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FDA declines to authorize common antidepressant as COVID treatment

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© Reuters. FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

By Leroy Leo and Michael Erman

(Reuters) – The U.S. Food and Drug Administration has decided not to authorize the antidepressant fluvoxamine to treat COVID-19, saying that the data has not shown the drug to be an effective therapeutic for fighting the virus.

“Based on the review of available scientific evidence, the FDA has determined that the data are insufficient to conclude that fluvoxamine may be effective in the treatment of nonhospitalized patients with COVID-19 to prevent progression to severe disease and/or hospitalization,” the agency said in a document https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/EUA%20110%20Fluvoxamine%20Decisional%20Memo_Redacted.pdf published on Monday.

University of Minnesota professor Dr. David Boulware submitted the emergency use authorization request to the FDA that would have allowed doctors to prescribe fluvoxamine maleate to treat COVID-19 in non-hospitalized patients.

The generic drug belongs to an old, widely-used class of antidepressants called selective serotonin reuptake inhibitors, or SSRIs.

Boulware said that his request is less urgent with the availability of drugs like Pfizer Inc (NYSE:PFE)’s Paxlovid, but he still believes the data supports the drug’s use in some COVID patients.

“There are effective therapeutics that are available. But not everyone has access to them. Not everyone can tolerate them. Some people have contraindications,” Boulware said in an interview. “And if you go elsewhere in the world, low- and middle-income countries, they have access to no therapeutics.”

Boulware’s submission relied on data from three trials, especially a study of 1,497 non-hospitalized COVID patients in Brazil.

While the Brazilian study met its primary endpoint, showing a roughly 30% drop in hospitalizations in the group that received fluvoxamine, the FDA said there were uncertainties about the assessment, which measured reduction in emergency department visits lasting more than 6 hours.

Boulware said FDA had used a different measure to count hospitalizations in other drug trials, including only acute care that lasted at least 24 hours.

“The standard that they were holding for fluvoxamine was a different standard than the other big pharma trials, with Paxlovid and (Merck’s) molnupiravir and the monoclonals,” he said of other authorized COVID therapeutics.

“I was really quite disappointed that they did that,” he said.

Coronavirus

China slashes COVID quarantine time for international travellers

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© Reuters. FILE PHOTO: People line up at a nucleic acid testing station, following the coronavirus disease (COVID-19) outbreak, in Beijing, China, June 16, 2022. REUTERS/Thomas Peter/File Photo

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BEIJING/SHANGHAI (Reuters) – China on Tuesday slashed the quarantine time for inbound travellers by half in a major easing of one of the world’s strictest COVID-19 curbs, which have deterred travel in and out of the country since 2020.

Quarantine at centralised facilities has been cut to seven days from 14, and subsequent at-home health monitoring has been reduced to three days from seven, the National Health Commission said.

The latest guidelines from the health authority also eased quarantine requirements for close contacts of people who have tested positive for the new coronavirus.

China has cautiously eased its COVID curbs on cross-border travellers in recent months, with health officials saying the shorter incubation period of the Omicron variant allows for an adjustment of quarantine periods.

The Chinese capital Beijing in recent months has already reduced the quarantine period at centralised facilities to 10 days from 14.

China, last month, also removed some COVID-19 test requirements for people flying in from countries such as the United States.

“We believe that today’s announcement will be welcomed by the American business community,” the American Chamber of Commerce in Shanghai said on its official WeChat account.

The quarantine adjustment will make it easier for companies to bring staff to China, and for Chinese companies and their executives to visit the United States, AmCham said.

Stock markets rose in Hong Kong and the mainland, with the Hang Seng Index reversing losses and ticking up roughly 0.4% and the CSI300 Index gaining 0.7%.

Shares in mainland tourism companies jumped more than 5%.

China’s aviation regulator said this month it had been in touch with some countries to steadily increase the number of flights in the second half of 2022.

IN THE CLEAR

Beijing and Shanghai reported on Tuesday no new local COVID infections, the first time both cities were in the clear simultaneously since late February, after months of fighting their worst-ever outbreaks.

The milestone for the two cities, achieved on Monday, came after their daily caseloads dropped to single digits over the past week, allowing Shanghai to gradually resume eating in at restaurants and Beijing to reopen some leisure venues including the Universal Beijing Resort.

Shanghai Communist Party chief Li Qiang declared on Saturday that authorities had “won the war to defend Shanghai” against COVID-19.

The Walt Disney (NYSE:DIS) Co’s Shanghai Disney Resort said on Tuesday that it would reopen the Disneyland theme park on June 30; it had been shut for more than three months.

