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Sunday, July 11, 2021

Cancer death rates have dropped. But experts warn obesity may soon drive the disease

 U.S. cancer death rates for men, women and communities of color are falling, but obesity and unequal access to care could threaten hard-fought gains over the past two decades, a new report shows.

The annual American Cancer Society report, which measures cancer cases and deaths through 2018, paints a mixed picture of the nation's effort to combat the second leading cause of death, said Farhad Islami, the report's lead author and American Cancer Society's scientific director of cancer disparity research.

Death rates for lung cancer and melanoma improved significantly, but recent progress on breast and colon cancer deaths slowed, and prostate cancer death rates flattened after years of decline, the report said.

Experts said long-standing efforts to curb cigarette smoking and tobacco use along with improved medical care have yielded significant improvements in lung cancer deaths.

"The decrease in smoking is a huge reason," said Dr. Otis Brawley, a professor at Johns Hopkins University and former chief medical officer at American Cancer Society. "Keep in mind it is not just lung cancer, but smoking causes 18 different cancers."

New medications to treat people with melanoma that spread to other parts of the body also improved survival rates, Islami said.

The new report, published in the The Journal of the National Cancer Institute, includes death rates by age, sex, race, and ethnicity from 2001 through 2018 based on death certificates reported to states and the Centers for Disease Control and Prevention's National Center for Health Statistics.

Overall, cancer death rates fell at a faster rate from 2015 to 2018 compared with rates since 2001. Cancer death rates for men dropped 2.3% per year from 2015 to 2018, a faster than 1.8% decline each year from 2001 to 2015. Among women, cancer deaths dropped 2.1% per year from 2015 to 2018, compared with 1.4% per year from 2001 to 2015.  

Cancer death rates also dropped among all racial and ethnic group from 2014 to 2018. But death rates overall remain higher among Blacks compared with whites and other racial and ethnic groups.

Despite slowing death rates in most types of cancer for men and women, not all trends were positive. Death rates increased from cancer in the brain, nervous system and pancreas among men and women. In men, oral and throat cancers are on the rise, and liver and uterine cancers in women.

However, experts warn that obesity could soon overtake smoking as the nation’s main driver of new cancer cases. And the figures show positive strides on common cancers such as breast and colon cancers have slowed. One possible factor is rising obesity, Islami said.

Brawley agrees an "energy imbalance" of eating too much and not exercising enough is putting more Americans at risk for cancer. Brawley cited previous research that predicted such rising obesity and lack of exercise would usurp tobacco this decade as the leading cause of cancer 

"Think about tobacco control pushing the rate down and energy imbalance pushing the rate up at the same time, "Brawley said. "And by the way, the cancers that are going up or the cancers that are not going down in death rate in this study are the ones most closely associated with energy imbalance."

The data do not capture cancer cases and deaths since the beginning of the COVID-19 pandemic in 2020, but researchers fear a slowdown in screening during lockdowns could mean doctors and patients are missing early-stage cases.

"They may be diagnosed a year later," Islami said. "Increasing the proportion of cancers at a more advanced stage will eventually translate to higher death rates, unfortunately."

https://www.usatoday.com/story/news/health/2021/07/08/cancer-death-rates-drop-obesity-drive-disease/7880844002/

Oncology biotech Immuneering files for a $100 million IPO

  Immuneering, a preclinical biotech targeting signaling pathways to treat cancer and neurological diseases, filed on Friday with the SEC to raise up to $100 million in an initial public offering.


Immuneering's oncology programs target mutations of the MAPK and mTOR pathways, which run parallel to each other and are inappropriately activated in over half of all cancers. The company's lead program, IMM-1-104, is a highly selective dual-MEK inhibitor being developed for the treatment of advanced solid tumor patients harboring RAS mutant tumors. Immuneering plans to submit an IND for IMM-1-104 in the first quarter of 2022 and anticipates filings at least one additional oncological IND in both 2023 and 2024.

The Cambridge, MA-based company was founded in 2008 and plans to list on the Nasdaq under the symbol IMRX. Immuneering filed confidentially on May 13, 2021. Morgan Stanley, Jefferies, Cowen, and Guggenheim Securities are the joint bookrunners on the deal. No pricing terms were disclosed.

