North Korea on Friday said the latest fever cases detected in its border region with China were tested to be influenza, not coronavirus infections as initially feared.
The report by North Korea’s official Korean Central News Agency came a day after the North said it locked down unspecified areas in Ryanggang province after four people had fevers that were suspected to be COVID-19.
North Korea maintains it has had no confirmed coronavirus cases since Aug. 10, when leader Kim Jong Un declared a widely disputed victory over the virus, just three months after the country acknowledged an omicron outbreak.
KCNA said diagnostic tests of samples, the nature of the symptoms, and information gained from contract tracing led health workers to conclude that the fevers were caused by influenza. The patients have since returned to normal temperatures, it said.
North Korean officials lifted the lockdown but urged residents to maintain vigilance by continuing to wear masks and reporting to health authorities immediately if they experience fever symptoms.
While Kim claimed that the country’s success against the virus would be recognized as a global health miracle, experts believe North Korea has manipulated disclosures on its outbreak to help him maintain absolute control. The victory statement signals Kim’s aim to move to other priorities, including a possible nuclear test, experts say.
After admitting to a coronavirus outbreak in May, North Korea reported about 4.8 million “fever cases” across its mostly unvaccinated population of 26 million but only identified a fraction of them as COVID-19. Experts say the country’s official death toll of 74 is abnormally small, considering the country’s lack of public health tools.
North Korea dubiously insists that rival South Korea was responsible for its COVID-19 outbreak and has warned of “deadly” retaliation, saying that the virus was transported by anti-Pyongyang propaganda leaflets and other materials flown across the border by balloons launched by South Korean civilian activists. South Korea has dismissed such claims as unscientific and “ridiculous.”
Total Doses Distributed = 806,829,135. Total Doses Administered = 608,937,334. Number of People Receiving 1 or More Doses = 262,643,277. Number of People Fully Vaccinated = 223,914,723.
COVID-19 vaccines tweaked to better match today’s omicron threat are expected to roll out in a few weeks but still up in the air is how much benefit the booster shots will offer, who should get one — and how soon.
Pfizer and rival Moderna both asked U.S. regulators this week to authorize modified versions of their booster vaccine — shots that are half the original recipe and half protection against BA.4 and BA.5, the newest versions of omicron.
The Food and Drug Administration ordered that recipe at the end of June, and now has to decide if this combination — what scientists call a “bivalent vaccine” — is ready.
The Biden administration hopes updated boosters could help blunt a winter COVID-19 surge in a population weary of the virus — and of vaccinations. But while the first-ever modification to these vaccines is momentous, it’s more of an expected next step — like how flu vaccines get updated every year — than a true next-generation shot.
“We need to give a clear, forward-looking set of expectations,” said University of Pennsylvania immunologist E. John Wherry, who compares vaccine tweaks to periodically updating your computer software.
WHY DID FDA ORDER COMBO SHOTS?
BA.5 currently is causing nearly all COVID-19 infections in the U.S. and much of the world. Current COVID-19 vaccines match the coronavirus strain that circulated in early 2020. And while those vaccinations still offer strong protection against serious illness or death from COVID-19, there’s little effectiveness against infection from the wildly mutated omicron family.
The gamble is that BA.5, or something similar, still will be circulating when cold weather hits so the combo shots will be a good match. (Vaccines target the spike protein that coat the coronavirus, and the BA.4 and BA.5 spikes are identical although those strains vary in other ways.)
HOW WERE THE MODIFIED SHOTS TESTED?
Pfizer and Moderna both studied an earlier tweak to their vaccines that targets the original omicron, called BA.1, that hit last winter, plus even earlier variants.
FDA will use data from human testing of the BA.1-tweaked doses plus mice tests of the BA.5-targeted version to decide if the newest update spurs virus-fighting antibodies enough to warrant another shot.
But data on the newest tweak will come later in the year, to help assess the value of modified shots. Moderna has started a human study of its BA.5 combo shot; Pfizer and its partner BioNTech expect to open a similar study soon.
WILL THEY WORK BETTER?
No one knows. Dr. Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia and an FDA vaccine adviser, said the antibody jump from that earlier BA.1-tweaked candidate was “underwhelming.”
