White House Warns Of COVID Surges In The Winter

White House warns of Covid surges in the winter - POLITICO

Source: Politico, by Hannah Farrow

Covid cases surged during the last two winters and are likely to again this year — unless the country can prepare and act, White House Covid-19 response coordinator Ashish Jha said Sunday morning.

“If we don’t get ahead of this thing, we’ll have a lot of waning immunity, this virus continues to evolve and we may see a pretty sizable wave of infections, hospitalizations and deaths this fall and winter,” Jha said on ABC’s “This Week.”

Congress needs to provide resources, Jha said, specifically $22.5 billion, a number that will help with a vaccine supply that’s dwindling. In March, White House Coronavirus Response Coordinator Jeff Zients said: “If the science shows that fourth doses are needed for the general population later this year, we will not have the supply necessary to ensure shots are available.”

The money, once allocated, would go toward Covid vaccine supply and coronavirus testing.

“If Congress doesn’t step up and fund these, I think, urgent and emergent priorities … they can’t wait until the fall, it will be too late,” Jha said.

And the proof is in the jab. With cases increasing in the Northeast, deaths remain low because of high vaccination rates.

“That’s not true for the whole country,” Jha said.

With enough resources to get more people vaccinated and more therapeutics in place, he said, “I do think we can get through this winter without a lot of suffering and death.”

FDA Grants Emergency Authorization For First COVID-19 Breathalyzer Test

FDA grants emergency authorization for first COVID breath test | KHQA

Source: USA Today, by Jeanine Santucci

Americans will be able to find out if they have COVID-19 with a breathalyzer test, the Food and Drug Administration announced Thursday.

The FDA granted an emergency use authorization to a test produced by InspectIR Systems that collects a breath sample and analyzes for chemical compounds associated with the coronavirus, the first of its kind to be authorized for use.

In a study of 2,409 people, the test correctly identified a positive COVID infection in 91.2% of cases and correctly identified negative samples 99.3% of the time, the FDA said in a release. A similar result was seen in a follow-up study focused on the contagious omicron variant of the coronavirus.

According to InspectIR, the test is performed by exhaling into a tube in a similar manner to blowing up a balloon and produces results within three minutes.

The FDA said the testing instrument is about the size of a piece of carry-on luggage, and that breath tests can be performed in doctor’s offices, hospitals, and other testing sites.

“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “The FDA continues to support the development of novel COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the U.S. for the next public health emergency.”

The FDA said a positive result yielded through the InspectIR COVID-19 breathalyzer should be confirmed with a molecular test.

TSA Stops Mask Enforcement After Federal Judge Voids Mandate

Biden Doubled Mask Fines for Travelers. What Does it Mean for Passengers? -  The New York TimesSource: The Washington Post, by Michael Laris and Justin George

Federal officials stopped enforcement of a federal mask mandate Monday in transportation settings after a federal judge struck down the requirement, raising public health concerns and prompting several airlines to announce that face coverings are optional on domestic flights.

 

U.S. District Judge Kathryn Kimball Mizelle of the Middle District of Florida said the mandate exceeds the statutory authority of the Centers for Disease Control and Prevention. Federal officials last week had extended the mask mandate for commercial flights and in other settings, including on buses, ferries and subways, until at least May 3.

 

The transportation mandate has been among the highest-profile mask requirements in the country, persisting after most school districts and other jurisdictions have allowed similar mandates to expire. Conflicts over masks have been particularly acute on airplanes, where some flight attendants have been physically attacked and verbally abused for enforcing mask rules.

The decision comes as coronavirus cases are again climbing in the Northeast as the BA.2 omicron subvariant, which is more contagious than its predecessor, becomes the predominant strain in the United States. Health officials say it’s not clear whether the rise is the start of a larger surge.