Authorities, however, were adamant the government’s so-called dynamic zero COVID policy, which aims at blocking flare-ups from spreading as they crop up, remains in place.

Beijing would “fight against any new outbreaks at the outset and with speed and resolutely break their transmission channel”, Cai Qi, the city’s top Communist Party chief, was quoted as saying in a report by the party-backed Beijing Daily.

Earlier on Monday, the Beijing Daily apparently misquoted Cai as saying the city would maintain its COVID control effort for “the next five years”.

The newspaper afterwards removed the reference and its chief, Zhao Jingyun, said it was an error but that did not prevent some suspicion among the public.

“Surely it wasn’t a mistake! It’s meant to gauge public opinion!” said a user of the Weibo (NASDAQ:WB) social media platform.

Another Weibo user said even if it was a mistake, “at least the higher-ups are now aware of how helpless we all feel and how we detest the current counter-epidemic policies”.

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Coronavirus

Beijing, Shanghai both free of new local COVID cases for first time in months

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© Reuters. FILE PHOTO: People line up at a nucleic acid testing station, following the coronavirus disease (COVID-19) outbreak, in Beijing, China, June 16, 2022. REUTERS/Thomas Peter/File Photo

BEIJING/SHANGHAI (Reuters) – China’s capital, Beijing, and the financial hub of Shanghai reported on Tuesday no new local COVID infections, the first time both cities were in the clear at the same time since late February, after months of fighting their worst-ever outbreaks.

The milestone for the two cities, achieved on Monday, came after their daily caseloads dropped to single digits over the past week, allowing Shanghai to gradually resume eating in at restaurants and Beijing to reopen some leisure venues including the Universal Beijing Resort.

Shanghai Communist Party chief Li Qiang declared on Saturday that authorities had “won the war to defend Shanghai” against COVID-19, following a crushing two-month citywide lockdown that was finally lifted in early June.

Authorities, however, remained wary and were adamant that the government’s so-called dynamic zero COVID policy, which aims at blocking flare-ups from spreading as they crop up, remains in place.

Beijing would “fight against any new outbreaks at the outset and with speed and resolutely break their transmission channel”, Cai Qi, the city’s top Communist Party chief, was quoted as saying in a report by the party-backed Beijing Daily.

The city would build “a solid virus barrier”, Cai was quoted as saying on Monday.

Earlier on Monday, the Beijing Daily apparently misquoted Cai as saying the city would maintain its COVID control effort for “the next five years”.

The newspaper afterwards removed the reference and its chief, Zhao Jingyun, said it was an error but that did not prevent some suspicion among the public.

“Surely it wasn’t a mistake! It’s meant to gauge public opinion!” said a user of the Weibo (NASDAQ:WB) social media platform.

Another Weibo user said even if it was a mistake, “at least the higher-ups are now aware of how helpless we all feel and how we detest the current counter-epidemic policies”.

Despite easing COVID restrictions in Beijing and Shanghai, their combined 47 million residents have been told to go through COVID testing every few days, to maintain access to public spaces and transport.

Elsewhere in mainland China, a total of 22 domestically transmitted infections were reported for June 27, including five in the southern technology hub Shenzhen.

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Coronavirus

U.S. appeals court vacates federal vaccine mandate pending additional hearing

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© Reuters. FILE PHOTO: A resident over 50 years old and immunocompromised receives a second booster shot of the coronavirus disease (COVID-19) vaccine in Waterford, Michigan, U.S., April 8, 2022. REUTERS/Emily Elconin

WASHINGTON (Reuters) – A U.S. appeals court panel said on Monday it would convene a full panel to reconsider President Joe Biden’s executive order requiring civilian federal employees to be vaccinated against COVID-19, and set aside the order pending that hearing.

The U.S. Court of Appeals for the Fifth Circuit, which is based in New Orleans, had reinstated the vaccine order in April by a 2-1 vote after it was blocked by a district court judge in January. [L2N2W530Z]

The court said on Monday that it would reconsider the case en banc, which means it will be heard by a larger panel of judges. No date was given for the hearing. Pending that hearing, the court said it would vacate the April ruling, which means that Biden’s order cannot be enforced.

Biden said in September he would require about 3.5 million government workers to get vaccinated by Nov. 22, barring a religious or medical accommodation, or face discipline or firing. Despite the legal fight, more than 90% of federal workers were vaccinated by December, the White House said last year.

The president’s vaccine and mask mandates have faced stiff opposition, led by Republicans, which have turned public safety measures endorsed by disease experts into a political and legal battle in the United States.

The United States passed the milestone of 1 million dead from the coronavirus in May. More than 250 people still die of the disease daily, according to the U.S. Centers for Disease Control and Prevention.

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