SEATTLE (AP) — U.S. researchers gave the first shot to the first person in a test of an experimental coronavirus vaccine Monday — leading off a worldwide hunt for protection even as the pandemic surges.
With a careful jab in a healthy volunteer’s arm, scientists at the Kaiser Permanente Washington Research Institute in Seattle begin an anxiously awaited first-stage study of a potential COVID-19 vaccine developed in record time after the new virus exploded from China and fanned across the globe.
“We’re team coronavirus now,” Kaiser Permanente study leader Dr. Lisa Jackson said on the eve of the experiment. “Everyone wants to do what they can in this emergency.”
The Associated Press observed as the study’s first participant, an operations manager at a small tech company, received the injection inside an exam room. Three others were next in line for a test that will ultimately give 45 volunteers two doses, a month apart.
“We all feel so helpless. This is an amazing opportunity for me to do something,” Jennifer Haller, 43, of Seattle, said as she awaited the shot.
She’s the mother of two teenagers and “they think it’s cool” that she’s taking part in the study.
After the injection, she left the exam room with a big smile: “I’m feeling great.”
Monday’s milestone marked just the beginning of a series of studies in people needed to prove whether the shots are safe and could work. Even if the research goes well, a vaccine wouldn’t be available for widespread use for 12 to 18 months, said Dr. Anthony Fauci of the U.S. National Institutes of Health.
Still, finding a vaccine “is an urgent public health priority,” Fauci said in a statement Monday. The new study, “launched in record speed, is an important first step toward achieving that goal.”
This vaccine candidate, code-named mRNA-1273, was developed by the NIH and Massachusetts-based biotechnology company Moderna Inc. There’s no chance participants could get infected from the shots because they don’t contain the coronavirus itself.
It’s not the only potential vaccine in the pipeline. Dozens of research groups around the world are racing to create a vaccine against COVID-19. Another candidate, made by Inovio Pharmaceuticals, is expected to begin its own safety study — in the U.S., China and South Korea — next month.
The Seattle experiment got underway days after the World Health Organization declared the new virus outbreak a pandemic because of its rapid global spread, infecting more than 169,000 people and killing more than 6,500.
COVID-19 has upended the world’s social and economic fabric since China first identified the virus in January, with regions shuttering schools and businesses, restricting travel, canceling entertainment and sporting events, and encouraging people to stay away from each other.
Starting what scientists call a first-in-humans study is a momentous occasion for scientists, but Jackson described her team’s mood as “subdued.” They’ve been working round-the-clock readying the research in a part of the U.S. struck early and hard by the virus.
Still, “going from not even knowing that this virus was out there … to have any vaccine” in testing in about two months is unprecedented, Jackson told The AP.
Some of the study’s carefully chosen healthy volunteers, ages 18 to 55, will get higher dosages than others to test how strong the inoculations should be. Scientists will check for any side effects and draw blood samples to test if the vaccine is revving up the immune system, looking for encouraging clues like the NIH earlier found in vaccinated mice.
“We don’t know whether this vaccine will induce an immune response, or whether it will be safe. That’s why we’re doing a trial,” Jackson stressed. “It’s not at the stage where it would be possible or prudent to give it to the general population.”
Most of the vaccine research under way globally targets a protein aptly named “spike” that studs the surface of the new coronavirus and lets it invade human cells. Block that protein and people won’t get infected.
Researchers at the NIH copied the section of the virus’ genetic code that contains the instructions for cells to create the spike protein. Moderna encased that “messenger RNA” into a vaccine.
The idea: The body will become a mini-factory, producing some harmless spike protein. When the immune system spots the foreign protein, it will make antibodies to attack — and be primed to react quickly if the person later encounters the real virus.
That’s a much faster way of producing a vaccine than the traditional approach of growing virus in the lab and preparing shots from either killed or weakened versions of it.
But because vaccines are given to millions of healthy people, it takes time to test them in large enough numbers to spot an uncommon side effect, cautioned Dr. Nelson Michael of the Walter Reed Army Institute of Research, which is developing a different vaccine candidate.
