Search This Blog

Saturday, August 28, 2021

Schools with large Covid outbreaks 'aren’t following fed mask, vaccine guidance'

 CDC Director Dr. Rochelle Walensky said Friday that recently reopened schools that are already struggling with large-scale Covid outbreaks generally aren’t following federal guidelines that recommend students and staff wear masks indoors and get vaccinated when eligible.

Pediatric Covid hospitalizations in the U.S. reached their highest reported levels this week, and Walensky said school closures will occur in districts with insufficient safeguards to block community spread of the virus. Speaking at a White House Covid-19 briefing, Walensky called on schools to adopt a multilayered approach that also includes social distancing, enhanced ventilation and Covid testing to prevent outbreaks.

“I want to strongly appeal to those districts who have not implemented prevention strategies and encourage them to do the right thing to protect the children under their care,” Walensky said. “In our outbreak investigations, large-scale quarantines or large number of cases are generally occurring in schools because schools are not following our guidance.”

Walensky, who didn’t call out any school districts by name, said the Centers for Disease Control and Prevention studied an outbreak in Northern California where an unvaccinated, symptomatic teacher read to a class without a mask, spreading the virus to students, staff and their families. And in Florida, Hillsborough County Public Schools reported this month that nearly 10,400 students and almost 340 staff members were in isolation or quarantine after close contact with a positive Covid case.

The CDC also studied Covid measures in Los Angeles County, where prevention strategies kept the rate of cases in schools lower than the rate of cases in the county. Case rates among children and adolescents in schools with Covid mitigation protocols were more than three times lower last winter than community case rates, Walensky said.

Walensky added that the CDC has seen increased pediatric Covid cases and hospitalizations in recent weeks, driven by the increased transmissibility of the delta variant.

“Schools should implement as many of these prevention layers as possible simultaneously, and this serves to protect our children, even if there are inevitable breaches in any single layer,” Walensky said.

https://www.cnbc.com/2021/08/27/cdc-director-says-some-schools-arent-following-us-mask-and-vaccine-guidance.html

Harris's delayed trip to Vietnam ratchets up Havana Syndrome fears

 The medical evacuation of at least two U.S. diplomats in Vietnam ahead of a visit by Vice President Harris has exposed the Biden administration’s struggle to answer questions surrounding so-called Havana Syndrome.  

Hundreds of American officials are believed to be suffering serious health issues from unidentified health incidents (UHI) occurring at U.S. posts across the globe – occurrences many posit to be attacks on American personnel.

The U.S. staff evacuation in Vietnam, first reported by NBC news, forced the vice president to delay her arrival in the country on Tuesday — drawing attention to an issue the administration has been reticent to discuss.  

“The issue in Vietnam was the highest level reaction we have ever seen publicly,” said Mark Zaid, a lawyer who is representing more than two dozen people affected by UHI.  

“And that now raises the questions of if it was serious enough to protect the Vice President, what about everyone else who's serving in these locations?”

President Biden took office promising to more urgently address the unanswered questions surrounding Havana Syndrome — named for the most high-profile of these incidents that emerged in 2016 among diplomats serving in Havana, Cuba. 

Impacted U.S. officials have reported hearing a high pitched sound that seemed to come from one specific direction, followed by feelings of intense pressure around the face and ears and that has triggered overwhelming nausea.

Documented injuries range from short- and long-term symptoms of brain fog and headaches, vertigo, insomnia, among other cognitive and physical issues that have, for some, hastened their retirement from the government. 

The administration has set up investigative task forces encompassing the CIA, National Security Council, the Department of Defense and the State Department, but have yet to coalesce around a concrete explanation for the UHIs. 

“The interagency is actively examining a range of hypotheses, but has made no determination about the cause of these incidents or whether they constitute an attack of some kind by a foreign actor,” a State Department spokesperson wrote in an email to The Hill. 

Lawmakers and advocates are frustrated by the slow pace of searching for answers. 

“Ongoing reports of these health incidents requires the full attention of the Biden administration and a coordinated interagency response,” Sen. Jeanne Shaheen (D-N.H.), who has introduced legislation to provide benefits for victims of the incidents, tweeted amid reports about the incident in Vietnam. 

“We must determine causation, provide impacted personnel with medical care they need and issue clear workforce guidance on the threat and how to mitigate it.” 

