Pfizer vaccine closer to getting OK in U.S.; UK rolls out first doses

A nurse administers the Pfizer-BioNTech COVID-19 vaccine at Guy's Hospital...

A nurse administers the Pfizer-BioNTech COVID-19 vaccine at Guy's Hospital in London on Tuesday. Credit: AP/Frank Augstein

The analysis of Pfizer’s COVID-19 vaccine by Food and Drug Administration scientists comes ahead of a Thursday meeting where the FDA's independent advisers will debate if the evidence is strong enough to recommend vaccinating millions of Americans.

A final FDA decision and the first shots could follow within days.

Also on Tuesday, Britain began vaccinations with Pfizer and German partner BioNTech's vaccine. The FDA later this month will consider one developed by Moderna. Additionally, a medical journal published early data suggesting a third vaccine, AstraZeneca's, also protects people, though not as much as the U.S. frontrunners.

FDA scientists reanalyzed data from Pfizer's huge, still-unfinished study and found that so far, the vaccine appears safe and more than 90% effective across patients of different ages, races and those with underlying health conditions. The FDA specifically confirmed it works well in older people, who are especially vulnerable.

Thursday's public meeting will be closely watched by health authorities around the world and is considered key to bolstering confidence in the vaccines amid skepticism about its safety among many Americans.

"We want people to see this discussion, to see the issues that are brought up, and have a vigorous discussion of the data elements by the outside experts," FDA Commissioner Stephen Hahn said in an interview. "That will be an important part of showing what goes into our decision making."

Long Island manufacturer wins $12.7M contract to develop COVID-19 test

Chembio researchers perform a coronavirus test in the company's Long...

Chembio researchers perform a coronavirus test in the company's Long Island laboratory.  Credit: Chembio Diagnostics Inc.

A Hauppauge manufacturer has won a federal contract to develop an antigen test for COVID-19 and influenza after losing federal permission to sell an antibody test in June.

Chembio Diagnostics Inc. said it has been awarded $12.7 million from the U.S. Department of Health and Human Services’ Biomedical Advanced Research & Development Authority, or BARDA, to develop the COVID/influenza antigen test and seek emergency authorization from the U.S. Food and Drug Administration for sales in the current flu season.

The 20-minute test would determine if a patient has COVID-19 by detecting fragments of proteins found on or within the virus. It also would be capable of detecting influenza A and B simultaneously, using a nasal or nasopharyngeal swab.

"We believe rapid, point-of-care tests can improve clinical outcomes and play a major role in combating this ongoing pandemic, especially during the upcoming flu season," CEO Richard Eberly said last week.

The map below shows the concentration of cases in communities across Long Island.

This map shows the concentration of cases on Long Island,...

This map shows the concentration of cases on Long Island, with Nassau data as of Sunday and Suffolk data as of Monday. 

Search the map and view charts showing the latest local trends in testing, hospitalizations, deaths and more.

Experts: Diversity is critical in COVID-19 clinical trials

David Evans, a clinical trial participant, stands on his deck at...

David Evans, a clinical trial participant, stands on his deck at his home in Baldwin on Friday. Credit: Newsday/Alejandra Villa Loarca

Participants in U.S. clinical trials for the two vaccines under review are more racially and ethnically diverse than for most trials, said Namandjé Bumpus, director of the pharmacology and molecular sciences department at Johns Hopkins University in Baltimore.

But Blacks are underrepresented in both, compared to their share of the U.S. population, and Latinos and Asians are underrepresented in one, according to data from the companies developing the vaccines.

And diversity in clinical trials is critical, Bumpus said. Drugs can affect people differently based upon their race or ethnicity, and those "genetic differences can mean a drug that works for you doesn’t work for me at the same dose," or can be more likely to be harmful, she said.

After David Evans read that Black and Latino people are underrepresented in research on drug safety and effectiveness, he volunteered to be part of a clinical trial.

"The more people that get involved and volunteer and show that the vaccine is hopefully safe rather than not safe, then the more people will go ahead and get the vaccine to get the economy going and open things up," said Evans, 73, of Baldwin.

This LI firm repurposed products to stay alive

Ian McCarthy, director of sales and business development, sits behind...