The CDC’s masking order has been enforced through directives issued by the Transportation Security Administration. A Biden administration official, who shared guidance with reporters on the condition of anonymity, said Monday evening that the court decision means the CDC’s order is “not in effect at this time. Therefore, the TSA will not enforce its Security Directives” requiring the face coverings.

Airlines began announcing they were dropping the requirement, with some caveats for international destinations. In a statement, United Airlines said that “effective immediately, masks are no longer required at United on domestic flights, select international flights (dependent upon the arrival country’s mask requirements) or at U.S. airports.”

In the Washington region, Metro announced late Monday that masks are optional on its rail and bus systems for customers and Metro employees.

In her decision Monday, Mizelle, who was appointed by President Donald Trump and clerked for Supreme Court Justice Clarence Thomas, said the CDC had relied on a 1944 law, the Public Health Service Act, to impose the mandate. But the government’s argument that it put the mask requirement in place for the purpose of “sanitation” falls short, Mizelle argued.

“Wearing a mask cleans nothing. At most, it traps virus droplets. But it neither ‘sanitizes’ the person wearing the mask nor ‘sanitizes’ the conveyance,” Mizelle wrote.

 

The case was brought on behalf of a legal group known as Health Freedom Defense Fund and airline passengers, including Ana Daza, who said she has anxiety aggravated by wearing a mask.

Mizelle found for the plaintiffs on three key issues, ruling that the CDC had exceeded its legal authority, that it had improperly avoided notice and comment procedures, and that its mandate was “arbitrary and capricious.” In her ruling, Mizelle argued that the mask mandate wrongly curtailed passengers’ freedom of movement.

“Anyone who refuses to comply with the condition of mask wearing is — in a sense — detained or partially quarantined by exclusion” from their means of transportation, she wrote.

 

Industry trade group Airlines for America said U.S. airlines “have been strong advocates for eliminating pandemic-era policies and are encouraged by the lifting of the federal transportation mask mandate.” The group said high U.S. immunity levels and widespread vaccine accessibility, plus hospital grade cabin-air filtration, should give travelers confidence.

The CDC said Monday it doesn’t comment on pending litigation.

In a legal filing last month defending the mandate, Justice Department lawyers said the plaintiffs in this case had relied on an “unduly narrow and grammatically incorrect” interpretation of the public health law. They noted that Congress had authorized health officials to make and enforce regulations “necessary to prevent the introduction, transmission, or spread of communicable diseases” from outside the country, or within it, using “sanitation” and “other measures.” They also noted that the Supreme Court, in a case last year, said those measures relate directly to preventing the interstate spread of disease “by identifying, isolating, and destroying the disease itself.”

 

Masking requirements have generally been made after considering emerging epidemiology on restricting the spread of the virus, and not on an “arbitrary or capricious” basis, Jeanne Marrazzo, director of the Division of Infectious Diseases at the University of Alabama at Birmingham, said in an email while quoting the words Mizelle used in her ruling.

“I believe the CDC was simply erring on the side of caution given the extraordinary mixing opportunities afforded by airports and mingling that occurs there,” she said. “On the plane, while it’s flying, as I have said before, air exchange is good, but we still don’t know HOW good it is with this much more contagious new variant.”

The Biden administration announced the mandate quickly after President Biden came into office, following the Trump administration’s resistance. Airline policies at the time had required that masks be worn.

 

“This is obviously a disappointing decision,” White House press secretary Jen Psaki said Monday, adding that the CDC and White House continue to recommend wearing masks in public transportation settings.

She said the Department of Homeland Security — which includes the TSA — was reviewing the decision. The Justice Department will “make any determinations about litigation,” Psaki said. A Justice Department spokeswoman said the agency is reviewing the decision and declined to comment further.

Sara Nelson, president of the Association of Flight Attendants-CWA, which represents nearly 50,000 flight attendants at 17 airlines, said many legal uncertainties remained on Monday. In a statement, she urged “calm and consistency in the airports and on planes.”

