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They volunteered for COVID-19 vaccine trials. Months later, they’re still ‘in limbo’ awaiting FDA authorization.

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Troy Petenbrink thought he was doing his part to help humanity when he signed up for a clinical trial for a COVID-19 vaccine. The first two had gone well and he figured the more vaccines the better in a desperate world.

The Washington, D.C., resident got two sets of shots – one a placebo and one the actual vaccine – in January-February and April-May. Then, he settled in for what he assumed would be a short wait for the Novavax vaccine to be federally authorized.

“I wanted this stuff out there,” he said, citing concerns about the safety of his 91-year-old mother-in-law from the coronavirus. “I was like, ‘Let’s do this, let’s get the ball rolling here.'”

But months later, he’s still waiting for Novavax to apply for that authorization from the Food and Drug Administration. And while other fully vaccinated people are going to gyms, movie theaters and bars, Petenbrink is struggling to convince strangers that he’s protected.

“I really am in limbo,” he said.

Troy Petenbrink posted this selfie the day he got his first Novavax shot. Months later he’s still waiting for his vaccine to be recognized.

A freelance travel writer, Petenbrink had to turn down an assignment because the cruise line only accepts the three authorized vaccines, from Pfizer-BioNTech, Moderna and Johnson & Johnson. He recently tried to go to a bar with his partner, but was turned away because he hadn’t received one of the three FDA-authorized vaccines.

“No one along the way explained any of this as a possibility,” he said of the clinical trial.

About 50,000 Americans are in the same situation, having volunteered for either the Novavax or AstraZeneca vaccine trials.

Both vaccines have shown strong effectiveness and safety data. AstraZeneca’s vaccine has been distributed across the U.K., Europe and other parts of the world.

But both companies have declined to submit their vaccines for authorization in the U.S. Novavax has had issues producing its vaccine and AstraZeneca faced safety questions abroad, though most countries have decided its benefits outweighed its risks, particularly among older people.

Will COVID vaccine booster shots be needed? It’s likely, experts say, but the immunocompromised should be prioritized.

Still, Americans who had either set of shots face trouble proving they’re vaccinated.

The Centers for Disease Control and Prevention did not respond to a request for a comment about their circumstance.

Petenbrink said that when he asked, the CDC sent him “this most vague statement, which is like ‘You are approved for public health purposes.'”

“That’s nice, but it doesn’t do anything for me who wants to live my life and do the things I want to do as a vaccinated person,” he said.

He and others have the normal CDC-issued vaccine card, but anyone who gives it more than a cursory glance will notice the word “Novavax” clearly printed out under the “product name.”

AstraZeneca responded to a request for comment with a statement: “Consistent with CDC guidance, AstraZeneca is working with trial sites to provide vaccine cards to study participants who received AZD1222.”

Francesca Anacleto, 12, receives her first Pfizer COVID-19 vaccine shot from nurse Jorge Tase, in Miami Beach, Florida, on Wednesday.

Francesca Anacleto, 12, receives her first Pfizer COVID-19 vaccine shot from nurse Jorge Tase, in Miami Beach, Florida, on Wednesday.

Stanley Erck, president and CEO of Novavax, described the situation as a “critical problem” that he and others at the company are doing everything they can to address.

“I get more letters about that every day than anything else,” Erck said in a Friday interview.

He said the company’s production issues are resolved and expects to submit a package to the FDA, likely in October, with distribution to begin by early next year.

“We plan on being full-steam in 2022,” he said, explaining Novavax now sees its primary role as providing booster shots.

Petenbrink, who got vaccinated at Howard University, said he knows at least four others who have dropped out of the Novavax study and “got the real” shots.

It’s unlikely that getting additional shots will be risky, though it hasn’t been fully studied.

In a British trial that mixed and matched vaccines, people who received the Pfizer-BioNTech vaccine after a first dose of AstraZeneca were extremely well protected. But no one got two doses before a third of Pfizer-BioNTech, and results haven’t yet been published of a trial combining Novavax’ with other vaccines.