“What the administration is asking us to do is to accept this bivalent vaccine as significantly better” than another dose of today’s vaccine, he said. “It would be nice if there were data to support that.”
Plus, antibodies wane over time. That’s why protection against infection doesn’t last as long as protection against serious illness, which depends on a different part of the immune system, its “memory” cells.
Still, current shots are so outdated that an update makes sense, said Dr. Walter Orenstein of Emory University, a former vaccine director at the Centers for Disease Control and Prevention. While he’d like to see more data, he plans to get the new booster.
WHO SHOULD GET AN UPDATED SHOT?
That’s up to the CDC, which called a meeting of its influential vaccine advisers next Thursday and Friday to help decide.
Pfizer wants to open its updated boosters to everyone 12 and older who’s already had a primary series of today’s vaccine, while Moderna has applied only for adult use. CDC will determine if people at highest risk should go first.
A government rollout plan anticipates that people who’ve already gotten their initial vaccinations would qualify for one of the new combination shots, regardless of how many boosters they’ve already had.
WHEN SHOULD THOSE ELIGIBLE GET THE NEW BOOSTER?
Again, the CDC will weigh in, after considering how many doses will be available in early September versus later in the fall. The Biden administration has purchased more than 170 million doses.
But immunologists caution not to race out for a new shot if you recently had a dose of the original vaccine or an infection. That’s because if you still have a lot of antibodies in your bloodstream, they’ll recognize and attack the brand new antibodies that vaccine dose is supposed to produce.
So if you already got a booster in July or August and then seek the new combo shot in September, “you’ll receive very little additional boosting from that,” Wherry said. He recommends waiting four to six months.
WILL PEOPLE ROLL UP THEIR SLEEVES AGAIN?
Americans have been reluctant to keep up with COVID-19 vaccinations. While three-quarters of Americans 12 and older have gotten their initial vaccinations, only half got a first booster shot — deemed crucial for the best protection against variants. And just a third of people 50 and older who were advised to get a second booster when omicron arrived did so.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
Pfizer’s COVID-19 pill appears to provide little or no benefit for younger adults, while still reducing the risk of hospitalization and death for high-risk seniors, according to a large study published Wednesday.
The results from a 109,000-patient Israeli study are likely to renew questions about the U.S. government’s use of Paxlovid, which has become the go-to treatment for COVID-19 due to its at-home convenience. The Biden administration has spent more than $10 billion purchasing the drug and making it available at thousands of pharmacies through its test-and-treat initiative.
The researchers found that Paxlovid reduced hospitalizations among people 65 and older by roughly 75% when given shortly after infection. That’s consistent with earlier results used to authorize the drug in the U.S. and other nations.
But people between the ages of 40 and 65 saw no measurable benefit, according to the analysis of medical records.
The study has limitations due to its design, which compiled data from a large Israeli health system rather than enrolling patients in a randomized study with a control group — the gold-standard for medical research.
The findings reflect the changing nature of the pandemic, in which the vast majority of people already have some protection against the virus due to vaccination or prior infection. For younger adults, in particular, that greatly reduces their risks of severe COVID-19 complications. The Centers for Disease Control and Prevention recently estimated that 95% of Americans 16 and older have acquired some level of immunity against the virus.
“Paxlovid will remain important for people at the highest risk of severe COVID-19, such as seniors and those with compromised immune systems,” said Dr. David Boulware, a University of Minnesota researcher and physician, who was not involved in the study. “But for the vast majority of Americans who are now eligible, this really doesn’t have a lot of benefit.”
A spokesman for Pfizer declined to comment on the results, which were published in the New England Journal of Medicine.
The U.S. Food and Drug Administration authorized Paxlovid late last year for adults and children 12 and older who are considered high risk due to conditions like obesity, diabetes and heart disease. More than 42% of U.S. adults are considered obese, representing 138 million Americans, according to the CDC.
At the time of the FDA decision there were no options for treating COVID-19 at home, and Paxlovid was considered critical to curbing hospitalizations and deaths during the pandemic’s second winter surge. The drug’s results were also far stronger than a competing pill from Merck.