“The last thing we need for workers on the frontlines or passengers traveling today is confusion and chaos,” she said.

Nelson urged travelers to check with airlines for their masking requirements. She said clear communication would help flight attendants and other front-line workers avoid problems that could stem from the confusion over changing rules.

“In aviation operations, it is impossible to simply flip a switch from one minute to the next. It takes a minimum of 24-48 hours to implement new procedures and communicate this throughout the entire network,” she said.

A March poll by the health group KFF found Americans were roughly divided on whether the federal government should extend the mask requirement for airplanes, trains and other public transportation (48 percent) or let it expire (51 percent). More than 7 in 10 Democrats said it should be extended, while 76 percent of Republicans supported letting it expire.

Fliers on Monday had mixed reactions.

Stephanie Dexter, her husband, Brad, and their daughter, Eva, wore surgical masks and cone-shaped K95 masks as they walked out of Reagan National Airport on Monday afternoon. They had flown Eva from Omaha to D.C. for a spring vacation, where they planned to visit monuments and museums. The mask mandate did not weigh heavily on their minds.

“We were fine wearing them today,” said Stephanie Dexter. “I’m an asthmatic. I’m fine not getting sick.”

Phil Delin, 67, of Prince George’s County, Md., said he had heard “a sprinkle” about the judge’s ruling before he arrived at the airport with his golf clubs for a trip to Las Vegas.

“I still don’t understand a Florida judge reversing a federal mandate when the mandate is backed by as much science as it is,” he said. He had no second thoughts about wearing a mask aboard his Monday night flight.

Simon Rojas, 29, who had flown back into Reagan National from Las Vegas in shorts, stood outside while waiting for his ride as a chilly wind forced others waiting for a ride back into the terminal. He said he was pleased the judge ruled against the mandate, saying it made no sense to wear a mask on a plane when people are so close and are lifting masks to drink and eat.

“Just take them off,” Rojas, of Laurel, Md., said of mask regulations. “In the news, they’ve been saying the death rate is going down, right? Also, I think if you’re in such a closed space like a plane, that mask isn’t doing anything.”

The Biden administration has faced growing pressure to lift the mask requirement for air travel and public transit. Earlier this month, Republican leaders on the House and Senate transportation committees reiterated their call for Biden to “rescind or decline to extend the mask mandate.”

In late March, 21 mostly Republican-led states sued the government, seeking to immediately end the mask requirement.

Last month, executives from 10 airlines, including American, United and Delta, sent a letter to Biden urging him to end pandemic-related travel policies, including the mask mandate.

The ruling comes as airlines are seeing a surge in spring travel — one the industry anticipates will extend through the summer and beyond. Transportation Security Administration officials have reported an increase in the number of people screened at airport checkpoints, with many days routinely topping the 2 million mark, as they had before the pandemic.

Coronavirus Cases On The Rise In L.A. County, Prompting Calls For Spring Break Caution

Coronavirus cases on the rise in L.A. County, prompting calls for spring  break caution - Los Angeles TimesSource: Los Angeles Times, by Luke Money, Rong-Gong Lin II

Coronavirus cases are once again on the rise in Los Angeles County, according to data released Monday, prompting officials to urge residents to keep up safety protocols as the spring break holiday season arrives.

Data show that for the seven-day period that ended Monday, an average of 960 new cases were reported daily countywide, which equates to 67 cases a week for every 100,000 residents. That’s up 23% from the previous week, when L.A. County reported an average of 783 cases a day.

Caseloads of this magnitude remain a far cry from the tens of thousands of new daily infections during the height of the Omicron surge. In mid-January, L.A. County was reporting 42,000 new coronavirus cases a day.

Nevertheless, the trendline is the source of some concern, especially given the proliferation of BA.2 — an Omicron subvariant estimated to be 30% to 60% more contagious than the earlier version that swept the globe last fall and winter.

Scientists are also now tracking an even more potentially contagious subvariant, XE, which some early estimates indicate may be 10% more transmissible than BA.2.

