Former FDA head Gottlieb says ‘true Delta wave’ has yet to hit Northeast

 Former FDA chief Scott Gottlieb is warning that the “true Delta wave” has yet to begin in the Northeast — and predicted it would start soon after Labor Day.

“I think there’s sort of a perception that we’re sort of through this Delta wave here in the Northeast because we’ve seen Delta cases go up and go down in places like the New York metropolitan region. We’re also seeing positive [tests] come down,” said Dr. Gottlieb, the former head of the federal Food and Drug Administration, on CNBC’s “Squawk Box” on Friday.

But Gottlieb said he doesn’t think the recent uptick in COVID-19 cases was the “true Delta wave.

“I think that that was a Delta warning,” he said. “I think our true Delta wave is going to start to build after Labor Day here in the Northeast and the northern part of the country.”

Gottlieb said he believes that people gathering for Labor Day festivities and kids returning to school soon after will serve as “incubators for spread.

“Now whether we see a wave of infection as dense and severe as the South, I don’t think that’s going to be the case because we have a lot more vaccination; we’ve had a lot of prior infection, which we also know is protective,” he said. “But we will probably see a build in cases here in the Northeast. I don’t think that we’re done with this.”

The number of daily COVID-19 deaths in the US has now reached a rolling seven-day average of more than 1,550 — an amount not seen since March, figures show.

In terms of Labor Day this year compared to 2020, coronavirus cases, hospitalizations and deaths in the US are all hugely up this holiday.

New daily cases are averaging more than 163,720, up from around 39,350 in September 2020, hospitalizations have hit nearly 100,000 compared to not even 41,000 last year, and the roughly 1,560 daily deaths this year were around 800 last Labor Day, CNN reported.

Dr. Rochelle Walensky, the head of the federal Centers for Disease Control and Prevention, had urged unvaccinated people not to travel over Labor Day weekend and warned everyone to consider the risks amid the spread of the Delta variant.

“Given where we are with disease transmission right now, we would say that people need to take their own these risks into their own consideration as they think about traveling,” Walensky said last week during a White House COVID-19 briefing. “If you are unvaccinated, we would recommend not traveling.”

The seven-day average of new cases in the US is 129,000 cases per day — a whopping jump over July — while virus-related hospitalizations remained relatively steady at 11,500 daily, according to CDC data Thursday.

https://nypost.com/2021/09/06/ex-fda-head-scott-gottlieb-true-delta-wave-yet-to-hit-northeast/

Judge denies request for Ohio hospital to treat COVID-19 patient with Ivermectin

A Butler County, Ohio, judge has denied a preliminary injunction request that would have ordered West Chester hospital to treat a COVID-19 patient with Ivermectin, despite a CDC warning against it.

Butler County Judge Michael Oster issued the ruling Monday, saying while it is impossible not to feel sympathetic toward the patient and his family, the court made the decision in accordance with Ohio law.

The case has made national headlines. A COVID-19 patient's wife wants her husband to be treated with Ivermectin, despite a CDC warning against it.

Jeffrey Smith, 51, of Fairfield Township, is in the intensive care unit at the University of Cincinnati West Chester Hospital.

Smith was diagnosed with COVID-19 on July 9. He was admitted into the hospital six days later and has been on a ventilator for over 30 days.

His wife, Julie Smith, wanted him to be treated with the controversial drug.

Ivermectin is mainly used in the United States to treat or prevent parasites in animals. It has also been used to treat humans, approved by the FDA to treat people with intestinal strongyloidiasis and onchocerciasis, two conditions caused by parasitic worms.

The Centers for Disease Control and Prevention has warned against using ivermectin as a treatment for COVID-19, saying it's not an anti-viral drug and could be dangerous when not used properly.

Doctors at the hospital refused to treat Jeffrey Smith with the drug.