Petenbrink said he’s asked the CDC, Food and Drug Administration and Novavax for their recommendations on what he should do about traveling or the safety of getting another set of shots, but hasn’t heard back from any of the three.

Despite the hassle and the daily medical form he has to fill out, Petenbrink doesn’t regret participating in the trial. But he worries experiences like his will turn people off the next time. “It’s a hard message for other people who look at clinical trials in the future,” he said.

Contact Karen Weintraub at kweintraub@usatoday.com.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

This article originally appeared on USA TODAY: Novavax, AstraZeneca COVID vaccine trial volunteers waiting for FDA OK



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India tests nuclear-capable missile amid tensions with China

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NEW DELHI (AP) — India has test-fired a nuclear-capable intercontinental ballistic missile with a range of 5,000 kilometers (3,125 miles) from an island off its east coast amid rising border tensions with China.

The successful launch on Wednesday was in line with “India’s policy to have credible minimum deterrence that underpins the commitment to no first use,” said a government statement.

The Agni-5 missile splashed down in the Bay of Bengal with “a very high degree of accuracy,” said the statement issued on Wednesday night.

Beijing’s powerful missile arsenal has driven New Delhi to improve its weapons systems in recent years, with the Agni-5 believed to be able to strike nearly all of China.

India is already able to strike anywhere inside neighboring Pakistan, its archrival against whom it has fought three wars since gaining independence from British colonialists in 1947.

India has been developing its medium- and long-range nuclear and missile systems since the 1990s amid increasing strategic competition with China in a major boost to the country’s defense capabilities.

Tension between them flared last year over a long-disputed section of their border in the mountainous Ladakh area. India is also increasingly suspicious of Beijing’s efforts to heighten its influence in the Indian Ocean.

Talks between Indian and Chinese army commanders to disengage troops from key areas along their border ended in a stalemate earlier this month, failing to ease a 17-month standoff that has sometimes led to deadly clashes. India and China fought a bloody war in 1962.



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Friedman, Dodgers facing decisions on FAs, Bauer this winter

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LOS ANGELES (AP) — Andrew Friedman is headed into an offseason filled with crucial decisions involving the Los Angeles Dodgers’ big-name free agents, a rebuild of the starting rotation and Trevor Bauer’s future with the team.

As always, Friedman is guided by the ultimate goal of the monied Dodgers, saying, “The number one objective is to put ourselves in the best position to win in 2022.”

After coming within two wins of reaching the World Series for the fourth time in five years, the Dodgers’ president of baseball operations defined the team’s postseason as “our struggle to consistently score runs.”

“We needed someone to step up and pull an Eddie Rosario,” Friedman said, referring to the Atlanta Braves left fielder who was named MVP of the NL Championship Series.

“After we made the Trea Turner deal, in my opinion, one through eight, it was the deepest and best lineup I’ve been around. But it didn’t quite play like that over those two months. It was a little bumpier than I would’ve expected,” he said Wednesday. “Figuring out the why of that is the hard part.”

The turbulence began well before the postseason.

Reigning NL Cy Young Award winner Bauer went on paid administrative leave in early July under MLB’s joint domestic violence and sexual assault policy. MLB is conducting its own investigation and has yet to announce any findings. Bauer, through his representatives, has denied any wrongdoing.

Asked if Bauer will pitch for the team again, Friedman said they remain in the same position as before.

“It’s being handled by the league office,” he said. “Whatever they decide, we’ll have to figure out from there what makes the most sense for us.”

If MLB suspends Bauer, it could create a domino effect on the team’s payroll plans.

“The extent of it, I don’t know yet,” Friedman said.

The Dodgers began the season with eight starters and tried to get through the postseason with just Walker Buehler, Max Scherzer and 20-game winner Julio Urías. The lack of depth was exposed by the team’s decisions to use Scherzer in relief in Game 5 of the NL Division Series and Urías out of the bullpen in Game 2 of the NLCS that left both pitchers tired in their later starts.

