FDA pulls authorization for last remaining monoclonal antibody treatment

The U.S. Food and Drug Administration said on Wednesday that it has pulled its emergency authorization for bebtelovimab from Eli Lilly, which was the last remaining COVID-19 antibody therapy in use, because newer BQ and XBB subvariants of the coronavirus have rendered it ineffective. “Given that a COVID-19 infection is likely to be caused by a non-susceptible SARS-CoV-2 variant, and consistent with the terms and conditions of the Letter of Authorization, bebtelovimab is not currently authorized for emergency use in any U.S. region at this time,” the FDA said in a statement. It added that Eli Lilly has paused commercial distribution of the drug until further notice. The agency recommended that remaining supplies of bebtelovimab be held in case another variant that is more susceptible to the treatment becomes prevalent in the future. Eli Lilly confirmed it has complied with the order and is working on new potential treatments. “Lilly will continue to search and evaluate monoclonal antibodies to identify potential candidates for clinical development against new variants,” the company said in a statement.

What Bay Area health experts say about masking amid rising COVID cases

Some people may be wondering how to navigate a period in the pandemic where precautions are largely up to the individual. As the holidays arrive and COVID numbers show signs of climbing again — albeit not so far to previous surge levels — what are currently the best practices to stay healthy? How much safety is needed? We spoke to Bay Area public health experts for their perspectives on masking and other precautions heading into the holidays, and the verdict was to be as careful as you need to be, for yourself and the people around you. Read more about the latest advice on whether to don a mask again when you go shopping and how to prepare for big family gatherings during the festive season.

Hospital entry screenings have little benefit, Yale study suggests

Hospital entrance screenings, such as asking about symptoms or taking the temperature of people entering the facility, offer limited benefits in controlling the spread of COVID-19 infection, according to a study conducted at Yale New Haven Hospital in Connecticut. Of the 951,033 screenings performed at the academic medical center between March 2020 and May 2021 only about 0.07% identified people who had a fever, shows the report published in JAMA Internal Medicine. The facility employed 30 full-time equivalent staff members to maintain its 24-hour screening program, which equated to about $1.3 million in total annual compensation. The measures — required by the U.S. Department of Labor — rely on self-reported factors such as symptoms or exposure history and are intended to reduce risk to patients and health care workers, two physicians from UCSF and NYC Health wrote in an editor’s note accompanying the study. “Surveillance screening is expensive for healthcare systems and a daily annoyance for those who work there,” they said. “The authors suggest that screening may have maximum utility during the early phase of a public health crisis. Nonetheless, self-reported symptoms have a low sensitivity for true infection with COVID-19, so it remains unclear the degree to which screening measures are truly effective in reducing the spread of COVID-19.”

San Jose church that defied COVID orders won’t have to pay state fines

Bowing to U.S. Supreme Court rulings allowing religious institutions to hold worship services during the COVID-19 pandemic, the California Supreme Court refused Wednesday to reinstate $190,000 in fines against a San Jose church and its pastors for defying state and county limits on indoor public gatherings. Calvary Chapel San Jose and its pastors, Mike McClure and Carson Atherley, were found in contempt of court by a Santa Clara County judge in December 2020 and in February 2021 for violating state and local orders to restrict attendance at indoor services. The restrictions were aimed at limiting respiratory transmission of the deadly coronavirus. Read more about a series of court cases that pitted public health policy against freedom of religion.

Paxlovid safe for pregnant patients and fetuses, study finds

Pregnant women who used Paxlovid tolerated the antiviral medication well and without evidence of an increase in complications affecting them or their fetuses, according to a new study by researchers at Johns Hopkins. In the report published Tuesday in JAMA Network Open, the researchers selected participants from 3,442 pregnant women with mild or moderate COVID-19 infections who were seen within the Johns Hopkins Health Systems between March 15, 2020, and Aug. 20, 2022. From this group, 47 people who met the study criteria were given the combination of drugs nirmatrelvir and ritonavir, which make up Paxlovid, and 96% of the participants completed the course of therapy, tolerating it well. Of these, 25 of the participants delivered babies following the treatment, with 12 of the deliveries done by cesarean section. Of those, 9 were scheduled and not related to the Paxlovid treatment. Two participants were hospitalized for pre-existing conditions and not severe COVID. “Based on our results, we feel that the benefit to both the mother and the developing fetus of preventing severe COVID outweighs any potential risks from Paxlovid therapy,” said study lead author William Garneau, assistant professor of medicine at the Johns Hopkins University School of Medicine, in a press release accompanying the study.