Last month, Julie Smith got a temporary order from Butler County Common Pleas Judge Gregory Howard. He ordered doctors to administer the drug, but that order only lasted 14 days.

Last week, Julie Smith and attorneys for UC West Chester returned to court to argue the case again — this time in front of Judge Oster.

Julie Smith said despite her husband being treated with Remdesivir, steroids and plasma, his condition continued to decline. She said she read articles in other cases where COVID-19 patients' conditions reportedly improved after being given Ivermectin.

"It just gave me hope there was something to try, that I didn't just have to sit there and let him die. That I could fight," Julie Smith said.

The Smiths received a prescription for Ivermectin from Dr. Fred Wagshul, a pulmonologist out of Centerville. Wagshul said in a courtroom Thursday that he knew little about the patient at the time he wrote a prescription for Ivermectin.

But even after getting the prescription, doctors and UC West Chester refused to treat Jeffrey Smith with Ivermectin. They only did so after they were court-ordered, but since it was a temporary order, the case was back in court.

"While the case at bar has emotion to it, the following decision will be strictly based upon the standards of law on a preliminary injunction case," the ruling stated. "As such, public policy would not favor the granting of the injunction by clear and convincing evidence."

Oster detailed in his ruling that while the court is sympathetic toward the Smiths, "public policy should not and does not support allowing a physician to try 'any' type of treatment on human beings. Rather, public policy supports the safe and effected development of medications and medical practices. A clinical trial would be one such method of a developmental process. However, a clinical trial is not at issue in this case."

Oster went on to say that no strong evidence by any study has shown that Ivermectin should be recommended for a COVID-19 patient and based on current evidence, the drug is not an effective treatment. Oster said that even Wagshul could not say that continued use would benefit Smith.

Oster said Smith can be safely moved to a hospital where Wagshul has privileges if continued use of Ivermectin is desired.

UC Health issued the following statement on the ruling:

"At UC Health, we respect the expertise of our clinicians and appreciate the scientific rigor used to develop treatments, medications and other therapies. We do not believe that hospitals or clinicians should be ordered to administer medications and/or therapies, especially unproven medications and/or therapies, against medical advice. We are grateful for the judge’s careful consideration and for the judicial process in this matter.

This news, while positive in support of respect for science and the expertise of medical professionals, does not change the fact that there are many people suffering from COVID-19 in our communities. We implore all members of the community to do what we know works: wear a mask, become fully vaccinated and use social distancing whenever possible."

Attorneys for the Smiths argued Ivermectin appears to be working on Jeffrey Smith.

"Over the last three days, his vent setting has dropped. Before Ivermectin, his vent setting was at 100%. His vent setting has now dropped to 50%," said Ralph Lorigo, Smiths' attorney.

Attorneys for the hospital claim that there has not been a notable improvement since the treatment began.

https://www.wlwt.com/article/judge-denies-request-for-west-chester-hospital-to-treat-covid-19-patient-with-ivermectin/37491731#

New ‘mu’ COVID variant now found in 49 U.S. states

 Since being discovered in Colombia in January, the mu variant of COVID-19 has spread to nearly four dozen countries and has made its presence known in Hawaii and Alaska. It has so far been found in 49 states with Nebraska being the only state to not have a mu variant case detected.

Health officials believe mu is even more transmissible than the delta variant and has the potential to resist vaccines.

In the U.S., the mu variant has been detected in 49 states and the District of Columbia, according to Newsweek.

California has reported the highest number of the latest variant with 384. A total of 167 of those cases were found in Los Angeles County.

“The identification of variants like mu, and the spreading of variants across the globe, highlights the need for L.A. County residents to continue to take measures to protect themselves and others,” said Dr. Barbara Ferrer, director of LA County Public Health, in a statement.

“This is what makes getting vaccinated and layering protections so important. These are actions that break the chain of transmission and limits COVID-19 proliferation that allows for the virus to mutate into something that could be more dangerous.”

