White House unveils plans to roll out COVID-19 vaccines for kids 5 and under

 Ten million pediatric COVID-19 vaccine doses will be available for states, Tribes and other jurisdictions to pre-order in anticipation of vaccinations for kids ages 5 and younger beginning before the end of the month, the White House announced Thursday.

Administration officials outlining the plan said vaccines will be distributed across thousands of different sites, but they will put a focus on frontline providers like pediatricians and primary care doctors, as that is where they expect many families will want to go. 

Officials said they estimate that 85 percent of children under the age of 5 live within five miles of a potential vaccination site. 

“We know that there are many parents who’ve been eagerly awaiting the opportunity to vaccinate their youngest kids and we share their eagerness,” a senior administration official said. “Everyday, all day right now we are focusing on getting ready to have this as accessible as possible to as many families as possible.”

Jurisdictions were able to pre-order five million doses combined of Pfizer and Moderna’s shots beginning last Friday, and another five million were made available on Wednesday, officials said during a briefing with reporters.  The doses cannot ship until the Food and Drug Administration gives its authorization. 

To date, jurisdictions have ordered just 58 percent of the available Pfizer doses and 34 percent of the available Moderna doses. But officials stressed it was still early in the ordering process, and it followed a similar pattern to what they saw with vaccines for adults and adolescents.

“Our experience is that the longer the ordering stays open, the more likely the states come forward. So some of this is a matter of letting them know the ordering is available and that they can begin that process,” a senior administration official said. “We’re not too worried or focused on that and we’ll continue to do these outreaches.” 

Aside from pediatricians’ offices, specially-packaged vaccines will be made available at community health centers, rural health clinics, children’s hospitals, public health clinics, local pharmacies and other community-based organizations. Officials said they will also undertake a campaign to educate parents more fully about the vaccines.

One of the most important lessons officials said they learned from the earlier vaccination campaigns is the need for trusted messengers to overcome vaccine hesitancy. While some parents are eager to get their kids vaccinated as soon as possible, vaccination rates have lagged for older children, indicating rates may lag for young children as well. 

Only about 30 percent of children 5 to 11 have been vaccinated, according to the Centers for Disease Control and Prevention.

“We are going to meet people where they are and answer their questions. And so what we are trying to do is, we’re trying to ensure that those people in communities including pediatricians, have the information that they need to answer parents questions,” a senior administration official said.

Children under 5 are the only age group that still has no vaccine available. 

An FDA advisory committee is scheduled to meet on June 14 and 15 to consider the applications from Pfizer and Moderna, and a CDC panel will meet Friday and Saturday, June 17 and June 18. 

Vaccines would start getting administered once CDC Director Rochelle Walensky signs off. Officials said they anticipate vaccines will start to be delivered to sites over that weekend, but because June 20 is a federal holiday, vaccinations won’t begin in earnest until June 21.

https://thehill.com/policy/healthcare/3516745-white-house-unveils-plans-to-roll-out-covid-19-vaccines-for-kids-5-and-under/

Biden says he is weighing executive orders on abortion rights

 President Biden said late Wednesday that he is considering signing an executive order on abortion rights if the Supreme Court overturns Roe v. Wade later this month, offering a window into the administration’s thinking as officials prepare for the ruling.  

“There’s some executive orders I could employ, we believe. We’re looking at that right now,” Biden said during a taped appearance on “Jimmy Kimmel Live!,” prompting a round of applause from the audience.  

Biden did not expand on what executive orders he is considering. He also urged voters to vote Republicans out of office come November so that Democrats can pass federal legislation codifying Roe v. Wade.  

“It’s clear that if, in fact, the decision comes down the way it does and these states impose the limitations they’re talking about, it’s going to cause a mini revolution and they’re going to vote a lot of these folks out of office,” Biden said.  

His comments come after a group of Democratic senators led by Sens. Elizabeth Warren (D-Mass.) and Patty Murray (D-Wash.) wrote to Biden on Tuesday urging him to sign an executive order “directing the federal government to develop a national plan to defend Americans’ fundamental reproductive rights, including their right to an abortion.”  

