U.S.-contractors shots edict blocked by judge

Government order crossed the line, he finds

A health worker collects a swab sample from traveler at a railway station to test for the coronavirus before allowing her to enter the city, in Mumbai, India, Tuesday, Dec. 7, 2021. (AP Photo/Rajanish Kakade)
A health worker collects a swab sample from traveler at a railway station to test for the coronavirus before allowing her to enter the city, in Mumbai, India, Tuesday, Dec. 7, 2021. (AP Photo/Rajanish Kakade)


A federal judge Tuesday blocked President Joe Biden's administration from enforcing a covid-19 vaccine mandate for employees of federal contractors, the latest in a string of victories for Republican-led states pushing back against pandemic policies.

U.S. District Judge R. Stan Baker in Augusta, Ga., issued a stay to bar enforcement of the mandate nationwide.


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The order came in response to a lawsuit from several contractors and seven states -- Alabama, Georgia, Idaho, Kansas, South Carolina, Utah and West Virginia. It applies across the U.S. because one of those challenging the order is the trade group Associated Builders and Contractors Inc., whose members do business nationwide.

Baker found that the states are likely to succeed in their claim that Biden exceeded authorization from Congress when he issued the requirement in September.

"The Court acknowledges the tragic toll that the COVID-19 pandemic has wrought throughout the nation and the globe," wrote the judge, an appointee of former President Donald Trump. "However, even in times of crisis this Court must preserve the rule of law and ensure that all branches of government act within the bounds of their constitutionally granted authorities."

With Tuesday's ruling, all three of Biden's broad vaccination mandates affecting the private sector have been put on hold by courts. Judges already issued a stay regarding one that applies to businesses with 100 or more employees and another for health care workers across the U.S.

Separately, Biden has imposed vaccination requirements for employees of the federal government and the military.

The mandates are a key part of the administration's strategy to stop the spread of covid-19, which has killed more than 791,000 Americans.

A White House spokeswoman said the Justice Department would continue to defend the contractor mandate.

"The reason that we proposed these requirements is that we know they work, and we are confident in our ability, legally, to make these happen across the country," White House press secretary Jen Psaki said at a briefing Tuesday.

Biden issued an executive order Sept. 9 requiring federal contractors and subcontractors to comply with workplace safety guidelines developed by a federal task force. That task force subsequently issued guidelines that new, renewed or extended contracts include a clause requiring employees to be fully vaccinated by Jan. 18. That meant those receiving a two-dose vaccine must get their second shots by Jan. 4.

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Limited exceptions were allowed for medical or religions reasons. The requirements would apply to millions of employees of federal contractors, which include defense companies and airlines.

"This is a big win in removing compliance hurdles for the construction industry, which is facing economic challenges, such as a workforce shortage of 430,000, rising materials prices and supply chain issues," Ben Brubeck, a vice president of the construction industry group, said in a statement.

Georgia Gov. Brian Kemp, a Republican, said in a Twitter message that the ruling will provide relief to workers "who were in fear of being forced to choose between this vaccine and their livelihood."

Other Republican officials also praised the court ruling. Alabama Gov. Kay Ivey said the mandate was "just an outrageous overreach by the federal government."

WORLD'S 1ST SHOT

One year ago, a grandmother named Margaret Keenan, then 90, rolled up her sleeve at University Hospital Coventry in the English midlands to take her place in history.

Keenan became the first person in the world to receive Pfizer's covid vaccine outside a clinical trial. It was a turning point in the pandemic, raising hopes that there was a path out of the crisis, along with questions about how well the rapidly created shots would perform.

Now, after 8 billion doses, the impact is clear. The vaccines -- not just from Pfizer but also Moderna, AstraZeneca, Johnson & Johnson and others -- have slashed hospitalizations and deaths in countries where they've been rolled out widely. In Europe alone, research shows they've saved about half a million lives among people 60 and older.

But they haven't vanquished the virus. Cases have quadrupled in the past year, vast parts of the globe haven't gained access to vaccines and variants keep emerging, bringing new waves of infections, the return of lockdowns and restrictions on travel.

And now, two years into the pandemic, there is omicron, a heavily mutated variant. It's put the world on edge, leaving everyone waiting for information on the severity of the strain and how well vaccines will work against it.

"Vaccines are a major miracle of modern science," said Sarah Pitt, a virologist at the University of Brighton in England. But some governments "decided they were going to vaccinate their way out of the pandemic. What we'll do is vaccinate everybody, and it will all be fine. Of course, that was never going to work."

The first Pfizer shot in the U.S. came on Dec. 14, 2020, a week after Keenan got her vaccination. China had started doling out its own vaccines in the summer of 2020.

Since Keenan's moment, many developed nations, including the U.K., have immunized the majority of their populations.

But the rollout over the past year hasn't been smooth, partly because of delivery snags and rare but potentially serious side effects that have fueled hesitancy in some quarters. Scientists also worry that vaccine disparities will breed more dangerous strains that pose a risk to all nations.

The covid-19 shots, developed in record time, have succeeded but aren't 100% effective, and some people who are protected can still become infected and transmit the illness to others.

Those cases appear to be more frequent with the delta variant surging and immunity waning in people who were vaccinated months ago. In Europe, the latest surge in infections has put Austria back in lockdown, while Germany may be about to make vaccines compulsory.