On Aug. 30, the World Health Organization called the mu variant a variant of interest due to its ability to be more transmissible than any of the other strains of COVID-19.

The Centers for Disease Control and Prevention has not yet made similar classifications about mu in the U.S.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said that health officials were maintaining a “close eye” on the mu variant despite it being “not at all even close” to becoming the dominant COVID-19 strain in the U.S.

“Even though it has not in essence taken hold to any extent here we always pay attention to at all times variants,” Fauci said.

The U.S. saw its peak of mu variant cases in mid-July but case numbers involving that variant have been declining since, signaling either a weakening of the strain or indicating a worrisome future.

https://www.nydailynews.com/news/national/ny-mu-variant-covid-19-us-coronavirus-vaccine-20210906-4aslq6ueqndb5myst5blsynqoq-story.html

Cancer vaccine developed using Oxford-AstraZeneca vaccine tech

 

Scientists are utilising the same technology used in the creation of the Oxford-AstraZeneca COVID-19 jab to develop a vaccine to treat cancer.

Researchers at the University of Oxford and the Ludwig Institute for Cancer Research have designed a two-dose therapeutic cancer vaccine using Oxford’s viral vector vaccine technology. The cancer vaccine, which has already been tested in mouse tumour models, has been shown to increase the levels of anti-tumour T cells infiltrating the tumours and improve the efficacy of cancer immunotherapy.

The study has been published in the Journal for ImmunoTherapy of Cancer.

Immunotherapy

The process of cancer immunotherapy involves turning a patient’s own immune system against a tumour. PD-1 is a checkpoint protein on immune cells called T cells. It normally acts as a type of ‘off switch’ that helps to prevent the T cells from attacking other cells in the body. Anti-PD-1 immunotherapy works by taking the brakes off these anti-tumour T cells, enabling them to kill cancer cells. Although this therapy has proved hugely successful in some cancer patients, it is ineffective for most.

Researchers have sighted low levels of anti-tumour T cells in some patients as one of the reasons for the poor efficacy of anti-PD-1 cancer therapy. The vaccine technology behind the Oxford-AstraZeneca COVID-19 vaccine generates strong CD8+ T cell responses, which are required for good anti-tumour effects.

In this study, the researchers developed a two-dose therapeutic cancer vaccine with different prime and boost viral vectors, one of which is the same as the vector in the Oxford-AstraZeneca COVID-19 vaccine. To create a vaccine that specifically targets cancer cells, it was designed to target two MAGE-type proteins that are present on the surface of many types of cancer cells. Known as MAGE-A3 and NY-ESO-1, these two targets were previously validated by the Ludwig Institute.

Reduction in tumour size

When trialled in preclinical experiments using mouse tumour models, the vaccine increased the levels of tumour-infiltrating CD8+ T cells and enhanced the response to anti-PD-1 immunotherapy. The combined vaccine and anti-PD-1 treatment resulted in a greater reduction in tumour size and improved the survival of the mice compared to anti-PD-1 therapy alone.

Benoit Van den Eynde, Professor of Tumour Immunology at the University of Oxford, Member of the Ludwig Institute for Cancer Research and Director of the de Duve Institute, Belgium, said: “We knew from our previous research that MAGE-type proteins act like red flags on the surface of cancer cells to attract immune cells that destroy tumours.

“MAGE proteins have an advantage over other cancer antigens as vaccine targets since they are present on a wide range of tumour types. This broadens the potential benefit of this approach to people with many different types of cancer.

“Importantly for target specificity, MAGE-type antigens are not present on the surface of normal tissues, which reduces the risk of side effects caused by the immune system attacking healthy cells.”

In the next step of this research, scientists will carry out a Phase 1/2a clinical trial of the cancer vaccine in combination with anti-PD-1 immunotherapy in 80 patients with non-small cell lung cancer. This trial is due to take place later this year as a collaboration between Vaccitech Oncology Limited (VOLT) and Cancer Research UK’s Centre for Drug Development.

