Omicron variant

The FDA Has Authorized New Omicron Booster Shots

Pfizer and Moderna have released a new COVID booster shot that will target the highly contagious BA.4 and BA.5 omicron variant.

COVID boosters are getting an omicron makeover and could go into arms by the weekend.

“I will be at the front of the line at the pharmacy getting my vaccination. I’m very confident about this,” said Dr. Robert Califf, the FDA commissioner.

The Food and Drug Administration has authorized a formula change to target the highly contagious omicron BA.4 and BA.5 variants.

Anyone at least two months past their last COVID-19 shot is eligible. Moderna is authorized for those age 18 and older. For Pfizer and Biontech’s it’s 12 and up.

Health officials say it’s to get ahead for fall and winter when the virus has mutated and spread because more people are inside.

“The idea here is the more up to date you are, the better chance we have of looking at what may come afterwards,” said Dr. Peter Marks, the FDA vaccine chief.

Pfizer and Moderna can now ship out the omicron formulated boosters.

State and local health departments began placing pre-orders last month.

The decision has faced some criticism though.

Regulators say the new vaccine formula is similar enough that safety is sound.

But how well it works in humans is unclear.

Both Moderna and Pfizer submitted efficacy results from animal studies.

That research did show a better antibody response to all the omicron subvariants compared to the original formula.

Clinical trials on humans are set to begin next month.

“f we wait for those data in human data, not just mice data, in human data we will be using what I would be using what I would consider to be a very outdated vaccine,” said Dr. Rochelle Walensky, the CDCd director.

The CDC still needs to sign off and officially recommend the new booster formula. Their advisors are meeting this week.

: newsy.com

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WHO: World Coronavirus Cases Fall 24%, Deaths Rise In Asia

By Associated Press
August 19, 2022

The U.N. health agency said there were 5.4 million new COVID-19 cases reported last week, a decline of 24% from the previous week.

New coronavirus cases reported globally dropped nearly a quarter in the last week while deaths fell 6% but were still higher in parts of Asia, according to a report Thursday on the pandemic by the World Health Organization.

The U.N. health agency said there were 5.4 million new COVID-19 cases reported last week, a decline of 24% from the previous week. Infections fell everywhere in the world, including by nearly 40% in Africa and Europe and by a third in the Middle East. COVID deaths rose in the Western Pacific and Southeast Asia by 31% and 12% respectively, but fell or remained stable everywhere else.

At a press briefing Wednesday, WHO Director-General Tedros Adhanom Ghebreyesus said reported coronavirus deaths over the past month have surged 35%, and noted there had been 15,000 deaths in the past week.

“15,000 deaths a week is completely unacceptable, when we have all the tools to prevent infections and save lives,” Tedros said. He said the number of virus sequences shared every week has plummeted 90%, making it extremely difficult for scientists to monitor how COVID-19 might be mutating.

“But none of us is helpless,” Tedros said. “Please get vaccinated if you are not, and if you need a booster, get one.”

On Thursday, WHO’s vaccine advisory group recommended for the first time that people most vulnerable to COVID-19, including older people, those with underlying health conditions and health workers, get a second booster shot. Numerous other health agencies and countries made the same recommendation months ago.

The expert group also said it had evaluated data from the Pfizer-BioNTech and Moderna vaccines for younger people and said children and teenagers were in the lowest priority group for vaccination, since they are far less likely to get severe disease.

Joachim Hombach, who sits on WHO’s vaccine expert group, said it was also uncertain whether the experts would endorse widespread boosters for the general population or new combination vaccines that target the Omicron variant.

“We need to see what the data will tell us and we need to see actually (what) will be the advantage of these vaccines that comprise an (Omicron) strain,” he said.

Dr. Alejandro Cravioto, the expert group’s chair, said that unless vaccines were proven to stop transmission, their widespread use would be “a waste of the vaccine and a waste of time.”

