Coronavirus updates: Pfizer to seek vaccine approval ‘within days’; FDA grants emergency use for first at-home rapid test

7 min readNov 18, 2020

Pfizer and BioNTech plan to submit a request “within days” to the Food and Drug Administration for emergency-use approval of a vaccine they say has shown to be 95% effective in mass testing.

“Our objective from the very beginning was to design and develop a vaccine that would generate rapid and potent protection against COVID-19 with a benign tolerability profile across all ages,” said Ugur Sahin, M.D., CEO of BioNTech. “We believe we have achieved this.”

The companies said they expect to produce up to 50 million vaccine doses globally by year’s end and up to 1.3 billion doses by the end of 2021. Experts say frontline healthcare workers are expected to be first in line for inoculation.

The Phase 3 clinical trial began on July 27 and has enrolled 43,661 participants to date, the companies said.

Pfizer, based in New York, appears to be just a step ahead of Moderna, a Cambridge, Massachusetts-based biotechnology company. Moderna announced Monday that its candidate vaccine appears to be 94.5% effective against the disease. It was not immediately clear when Moderna would seek FDA approval.

📈 Today’s numbers: The U.S. has reported more than 11.3 million cases and more than 248,500deaths, according to Johns Hopkins University data. The global totals: 55.5 million cases and 1.33 million deaths.

🗺️ Mapping coronavirus: Track the U.S. outbreak in your state.

This file will be updated throughout the day. For updates in your inbox, subscribe to The Daily Briefing newsletter.

16-year-old Katelyn Evans gets the first of two shots as part of a trial testing Pfizer’s COVID-19 vaccine in minors.
Pfizer to seek FDA approval for vaccine within days
Pfizer and BioNTech plan to submit a request “within days” to the FDA for emergency-use approval of their vaccine. The companies said their ongoing Phase 3 testing has found the vaccine to be 95% effective, up from a preliminary finding of 90%. The data also will be submitted to other regulatory agencies around the world, the companies said in a statement. If given approval, Pfizer would become the first company to release an FDA-authorized COVID-19 vaccine.

“The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world.”

COVID immunity could last for years, study says
COVID-19 infections could result in immunity that could last for years, a new study indicates. The study, published online but not yet been peer reviewed, found that most participants in the study who had been infected with COVID-19 retained enough immune cells to fend off infection eight months later. That could indicate immunity may remain for years, the authors of immune memory study said.

“That amount of memory would likely prevent the vast majority of people from getting hospitalized disease, severe disease, for many years,” Shane Crotty, a virologist at the La Jolla Institute of Immunology who co-led the new study, told The New York Times.

Bedsores a growing concern as COVID hospitalizations rise
Hospitals are putting extra focus on preventing pressure injuries, known as bedsores or pressure ulcers, as coronavirus cases continue to rise across the country and ICU beds fill with critically ill patients. The National Pressure Injury Advisory Panel (NPIAP) estimates pressure injuries affect more than 2.5 million patients each year and claim over 60,000 lives. Dr. William Padula, president-elect of NPIAP and professor at University of Southern California, worries that pressure injuries may increase this year amid estimates there could be up to 19,000 new COVID-19 hospitalizations per day by Dec. 7. Padula said pressure injuries can occur within hours of being in the ICU immobilized and on a ventilator.

“The skin is the largest organ system,” said Dr. Martine Sanone, associate professor of geriatrics and palliative medicine at Icahn School of Medicine at Mount Sinai. “However, when we think of critical illness, we forget about that first barrier.”

– Adrianna Rodriguez

Nursing home cases surpass 10K in a week, an all-time high
New coronavirus cases have surged to an all-time high at nursing homes across the country despite federal efforts to shield residents through aggressive testing and visitor restrictions, a new report shows. Federal data shows 10,279 COVID-19 cases during the week of Nov. 1, the most recent data available. The figures surpassed the previous high of 9,903 cases in late July, according to a report by the American Health Care Association and National Center for Assisted Living.

