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U.S. puts new warning on J&J coronavirus vaccine for autoimmune disorder

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The U.S. Food and Drug Administration on Monday added a warning to the fact sheet for Johnson & Johnson's COVID-19 vaccine saying that data suggests there is an increased risk of a rare neurological disorder in the six weeks after inoculation.

In a letter to the company, the FDA classified the chances of getting Guillain-Barré syndrome (GBS) after vaccination as being "very low." Still, it said J&J vaccine recipients should seek medical attention if they have symptoms including weakness or tingling sensations, difficulty walking or difficulty with facial movements.

Around 12.8 million people have received J&J's one-dose vaccine in the United States. The FDA said 100 preliminary reports of GBS in the vaccine recipients include 95 serious cases that required hospitalization and one reported death.

J&J said in a statement that it was in discussion with regulators about the cases of GBS. It said the rate of reported cases of GBS in J&J vaccine recipients exceeds the background rate only by a small degree.

GBS is a rare neurological condition in which the body's immune system attacks the protective coating on nerve fibers. Most cases follow a bacterial or viral infection. Most people fully recover from GBS.

The condition has been linked in the past to vaccinations - most notably to a vaccination campaign during a swine flu outbreak in the United States in 1976, and decades later to the vaccine used during the 2009 H1N1 flu pandemic.

According to a statement from the U.S. Centers for Disease Control and Prevention (CDC), most of the cases were in men, many of whom were 50 or older. It did not find higher than expected cases of GBS in recipients of the mRNA-based vaccines from Pfizer Inc/BioNTech SE and Moderna Inc.

Last week, European regulators recommended a similar warning for AstraZeneca's COVID-19 shot, which is based on a similar technology as Johnson & Johnson's vaccine.

The warning is another setback for the J&J shot, which was supposed to be an important tool for vaccinating in hard-to-reach areas and among those hesitant to be vaccinated because it requires only one shot and has less stringent storage requirements than the Pfizer or Moderna vaccines.

But use of the vaccine has already been linked to a very rare, potentially life threatening blood clotting condition and slowed by production problems at the main plant where it is being made.

U.S. regulators decided in April that the vaccine's benefits outweighed the risk from the blood clotting issue.

The warning was first reported by the Washington Post on Monday.

COVID-19

WHO declares end to COVID global health emergency

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The World Health Organization said Friday that COVID-19 no longer qualifies as a global emergency, marking a symbolic end to the devastating coronavirus pandemic that triggered once-unthinkable lockdowns, upended economies and killed millions of people worldwide.

The announcement, made more than three years after WHO declared the coronavirus an international crisis, offers some relief, if not an ending, to a pandemic that stirred fear and suspicion, hand-wringing and finger-pointing across the globe, AP reported. 

The U.N. health agency’s officials said that even though the emergency phase was over, the pandemic hasn’t finished, noting recent spikes in cases in Southeast Asia and the Middle East.

WHO says thousands of people are still dying from the virus every week, and millions of others are suffering from debilitating, long-term effects.

“It’s with great hope that I declare COVID-19 over as a global health emergency,” WHO Director-General Tedros Adhanom Ghebreyesus said.

“That does not mean COVID-19 is over as a global health threat,” he said, warning that new variants could yet emerge. Tedros noted that while the official COVID-19 death toll was 7 million, the real figure was estimated to be at least 20 million.

Tedros said the pandemic had been on a downward trend for more than a year, acknowledging that most countries have already returned to life before COVID-19.

He bemoaned the damage that COVID-19 had done to the global community, saying the pandemic had shattered businesses, exacerbated political divisions, led to the spread of misinformation and plunged millions into poverty.

When the U.N. health agency first declared the coronavirus to be an international crisis on Jan. 30, 2020, it hadn’t yet been named COVID-19 and there were no major outbreaks beyond China.

More than three years later, the virus has caused an estimated 764 million cases globally and about 5 billion people have received at least one dose of vaccine.

In the U.S., the public health emergency declaration made regarding COVID-19 is set to expire on May 11, when wide-ranging measures to support the pandemic response, including vaccine mandates, will end. Many other countries, including Germany, France and Britain, dropped most of their provisions against the pandemic last year.

When Tedros declared COVID-19 to be an emergency in 2020, he said his greatest fear was the virus’ potential to spread in countries with weak health systems.

Most recently, WHO has struggled to investigate the origins of the coronavirus, a challenging scientific endeavor that has also become politically fraught.

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COVID-19 in Iran: Nearly 900 new cases, 24 deaths recorded

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The Iranian health ministry announced on Sunday that more than 890 new cases of COVID-19 have been identified across the country during the past 24 hours, adding that 24 patients have died in the same period of time, Fars News Agency reported.

"A sum of 891 new patients infected with COVID-19 have been identified in the country based on confirmed diagnosis criteria during the past 24 hours," the Iranian Health Ministry's Public Relations Center said on Sunday, adding, "454 patients have been hospitalized during the same time span."

The ministry’s public relations center said 611 people infected with COVID-19 are in critical condition.

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China says 200 million treated, pandemic ‘decisively’ beaten

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China says more than 200 million of its citizens have been diagnosed and treated for COVID-19 since it lifted strict containment measures beginning in November.

With 800,000 of the most critically ill patients having recovered, China has “decisively beaten” the pandemic, according to notes from a meeting of the ruling Communist Party’s all-powerful Politburo Standing Committee presided over by President and party leader Xi Jinping, AP reported. 

China enforced some of the world’s most draconian lockdowns, quarantines and travel restrictions and still faces questions about the origins of the virus that was first detected in the central Chinese city of Wuhan in late 2019. Heavy-handed enforcement prompted rare anti-government protests and took a heavy toll on the world’s second-largest economy.

The official Xinhua News Agency quoted Xi as saying that policies to control the outbreak had been “entirely correct.” The abrupt lifting in November and December of the “zero COVID” policy that had sought to eliminate all cases of the virus led to a surge in infections that temporarily overwhelmed hospitals.

Case numbers have since peaked and life has largely returned to normal, although international travel in and out of China has yet to return to pre-pandemic levels.

China is now transitioning to a post-pandemic stage after a fight against the outbreak that was “extraordinary in the extreme,” Xinhua said.

The government will continue to “optimize and adjust prevention and control policies and measures according to the times and situations with a strong historical responsibility and strong strategic determination,” Xinhua said.

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