Adrian Hill, Lakshmi Mittal and Family Professorship of Vaccinology and Director of the Jenner Institute, University of Oxford, said: “This new vaccine platform has the potential to revolutionise cancer treatment. The forthcoming trial in non-small cell lung cancer follows a Phase 2a trial of a similar cancer vaccine in prostate cancer undertaken by the University of Oxford that is showing promising results.

“Our cancer vaccines elicit strong CD8+ T cell responses that infiltrate tumours and show great potential in enhancing the efficacy of immune checkpoint blockade therapy and improving outcomes for patients with cancer.”

Tim Elliott, Kidani Professor of Immuno-oncology at the University of Oxford and co-Director of Oxford Cancer, said: “In Oxford, we are combining our fundamental scientific expertise in immunology and antigen discovery with translational research on vaccine platforms.

“By bringing these teams together, we can continue to address the significant challenge of broadening the positive impact of immunotherapy to benefit more patients.”

https://www.healtheuropa.eu/cancer-vaccine-developed-using-oxford-astrazeneca-vaccine-technology/110725/

Foxconn's Gou hopes for up to 9mln BioNTech shots for Taiwan this year

 Taiwan could get up to 9 million doses of BioNTech SE's COVID-19 vaccine this year, the founder of Taiwanese tech giant Foxconn said on Monday, laying out a delivery timetable for a vaccine order that became heavily politicised. Taiwan had blamed China, which claims the island as its own territory, for nixing an original order from the German firm this year - charges Beijing has angrily denied.

Taiwan's government then allowed major Apple Inc supplier Foxconn - formally Hon Hai Precision Industry Co Ltd - as well as its high-profile billionaire founder, Terry Gou, along with Taiwan Semiconductor Manufacturing Co Ltd, to negotiate on its behalf for the doses.

The first batch of BioNTech shots arrived last week. A Taiwanese Buddhist group has also ordered 5 million shots, with government approval.

Writing on his Facebook page, Gou said the second batch of vaccines should arrive before the end of the week, with the third batch coming around the middle of the month.

"Following on, it is estimated 700,000 to 800,000 doses per week will come as weekly arrivals, so the target of 8-9 million doses this year will be reached as soon as possible, but we are also working hard to get more to Taiwan this year," he added.

BioNTech did not immediately respond to a request for comment.

Gou was not able to be at the airport to welcome the first batch as he was in quarantine after returning from a trip to Europe.

He said that "at the moment" there were no plans for him to receive the second batch in person to "avoid dragging in lots of people".

Taiwan is getting the shots, jointly developed with Pfizer Inc, earlier than expected as a delay in regulatory approval of the shot for use in mainland China made a surplus available for the island. The vaccine is approved for use in Chinese-run Hong Kong and Macau.

Taiwan's COVID-19 pandemic is well under control, with a vaccination programme proceeding smoothly, though only around 5% of the population are fully inoculated.

https://www.zawya.com/mena/en/life/story/Foxconns_Gou_hopes_for_up_to_9mln_BioNTech_shots_for_Taiwan_this_year-TR20210906nL1N2Q804GX1/

Sinovac booster shot reverses drop in antibody activities against Delta-study

 A booster dose of Sinovac Biotech's COVID-19 vaccine reversed a decline in antibody activities against the Delta variant, a study showed, easing some concerns about its longer-term immune response to the highly contagious strain of the virus.

The study comes amid concerns about the Chinese vaccine's efficacy against Delta, which has become the dominant variant globally and is driving a surge in new infections even in the most vaccinated countries.

Several countries which have relied heavily on the Sinovac vaccine have begun giving booster shots developed by Western manufacturers to people fully vaccinated with the Chinese shot.

Neutralising antibody activities against Delta were not detected in samples taken from vaccine recipients six months after they received the second dose of Sinovac's CoronaVac vaccine, according to the study published on Sunday before a peer review.