Rep. Joaquin Castro (D-Texas), wrote in an email to The Hill that the incidents in Vietnam are “concerning” especially because they have occurred so close to the vice president’s visit. 

“As a member of both the Foreign Affairs Committee and the Intelligence Committee, I will continue to push the State Department and intelligence community to investigate these incidents and deter them from happening in the future,” he said.  

Incidents have been reported across the globe, in Cuba, China, countries in South America, Central Asia and Europe. There have even been reports in the United States, including a suspected attack at the Ellipse near the White House

Sources familiar with these unexplained health incidents say while the State Department is doing what it can to communicate with staff, at times information is blocked by reasoning of national security implications.

“We’re all aware of that [but] you have to give people information even if it’s, ‘we’re working on this,’ because the anxiety is so high,” one of the sources said. 

“These people are on the edge, they’re fragile.”

Zaid said the lack of transparency has served as a roadblock to representing his clients — some are even unable to tell him where the incident took place.

Secretary of State Antony Blinken sent out a department-wide message on Aug. 5 acknowledging the administration’s lack of knowledge surrounding the attacks and the risk they pose to diplomats and their families who could also be targets.  

“I wish we had more answers for you,” he wrote in the message. 

One source familiar with the issue complained the State Department is not releasing information about where suspected Havana Syndrome attacks have occurred. In addition,  it’s unclear if staff continue to be housed where the energy-source attacks were experienced, such as apartments. 

“I would want to know, before I'm getting ready to jet off to wherever, what is the history there and if it had been attacked,” the source said. 

Lawmakers recently secured $30 million in the Senate version of the defense policy bill to help improve treatment for those who have experienced UHI.

And another bill approved by the Senate in June and awaiting a vote in the House would allow financial support to injured State and CIA employees.

But Zaid said the legislation has serious gaps, excluding those who work for agencies beyond the CIA and State as well as others.

“They don't take into account past cases. They’re not taking into account family members who were impacted as much as the federal employees and were in the foreign countries because of their spouses who work for the federal government. They're not taking into account in some cases interns who worked for the federal government but weren't considered full federal employees but were there for the U.S. government. They're not taking into account retirees, including from Cuba,” he said. 

The legislation also leaves it to each department to determine who should qualify for assistance, something Zaid said will lead to “completely arbitrary and capricious determinations.”

“Congress and/or the executive branch need to develop guidelines that would apply to everyone equally. There shouldn't be a difference between CIA and State Department just because the medical officials in those agencies had different views. There needs to be a government-wide understanding and definitions of what they're looking for and how they're going to respond to these cases. Otherwise it's going to be patently unfair,” he said.

This discrepancy is causing confusion in the State Department. 

In a message sent out to members of the American Foreign Service Association (AFSA), the labor union for the Foreign Service, the group said it was pushing for parity for staff who suffered from UHIs in China. The message called for the State Department to treat equally “confirmed” and “unconfirmed” victims with compensation and medical treatment. 

Still, AFSA acknowledged close engagement from senior State Department leadership.

“AFSA has been encouraged by the recent progress made with the Department to address the challenges faced by our members,” the group said in their letter.

A State Department spokesperson told The Hill that the Department does everything possible to provide immediate and appropriate attention and care when an employee reports a possible UHI. 

“In coordination with our partners across the U.S. Government, we are vigorously investigating reports of possible unexplained health incidents wherever they are reported,” the spokesperson continued, saying it is a top priority for Blinken.

The spokesperson further said that the Task Force works with each U.S. mission abroad to communicate “a tailored and appropriate message... to the workforce and the community that accurately portrays the conditions at each post.”

https://thehill.com/policy/international/asia-pacific/569791-harriss-delayed-trip-to-vietnam-ratchets-up-new-fears-about

French biotech Valneva moves a step closer to COVID-19 vaccine approval

 The French biotech Valneva has filed for initial approval of its COVID-19 vaccine candidate from the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA). The move, which Valneva hopes will result in a green light by year-end, boosted its share price by over 5%.

Although it hails from the continental side of the English Channel, Valneva’s big existing contract—for 100 million doses in 2021 and 2022, with the option for another 90 million through 2025—is with the British government, and the sole manufacturing site for its potential COVID-19 vaccine is in Scotland.