“The science can go very quickly but, first, do no harm, right?” he told reporters last week.
The Seattle research institute is part of a government network of centers that test all kinds of vaccines, and was chosen for the coronavirus vaccine study before COVID-19 began spreading widely in Washington state.
Kaiser Permanente screened dozens of people, looking for those who have no chronic health problems and aren’t currently sick. Researchers aren’t checking whether would-be volunteers already had a mild case of COVID-19 before deciding if they’re eligible. If some did, scientists will be able to tell by the number of antibodies in their pre-vaccination blood test and account for that, Jackson said. Participants will be paid $100 for each clinic visit in the study.
VIDEO: Dr. Krishna Tewari on COVID-19, its Permanent Impact on Medicine, Medical Policy and His Network
TAMPA, Fla. (FNN) – In this week’s episode of the FNN Politics & Power Series, Dr. Krishna Tewari, hospitalist and CEO of Inpatient Specialists Group, LLC, spoke with Mellissa about his network of fellow hospitalists, the COVID-19 pandemic and its permanent impact on medical innovation, the impact of Tampa’s growing population on his business, and more.
Catch new episodes of the FNN Politics & Power Series every Thursday at 1pm ET on Facebook (@Florida National News or @FNN News TV) or on YouTube (www.youtube.com/c/floridanationalnews).
After Biden’s First Year, the Virus and Disunity Rage On
WASHINGTON (AP) — From the inaugural platform, President Joe Biden saw American sickness on two fronts — a disease of the national spirit and the one from the rampaging coronavirus — and he saw hope, because leaders always must see that.
“End this uncivil war,” he implored Americans on Jan. 20, 2021. Of the pathogen, he said: “We can overcome this deadly virus.”
Neither malady has abated.
For Biden, it’s been a year of lofty ambitions grounded by the unrelenting pandemic, a tough hand in Congress, a harrowing end to an overseas war and rising fears for the future of democracy itself. Biden did score a public-works achievement for the ages. But America’s cracks go deeper than pavement.
In this midterm election year, Biden confronts seething divisions and a Republican Party that propagates the delusion that the 2020 election — exhaustively vetted, validated many times over, fair by all measures — was stolen from Donald Trump. That central, mass lie of a rigged vote has become a pretext in state after state for changing election rules and fueling even further disunity and grievance.
In the dispiriting close of Biden’s first year, roadblocks stood in the way of all big things pending.
The Supreme Court blocked his vaccinate-or-test mandate for most large employers. Monthly payments to families that had slashed child poverty ran out Friday, with no assurance they will be renewed. Biden’s historic initiative to shore up the social safety net wallowed in Congress. And people under 40 have never seen inflation like this.
Only two days after Biden’s lacerating speech in Atlanta invoking the darkest days of segregation, he saw his voting rights legislation run aground when Democratic Sen. Krysten Sinema of Arizona announced her opposition to changing Senate rules to allow the bill to pass by a simple majority.
Her rationale: Altering the rules would only “worsen the underlying disease of division infecting our country.”
For all of that, Barack Obama was on to something when he paid his old vice president an odd compliment late in the 2020 campaign. Elect Joe Biden, he said, and after four years of flamboyant Trump dramas and crazy tweets, folks could feel safe ignoring their president and vice president for a spell.
“You’re not going to have to think about them every single day,” Obama said. “It just won’t be so exhausting. You’ll be able to go about your lives.”
Indeed America saw normalcy, some say dignity, return to the White House. Pets came back and so did daily press briefings for the public.
The Trump-era political muzzle came off public health authorities, freeing them to confuse the public all on their own.
First lady Jill Biden’s studded “Love” jacket at a global summit not-so-subtly countered the “I Really Don’t Care, Do U?” jacket her predecessor wore on her flight to a migrant child detention center.
Instead of promising the world and delivering a Potemkin village (as when Trump declared the virus “very much under control” in February 2020), the Biden White House set pandemic and other goals that were modest to a fault, then exceeded them. The old game of lowering expectations and then taking credit for beating them was back, though such boasting was gone when the dual punch of the delta and omicron variants landed.