The FDA made its decision based on a Pfizer study in high-risk patients who hadn’t been vaccinated or treated for prior COVID-19 infection.
“Those people do exist but they’re relatively rare because most people now have either gotten vaccinated or they’ve gotten infected,” Boulware said.
Pfizer reported earlier this summer that a separate study of Paxlovid in healthy adults — vaccinated and unvaccinated — failed to show a significant benefit. Those results have not yet been published in a medical journal.
More than 3.9 million prescriptions for Paxlovid have been filled since the drug was authorized, according to federal records. A treatment course is three pills twice a day for five days.
A White House spokesman on Wednesday pointed to several recent papers suggesting Paxlovid helps reduce hospitalizations among people 50 and older. The studies have not been published in peer-reviewed journals.
“Risk for severe outcomes from COVID is along a gradient, and the growing body of evidence is showing that individuals between the ages of 50 and 64 can also benefit from Paxlovid,” Kevin Munoz said in an emailed statement.
Administration officials have been working for months to increase use of Paxlovid, opening thousands of sites where patients who test positive can fill a prescription. Last month, U.S. officials further expanded access by allowing pharmacists to prescribe the drug.
The White House recently signaled that it may soon stop purchasing COVID-19 vaccines, drugs and tests, shifting responsibility to the private insurance market. Under that scenario, insurers could set new criteria for when they would pay for patients to receive Paxlovid.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
The report Wednesday by the Democratic-led House Select Subcommittee on the Coronavirus Crisis also sheds new light on the role that television personalities played in bringing hydroxychloroquine to the attention of top White House officials. Investigators highlighted an email from Fox News’ Laura Ingraham and others from Dr. Mehmet Oz, the celebrity heart surgeon who had a daytime TV show and is now the Republican Senate nominee in Pennsylvania. Ingraham attended an Oval Office meeting with President Donald Trump, who himself took the anti-malaria drug.
The FDA originally authorized use of hydroxychloroquine in late March 2020 based on small studies suggesting it could have some effectiveness against the coronavirus. At that time, many researchers hoped that existing antiviral drugs could be used to fight the virus. But by June, FDA officials had concluded the drug was likely ineffective and could cause potentially dangerous heart complications, revoking its emergency use.
Efforts by the Trump administration to control the release of COVID-19 guidance and install political operatives at public health agencies have been well documented.
The report by the House subcommittee investigating the government’s COVID-19 response focused on pressure at the FDA, which serves as gatekeeper for the drugs, vaccines and other countermeasures against the virus.
Much of the information comes from an interview with the agency’s former commissioner, Dr. Stephen Hahn, who was picked for the job by Trump in late 2019. Frustrated by the pace of FDA’s medical reviews, Trump repeatedly accused Hahn — without evidence — of delaying decisions on COVID-19 drugs and vaccines “for political reasons.”
Although FDA commissioners are politically appointed, the agency’s scientists are expected to conduct their reviews free from outside influence. Indeed, the FDA’s credibility largely stems from its reputation for scientific independence.
But Hahn told investigators that he felt “persistent” pressure from Trump aide Peter Navarro to reauthorize hydroxychloroquine after the FDA’s decision to pull its emergency use.
Much of the report focuses on actions taken by Navarro and Dr. Steven Hatfill, a virologist and outside adviser described by the subcommittee as a “full-time volunteer” on COVID-19 for the White House.
“Dr. Hatfill and Mr. Navarro devised multiple pressure schemes targeting FDA and federal officials who they contended were wrongly impeding widespread access to hydroxychloroquine,” according to the report.
In his response, Hatfill said: “We never wrongly pressured anyone. We simply followed the science and the overwhelming evidence as detailed in several studies available at the time.”
Navarro, in an emailed statement, said the subcommittee was “wrongly” perpetuating that hydroxychloroquine “was somehow dangerous.” He also said he has chronicled his battles with the FDA in his White House memoir.
Importantly, there’s no evidence that White House efforts ultimately changed the FDA’s decisions on hydroxychloroquine or any other therapies.
Investigators also cited a March 28, 2020, email from Oz to Dr. Deborah Birx, White House coronavirus response coordinator, stating that the drug “appears safe and results are better than expected.”