The surge in cases among the nation’s most vulnerable residents comes as cases, hospitalizations and deaths surge nationwide.

“We have been begging people the last eight months to wear a mask, socially distance and to be careful,” said Mark Parkinson, president and CEO of AHCA/NCAL. “Unfortunately, the public has not listened or complied.”

– Ken Alltucker

Chicago schools to resume in-person classes in January
Chicago Public Schools plans to welcome some students back into classrooms in January, officials announced Tuesday. Parents can decide whether they want to send their children to classrooms or continue remote learning. Students enrolled in moderate and intensive classrooms and pre-kindergarten are scheduled to return Jan. 11, 2021. Students in kindergarten through 8th grade will be back on Feb. 1. Officials have not announced a return date for high school students yet.

The Chicago Teachers Union strongly opposed the news, calling it “arbitrary.” But school officials believe children can safely return to classrooms, pointing to other states and some European countries that are keeping schools open despite a surge in COVID-19 cases.

“It’s our moral imperative to do everything in our power to safely open schools beginning with our youngest and highest-needs learners,” said Chicago schools CEO Janice Jackson.

FDA allows 1st rapid test that gives results at home
U.S. regulators on Tuesday allowed emergency use of the first rapid coronavirus test that can be performed and developed entirely at home. The FDA granted emergency authorization to the 30-minute test kit from Lucira Health, a California manufacturer. The company’s test allows users to swab themselves to collect a nasal sample. The sample is then swirled in a vial that plugs into a portable device, that interprets the results and displays whether the person tested positive or negative for coronavirus.

Study: Museums losing millions due to COVID-19
A new American Alliance of Museums study released Tuesday showed that recent COVID-19 surges are doing a number on already-hurting museums. According to an October AAM survey of 850 respondents from across the USA about the continued impact of coronavirus on museums, millions of dollars are being lost — with around a third of institutions facing permanent closure — and job loss is mounting as nearly 30% of American museums remain closed since the March lockdown.

“The financial state of U.S. museums is moving from bad to worse,” Laura Lott, AAM’s president and CEO, said in a statement. “Those that have reopened are operating on an average of 35% of their regular attendance — a reduction that is unsustainable long-term. Those that did safely serve their communities this summer do not have enough revenue to offset higher costs, especially during a potential winter lockdown. Without financial help, we could see thousands of museums shutter forever.”

Montana Gov. Steve Bullock issues stricter rules, curfew
Montana Gov. Steve Bullock announced a new round of directives Tuesday, which will limit crowd size and close bars, restaurants and casinos at 10 p.m., in an effort to slow the spread of the coronavirus. The new directives go into effect 5 a.m. Friday.

“The situation is serious in Montana, and it is serious across the nation,” Bullock said. “We need to turn things around over the next few months while we wait on a widely distributed vaccine or else we risk hospitals that turn patients away and risk any further ability to control the spread.”

Montana is among the 36 states with a mask mandate. What are the rules in your state? Check the list.

– Phil Drake, Great Falls Tribune

Los Angeles plans new restrictions, including curfew
Los Angeles County imposed new restrictions on businesses Tuesday and is readying plans for a mandatory curfew for all but essential workers if coronavirus cases keep spiking. The county of 10 million residents — the nation’s most populous — has seen daily confirmed cases more than double in the last two weeks to nearly 2,900. Hospitalizations have topped 1,100, a rise of 30% in that period.

The county, which for most of the pandemic has had a disproportionately large share of California’s cases, issued new restrictions ordering nonessential retail businesses to limit indoor capacity to 25% and restaurants to 50% capacity outdoors. Restaurants already are not allowed to serve customers indoors. All those businesses must close at 10 p.m. The changes take effect Friday.

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Contributing: The Associated Press

Coronavirus updates: Pfizer to seek vaccine approval ‘within days’; FDA grants emergency use for first at-home rapid test

Written by nexx