Even so, the discipline, drive and baseline competence from the new White House produced notable results. Biden won a bipartisan infrastructure package that had eluded his two predecessors, coming away with a legacy-shaping fix for the rickety pillars of industry and society.
The first signs of that law in action came this month when Washington approved New York City’s Second Avenue subway project to a final engineering phase before shovels hit the ground. The project, which would add three train stops in East Harlem, stalled under Trump.
Americans everywhere will be seeing plenty more orange construction cones for years to come. In just one initiative under the program, 15,000 highway bridges are in line for repairs.
Biden steered more judges through Congress to the federal bench than any recent predecessor. He won approval of a Cabinet that was half women and a minority of white people for the first time. More than 6 million people are back at work and half a billion COVID-19 vaccines have been put in arms, but the nation has a long way to go to return to its pre-pandemic state.
“I think it’s a lot of achievements, a lot of accomplishment, in the face of some very serious obstacles,” Biden’s chief of staff, Ron Klain, told The Associated Press on the cusp of Biden’s second year in office. “The Biden presidency remains a work in progress.”
Matthew Delmont, a civil rights historian at Dartmouth, expected more from Biden by virtue of Biden’s decades of experience as a savvy operator in the capital.
He had anticipated a far more effective COVID-19 response and more urgency, sooner, in countering the rollback of voting rights and tilting of election rules that Republicans are attempting across the country.
“There’s something to be said for the professionalism of the White House and not going from one fire to the next,” Delmont said. “What I worry is that the Washington he understands isn’t the Washington we have anymore.”
Political science professor Cal Jillson at Southern Methodist University in Dallas said Biden has displayed “warning track power” — the ability in baseball to hit long but not, as yet, over the fence.
“There are not so much wins and losses as partial progress on many fronts,” he said.
In Biden, Jillson sees a leader who brought the even keel that Obama had talked about from the campaign stage but also one who only rarely delivers a speech worth remembering.
“While there are vast partisan differences in how Biden is seen, in general he is seen as stable but not forceful,” he said.
That’s how Biden has come across to John Ferguson, a retired diplomatic officer in Lovettsville, Virginia, who considers Biden “infinitely better than Trump” but adds: “He seems to give a speech every four hours and he’s not very good at it.”
In large measure, Biden’s innate civility and predictability brought the sort of climate change that the world could get behind.
Here once more was a president who believed deeply in alliances and vowed to repair an American reputation frayed by the provocateur in office before him.
There would be no more puzzling feelers about buying Greenland. No more doting looks at Russian President Vladimir Putin; instead, Biden stepped up diplomatic confrontation over Putin’s designs on Ukraine. There would be no eerie uplit gatherings around glowing orbs with rulers of dissent-crushing Arab countries like Trump’s photo op with the Saudis.
But the world also witnessed Biden’s debacle in Afghanistan, a chaotic withdrawal that brought more than 124,000 to safety but stranded thousands of desperate Afghans who had been loyal to the United States and hundreds of U.S. citizens and green card holders.
Discounting warnings from military and diplomatic advisers, Biden misjudged the Taliban’s tenacity and the staying power of Afghan security forces that had seen crucial U.S. military support vanish. He then blamed Afghans for all that went wrong. Millions of Afghans face the threat of famine in the first winter following the Taliban takeover.
“He needs to be honest about the mistakes that were made,” said Republican Rep. Peter Meijer of Michigan, who served with aid workers in Afghanistan after a military career and voted in Congress to impeach Trump. ”He will say, ‘The buck stops with me,’ after he’s blamed everybody else for how something turned out.”
All presidents enter the world’s most powerful office buoyed by their victory only to confront its limitations in time. For Biden, that happened sooner than for most. A polarized public, Trump’s impeachment trial and an evenly divided Senate saw to that.
Biden entered office with a list of to-dos amassed by his party. His quest for a sweeping “Build Back Better” program of social spending turned into a months-long slog, hostage to disagreement between Democrats of the left and center and sometimes to just one man, West Virginia Sen. Joe Manchin, or Manchin and Sinema together.