Announcing the move Monday, Valneva said the top-line results for its large-scale Phase III trial were likely to emerge early in the fourth quarter. As has become standard practice in the pandemic, in order to speed up the process, Valneva on Monday launched a “rolling submission” for authorization, meaning the drug regulator will consider data as it becomes available, rather than all at once after trials conclude.

“We are pleased to begin the regulatory review process for our COVID-19 vaccine with the MHRA,” said the company’s chief medical officer, Juan Carlos Jaramillo, in a statement. “We are working hard to make our vaccine candidate available as soon as possible.”

At the time of publication on Monday afternoon, European time, Valneva’s share price had risen 5.8% on the news of its application.

As one of the latecomers to the COVID-19 vaccine game, Valneva’s vaccine (VLA2001) would probably be used as a booster; a U.K.-government-funded clinical trial is evaluating it and other candidates for this purpose.

VLA2001 is the only vaccine candidate being evaluated in Europe that is based on a killed-off version of the SARS-CoV-2 virus itself. Because it takes this broader (and relatively traditional) approach rather than focusing on the virus’s spike protein, it could be that it proves successful in handling variants where the spike protein has significantly mutated.

Back in April, talks between Valneva and the European Commission broke down because, the EU executive said, the company failed to meet “a certain set of conditions.” Valneva’s prioritization of the U.K.’s order was reportedly a factor, and the subsequent resurrection of the talks in late June suggested that the EU no longer saw this as a blocker.

However, Valneva still has no EU purchase agreement. “Valneva continues to have productive discussions with the European Commission,” a spokesperson said Monday, declining to give any further details.

https://fortune.com/2021/08/23/valneva-shares-pop-french-biotech-uk-initial-approval-covid-19-vaccine/

U.S. resumes supply of Lilly's COVID-19 antibody combo to some states

 U.S. health officials on Friday decided to resume the supply of Eli Lilly's COVID-19 antibody cocktail to states where variants resistant to it are low, saying the therapy could work against the fast-spreading Delta variant based on lab studies.

The Department of Health and Human Services narrowed the scope of authorization for the dual-antibody therapy, bamlanivimab and etesevimab, to states including Colorado, Connecticut and Illinois, Indiana.

With the Delta variant becoming the dominant strain, the prevalence of variants resistant to the therapy is steadily decreasing, the agency said https://www.phe.gov/emergency/events/COVID19/investigation-MCM/Bamlanivimab-etesevimab/Pages/resumption-in-distribution-bamlanivimabetesevimab.aspx.

Based on lab tests, the drugs administered together are expected to retain activity against the Delta variant, but not against Delta plus and variants first identified in Brazil, South Africa and Colombia, it said.

The department had in June paused its distribution after the therapy failed to show effectiveness against the coronavirus variants that were first identified in Brazil and South Africa.

The supply of standalone etesevimab to be paired with existing supply of bamlanivimab is also being resumed to some states.

Regeneron's antibody therapy REGEN-COV, and GlaxoSmithKline Plc and partner Vir Biotechnology's sotrovimab may be used in all states, territories, and U.S. jurisdictions as they are likely to be effective against most variants including Delta, the agency said.

Bamlanivimab and etesevimab, REGEN-COV and sotrovimab are authorized for use in people 12 years and above with mild-to-moderate infection and are at high risk for progression to severe COVID-19. 

https://finance.yahoo.com/news/1-u-resumes-supply-lillys-225035229.html

Delta variant poses twice risk of hospitalisation vs. Alpha variant, study

 People who become infected with the Delta variant of COVID-19 are twice as likely to be admitted to hospital as those who have the Alpha variant, a new study suggests.

The study, carried out by Public Health England and Cambridge University, is the first of its kind to compare the hospitalisation risk of the two variants and highlights the need for people to be fully vaccinated, its authors say.

Dr Gavin Dabrera, a consultant epidemiologist at the National Infection Service, Public Health England, said: "This study confirms previous findings that people infected with Delta are significantly more likely to require hospitalisation than those with Alpha, although most cases included in the analysis were unvaccinated.

"We already know that vaccination offers excellent protection against Delta and as this variant accounts for over 98% of COVID-19 cases in the UK, it is vital that those who have not received two doses of vaccine do so as soon as possible."

