Thursday, February 25, 2021

HEALTH

FDA authorizes Pfizer vaccine; Trump tweets

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As the COVID-19 vaccine rolls out, people are wondering if they will be required to take it to go back to work. History provides some clues.

USA TODAY

Ten months and 20 days after the first case of COVID-19 was confirmed in the United States, the Food and Drug Administration has granted emergency authorization to a vaccine that data shows is highly effective at preventing a disease that has killed nearly 300,000 Americans. 

The vaccine, from Pfizer and its German partner BioNTech, was developed at a historically swift pace, besting early estimates that projected it would be a year or more before a COVID-19 vaccine would be authorized.

Cutting-edge science and extraordinary funding helped compress that timeline, leading to a vaccine believed to be more than 90% effective in blocking the symptoms of COVID-19 and that has shown no major, unexpected safety problems.

“This is a light at the end of the long tunnel of this pandemic,” declared Dr. Sally Goza, president of the American Academy of Pediatrics. About 2.9 million frontline health care workers and nursing home residents are expected to receive the vaccine in the first few days.

But the authorization of Pfizer’s vaccine will not immediately halt a pandemic that continues to infect and kill Americans at a record rate.

Multiple vaccines — including a similar one set to be reviewed by the FDA next week — will likely be needed to supply enough shots to slow the virus’ spread over coming months. Distribution of the vaccine presents expensive, challenging problems. And health experts worry that once all that work is done, not enough Americans will elect to take the vaccine.

More news today:

  • President Donald Trump said late Friday that Pfizer had “passed the gold standard of safety,” in a video statement hailing the vaccine as “one of the greatest scientific accomplishments in history.”
  • The Trump administration announced Friday that it had purchased an additional 100 million doses of a coronavirus vaccine made by Moderna, bringing the federal government’s total order from the company to 200 million doses.
  • New York City will shut down indoor dining starting Monday due to an uptick in “infection rates,” Gov. Andrew Cuomo said
  • There’s been a delay in the vaccine being developed by Sanofi and GlaxoSmithKline. The companies said that study results found older patients failed to demonstrate a sufficient immune response against the virus. 

📰 What we’re reading: In one small Kansas town, officials resisted a mask mandate. Now, its residents — along with other rural areas reluctant to impose precautionary measures — are paying the price, as COVID-19 rates skyrocket with an intensity not seen in urban counties.

📈 Today’s numbers: The U.S. has reported more than 15.8 million cases and more than 295,000 deaths, according to Johns Hopkins University data. The global totals: 71 million cases and more than 1.5 million deaths.

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

Trump: First US vaccines will be administered ‘in less than 24 hours’

In a video announcing the emergency authorization of Pfizer’s vaccine, President Donald Trump called the vaccine a “medical miracle” that will “save millions of lives and end the pandemic once and for all.” He said the first doses would be administered in the U.S. “in less than 24 hours.”

“Through Operation Warp Speed, my administration provided a total of $14 billion to accelerate vaccine development and to manufacture all of the top candidates in advance. This included a nearly $2 billion investment in Pfizer to produce 100 million doses of the vaccine with an option to produce 500 million additional doses. And I’m proud to say that we have made sure that this vaccine will be free for all Americans. Through our partnership with FedEx and UPS, we have already begun shipping the vaccine to every state and zip code in the country,” Trump said in the video.

Trump’s announcement comes hours after media outlets documented White House attempts at pressuring the FDA to authorize a coronavirus vaccine on Friday, ahead of its plan to authorize on Saturday or Sunday. 

Dozens of other lawmakers released statements cheering the news as well.

“This decision is the best Christmas present the American people could receive when it comes to fighting this pandemic,” Republican Sen. Lindsey Graham, of South Carolina, wrote on Twitter.

“While we celebrate the authorization of the first coronavirus vaccine, we cannot ignore the immense, ongoing human toll of this pandemic – which has already claimed nearly 300,000 lives and is currently surging across the country,” Democratic Sen. Mazie Hirono, of Hawaii, said on Twitter.

Wisconsin woman reunites with family after battling virus for nearly 3 months

After spending over 80 days battling COVID-19 in a Wisconsin hospital , Nancy Van Dyn Hoven on Friday was reunited with her family and friends at long last — and just in time for the holidays.

“Other than 2020 being awful, this is just the best,” Van Dyn Hoven, 60, said Friday at home, chuckling with her husband, Dennis, and daughter, Stacy Arnoldussen, at her side. “It’s all I could ask for.” 

Dr. Anthony Zeimet, an infectious diseases specialist at the hospital and Nancy’s doctor, said the severity of her illness was particularly surprising, because she was just 59 years old — she turned 60 in the hospital — and had no underlying health conditions that would put her at higher risk of severe illness.

“The virus kind of ravaged her body,” Zeimet said. “It just goes to show that, with COVID, we don’t know who’s going to do well or do poorly. Nancy was someone who, when she was first admitted, we thought she’d do pretty well. … Unfortunately, she ended up being here for 80-plus days.”