“There is a fine political line between forcing Congress’ hand with detailed guidance and short timelines and allowing Congress to spin its wheels endlessly,” Jillson said. “Biden has not found the sweet spot, but in such a narrowly divided Congress there may be no sweet spot.”
Biden came late, by some reckonings, to the Trump-inspired Republican efforts in state capitals to revise how people can vote, how those votes are counted and who oversees elections. Defending democratic processes is a universal concern but also, in Delmont’s view, the overarching civil rights issue of this time.
“Right now it feels like there’s a lot more passion and energy from folks who would like to restrict or roll back voting rights,” Delmont said. Absent an effective defense of those rights by Biden, “I can’t say that he’s doing enough to repay the Black Americans who put him in the White House.”
Meantime, day after day, event after event, it was the virus that commanded Biden’s attention. “That challenge casts a shadow over everything we do,” Klain said. “I think we’ve made historic progress there but it’s still a challenge.”
Biden is the second U.S. president to be humbled by the coronavirus, which has killed some 846,000 people in this country.
The U.S. is now much better equipped against COVID-19. America’s medical arsenal is stronger by orders of magnitude than in the pandemic’s first year and the relief money pumped to households, communities and states also made a big difference, though at a cost of stirring inflation.
The Biden administration has been strikingly successful in procuring vaccines and clearing the way for new antiviral medicines that can be taken at home, which should relieve the strain on hospitals once those pills become widely available.
But testing continues to be a core failure, and millions of Americans still refuse to get vaccinated.
Rapid tests are frustratingly difficult to find, and expensive. PCR tests still take three to five days in many cases to get results. That means Americans will continue to be several steps behind the virus, especially with omicron. It remains to be seen if the administration’s new testing push leads to a meaningful change.
Trump was undone by his bluster, his inability to own up to the seriousness of the situation and his failure to communicate the stakes truthfully to Americans. But Biden has not been entirely free of hubris.
His mask-less springtime stroll with Vice President Kamala Harris in the Rose Garden may be remembered as an ill-conceived example to the country. Biden’s July Fourth celebration of American “independence” from the virus was premature, to put it charitably, despite hedging his remarks in recognition of the dangerous delta variant then stirring.
His portrayal of a “pandemic of the unvaccinated,” meant to nudge those who won’t get the needle, further illustrated the country’s us-and-them divide and wasn’t exactly true. Fully vaccinated people account for a growing number of cases across the country, though they are far less likely to suffer from it as much as the unvaccinated do. Equally vexing for Biden is that those most protected against the virus remain most afraid of it.
On the other side of the political divide, prominent Republican governors have actively opposed vaccination and mask mandates.
Anti-government sentiment, nurtured by misinformation, has been aimed at public health advisers and their recommendations, long regarded as beyond the political scrum.
As the pandemic enters its third year, the notion that the U.S. may not be able to crush the coronavirus and may have to settle for living with it — a thought that sparked outrage when it briefly surfaced in Trump’s time — may now be gaining currency.
Biden’s campaign promise from October 2020 hangs in the balance: “I’m going to shut down the virus, not the country.”
IN THE WORLD’S EYES
Biden campaigned on a promise to restore U.S. leadership, with dignity, among the democracies. He’s made good on the style of that while disappointing supporters at home and allies abroad on some of the substance.
Apart from his bungled Afghanistan withdrawal, his efforts to bring Iran back into compliance with the 2015 nuclear accord and reverse Trump’s withdrawal of the U.S. from the deal have been met only by Iran moving closer than before to nuclear capabilities.
With some of the autocrats he had promised to confront on human rights, Saudi’s crown prince among them, he has equivocated.
Steven A. Cook, a Middle East expert and senior fellow at the Council for Foreign Policy, branded Biden’s foreign policy “ruthless pragmatism,” especially when it comes to undemocratic Middle East governments. Domestic politics, including Biden’s own concerns about voter abhorrence for high gas prices, have kept him from making America the out-front example of fighting climate change that he’d promised it would be.
