs, the BBC notes. The results come after another study also found CPC-based mouthwashes to be effective in reducing viral load.

4

Coronavirus immunity could 'last for years,' new study suggests

A new study conducted by several leading labs, including the La Jolla Institute of Immunology, found that most people who have recovered from a coronavirus infection within the last eight months likely have enough immune cells to fight off reinfection. While it's unclear exactly how long immunity will last, the new study has eased experts' concerns of short-lived protection based on studies that pointed to swiftly declining antibodies. But antibodies are just one facet of the body's complex immune system, and the new study indicated that T cells show only a slight decay several months out from infection, while B cells, which produce new antibodies as needed, actually had increased in number in most participants. While more studies will be required, it's not "unreasonable to think that these immune memory components would last for years," Deepta Bhattacharya, an immunologist at the University of Arizona, told The New York Times.

5

Former FDA commissioner says pandemic could be 'effectively' ended in 2021

In light of highly encouraging vaccine data from Pfizer and Moderna, former Food and Drug Administration Commissioner Scott Gottlieb predicted the COVID-19 pandemic can be "effectively" ended in 2021. "Once we get these vaccines in sufficient quantities heading into 2021, the combination of the fact that a lot of the population will have already had COVID, combined with the fact that we'll be vaccinating the public with a highly effective vaccine, we could effectively end this pandemic in 2021 with our technology," Gottlieb said to CNBC. Both vaccines still need to receive FDA approval. But if they do, Dr. Anthony Fauci, the nation's top infectious disease expert, has predicted the general public could potentially receive a COVID-19 vaccine by April 2021. Gottlieb added on Twitter that "the acute phase of the U.S. pandemic will end in 2021." But for now, as COVID-19 cases continue to spike around the country, Gottlieb added that "we must work together to get through the next 3 months."

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