Although Nancy’s recovery is far from over and she has a long road of rehabilitation services ahead, Friday marked the end of a months-long struggle with the virus. Read more about her story.

— Samantha West, Appleton Post-Crescent

US buys another 100M doses of Moderna’s vaccine

The Trump administration announced Friday that it had purchased an additional 100 million doses of a coronavirus vaccine made by Moderna, bringing the federal government’s total order from the company to 200 million doses. The additional doses would “provide for continuous delivery through the end of June 2021,” the U.S. Department of Health and Human Services said in a press release.

“Securing another 100 million doses from Moderna by June 2021 further expands our supply of doses across the Operation Warp Speed portfolio of vaccines,” HHS Secretary Alex Azar said in a statement. “This new federal purchase can give Americans even greater confidence we will have enough supply to vaccinate all Americans who want it by the second quarter of 2021.”

Moderna became the second vaccine maker in the U.S. to request authorization from the FDA at the end of last month. The company’s latest findings showed that of 196 people in the clinical trial who caught COVID-19, 185 of them had received the placebo, while only 11 received the active vaccine. That works out to an effectiveness rate above 94%.

Reports of White House threatening FDA chief’s job could undercut agency’s credibility, scientists worry

Reports Friday that the White House was pressuring the FDA to authorize a coronavirus vaccine comes as the agency has already faced tremendous pressure over the past months to both approve COVID-19 drugs that it was less than convinced of and to speed the vaccine approval process. Despite some early stumbles, the FDA has worked to hold firm on its timeline to following the science rather than succumbing to politics.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in August that he would quit if he were under political pressure to speed a vaccine to market before it was ready. 

By all accounts, the FDA had been ready to issue the Emergency Use Authorization by Saturday or Sunday, so the effort from Trump is not likely to make an enormous different. Scientists worry what it could do is undercut faith in the agency’s process and the COVID-19 vaccine itself, already fragile due to early  and misinformation.

“If the story is accurate, then indeed I am concerned that it will undermine public confidence in the science-based process of authorization by the FDA and recommendation by the CDC’s Advisory Committee on Immunization practices,” said L.J. Tan, chief strategy officer for the Immunization Action Coalition, a nonprofit that works with the CDC to distribute information about vaccines.

The FDA is clearly trying to do a thorough review in very difficult circumstances, said Gillian Woollett, a senior vice president and expert on FDA guidance and regulatory issues at the health care consulting firm Avalere Health.

“Commissioner Hahn should know that his efforts to keep FDA focused on the scientific and data-driven basis for their decisions is greatly appreciated by many; this will vastly increase the public confidence in the vaccine when it becomes available.”

– Elizabeth Weise

Biden calls for leadership in ‘teeth’ of COVID-19 crisis

President-elect Joe Biden led off his announcement of administration appointees Friday with warnings about “a grim milestone” in the COVID-19 crisis and sought to promote confidence in the vaccines federal regulators are considering for approval.

“This is serious business,” Biden said. “We’re in the teeth of a crisis right now.”

Biden said that President Donald Trump should be offering more leadership now to provide a national strategy for dealing with the virus and to prepare more for distributing vaccines.

“This nation needs presidential leadership right now,” Biden said. “We can wish this away, but we have to face it head on.”

– Bart Jansen and John Fritze

Florida’s DeSantis lashes out at former data scientist Rebekah Jones

Gov. Ron DeSantis lashed out Friday at a former Florida data scientist turned whistleblower whose home was raided by a state law enforcement team wielding a sledgehammer earlier this week.

“Just because you’re a darling of some corners of the fever swamps, that does not exempt you from following the law,” DeSantis said during an appearance in Tampa.

The video of law enforcement’s arrival at the Tallahassee home of Rebekah Jones has gone viral and the former health department data scientist has denied allegations that she accessed a state emergency alert system to urge former co-workers to speak out about the DeSantis administration’s handling of the coronavirus.

DeSantis said Friday that what Jones is accused of doing is “clearly a felony offense.” Jones, who has not been charged, was fired from the Department of Health in May. Jones said she was let go by the agency for refusing to falsify data on COVID-19.

– John Kennedy, Sarasota Herald-Tribune

Indoor dining to close in New York City, Cuomo says

New York Gov. Andrew Cuomo revealed new details Friday on the state’s plan to combat the coronavirus this winter, with updated restrictions for communities in “red” and “orange” zones expected to take effect Monday.

Among the changes is that gyms and salons will be able to remain open in orange zones, with capacity at 25% and weekly staff testing. Indoor dining will be closed in New York City, while decision on potential new restrictions on indoor dining for other communities statewide will be made on Monday, Cuomo said.

– David Robinson and Jon Campbell, New York State Team

US borders with Canada, Mexico to stay closed through at least Jan. 21

As expected, U.S. border closures will be extending into the New Year.