Earlier this week, British authorities authorized an updated version of Moderna’s COVID-19 vaccine that targets Omicron and the U.K. government announced it would be offered to people over 50 beginning next month.

Additional reporting by The Associated Press.

: newsy.com

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CDC Drops Quarantine, Distancing Recommendations For COVID

The changes are driven by a recognition that an estimated 95% of Americans 16 and older have acquired some level of immunity.

The nation’s top public health agency relaxed its COVID-19 guidelines Thursday, dropping the recommendation that Americans quarantine themselves if they come into close contact with an infected person.

The Centers for Disease Control and Prevention also said people no longer need to stay at least 6 feet away from others.

The changes, which come more than 2 1/2 years after the start of the pandemic, are driven by a recognition that an estimated 95% of Americans 16 and older have acquired some level of immunity, either from being vaccinated or infected, agency officials said.

“The current conditions of this pandemic are very different from those of the last two years,” said the CDC’s Greta Massetti, an author of the guidelines.

Many places around the country long ago abandoned social distancing and other once-common precautions, but some of the changes could be particularly important for schools, which resume classes this month in many parts of the country.

Perhaps the biggest education-related change is the end of the recommendation that schools do routine daily testing, although that practice can be reinstated in certain situations during a surge in infections, officials said.

The CDC also dropped a “test-to-stay” recommendation, which said students exposed to COVID-19 could regularly test — instead of quarantining at home — to keep attending school. With no quarantine recommendation anymore, the testing option disappeared too.

Masks continue to be recommended only in areas where community transmission is deemed high, or if a person is considered at high risk of severe illness.

School districts across the U.S. have scaled back their COVID-19 precautions in recent weeks even before the latest guidance was issued. Some have promised a return to pre-pandemic schooling.

Masks will be optional in most districts when classes resume this fall, and some of the nation’s largest districts have dialed back or eliminated COVID-19 testing requirements.

Public schools in Los Angeles are ending weekly COVID-19 tests, instead making at-home tests available to families, the district announced last week. Schools in North Carolina’s Wake County also dropped weekly testing.

Some others have moved away from test-to-stay programs that became unmanageable during surges of the Omicron variant last school year.

The American Federation of Teachers, one of the nation’s largest teachers unions, said it welcomes the guidance.

“Every educator and every parent starts every school year with great hope, and this year even more so,” President Randi Weingarten said. “After two years of uncertainty and disruption, we need as normal a year as possible so we can focus like a laser on what kids need.”

The new recommendations prioritize keeping children in school as much as possible, said Joseph Allen, director of Harvard University’s healthy building program. Previous isolation policies forced millions of students to stay home from school, he said, even though the virus poses a relatively low risk to young people.

“Entire classrooms of kids had to miss school if they were deemed a close contact,” he said. “The closed schools and learning disruption have been devastating.”

Others say the CDC is going too far in relaxing its guidelines.

Allowing students to return to school five days after infection, without proof of a negative COVID-19 test, could lead to outbreaks in schools, said Anne Sosin, a public health researcher at Dartmouth College. That could force entire schools to close temporarily if teachers get sick in large numbers, a dilemma that some schools faced last year.

“All of us want a stable school year, but wishful thinking is not the strategy for getting there,” she said. “If we want a return to normal in our schools, we have to invest in the conditions for that, not just drop everything haphazardly like we’re seeing across the country.”

The average numbers of reported COVID-19 cases and deaths have been relatively flat this summer, at around 100,000 cases a day and 300 to 400 deaths.

The CDC previously said that if people who are not up to date on their COVID-19 vaccinations come into close contact with a person who tests positive, they should stay home for at least five days. Now the agency says quarantining at home is not necessary, but it urges those people to wear a high-quality mask for 10 days and get tested after five.

The agency continues to say that people who test positive should isolate from others for at least five days, regardless of whether they were vaccinated. CDC officials advise that people can end isolation if they are fever-free for 24 hours without the use of medication and they are without symptoms or the symptoms are improving.