Scientists are now racing to update the current shots to combat omicron if necessary, and some are aiming to target multiple variants in one shot. Omicron's mutations suggest that it is likely to evade the protection of vaccines to at least some extent, but there is also some tentative evidence that it won't cause more severe illness than previous versions of the virus. Answers to some of those key questions are expected in the coming days.

With studies showing that vaccine effectiveness wanes over time, governments are accelerating booster campaigns. Pills from Merck and Pfizer are on the way, adding to the arsenal against the virus.

Given that vaccines aren't a silver bullet, some health experts say that, rather than counting so heavily on shots, governments should have maintained other measures, from masks to testing, for longer.

"We're so fortunate to have vaccines," said David Heymann, a professor at the London School of Hygiene and Tropical Medicine and former World Health Organization official. "In the U.K. and many countries with high vaccination levels, public health leaders believe, and I think they're probably right, that they've been able to delink serious illness from infection because of vaccines. But they haven't been able to prevent infection with this generation of vaccines."

Inequality has also been an issue in the drive to inoculate populations. Instead of vaccines being distributed evenly, rich countries raced ahead, creating a glaring gap in access. Health advocates have pushed to expand shipments, technology and production capacity.

Bruce Aylward, senior adviser to the WHO's director-general, says more affluent countries should focus on helping lower-income nations that are struggling with a "toxic mix" of low vaccination levels, weak testing, fragile health systems and other factors. Otherwise, the virus will continue to have places to take hold and adapt.

"You are playing with fire" if you don't keep pressure on the virus in all parts of the world, he said. "This virus will mutate, and if any of those mutations are favorable to transmission, they will emerge and they will dominate, and then you run into potential problems."

CALIFORNIA BRACES

California is preparing for a winter covid-19 surge -- if not from the omicron variant, then from the delta variant, which still poses a severe threat and has already caused surges in other states.

The state has been doing better than other parts of the country, but officials say they want to be ready.

Planning is well underway in central California, which has recently experienced a reprieve in covid-19 hospitalizations, down nearly 30% since mid-November.

Still, the San Joaquin Valley's most populous county, Fresno, has a hospitalization rate more than triple that of Los Angeles County, and Fresno officials are expecting the seasonal surge to again be bad.

"An anticipated winter surge ... may strike in the next few weeks," said Dr. Rais Vohra, interim health officer for Fresno County. But unlike last year, there are no plans for alternative care sites or cots at the convention center. "So if we have a surge, we're really just left with what resources the hospitals are able to leverage just on their own campuses."

If hospitals get extremely busy, they may be forced to implement crisis standards of care, Vohra said, potentially being required to ration health care to patients based on who is more likely to survive.

"December is going to be a very critical month for us to watch the numbers," Vohra said. "Because if we do get a winter surge, then I think it will show up within the month of December. And if it starts, then it may last throughout the winter months, because that's exactly what happened last year."

Nursing homes have become an area of focus in Los Angeles County. The county Department of Public of Health on Monday ordered that all skilled nursing facility residents, workers and contractors who might encounter residents must test for the coronavirus once a week, regardless of vaccination status, between Dec. 15 and Jan. 31.

Also, all visitors to such nursing homes will need to provide a recent negative coronavirus test before entry.

Officials in at least one county, San Diego, are suspecting that an uptick in locally reported cases late last week may be the initial sign of an increase in transmission related to Thanksgiving.

PLANT-BASED VACCINE

Also Tuesday, pharmaceutical companies Medicago and GlaxoSmithKline announced "positive efficacy and safety results" from a global trial using what they say is the world's first plant-based coronavirus vaccine.

Studying 24,000 adults across six countries, the late-stage trial found that the overall efficacy rate of the vaccine candidate was 71%, rising to 75.3% against "COVID-19 of any severity for the globally dominant Delta variant." However, the trial did not include the newly identified omicron variant.

The global Phase 3 placebo-controlled efficacy study used Canada-based Medicago's plant-based vaccine in combination with British drugmaker GSK's pandemic adjuvant, an ingredient that works to boost the immune response and efficacy of others' vaccines.

It does not yet have a brand name, the companies said, but is currently referred to as "CoVLP."

Plant-based vegan and vegetarian alternatives in food and materials markets have become increasingly popular globally, as consumers choose them for environmental or religious reasons, but Brian Ward, medical officer at Medicago, said it would not be appropriate to categorize the vaccine candidate as such: "The plants that are used simply act as bioreactors to produce the antigen."

The companies said they hoped the vaccine would diversify the pool of shots available and said the trial had shown that it was "well-tolerated, with no related serious adverse events reported in the vaccine group."

"This is an incredible moment for Medicago and for novel vaccine platforms. The results of our clinical trials show the power of plant-based vaccine manufacturing technology," Takashi Nagao, CEO and president of Medicago, said in a statement. "If approved, we will be contributing to the world's fight against the COVID-19 pandemic with the world's first plant-based vaccine for use in humans."

The vaccine candidate has not been approved by any regulatory authority.

Information for this article was contributed by Geoff Mulvihill, David A. Lieb, Josh Boak and Kimberly Chandler of The Associated Press; by James Paton of Bloomberg News (TNS); by Rong-Gong Lin II and Luke Money of the Los Angeles Times (TNS); and by Adela Suliman of The Washington Post.


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