“The evidence is becoming clearer that given the current approved vaccines and the reality of a mutating virus, some of us will need to boost our immune systems a couple of times during the year in order to be optimally protected,” county Public Health Director Barbara Ferrer said in a statement. “This includes those infected with Omicron over the winter, since natural immunity … also wanes over time.”

Given that many residents are likely to travel or gather in the coming weeks — either for spring break or to mark holidays such as Easter, Ramadan or Passover — Ferrer said it remains important to “do our very best to make use of the powerful tools at hand, vaccinations, boosters, testing, and masking, to keep ourselves and those most vulnerable to severe illness, as safe as possible.”

There are more than 1.7 million L.A. County residents age 5 and up who haven’t received a single vaccination dose, and an additional 2.8 million vaccinated residents who haven’t received a booster, even though they’re eligible for one.

L.A. County’s coronavirus case rate hit a post-winter surge low of about 609 cases a day from March 18 to 24. That was about two weeks after the region ended its universal requirement to wear masks in indoor public spaces — one of the last counties in California to do so.

Since then, the countywide case rate has ticked upward, a development officials have said is likely fueled by a combination of waning immunity, the loosening of masking rules and the spread of BA.2.

The daily reported caseload is just one of many metrics health officials utilize to track and assess the pandemic’s trajectory. Another, the proportion of conducted tests that are confirming coronavirus infection, has also inched up slightly as of late, but remains low at 1%, county health officials said.

And while cases have crept up a bit, the number of people hospitalized with COVID-19 countywide has continued to trend downward. As of Sunday, 265 coronavirus-positive patients were hospitalized countywide — down about 8% from a week ago.

Experts in California have said there are unmistakable signs of an uptick in coronavirus cases in the state. But whether this latest uptick ultimately proves to be a temporary blip or the harbinger of something more significant, however, remains to be seen.

For the weekly period that ended Thursday, California was averaging about 2,800 cases a day, or 50 cases a week for every 100,000 residents, up 9% over the prior week.

Orange County’s case rate is also increasing. Orange County’s case rate is about 134 cases a day, or 30 cases a week for every 100,000 residents, up 12% over the prior week.

San Francisco, which now has one of California’s highest case rates, on Thursday was recording about 127 cases a day, or 102 cases a week for every 100,000 residents, a 6% increase over the prior week.

A coronavirus case rate of 50 or more cases a week for every 100,000 residents is considered substantial, while a rate of 100 or more is considered high.

Dr. Robert Wachter, chair of UC San Francisco’s Department of Medicine, tweeted Thursday that the percentage of asymptomatic patients testing positive at UC San Francisco’s hospitals had risen to 2%, up from 1% in late March.

“If you’ve let guard down, time to be more careful,” he wrote.

By Monday, the rate had dipped back down to 1.6%, Wachter said in an email. That means that in San Francisco, there’s a 28% chance that at least one person attending a party with 20 asymptomatic people will test positive for the coronavirus.

Some experts are optimistic that the case numbers so far offer glimmers of hope that this spring will not bring a second Omicron surge on the magnitude of those seen elsewhere — such as Britain, where hospitals have once again come under strain.

Dr. Eric Topol, director of the Scripps Research Translational Institute in La Jolla, tweeted Saturday that “it’s clear that wave 6 (BA.2), yet still in the works, will not resemble” the fifth surge of the pandemic, or last winter’s Omicron surge.

But Myoung Cha, chief strategy officer for San Francisco-based Carbon Health, disagreed with “confident takes … that this surge won’t be big.” He noted many people this year are self-diagnosing with at-home tests — the results of which are not reliably reported to the government.

By contrast, lab tests conducted at official facilities are automatically reported to the authorities.

“The current case rates are massively undercounted versus prior surges,” Cha tweeted Sunday.