Saturday, July 10, 2021

Dallas County, TX reaches herd immunity

 Dallas County, Texas, has reached herd immunity with 80 percent of its population either being fully vaccinated against COVID-19 or having natural immunity as a result of past infections, a nonprofit announced Wednesday.

Herd immunity was reached on July 4 with 46.6 percent of the population receiving two shots of the vaccine and 48.7 percent having natural immunity from a previous COVID-19 infection, Parkland Center for Clinical Innovation (PCCI) said in a statement.

While this represents good progress, it is important that we understand the work is not over. We must continue to push for vaccinations so COVID and its variants can’t again take hold and diminish the progress we’ve made,” Steve Miff, the nonprofit’s CEO, said.

The nonprofit warned, however, that the target for herd immunity could jump to 88 percent due to the more contagious delta variant hitting the area. 

The new strain currently makes up 25 percent of cases currently in Dallas County. 

Philip Huang, the county’s health director, said it is “concerning” that cases and hospitalizations from the coronavirus are slightly up, but says “the numbers are still relatively low” in the area, The Dallas Morning News reported.

PCCI said 49 Dallas County ZIP codes have reached the 80 percent level needed for herd immunity. Forty-five, however, have not. 

“There are still significant pockets in the community that remain vulnerable,” Miff stated.

Health officials have been warning of spikes in cases where pockets of unvaccinated individuals reside as states with low vaccination rates are seeing their COVID-19 case count go up.

https://thehill.com/policy/healthcare/562012-dallas-county-reaches-herd-immunity-nonprofit-says

Covid passports planned in time for England’s autumn wave

 Covid-19 certificates will be required for customers to enter bars, restaurants and nightclubs under plans to tackle a fourth wave of the virus in a move that experts hope will boost jab rates among the young.

Entertainment venues in England would be forced to make customers use so-called vaccination passports from autumn, to prove that they had either had both doses or a negative test the day before. Recent figures have shown a reduction in the take-up of vaccines with first doses halving in two weeks. Fewer than 100,000 a day are being given out on average for the first time since April.

https://www.thetimes.co.uk/article/covid-passports-planned-in-time-for-englands-autumn-wave-hgg8wpggv

TSMC says it is in process of signing a deal for BioNTech COVID-19 vaccines

Taiwan chipmaker TSMC said on Sunday it was in the middle of the contract signing process to buy COVID-19 vaccines from Germany's BioNTech SE, part of a drawn out and highly politicised process for Taiwan to access the shot.

Taiwan's government has tried for months to buy the vaccine directly from BioNTech and has blamed China, which claims the self-ruled island as its own territory, for nixing a deal the two sides were due to sign earlier this year. China denies the accusations.

Last month, facing public pressure about the slow pace of Taiwan's inoculation programme, the government agreed to allow Terry Gou, the billionaire founder of Taiwan's Foxconn, as well as Taiwan Semiconductor Manufacturing Co (TSMC) to negotiate on its behalf for the vaccines, which would be donated to Taiwan's government for distribution.

"There are multiple parties. We are in the middle of the contract signing process. We will make announcements once the process is completed," TSMC said in a brief emailed statement, without elaborating.

BioNTech and Fosun did not immediately respond to requests for comment.

Gou's spokesperson said: "When there is further news, we will formally explain it to the outside world". She gave no details.

Speaking to reporters on Sunday, Premier Su Tseng-chang would only say that talks for the vaccine were ongoing.

"Once there is an definite outcome, we'll naturally report it to everyone."

A source briefed on the matter told Reuters that contract talks were "not yet 100% complete", while another source said while they were close to finalising the deal, uncertainties remained.

"It has become increasingly clear that it is not the Taiwan side who is complicating the signing of the contract," the second source said, referring to extra "obstacles" set up by Beijing.

China's Taiwan Affairs Office did not answer calls seeking comment outside of business hours on Sunday.

FOSUN CONTRACT

Gou and TSMC this month reached an initial agreement with a subsidiary of Shanghai Fosun Pharmaceutical Group Co Ltd, which has a contract with BioNTech to sell the COVID-19 vaccines in China, Hong Kong, Macau and Taiwan, sources told Reuters previously.

Both Gou and TSMC are seeking 5 million doses each.