Also on Thursday, the Food and Drug Administration updated its recommendations for how many times people exposed to COVID-19 should test.

Previously, the FDA had advised taking two rapid antigen tests over two or three days to rule out infection. Now the agency recommends three tests.

FDA officials said the change was based on new studies that suggest the old protocol can miss too many infections and result in people spreading the coronavirus, especially if they don’t develop symptoms.

Additional reporting by The Associated Press.

: newsy.com

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Biden Tests Positive For COVID-19, Has ‘Mild Symptoms’

The 79-year-old Biden is fully vaccinated after getting two initial doses of the coronavirus vaccine and two boosters since.

President Joe Biden tested positive for COVID-19 on Thursday, underscoring the persistence of the highly contagious virus as new variants challenge the nation’s efforts to resume normalcy after two and a half years of pandemic disruptions.

White House Press Secretary Karine Jean-Pierre said that Biden was experiencing “mild symptoms” and has begun taking Paxlovid, an antiviral drug designed to reduce the severity of the disease.

She said Biden “will isolate at the White House and will continue to carry out all of his duties fully during that time. He has been in contact with members of the White House staff by phone this morning, and will participate in his planned meetings at the White House this morning via phone and Zoom from the residence.”

Biden, 79, is fully vaccinated, after getting two doses of the Pfizer coronavirus vaccine shortly before taking office, a first booster shot in September and an additional dose March 30.

Up to this point, Biden’s ability to avoid the virus seemed to defy the odds, even with the testing procedures in place for those expected to be in close contact with him. Prior waves of the virus swept through Washington’s political class, infecting Vice President Kamala Harris, Cabinet members, White House staffers and lawmakers. Biden has increasingly stepped up his travel schedule and resumed holding large indoor events where not everyone is tested.

Top White House officials in recent months have been matter-of-fact about the likelihood of the president getting COVID, a measure of how engrained the virus has become in society — and of its diminished threat for those who are up to date on their vaccinations and with access to treatments.

When administered within five days of symptoms appearing, Paxlovid, produced by drugmaker Pfizer, has been proven to bring about a 90% reduction in hospitalizations and deaths among patients most likely to get severe disease.

In an April 30 speech to more than 2,600 attendees at the White House Correspondents’ Association dinner, Biden acknowledged the risks of attending large events, but said it was worthwhile to attend.

“I know there are questions about whether we should gather here tonight because of COVID,” he said. “Well, we’re here to show the country that we’re getting through this pandemic.”

Biden is far from the first world leader — and not the first U.S. president — to get the coronavirus, which has infected British Prime Minister Boris Johnson, French President Emmanuel Macron and more than a dozen other leaders and high-ranking officials globally.

When Biden’s predecessor, President Donald Trump, contracted the disease in October 2020, it was a far different time. Vaccines were not available and treatment options were limited and less advanced. After being diagnosed with COVID-19 at the White House, Trump was given an experimental antibody treatment and steroids after his blood oxygen levels fell dangerously low. He was hospitalized at Walter Reed National Military Medical Center for three days

While much of the world has resumed normal rhythms after the early lockdowns to control spikes in cases and deaths, the virus still serves as a disrupter in daily life as people are forced to change plans, isolate and calculate the risks of taking part in various activities.

And after more than two years and over a million deaths in the U.S., the virus is still killing an average of 353 people a day in the U.S., according to the Centers for Disease Control and Prevention. The unvaccinated are at far greater risk, more than two times more likely to test positive and nine times more likely to die from the virus than those who have received at least a primary dose of the vaccines, according to the public health agency.

The White House has faced a flurry of questions about COVID-19 protocols surrounding the president. The spring Washington outbreak came weeks after the Centers for Disease Control and Prevention eased face-covering guidance in most of the U.S.