But recipients of booster shots showed over 2.5-fold higher neutralizing potency against Delta about four weeks after the third dose, compared with the level seen about four weeks after the second shot, researchers from Chinese Academy of Sciences, Furan University, Sinovac, and other Chinese institutions said in the paper.

They did not discuss how specifically changes in antibody activity will affect Sinovac shot's efficacy in preventing people from getting sick from the variant.

The lab study involves samples from 66 participants, including 38 volunteers who received either two or three doses of the vaccine.

The World Health Organization plans to ship around 100 million doses of the Sinovac and Sinopharm COVID-19 shots by the end of this month, mostly to Africa and Asia, in its first delivery of Chinese vaccines.

But some countries rejected accepting the vaccines, citing lack of data on their effectiveness against Delta.

Around 1.8 billion doses of the Sinovac vaccine have been supplied globally including China by end August, according to the company.

https://www.yahoo.com/news/sinovac-booster-shot-reverses-drop-093610207.html

Biden DOJ vows to defend abortion access in wake of Texas heartbeat bill

 U.S. Attorney General Merrick Garland pledged to preserve access to abortions in response to Texas S.B. 8, which creates a civil cause of action against those who perform or abet abortions after a doctor can detect a fetus' heartbeat.

"While the Justice Department urgently explores all options to challenge Texas SB8 in order to protect the constitutional rights of women and other persons, including access to an abortion, we will continue to protect those seeking to obtain or provide reproductive health services pursuant to our criminal and civil enforcement of the FACE Act," Garland said in a statement Monday, referencing the Freedom of Access to Clinic Entrances Act which President Bill Clinton signed into law in 1994.

The attorney general explained that the FACE Act "prohibits the use or threat of force and physical obstruction that injures, intimidates, or interferes with a person seeking to obtain or provide reproductive health services. It also prohibits intentional property damage of a facility providing reproductive health services."

Garland pledged that the Department of Justice "will provide support from federal law enforcement when an abortion clinic or reproductive health center is under attack. We have reached out to U.S. Attorneys’ Offices and FBI field offices in Texas and across the country to discuss our enforcement authorities.

"We will not tolerate violence against those seeking to obtain or provide reproductive health services, physical obstruction or property damage in violation of the FACE Act," the attorney general concluded.

Texas' new abortion law enables private citizens to bring a civil lawsuit against an abortionist, or someone who aids and abets abortion, if the abortion provider detected the unborn baby's heartbeat before carrying out the procedure, or if they refuse to check for a heartbeat after roughly six weeks' gestation. Many abortion activists have condemned the law as effectively overturning the 1973 Roe v. Wade decision, since many women often do not realize they are pregnant until they pass six weeks' gestation.

By bringing up the FACE Act in the context of combatting S.B.8, Garland hinted that the DOJ may consider such private lawsuits a violation of the FACE Act. The DOJ did not immediately respond to Fox News' request for comment on the issue, however. The office of Texas Attorney General Ken Paxton also did not immediately respond to Fox News' request for comment on the issue.

Former Harvard Law professor Laurence Tribe urged Garland to take up a similar legal argument.

"It should be the announced position of Merrick Garland’s DOJ that claims asserted by bounty hunters under the Texas statute will be regarded as unlawful attempts to deprive persons of their constitutional rights and will be subject to civil and criminal sanctions as appropriate," Tribe tweeted.

S.B. 8 came into effect on September 1 after the Supreme Court voted 5-4 to deny an emergency appeal from abortion providers and others to sideline the law while appeals are made. The judges suggested that their order likely isn't the last word on whether the law can stand.

Last week, House Speaker Nancy Pelosi, D-Calif., pledged that the House of Representatives would vote on a bill codifying Roe v. Wade into law.

https://www.yahoo.com/news/biden-doj-vows-defend-abortion-201657412.html