The BioNTech vaccine drama has transfixed Taiwan and dominated headlines. A major Taiwanese Buddhist group, the Tzu Chi Foundation, is also trying to buy the shots, which were developed jointly with Pfizer.

China's government has repeatedly said that if Taiwan wants the vaccine, it has to respect commercial rules and do it through Fosun.

Germany's government has also been involved, saying it has been helping in the direct talks between Taiwan and BioNTech.

Taiwan has millions of vaccines on order, mainly from AstraZeneca Plc and Moderna Inc, while the United States and Japan have together donated almost five million doses to the island to help speed up vaccinations.

Around one-tenth of Taiwan's 23.5 million people have received at least one of the two-shot regimen, though Taiwan's own relatively small domestic coronavirus outbreak is now largely under control.

https://www.marketscreener.com/news/latest/TSMC-says-it-is-in-the-process-of-signing-a-deal-for-BioNTech-COVID-19-vaccines--35832235/ 

Pfizer to brief US health officials on coronavirus booster shot

 Pfizer is expected to brief U.S. health officials on the need for a COVID-19 booster shot in the upcoming days, several sources told The Washington Post

News of the reported briefing comes after government agencies pushed back on the vaccine manufacturer’s announcement this week that it was seeking authorization for a third dose of its coronavirus vaccination.  

Pfizer and six people familiar with the plans confirmed to the newspaper that a meeting could likely take place on Monday. The meeting is expected to be similar to a briefing the company gave to European officials last week on a potential booster shot.  

The people familiar with the matter, who spoke to the Post on the condition of anonymity, said those invited to the planned briefing include White House chief medical adviser Anthony Fauci, National Institutes of Health (NIH) Director Francis Collins and Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky

Janet Woodcock, acting commissioner for the Food and Drug Administration (FDA), chief COVID-19 science officer David Kessler and the surgeon general, Vivek Murthy, have also been invited, according to the Post. 

A Pfizer spokesperson confirmed the meeting to the Post, but the representative did not provide additional information. 

The Hill has reached out to Pfizer for comment, as well as the White House, CDC and the Department of Health and Human Services (HHS). 

The question about whether a COVID-19 booster shot is needed in the future sparked debate this week after Pfizer/BioNTech said they the companies had seen "encouraging data" from an ongoing trial of a third inoculation. 

The companies also cited data from the Israel Ministry of Health showing “vaccine efficacy in preventing both infection and symptomatic disease has declined six months post-vaccination.” 

However, U.S. health agencies quickly pushed back, with the CDC and FDA saying in a joint statement shortly after Pfizer’s announcement that “Americans who have been fully vaccinated do not need a booster shot at this time.” 

“FDA, CDC, and NIH are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary,” the statement added. “This process takes into account laboratory data, clinical trial data, and cohort data – which can include data from specific pharmaceutical companies, but does not rely on those data exclusively.” 

“We continue to review any new data as it becomes available and will keep the public informed,” the agencies said. “We are prepared for booster doses if and when the science demonstrates that they are needed.” 

Some experts have warned that pharmaceutical companies have a financial incentive to develop more shots of their vaccines and for the government to buy more doses. 

Fauci said Friday that Pfizer CEO Albert Bourla had called him to apologize for not warning top health officials ahead of the company’s announcement that it would seek FDA authorization for a third dose. 

The nation’s top infectious disease expert went on to say that the “coordination that’s been going on” between pharmaceutical companies and government agencies “on the rollout of the vaccines over the last four or five months has been extremely good.”

https://thehill.com/policy/healthcare/562421-pfizer-to-brief-us-health-officials-on-booster-shot-report

Biden urged to harden government for future pandemics

 Public health experts are urging the Biden administration to harden the federal government for future crises, warning that the U.S. is not prepared for the next pandemic.

The White House says it is laser-focused on bolstering the government’s ability to respond to another coronavirus-like outbreak. But doing so will require ample funding from Congress to help agencies react as quickly and effectively as possible to prevent a loss of life similar to COVID-19, which has killed more than 4 million people globally and more than 600,000 Americans.

Experts have said the U.S. was caught flat-footed by the coronavirus pandemic due to years of inadequate investments in public health infrastructure. The rapid spread of cases along with pressure on hospitals and clinical laboratories exposed critical weaknesses.