President Clinton experiencing mild symptoms after testing positive

Former President Bill Clinton said Wednesday that he is experiencing mild symptoms after he tested positive for COVID-19. “I’m grateful to be vaccinated and boosted, which has kept my case mild, and I urge everyone to do the same, especially as we move into the winter months,” Clinton said in a tweet. The 42nd president, who is 76, added, “I’m doing fine overall and keeping myself busy at home.”

CDC lifts masking, quarantine rules for homeless shelters

The U.S. Centers for Disease Control and Prevention has issued a set of revisions to its guidance for homeless service sites and in correctional and detention facilities, recommending that enhanced COVID-19 prevention strategies be implemented only when community levels are high (previously medium). Among the changes to the guidance, the public health agency dropped the requirement for shelters that “regardless of vaccination status, all clients, staff, and volunteers should continue wearing well-fitting masks or respirators.” It also no longer routinely recommends quarantine after someone is exposed to a person with COVID-19. The CDC adds an option to end isolation for people with COVID-19 after seven days with a negative coronavirus test. The guidance “emphasizes the importance of maximizing access to in-person visitation to promote correctional and detention facility residents’ mental health and well-being.”

Naturopath who sold fake vaccine cards gets nearly 3 years

A naturopathic doctor who sold fake COVID-19 immunization treatments and fraudulent vaccination cards during the height of the coronavirus pandemic was sentenced in California on Tuesday to nearly three years in prison, the Associated Press reports. Juli A. Mazi of Napa pleaded guilty last April in federal court in San Francisco to one count of wire fraud and one count of false statements related to health care matters. During Tuesday’s hearing, U.S. District Judge Charles R. Breyer handed down a sentence of 33 months, according to Joshua Stueve, a spokesperson for the U.S. Department of Justice. The case is the first federal criminal fraud prosecution related to fraudulent Centers for Disease Control and Prevention vaccination cards for COVID-19, according to the U.S. Department of Justice.

Mazi, who fired her attorneys and ended up representing herself, last week filed a letter with the court claiming sovereign immunity. Mazi said that as a Native American she is “immune to legal action.” She provided fake CDC vaccination cards for COVID-19 to at least 200 people with instructions on how to complete the cards to make them look like they had received a Moderna vaccine, federal prosecutors said. She also sold homeopathic pellets she fraudulently claimed would provide “lifelong immunity to COVID-19.” She told customers that the pellets contained small amounts of the virus and would create an antibody response, they said.

DoorDash cuts 1,250 jobs as deliveries ebb after pandemic

DoorDash is eliminating more than 1,200 corporate jobs, saying it hired too many people when delivery demand surged during the COVID-19 pandemic, the Associated Press reports. CEO Tony Xu said in a message to employees Wednesday that DoorDash was undersized before the pandemic and sped up hiring to catch up with its growth. It is cutting approximately 1,250 people. “Most of our investments are paying off, and while we’ve always been disciplined in how we have managed our business and operational metrics, we were not as rigorous as we should have been in managing our team growth. That’s on me. As a result, operating expenses grew quickly,” he said. DoorDash’s announcement comes just a few weeks after the San Francisco company posted solid quarterly results, saying its orders jumped 27% in the third quarter as it expanded overseas and added new grocery and retail offerings.

Bay Area hospitalizations of virus patients top 600 for first time in months

There were 613 patients with confirmed COVID-19 in hospitals across the Bay Area as of Tuesday, marking the first time since August that the figure topped 600, according to state data analyzed by The Chronicle. California reported a similar jump statewide with 3,532 hospitalizations — a 125% increase from a month ago. Los Angeles County accounted for about a third of those hospitalizations with 1,040 patients. Among Bay Area counties, San Francisco, Marin, Sonoma, Alameda, and Santa Clara counties are reporting the steepest rises in hospitalizations.