Due to the rise in coronavirus cases, the land borders with Canada and Mexico will remain closed through Jan. 21, Chad Wolf, acting secretary of the U.S. Department of Homeland Security announced on Friday.

The borders have been closed since March, with DHS issuing month-to-month extensions. He added that nonessential travel restrictions will be reevaluated “as this administration continues to make great progress on a vaccine for COVID.”

– Jenna Ryu

Kentucky snow leopard becomes first ever to test positive for coronavirus

A 5-year-old female snow leopard at the Louisville Zoo has tested positive for SARS-CoV-2, the virus that causes COVID-19 in humans. This is the first confirmed case of SARS-CoV-2 infection in a snow leopard, according to the Louisville Zoo.

The zoo announced the positive test of the snow leopard, NeeCee, Friday morning and said it is awaiting results of its other two male snow leopards — Kimti and Meru.

All the cats have “very mild symptoms,” according to a news release, as the Louisville Zoo continues to monitor their conditions closely. All cats are expected to recover, and no other animals are showing symptoms.

– Ben Tobin, Louisville Courier Journal

Delay in Sanofi and GSK’s vaccine after older people fail to show immune response

Sanofi and GlaxoSmithKline (GSK) announced Friday a delay in their COVID-19 vaccine program after study results found older patients failed to demonstrate a sufficient immune response against the virus.

The companies said in a joint statement the low immune response was likely due to an insufficient concentration of the antigen. Phase 1/2 trial interim results showed participants between 18 and 49 years old showed an immune response comparable to patients who recovered from COVID-19.

“The results of the study are not as we hoped,” Roger Connor, president of GSK Vaccines, said in the press release. “Our aim now is to work closely with our partner Sanofi to develop this vaccine, with an improved antigen formulation, for it to make a meaningful contribution to prevention COVID-19.”  

French company Sanofi and U.K.-based GSK said a Phase 2b study with the improved vaccine will start in February 2021 and will be available to the public by the end of next year pending its success.

The U.S. government paid up to $2.1 billion to test and produce 100 million doses under Operation Warp Speed. The majority of the $2.1 billion will go to Sanofi, which made the vaccine candidate. GSK made a booster that improves how the body responds to it. Read more here.

– Adrianna Rodriguez 

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Stark numbers show COVID’s vice-like grip on the US

The United States has now reported more deaths from COVID-19 than combat deaths in World War II. Johns Hopkins University shows 291,929 coronavirus deaths, several hundred more than the U.S. Department of Veterans Affairs says were lost in battle in World War II. South Dakota on Thursday became the second state to have 1 of every 10 of its people test positive, Johns Hopkins University data shows. North Dakota hit that mark on Thanksgiving.

The place with the most cases per person is Crowley County, Colorado, where about 22.7 percent of the people have tested positive, Johns Hopkins University says. Most of those cases came in a month. Additionally, a county in Hawaii became the United States’ final county to have a resident test positive for COVID-19, the Maui News reported Thursday. In the last month, the U.S. has seen more deaths from COVID-19 (51,518) than battle deaths from Vietnam (47,434).

– Mike Stucka

Will the vaccine be required? Any side effects? USA TODAY answers questions

More than 2,000 reader questions have been submitted to USA TODAY in the past two weeks as a vaccine rollout inches ever closer. USA TODAY’s editor-in-chief Nicole Carroll rounds some of them up in her latest column

  • Yes, it is safe. The approval process for vaccines is stringent and heavily reviewed. The FDA on Tuesday released a 53-page report summarizing data from Pfizer/BioNTech’s COVID-19 candidate vaccine trial. 
  • What are potential side effects? All three vaccine makers have reported mild to moderate reactions, including pain at injection site, fatigue and sore muscles and joints. Doctors say this is normal. 
  • The vaccine itself will be free, but health care providers can charge a fee for administering it, which can be paid for by insurance or a government relief fund. 
  • The vaccines require two doses, and they must be from the same manufacturer, as the composition and timing of vaccines differ. 
  • It is not known if you can still get sick or spread the virus to others after you’ve been vaccinated. However, the vaccines are at least 95% effective. It’s not known yet how long the vaccination lasts.
  • The vaccines weren’t tested on children, so school-age kids won’t be getting vaccinated at first. But college students are eligible, and colleges are debating whether they will, or when they will, be required. 

If you’d like to get The Backstory in your inbox every week, sign up here.

Boston Biogen conference was likely superspreader, study says

A study published Thursday suggests 205,000 to 300,000 COVID-19 cases across the U.S. and globally can be traced back to a two-day Boston conference.

The Biogen conference, held Feb. 26-27, is responsible for roughly 1.6% of all U.S. cases since the start of the pandemic, researchers estimated.

The study says that the conference is an example of what happens when the virus spreads unchecked, as the outbreak likely created “major outbreaks among individuals experiencing homelessness, spread[ing] throughout the Boston area including to other higher risk communities, and were exported to other domestic and international sites.”

COVID-19 resources from USA TODAY 

Contributing: The Associated Press

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