As the virus crept closer to Biden, then-White House press secretary Jen Psaki said Biden believed it to be “vitally important to him, to his presidency, to the American people,” to travel and continue to host large events.

She added of Biden, “Just like many Americans, he makes risk assessments.”

The highly transmissible omicron variant is the dominant strain in the U.S., but scientists say it poses a lower risk for severe illness to those who are up to date on their vaccinations. The BA.5 sub-strain, believed to be even more contagious, now makes up more than 65% of U.S. cases.

“There’s a lot of infections across America,” White House COVID-19 coordinator Dr. Ashish Jha said May 18, blaming the highly-transmissible variants, as well as relaxing mitigation measures like mask requirements.

The coronavirus pandemic helped put Biden in the White House, as he pledged to handle COVID-19 better than his predecessor. After initial months of success surging the nation’s supply and availability of vaccines, the virus became a morass for the Democrat in the first year of his presidency, as he struggled to boost the country’s vaccination rate and to stay ahead of the unpredictable disease.

As cases sharply declined earlier this year, Biden again highlighted his administration’s efforts to end the pandemic and help the nation regain a sense of normalcy.

In his State of the Union address on March 1, Biden said it was safe for most Americans to resume their normal pre-pandemic activities, citing declining case rates, vaccinations and newly developed therapeutics.

“Tonight, I can say we are moving forward safely, back to more normal routines,” he said. “It’s time for Americans to get back to work and fill our great downtowns again.”

Yet in recent weeks, U.S. officials have called for the public to exercise caution once again over the BA.5 variant, and appealed to the public to seek out booster shots if eligible and for most Americans to consider whether they should wear a face mask in public indoor settings.

“We should not let it disrupt our lives,” Dr. Anthony Fauci, the nation’s top infectious disease expert said July 12, “but we cannot deny that it is a reality that we need to deal with.”

The White House has sought to go above and beyond public health guidelines to protect the president, with all visitors and staff, required to attest to their vaccination status or submit to daily tests. Additionally, people expected to be in close proximity to Biden are tested daily.

Still, Biden has increasingly demonstrated a willingness to participate in larger, indoor events in recent months — riskier activities for contracting the virus — and many have had people not wearing masks. White House officials say Biden was intent on showing he can fulfill his presidential responsibilities without fear of the virus, believing he was well protected against severe outcomes

“His doctors are comfortable that he could continue to carry out his duties because of all these steps and precautions and protections he’s taken,” Psaki said on April 8.

In studies, the vaccines most widely used in the U.S. have been found to protect against severe illness and hospitalization, but new cases have emerged even among those who are fully vaccinated.

Additional reporting by The Associated Press.

: newsy.com

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CDC Endorses More Traditional Novavax COVID Shot For Adults

CDC officials said between 26 million and 37 million adults haven’t had a single dose of any COVID vaccine.

U.S. adults who haven’t gotten any COVID-19 shots yet should consider a new option from Novavax — a more traditional kind of vaccine, health officials said Tuesday.

Regulators authorized the nation’s first so-called protein vaccine against COVID-19 last week, but the final hurdle was a recommendation from the Centers for Disease Control and Prevention.

“If you have been waiting for a COVID-19 vaccine built on a different technology than those previously available, now is the time to join the millions of Americans who have been vaccinated,” Dr. Rochelle Walensky, CDC’s director, said in a statement, endorsing an earlier decision from an influential advisory panel.

Most Americans have gotten at least their primary COVID-19 vaccinations by now, but CDC officials said between 26 million and 37 million adults haven’t had a single dose — the population that Novavax, for now, will be targeting.

“We really need to focus on that population,” said CDC adviser Dr. Oliver Brooks, past president of the National Medical Association. Hopefully, the vaccine “will change them over from being unvaccinated to vaccinated.”

While it’s unclear how many will be persuaded by a more conventional option, “I’m really positive about this vaccine,” agreed fellow adviser Dr. Pablo Sanchez of Ohio State University.