Twitter opening to COVID misinformation dismays Bay Area health experts

Bay Area health experts were alarmed Tuesday at Twitter’s halt to enforcing its policy against COVID-19 falsehoods. They worry the platform can again become a super-spreader of doubt about the efficacy of vaccines and other lifesaving measures amid an ongoing pandemic. “I am absolutely terrified and despondent,” at the news, said Peter Chin-Hong, an infectious disease expert with UCSF, “Permitting misinformation is not just about freedom of speech. There is a direct pathway between misinformation and death if science-based interventions like vaccines are not embraced.” Read more reactions to the Twitter about-face from Bay Area health experts. 

Death rates skewed relatively younger in second year of pandemic: Harvard study

The median age of people who died due to COVID-19 infections decreased significantly in 2021 compared to the first year of the pandemic, according to a new report published Tuesday in the Annals of Internal Medicine. The researchers from Harvard found that despite 20.8% fewer COVID-19 deaths in 2021 than in 2020, years of life lost due to COVID-19 increased by 7.4%. The median age of people losing their lives to COVID-19 deaths decreased from 78 in 2020 to 69 in 2021, as low vaccine uptake and laxity toward COVID precautions coincided with mortality among relatively younger adults. “A shift in COVID-19 mortality to relatively younger people in the second pandemic year contributed to markedly increased premature mortality from this increasingly preventable death,” said corresponding author Mark Czeisler, a medical student at Harvard Medical School, in a press release. “Understanding the factors that contribute to this age shift is critical as we continue developing our knowledge of the COVID-19 pandemic.”

Twitter shift on COVID misinformation stirs memories of earlier falsehoods

Twitter’s end to enforcement of its policy against COVID misinformation worries public health officials who say it could again disseminate false claims about the coronavirus and the safety and effectiveness of vaccines. Twitter previously acted against COVID fake news purveyors and pandemic conspiracy theorists. Among those, David Icke was kicked off two years ago for COVID misinformation, including claims that Jews and 5G towers were behind the pandemic. Icke is a prominent advocate of the belief that a race of lizard people have taken over the Earth by posing as human leaders. Steve Bannon, former adviser to former President Donald Trump, was kicked off after calling for the beheading of Dr. Anthony Fauci, the nation’s leading infectious disease specialist. Among other Trump allies, Rep. Marjorie Taylor Greene was permanently banned in January for repeatedly spreading misinformation about COVID-19 and vaccine safety.

Nearly all people with long COVID report discrimination

An estimated 95% of people living with long COVID say they experienced some discrimination or stigma due to their condition, in a new study published in the journal Plos One. Researchers at the University of Southampton and Brighton and Sussex Medical School conducted two surveys, a year apart, of more than 1,100 people with persistent symptoms of coronavirus infection. Of the 95% reporting at least one type of stigma, 63% said they were  treated with less respect or lost contact with people they care about due to their health condition. Some 91% expected to experience stigma and discrimination from people who don’t see long COVID as a real illness, and 86% said their diagnosis left them with a profound sense of shame or embarrassment. “We were surprised to find that people with a clinical diagnosis of long COVID were more likely to report stigma than people without a formal diagnosis,” said Nisreen Alwan, public health professor at University of Southampton and co-lead author, adding the reason for that is not clear. “Perhaps because they are more likely to share their health status with others or perhaps because they have engaged more with health services.” More research is needed into how and where this stigma is manifested, she said. 

More than 9 in 10 Americans infected at least once, study finds

About 94% of Americans are estimated to have been infected by the coronavirus at least once, according to an analysis by researchers at Harvard, Yale and Stanford. Combined with vaccination, 97% of U.S. residents as of Nov. 9 were estimated to have some prior immunological exposure to COVID-19. About 29% of those were infected and vaccinated, just under 56% reinfected and vaccinated, 2.4% infected and unvaccinated, and 7% re-infected and unvaccinated. The results of the preprint study, published in MedRxiv, additionally found that of those never infected with COVID-19, 3.5% were vaccinated and 2.1% were unvaccinated. “Despite the high level of protection at the beginning of the 2022-2023 winter, risk of reinfection and subsequent severe disease remains present,” the authors wrote. “A more transmissible or immune evading (sub)variant, changes in behavior, or ongoing waning of immunity could lead to a new SARS-CoV-2 wave, as was observed at the end of 2021.”


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