In the latest study, researchers analysed healthcare data from 43,338 positive cases in England between 29 March and 23 May 2021, including information on vaccination status, emergency care attendance, hospital admission, and other demographic characteristics.

https://news.sky.com/story/covid-19-hospitalisation-risk-doubles-with-delta-variant-when-compared-to-alpha-variant-study-finds-12392137

2 die in Japan after shots from suspended Moderna vaccines - Japan govt

 Two people died after receiving Moderna COVID-19 vaccine shots that were among lots later suspended following the discovery of contaminants, Japan's health ministry said on Saturday.

The men in their 30s died this month within days of receiving their second Moderna doses, the ministry said in a release. Each had a shot from one of three manufacturing lots suspended on Thursday. The cause of the deaths is still being investigated.

Japan halted the use of 1.63 million Moderna doses https://www.reuters.com/world/asia-pacific/japan-withdraws-16-mln-moderna-covid-19-vaccine-doses-over-contamination-nikkei-2021-08-25 shipped to 863 vaccination centres nationwide, more than a week after the domestic distributor, Takeda Pharmaceutical, received reports of contaminants in some vials.

The government and Moderna had said no safety or efficacy issues had been identified and the suspension was just a precaution.

The contaminant is believed to be metallic particles, Japanese public broadcaster NHK reported, citing health ministry sources. 

https://www.marketscreener.com/quote/stock/MODERNA-INC-47437573/news/Moderna-Two-die-in-Japan-after-shots-from-suspended-Moderna-vaccines-Japan-govt-36269437/

Biden, Fauci discuss requiring COVID booster shots every 5 months

 President Biden on Friday said he and Dr. Anthony Fauci discussed requiring COVID-19 booster shots every five months rather than every eight as previously anticipated.

The shorter timeframe would increase the number of vaccine doses that the US will need to set aside for booster shots — as poorer nations clamor for more US donations.

“The question raised is should it be shorter than eight months? Should it be as little as five months? That’s being discussed. I spoke with Dr. Fauci this morning about that,” Biden said in the Oval Office during a visit from Israeli Prime Minister Naftali Bennett.

Biden said Friday that booster shots for Americans “will start here on Sept. 20 pending approval of the FDA and the CDC committee of outside experts.”

The president did not say what Fauci, the government’s top infectious disease expert, recommended regarding booster shot timing.

Israel began giving booster shots to senior citizens last month — rejecting the World Health Organization’s plea for “a moratorium on boosters” so that the Third World can get vaccines and reduce the possibility of new and more contagious mutations.

Pfizer and BioNTech have requested FDA approval for a booster shot for their two-dose vaccine, which is the most widely used option in the US — saying data shows a third shot improves the body’s ability to fight the virus. Moderna’s similar two-dose vaccine was made with the same technology.

President Joe Biden meets with Israeli Prime Minister Naftali Bennett in the Oval Office of the White House, Friday, Aug. 27, 2021, in Washington.
President Biden and Dr. Anthony Fauci discussed requiring COVID-19 booster shots every five months rather than every eight.
AP

Johnson & Johnson’s one-dose vaccine also works better with an extra shot, the company said this week.

The changing timeframe on booster shots threatens to undermine White House messaging, however, amid continued vaccine hesitancy among certain demographic groups.

Jeff Zients, Biden’s COVID-19 response coordinator, said Tuesday, “We expect the rule will be simple. Get your booster shot eight months after you got your second shot.”

According to CDC data, 73.5 percent of US adults have had at least one COVID-19 vaccine shot and 62.8 percent are fully vaccinated.

Vaccines dramatically lower the risk of serious symptoms, hospitalization and death, but the high rate of vaccination hasn’t stopped a surge in cases of the Delta variant of the virus — with a daily average of more than 156,000 new US COVID-19 cases over the past week, matching the case rate in late January.

Nurse Mary Ezzat fills out a vaccination card with a Pfizer COVID-19 booster sho at UCI Medical Center in Orange, CA, on Thursday, August 19, 2021. Jessica is a healthcare worker and is also immuno compromised.
The shorter timeframe to get a booster would increase the number of vaccine doses that the US will need to set aside.MediaNews Group via Getty Images
https://nypost.com/2021/08/27/biden-and-fauci-discuss-covid-19-booster-shots-every-5-months/