Ian McCarthy, director of sales and business development, sits behind a partition in his office at Brite Frame Fabricators in Bellport on Tuesday.  Credit: James Carbone

The demand for safety partitions made from flexible sheets of plastic in sturdy aluminum frames has sustained a small business in Bellport during the pandemic.

Brite Frame Fabricators shut down in March when the trade shows, special events and shopping malls that buy its visual display equipment were closed.

Seeing other display firms in Europe start to make safety partitions, Brite Frame employees "repurposed" the aluminum frames and plastic "in our warehouse to make a product that’s easy to assemble and can be shipped in a little FedEx tube," said Ian McCarthy, director of sales and business development at the three-year-old manufacturer.

The first partitions, which are sold under the CrystalFlex brand name, were delivered to a local university in June. The company has since called back its staff and launched a website to sell directly to customers.

More to know

Suffolk County's number of confirmed cases is skyrocketing, County Executive Steve Bellone said Tuesday, rising from 66 a day at the start of November to a figure that is routinely surpassing 1,000 a day now.

Deaths from COVID-19 in the U.S. have soared to more than 2,200 a day on average, matching the frightening peak reached last April, and cases per day have eclipsed 200,000 on average for the first time on record.

When Catholic schools declared their intention to have a fall sports season, student-athletes and their families weren't the only ones with a tough decision to make: game officials did, too.

Michigan canceled its annual rivalry game at Ohio State on Tuesday because of the COVID-19 outbreak within the Wolverines football program.

News for you

The Patchogue Arts Council, the Greater Patchogue Chamber of Commerce...

The Patchogue Arts Council, the Greater Patchogue Chamber of Commerce and the Village of Patchogue will present "MoCA Lights - Merry & Bright" from Dec. 10-12. Credit: K. Bell

See the holiday art around Patchogue. Main Street is getting ready for the holidays with "MoCA L.I.ghts - Merry & Bright" on Dec. 10-12. You can even enjoy it safely from your car.

A virtual Justin Bieber concert for NYE. The pandemic forced him to cancel a planned tour this spring and summer, but now he's set to perform his first concert in three years — and it will be livestreamed. "T-Mobile Presents New Year's Eve Live with Justin Bieber" will take place at 7:15 p.m. on Dec. 31. Find out more about tickets.

Use your quarantine baking skills to make Christmas cookies. Try your home-baking expertise by making iced sugar cookies, gingerbread men, snowballs or chocolate crinkles. We've got a roundup of Christmas cookie recipes for you to take on this season.

Plus: Join us on Thursday for our next Newsday Live webinar for a conversation about how the pandemic has worsened addiction and recovery. Health professionals and experts will discuss addiction at a time when COVID-19 has intensified the problem. Register for it here.

Sign up for text messages to get the most important coronavirus news and information.

Commentary

Dr. Anthony Fauci, director of the National Institute of Allergy...

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, speaks during a White House Coronavirus Task Force press briefing. Credit: Getty Images/Tasos Katopodis

Small groups, big danger. A Newsday editorial writes: Anthony Fauci's virtual appearance at Gov. Andrew M. Cuomo's COVID-19 news conference Monday was more than surprising.

It was a warning.

It was a warning because the nation's top infectious disease expert and native New Yorker lauded by Cuomo as "America's doctor" was there to talk about the potential "dark time" ahead. The effect of an expected Thanksgiving surge in infections plus the December holiday season would be peaks "superimposed on each other," Fauci said. "You have a surge upon a surge."

He added that things could "really get bad" in the middle of January.

That could mean crowded hospitals, further business restrictions, and more sorrow. And a major cause for that surge, cited by both Fauci and Cuomo, is indoor gatherings of family and friends.

Cuomo said Monday that over 70% of the virus spread is estimated to be coming from "small gatherings." In Nassau County, tracers are largely finding that's the reason for the spread. In Suffolk, during the first few weeks of November, the second-most common setting where people reported being exposed was at small gatherings such as social events and family celebrations, according to the Department of Health Services.

Epidemiologists say the origin of a spread can be difficult to determine when the virus is widespread within the community, but top leadership in New York is united in identifying the blinking danger of these small gatherings. Keep reading.

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