THE NOVAVAX DIFFERENCE

All of the vaccines used in the U.S. train the body to fight the coronavirus by recognizing its outer coating, the spike protein — and the first three options essentially turn people’s cells into a temporary vaccine factory. The Pfizer and Moderna vaccines deliver genetic instructions for the body to make copies of the spike protein. The lesser-used Johnson & Johnson option uses a cold virus to deliver those instructions.

In contrast, the Novavax vaccine injects copies of the spike protein that are grown in a lab and packaged into nanoparticles that to the immune system resemble a virus. Another difference: An ingredient called an adjuvant, that’s made from the bark of a South American tree, is added to help rev up that immune response.

Protein vaccines have been used for years to prevent other diseases including hepatitis B and shingles.

HOW WELL IT WORKS

Large studies in the U.S., Mexico and Britain found two doses of the Novavax vaccine were safe and about 90% effective at preventing symptomatic COVID-19. When the delta variant emerged last summer, Novavax reported a booster dose revved up virus-fighting antibodies that could tackle that mutant.

Typical vaccine reactions were mild, including arm pain and fatigue, but regulators did warn about the possibility of a rare risk, heart inflammation, that also has been seen with the Pfizer and Moderna vaccines, mostly in teen boys or young men.

But early on, manufacturing problems delayed the Novavax vaccine — meaning the shots were studied long before the omicron variant hit, so it’s not clear how well they hold up against the immune-evading mutant.

Still, Novavax points to lab testing that shows the first two shots do spur production of virus-fighting antibodies that are cross-protective against omicron, including the BA.5 subtype that’s currently the nation’s top threat. A booster dose further revved up cross-protective antibodies.

HOW TO USE NOVAVAX SHOTS

The CDC’s advisers unanimously endorsed the two-shot primary series. But several noted that it was important for regulators to clear a booster by the time, five or so months after their last dose, that Novavax recipients will need one.

Also, the two doses typically are given three weeks apart. But CDC officials said that like with other COVID-19 vaccines, it’s possible to wait up to eight weeks for the second dose — except for people at the highest risk, who need protection quickly.

WHAT HAPPENS NEXT

Walensky signed off on recommendations for adults to get the first two Novavax doses. In its first purchase, the U.S. government bought 3.2 million doses and vaccinations are expected to begin in the next few weeks.

The Novavax vaccine also is used in Europe, Canada, Australia, South Korea and other countries. Many allow booster doses, and European regulators recently cleared the shots to given as young as age 12.

The Maryland-based company likewise expects U.S. authorization of a booster dose and teen vaccinations to follow fairly soon.

And like other vaccine makers, Novavax is testing shots updated to better match the newest omicron subtypes — in anticipation of another round of boosters this fall and winter.

Additional reporting by The Associated Press.

: newsy.com

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A Chinese Entrepreneur Who Says What Others Only Think

China’s entrepreneur class is grappling with the worst economic slump in decades as the government’s zero Covid policy has shut down cities and kept would-be customers at home. Yet they can’t seem to agree on how loudly they should complain — or even whether they should at all.

A tech entrepreneur wrote in a big group chat in May that many members were too critical. “What people here do every day is criticizing the government and the system,” she wrote. “I can’t see any entrepreneurship in this.”

A top venture capitalist told his nearly nine million social media followers that as much as everyone had suffered from the pandemic, they should try to stay away from negative news and information.

zero Covid policy, which has put hundreds of millions of people under some kind of lockdowns in the past few months, costing jobs and revenues. He’s saying what many others are whispering in private but fear to say in public.

“The questions we should ask ourselves are,” he wrote in an article that was censored within an hour of posting but shared widely in other formats, “what caused such widespread negative sentiment across the society? Who should be responsible for this? And how can we change it?”