Emergency funding has helped public health agencies fight the coronavirus, but unless that level of spending can be sustained, the country is considered in danger of repeating the same mistakes.

"I just think it would be sort of foolhardy to not realize that this can happen again and take some action," said Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials. "So far, that's borne out. There's been huge, huge resources put out to public health. It's just, we need to stay the course for a few years to really see some of these improvements along."

Biden administration officials are in the midst of reviewing the nation’s biopreparedness policies, the result of an executive order the president issued on his first day in office.

The order also restored a global health security office that the Trump administration had consolidated.

Biden administration officials are frank about the need to act with urgency.

“We’ve been dealing with COVID since early 2020 and we know from experience that emerging infectious disease outbreaks don’t wait for one crisis to end for another to begin. And so this is long-term preparatory work and it’s urgent,” a senior administration official said.

“We obviously need to make sure that while we’re rebuilding from the COVID-19 pandemic that we’re preparing for the next one because it could come at any time.”

Historically, U.S. funding for health security has been disease-based. Spikes in funding have almost entirely been driven by specific events — like Zika, Ebola and SARS — and funded by emergency appropriations that eventually dried up.

Experts and advocates are now hoping the Biden administration can change that.

“I think the biggest challenge is persistence. We underestimate the microbial world at our peril, and if we don’t increase and then continue the investment we are making, we will continue to be underprepared for lethal threats,” said Tom Frieden, who served as director of the Centers for Disease Control and Prevention (CDC) during the Obama administration.

“Even more important than the amount of money is keeping at it.”

The coronavirus pandemic has made an outsized impact on the U.S. So far, the funding has matched it.

Biden’s $1.9 trillion American Rescue Plan signed into law in March included half a billion dollars in funding for a new Center for Epidemic Forecasting and Outbreak Analytics at the CDC.

Biden has also proposed spending $30 billion over four years on manufacturing, research and development to guard against future pandemics as part of his American Jobs Plan.

The Biden administration has set a goal of manufacturing 100 million vaccines within the first 100 days of the next outbreak.

It also wants to be able to identify pathogens within a few days, manufacture personal protective equipment more rapidly, and shore up the Strategic National Stockpile, which was ill-equipped to handle the spike in demand for critical supplies when COVID-19 took hold.

Plescia said the U.S. should overhaul antiquated data systems, as well as shore up the public health workforce. That won't take a substantial funding commitment, he said, but the money needs to be consistent.

"What Congress needs to do is just put forward some recurring funding for public health. Sure, that could get cut in years to come, but that's different than sort of the one-time resources we're getting now," Plescia said. "A lot of state, local governments are going to be hesitant to really take actions ... unless they see some kind of recurring funding."

Yet former officials and experts said they are concerned that as public attention shifts away from COVID-19, there will be less of an appetite in Congress for that level of robust and sustained funding.

“If we look at what has happened in the past, it’s always what has happened. It’s out of sight out of mind for public health protection funding,” said Frieden, who argued that money for public health should not be constrained by discretionary budget caps.

The senior administration official said the White House is engaging with members of Congress to ensure that public health efforts are more robustly funded, and expressed hope that lawmakers would not lose sight of the need to shore up the nation’s health apparatus, noting that there has been bipartisan support for biodefense.

In addition to the White House’s own review, there has been a push on Capitol Hill for the formation of a bipartisan 9/11-style commission to analyze the nation’s pandemic preparedness and response.

The bipartisan leaders of the Senate Health Committee are working on a legislative package to consider lessons learned during the COVID-19 response and ensure the public health system is fully modernized and in better shape to handle the next pandemic.

Some outside groups have undertaken their own reviews, and have offered recommendations. The White House is analyzing recommendations from experts in addition to gathering input from those within the government in its review.

The Bipartisan Policy Center is calling for the creation of a new federal board to oversee U.S. preparedness for future public health threats, and the allocation of $4.5 billion in annual mandatory funding for a new public health infrastructure account to support state and local governments.

“There needs to be intergovernmental coordination and federal oversight, there needs to be a 21st century public data structure, and there needs to be adequate public health funding,” said Anand Parekh, the center’s chief medical adviser.

https://thehill.com/policy/healthcare/562366-biden-urged-to-harden-government-for-future-pandemics