As is the case anytime COVID-19 shows signs of resurgence, the question on many people’s minds is when, or whether, health authorities may consider reimplementing restrictions.

In Philadelphia, where cases have jumped by more than 50% over the last 10 days, officials on Monday announced the return of an indoor mask mandate, effective April 18.

Philadelphia had preexisting criteria in place that would trigger a return to a mask order when average new cases a day exceeded more than 100 and when cases have risen by more than 50% in the previous 10 days. On Monday, officials reported that the city of 1.58 million people was averaging 142 new cases a day, or 63 cases a week for every 100,000 residents.

Philadelphia Mayor Jim Kenney said the return of the mask mandate in indoor public settings was needed to prevent higher case rates.

“Our city remains open; we can still go about our daily lives and visit the people and places we love while masking in indoor public spaces,” Kenney tweeted.

A number of universities in the Northeast have announced a return to universal mask policies. Columbia University, Georgetown University and American University have announced the return of indoor mask requirements recently.

So far, officials in L.A. County and the state have not indicated that conditions warrant the imposition of new measures or mandates — though, in both cases, they still urge residents to mask up indoors while in public.

Speaking with reporters last week, though, Ferrer said people should be concerned about the rise in the number of school outbreaks countywide. There were 14 new outbreaks in K-12 schools in L.A. County for the week that ended Thursday. For the previous week, there were four.

She noted that in some other settings where masking is still required — like nursing homes and homeless shelters — there has not been an increase in outbreaks.

Ferrer also expressed some optimism that a second increase in Omicron cases this spring wouldn’t be as bad as the winter surge. People who have been infected with the earlier Omicron subvariants earlier this winter, BA.1 or BA.1.1, are likely to have a degree of immune protection against the latest Omicron subvariant, BA.2, at least for the near future.

“I am hopeful … that given what we’ve seen and what we’re doing, we should be able to avoid a really big surge,” Ferrer said.

In a round of interviews with morning network shows, Dr. Ashish Jha, the incoming White House COVID-19 Response Coordinator, said he’s “not overly concerned right now” about the rise in cases nationally.

“Case numbers are rising. … We were expecting this, because we saw this in Europe a few weeks ago,” Jha said on NBC’s “Today” show. “But the good news is: We’re coming off of some very low infection numbers. Hospitalizations right now are the lowest they have been in the entire pandemic.

“So we’ve got to watch this very carefully. Obviously, I never like to see infections rising, I think we’ve got to be careful, but I don’t think this is a moment where we have to be excessively concerned,” Jha said.

Your Next COVID-19 Vaccine Will Be Different

Source: The Mercury News, by Lisa M. Krieger

After deploying four COVID-19 shots in a little more than two years, the nation is absorbing a troubling realization: That’s a pace that’s impossible to sustain.

This past week, experts began charting a path to a future that is less perfect – but more practical.

It means building a vaccine that targets more than one strain of the virus. It would reduce severe disease and death, but not prevent every infection. If the design is changed, all vaccines will be updated. Manufacturers will likely offer the same vaccine formulation to everyone, rather than a mélange of different products for different people on different schedules.

And the goal is to have it ready by next fall when the risk of illness is likely to soar. That’s a very tight deadline.

Faced with the triple threats of fading immunity, an evolving virus and holiday gatherings, “we have to be prepared, from a standpoint of national security, making sure that we can protect our population with a vaccine in hand,” Dr. Peter Marks told an expert advisory FDA committee on Wednesday.

What will that look like?

“If we settle down to one shot per year that combines COVID and flu, I think that will be sustainable,” said UC San Francisco infectious disease expert Dr. Peter Chin-Hong.

“Nobody will want to get a vaccine every six months,” he said. “So we have to change the strategy.”

The creation and distribution of COVID-19 vaccines will go down in history as one of medicine’s greatest achievements. Only one year after cases were first documented, a shot was available. Fifteen months later, an impressive total of four doses were available for many people: a two-dose primary series and two boosters.