“We’re got a really good group of young starting pitchers coming,” Friedman said, citing Mitch White, Andre Jackson, Bobby Miller, Ryan Pepiot and Landon Knack. “Gives us a really strong foundation of depth.”

Friedman and the front office have decisions to make on such key veterans as Scherzer, Clayton Kershaw, Corey Seager, Kenley Jansen and Chris Taylor, who will become free agents after the World Series.

“We’ll do everything we can to keep as many of this group together,” Friedman said, “but not standing in the way of a great opportunity and I’m sure there will be for different people.”

Kershaw, the 33-year-old three-time Cy Young Award winner, reinjured his left arm not long after returning from over a two-month absence for the same issue and wasn’t available to pitch in the postseason.

“He just wants to feel good again and get to the point where he’s healthy,” Friedman said.

Kershaw has spent his entire 14-year career in Los Angeles, where he’s been the longtime face of the franchise.

“There’s something nostalgic and great about Kersh playing for one team and winning another championship and having a parade,” Friedman said.

Offseason moves would be impacted if no agreement on a collective bargaining agreement is reached before the current deal expires Dec. 1.

“We need to be prepared accordingly,” Friedman said.

___

More AP MLB: https://apnews.com/hub/MLB and https://twitter.com/AP_Sports





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Senators have heated exchanges with AG Garland over DOJ school board memo

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Senators have heated exchanges with AG Garland over DOJ school board memo



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Drinking Coffee Has Some Super Benefits—Here Are 4 Health Perks of Your Morning Cup

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Drinking Coffee Has Some Super Benefits—Here Are 4 Health Perks of Your Morning Cup



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Nor'easter has New England bracing for floods, power outages

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Trump Jr. Gets A Reality Check After Comparing U.S. To Communist Czechoslovakia

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Donald Trump Jr. was ridiculed this week after he likened shortages of certain products in the U.S. under President Joe Biden to living in communist Czechoslovakia in the 1980s.

Trump Jr. made the remarks during conversation Saturday on Newsmax with Sebastian Gorka, a right-wing media personality and former aide to Donald Trump.

Gorka asked Trump Jr. to discuss the “empty shelves” and backlog of cargo ships in California due to supply-chain issues, given his “perspective” as someone who, “as a child, traveled behind the Iron Curtain and saw real socialism.”

“When conservatives say, ‘They’re socialists. The Democrats have gone radical,’ this isn’t an exaggeration, is it? You’ve seen it, Don,” Gorka added.

Trump Jr.’s mother, Ivana Trump, grew up in Czechoslovakia before moving first to Canada and then the U.S. in the 1970s. He told Gorka his Czech grandparents wanted him to understand the “freedoms and blessings we have here” in the U.S.

“So I traveled with them there every summer, you know, six, eight weeks. I’ve waited in those bread lines,” said Trump Jr., whose father was estimated to be worth more than $1 billion in the 1980s. “We’re starting to see the empty shelves that I experienced then in communist Czechoslovakia in the ’80s in America right now.”

Grocery stores in the U.S. are having problems stocking certain products due to the coronavirus pandemic, a worker shortage and shipping congestion at the Port of Los Angeles.

Some social media users and conservative media personalities have shown images of empty shelves to attack Biden over the supply-chain issues. However, some of these images have turned out to be photos from years ago.

Trump Jr. was slammed on social media for the absurd comparison. A number of people also pointed out that last year, at the peak of the pandemic during the Trump administration, shelves in stores across the country were stripped bare of certain essentials and people lined up for miles in their cars or for blocks on foot to get aid from food banks.

This article originally appeared on HuffPost and has been updated.

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How a pro-Trump “command center” at a hotel near the White House fueled January 6 efforts to block election certification

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How a pro-Trump “command center” at a hotel near the White House fueled January 6 efforts to block election certification



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