Birx forwarded the email to Hahn within the hour, saying “we should talk.”
A cancer specialist with no prior political experience, Hahn was widely criticized during the early COVID-19 response for decisions that appeared to cave to White House officials.
According to emails obtained by the committee, Hatfill described “constant fighting with (Dr. Anthony) Fauci and Dr. Hahn” over access to hydroxychloroquine during the summer. Fauci is the nation’s top infectious disease expert.
During this period Hatfill also urged Sen. Ron Johnson, R-Wis., to request a federal investigation into the handling of hydroxychloroquine, according to a letter submitted for the Congressional Record.
There’s no indication such a request was made. But in mid-August, Johnson and fellow Republican Sens. Mike Lee of Utah and Ted Cruz of Texas wrote the FDA seeking an explanation for the denial to reinstate hydroxychloroquine’s authorization. Johnson also chaired a Senate committee hearing in November 2020 on treatment options and complained that doctors who prescribed hydroxychloroquine for COVID had been “scorned.”
In the fall of 2020, the focus of both FDA and White House officials turned to the upcoming authorization of the first COVID-19 vaccines from Pfizer and Moderna.
As previously reported, the White House objected to an FDA requirement that vaccine makers gather two months of safety data before filing their applications, contending that condition would delay the launch of the shots. Trump had repeatedly stated the shots would be authorized before Election Day, despite government scientists signaling that timeline was unlikely.
The committee report suggested that the FDA’s guidance for vaccine manufacturers was delayed more than three weeks — from mid-September until early October — due to White House concerns.
Hahn told investigators the agency faced “pushback about the issue” from multiple officials, including Trump’s chief of staff, Mark Meadows, who told the FDA commissioner on Sept. 23, 2020, that the White House would not sign off on the two-month requirement.
On Oct. 6, the FDA quietly published its vaccine guidelines as part of a larger set of documents for drugmakers. After the materials posted online, Hahn said Meadows called him to indicate that the FDA guidelines were approved.
The online publication drew fury from the president on Twitter.
“New FDA rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!” Trump tweeted at his FDA commissioner.
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The number of coronavirus deaths reported worldwide fell by 15% in the past week while new infections dropped by 9%, the World Health Organization said Wednesday.
In its latest weekly assessment of the COVID-19 pandemic, the U.N. health agency said there were 5.3 million new cases and more than 14,000 deaths reported last week. WHO said the number of new infections declined in every world region except the Western Pacific.
Deaths jumped by more than 183% in Africa but fell by nearly a third in Europe and by 15% in the Americas. Still, WHO warned that COVID-19 numbers are likely severely underestimated as many countries have dropped their testing and surveillance protocols to monitor the virus, meaning that there are far fewer cases being detected.
WHO said the predominant COVID-19 variant worldwide is omicron subvariant BA.5, which accounts for more than 70% of virus sequences shared with the world’s biggest public viral database. Omicron variants account for 99% of all sequences reported in the last month.
Earlier this week, Pfizer asked U.S. regulators to authorize its combination COVID-19 vaccine that adds protection against the newest omicron relatives, BA.4 and BA.5, a key step towards opening a fall booster campaign.
The Food and Drug Administration had ordered vaccine makers to tweak their shots to target BA.4 and BA.5, which are better than ever at dodging immunity from earlier vaccination or infection.
Meanwhile, in the U.K., regulators authorized a version of Moderna’s updated COVID-19 vaccine last week that includes protection against the earlier omicron subvariant BA.1. British officials will offer it to people aged 50 and over beginning next month.
In Germany, Chancellor Olaf Scholz’s Cabinet approved legislation Wednesday that ensures basic protective measures against the coronavirus pandemic are continued during the fall and winter, when more virus cases are expected.
Meanwhile, in the Philippines, millions of students wearing face masks streamed back to primary and secondary schools across the country on Monday for their first in-person classes after two years of coronavirus lockdowns.
Officials had grappled with daunting problems, including classroom shortages, lingering COVID-19 fears, an approaching storm and quake-damaged school buildings in the country’s north, to welcome back nearly 28 million students who enrolled for the school year.