But, with each announced dose, interest fades. While 77% of the eligible U.S. population has gotten one shot, that rate dips to 65% who have gotten two shots and only 50% who have gotten three shots. The fourth dose is just beginning to be rolled out.

Vaccine protection is fading, too. After every shot, our immunity follows the same disappointing downward trajectory. Vaccines that are 91% effective in preventing hospitalization during the first two months fall to 78% after four months – and, over time, keep declining.

This means that people who got their one shot back in early 2021 are increasingly vulnerable.

Funding also will fade. Today’s federal funding free-for-all strategy won’t continue indefinitely, predict experts. Costs will be shifted to private insurers. That puts pressure on efficiency and effectiveness.

Yet the virus is here to stay. And it will keep changing. The virus has mutated two to 10 times faster than the flu, depending on the strain, reported virologist Trevor Bedford of the Fred Hutchinson Cancer Research Center in Seattle. He said it will continue mutating a little or a lot – either is possible.

Initially, experts hoped that a three-dose regimen would offer long-term protection. That strategy works for measles, mumps, rubella, hepatitis B, HPV and other viruses.

But COVID is different because it changes more, said Chin-Hong. That creates special challenges for vaccination planning.

This means things must move fast. The FDA hopes to decide on the composition of a future vaccine in May or June. While some clinical trials of potential products are already underway, vaccine manufacturers need several months to produce enough doses of a reconfigured vaccine, according to Robert Johnson, director of an infectious disease division within the Department of Health and Human Services.

The panel agreed on these points:

• The promise of a new “bivalent” or “multivalent” vaccine.

There’s a diminishing return by repeatedly giving the same “monovalent” vaccine, which targets the original strain, especially as new variants emerge. It also seems unlikely that an omicron-specific booster is the best idea. The virus changes so frequently that it could quickly be out of date.

A better approach may be to design something that targets two or more strains of the virus, called a “bivalent” or “multivalent” vaccine. Such vaccines are already in the works at Moderna and Novovax.

“A multivalent vaccine is going to be important in hopefully prolonging the duration of protection,” said Dr. Mark Sawyer, professor of clinical pediatrics at UC San Diego.

• Therapeutics must play a growing role.

Rather than constantly adding vaccines, we should seek the help of antiviral drugs, monoclonal antibodies and other future therapies to treat infections to keep people out of hospitals.

With 80% protection against hospitalization in older and sicker adults, “I think we may have to accept that level of protection and then use other alternative ways to protect individuals with therapeutics and other measures,” said Amanda Cohn of the U.S. Centers for Disease Control and Prevention.

• Take a more unified approach to manufacturing.

Vaccine makers should target the same strains, using similar doses, panelists said. It will prove impossible to keep track of multiple vaccines with different compositions.

The CDC must take the lead in deciding when the vaccines are no longer effective against severe illness, said Dr. Paul Offit, professor of pediatrics at The Children’s Hospital of Philadelphia. “At some level, the companies kind of dictate the conversation here,” he said.

If a new vaccine is needed to respond to a scary variant, it won’t just be a booster. The whole two-dose “primary series” would be replaced.

Better data and new designs are needed.

Because we’re in a rush, we’re relying on what the data tells us about the immune response in blood. But we also need to get better at interpreting what these lab studies mean for protection out in the real world, said Dr. Hayley Ganz, professor of pediatrics at Stanford University Medical Center. Antibody counts are important, she said. But so are other parts of the immune system, as well as clinical outcomes.

Finally, we need to know what future products await us in the research pipeline, even if they are not yet FDA authorized.

“The current mRNA vaccines are great. They can be turned around quickly,” said infectious disease expert Dr. Ofer Levy of Boston Children’s Hospital. “But it may be that other platforms emerge that give broader protection. So as we move forward, we don’t want to bake in a system that excludes other types of vaccines.”

Last Updated 05/25/2022

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