He said the lockdowns in Shanghai and other cities made it clear that wealth and social status meant little to a government determined to pursue its zero Covid policy. “We’re all nobodies who could be sent to the quarantine camps, and our homes could be broken into,” he wrote. “If we still choose to adapt to and put up with this, all of us will face the same destiny: trapped.”

staying out of politics is no longer an option for China’s business leaders. But some of his peers are reluctant, given the potential penalties.

steered away from the market economy and cracked down on some industries. It demonized entrepreneurs and went after some of the most prominent of them. Then when the mild, albeit contagious, Omicron variant of the coronavirus emerged in China this year, the government meddled with free enterprise as it hadn’t in decades.

The lockdowns and restrictions have done so much damage to the economy that Premier Li Keqiang summoned about 100,000 cadres to an emergency meeting in late May. He called the situation “severe” and “urgent,” citing sharp drops in employment, industrial production, electricity consumption and freight traffic.

Many business leaders believe that it will be hard to reverse the damage if the government doesn’t stop the zero Covid policy. Yet they feel that there’s nothing they can do to make Beijing change course.

The chairman of a big internet company told me that with all the pandemic restrictions, he and others were operating as if dancing with shackles on while expecting the sword of a lockdown to strike at any moment. With a big public company to run, he said, it would be too risky to be vocal. He hoped the economists could be more outspoken.

The chairman of a publicly listed conglomerate with many consumer-facing businesses said he had to shut down a few of his companies and let people go as revenues dropped off a cliff. He’s not a Christian, he said, but he has been praying to God every day to help him get through this tough period.

Astonishing data for 2021 tell the story. U.S. start-ups raised $330 billion, nearly double 2020’s record haul of $167 billion, according to PitchBook, which tracks private financing. More tech start-ups crossed the $1 billion valuation threshold than in the previous five years combined. The median amount of money raised for very young start-ups taking on their first major round of funding grew 30 percent, according to Crunchbase. And the value of start-up exits — a sale or public offering — spiked to $774 billion, nearly tripling the prior year’s returns, according to PitchBook.

The big-money headlines have carried into this year. Over a few days this month, three private start-ups hit eye-popping valuations: Miro, a digital whiteboard company, was valued at $17.75 billion; Checkout.com, a payments company, was valued at $40 billion; and OpenSea, a 90-person start-up that lets people buy and sell nonfungible tokens, known as NFTs, was valued at $13.3 billion.

Investors announced big hauls, too. Andreessen Horowitz, a venture capital firm, said it had raised $9 billion in new funds. Khosla Ventures and Kleiner Perkins, two other venture firms, each raised nearly $2 billion.

The good times have been so good that warnings of a pullback inevitably bubble up. Rising interest rates, expected later this year, and uncertainty over the Omicron variant of the coronavirus have deflated tech stock prices. Shares of start-ups that went public through special purpose acquisition vehicles last year have slumped. One of the first start-up initial public offerings expected this year was postponed by Justworks, a provider of human resources software, which cited market conditions. The price of Bitcoin has sunk nearly 40 percent since its peak in November.

But start-up investors said that had not yet affected funding for private companies. “I don’t know if I’ve ever seen a more competitive market,” said Ambar Bhattacharyya, an investor at Maverick Ventures.

Even if things slow down momentarily, investors said, the big picture looks the same. Past moments of outrageous deal making — from Facebook’s acquisitions of Instagram and WhatsApp to the soaring private market valuations of start-ups like Uber and WeWork — have prompted heated debates about a tech bubble for the last decade. Each time, Mr. Bahat said, he thought the frenzy would eventually return to normal.

Instead, he said, “every single time it’s become the new normal.”

Investors and founders have adopted a seize-the-day mentality, believing the pandemic created a once-in-a-lifetime opportunity to shake things up. Phil Libin, an entrepreneur and investor, said the pandemic had changed every aspect of society so much that start-ups were accomplishing five years of progress in one year.

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Omicron variant

Unusual Patterns