While Biden convened global summits for democracies and climate change as promised, and rejoined the Paris climate accord, his biggest effort on climate funding belly-flopped.
That, along with mixed administration efforts at home to keep natural gas and gasoline cheap and flowing while cutting fossil fuel use over the long term, threatens Biden’s aim of making the U.S. a leader by example on the climate.
The U.S. does look much more normal to the world again, though.
Biden and his diplomats are going all out on rebuilding the alliances that Trump trashed. He’s dealing head-on both with Russia and China. People who care about human rights welcome U.S. leadership on tough sanctions for China and Myanmar over their vicious mistreatment of minorities.
Overlaying everything, domestic or foreign, is a constant foreboding in the White House over what Trump might do next.
A year ago Trump left Washington for Florida, breaking one last tradition as president by refusing to attend Biden’s inauguration. He told a sparse crowd of supporters at Joint Base Andrews that they should expect a second act.
“We will be back in some form,” he said. “Have a good life. We will see you soon.”
FDA Expands Pfizer Boosters for More Teens as Omicron Surges
WASHINGTON (AP) – The U.S. is expanding COVID-19 boosters as it confronts the omicron surge, with the Food and Drug Administration allowing extra Pfizer shots for children as young as 12.
Boosters already are recommended for everyone 16 and older, and federal regulators on Monday decided they’re also warranted for 12- to 15-year-olds once enough time has passed since their last dose.
But the move, coming as classes restart after the holidays, isn’t the final step. The Centers for Disease Control and Prevention must decide whether to recommend boosters for the younger teens. Dr. Rochelle Walensky, the CDC’s director, is expected to rule later this week.
The FDA also said everyone 12 and older who’s eligible for a Pfizer booster can get one as early as five months after their last dose rather than six months.
FDA vaccine chief Dr. Peter Marks said in a statement the agency made its decision because a booster “may help provide better protection against both the delta and omicron variants,” especially as omicron is “slightly more resistant” to the vaccine-induced antibodies that help fend off infection.
Real-world data from Israel tracked more than 6,300 12- to 15-year-olds who got a booster there at least five months after their second Pfizer dose and found no serious safety concerns, the FDA said.
Likewise, the FDA said even more data from Israel showed no problems with giving anyone eligible for a Pfizer booster that extra dose a month sooner than the six months that until now has been U.S. policy.
Vaccines still offer strong protection against serious illness from any type of COVID-19. But health authorities are urging everyone who’s eligible to get a booster dose for their best chance at avoiding milder breakthrough infections from the highly contagious omicron mutant.
Children tend to suffer less serious illness from COVID-19 than adults. But child hospitalizations are rising during the omicron wave — most of them unvaccinated.
Pediatrician and global health expert Dr. Philip Landrigan of Boston College welcomed the FDA’s decisions, but stressed that the main need is to get the unvaccinated their first shots.
“It is among unvaccinated people that most of the severe illness and death from COVID will occur in coming weeks,” he said in an email. “Many thousands of lives could be saved if people could persuade themselves to get vaccinated.”
The vaccine made by Pfizer and its partner BioNTech is the only U.S. option for children of any age. About 13.5 million 12- to 17-year-olds — just over half that age group — have received two Pfizer shots, according to the CDC.
For families hoping to keep their children as protected as possible, the booster age limit raised questions.
The older teens, 16- and 17-year-olds, became eligible for boosters in early December. But original vaccinations opened for the younger teens, those 12 to 15, back in May. That means those first in line in the spring, potentially millions, are about as many months past their last dose as the slightly older teens.
As for even younger children, kid-size doses for 5- to 11-year-olds rolled out more recently, in November — and experts say healthy youngsters should be protected after their second dose for a while. But the FDA also said Monday that if children that young have severely weakened immune systems, they will be allowed a third dose 28 days after their second. That’s the same third-dose timing already recommended for immune-compromised teens and adults.
Pfizer is studying its vaccine, in even smaller doses, for children younger than 5.
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