The White House has been quietly preparing for the Supreme Court to overturn Roe v. Wade, a landmark ruling 50 years ago that said the right to have an abortion was constitutionally protected. 

The preparations intensified after a leaked draft opinion published by Politico in early May showed that the conservative majority on the court was poised to overturn Roe.  

White House officials have been meeting with state officials, abortion rights advocates and other stakeholders to understand the laws on the ground in various states.  

The White House has said that it plans to take some kind of action in response to the ruling but has offered few clues about what it will look like. Administration officials are not expected to lay out plans until after the ruling is issued sometime later this month, before the end of the Supreme Court’s current term.  

Still, experts say the Biden administration is severely limited in what it can do to counteract restrictive abortion laws in states if Roe is overturned. Thirteen states have so-called trigger laws restricting abortion that will take effect if Roe is overturned, and more states are expected to pass restrictions once the ruling is issued.  

Experts say, for example, that the administration could allow the use of Medicaid funding to pay for time off and travel for women who need to seek an abortion out of state or could expand guidance on the use of abortion pills.  

https://thehill.com/news/administration/3517080-biden-says-he-is-weighing-executive-orders-on-abortion-rights/

HHS report 'warns of extreme heat risks' in coming months

 States across the country are preparing for another blistering summer as average temperatures continue to climb thanks to climate change.

In an effort to better prepare municipalities, first responders and health systems for the toll these heat waves will take, the Office of Climate Change and Health Equity (OCCHE), part of the Department of Health and Human Services (HHS), this week released their second installment of the Climate Health Outlook.

First launched in May, the public health information series aims to protect “people and their health by giving advance notice to the communities that will be most impacted in the coming months,” said HHS Secretary Xavier Becerra in a press release.

The report is specific to June through August of 2022, while temperature forecasts were based on National Oceanic and Atmospheric Administration data. 

An extremely hot day is defined as any daily maximum temperature over the 95th percentile of the historical temperature distribution in each county. Estimates show the majority of extreme heat days will be focused in the southwest United States, putting nearly 22 million people at risk of heat-related health outcomes. 

According to authors, several groups of people are at particular risk, including the elderly who live alone, those in rural areas, people with poor access to health care, those who work outdoors and individuals living in urban settings with poor tree cover, among others. 

“Spikes in energy demand should be expected during summer months as air conditioning use increases,” the report said. “The combination of sagging power lines (copper expands as it heats up, thus increasing impedance and reducing throughput) and increased energy demands can cause power failures that make certain populations more vulnerable when the risk is highest.” 

Extreme heat can cause a myriad of health issues, including increased risk of hospitalization for heart disease, and increased risks of heat exhaustion, heat stroke, worsening asthma and respiratory diseases, and dehydration, which can cause kidney and blood pressure problems. In addition, certain medications can increase the risk of heat-related illness, and others may become less effective in higher temperatures. 

“Violence, crime, and suicide may increase with temperature, adding to the rates of depression and anxiety already associated with climate change,” authors noted. 

Of the 132 counties identified as having more than five expected extreme heat days in the month of June, the majority (56 percent) have a high number of residents without health insurance. Sixty-seven percent have a high number of residents living in areas without adequate tree cover, and 58 percent of counties are highly vulnerable, based on the CDC’s social vulnerability index.

For most of the continental United States, temperatures will be between 1.8 to 3.6 degrees above average between June and August, with central and western regions expected to experience temperatures 3.6 to 5.4 degrees above normal during this window — marking a significant increase from temperatures predicted for last summer. 

Between June and July 2021, heat-related deaths increased from two to 145 in Washington, zero to 119 in Oregon, and 12 to 25 in California compared with the same time in 2020. For Washington, the 2021 heat wave marked the deadliest weather event in the state’s history, local media reported at the time. 

OCCHE’s recommendations for outdoor workers facing extreme heat include building a heat tolerance by easing into outdoor work, taking breaks in shaded areas and checking in on workers wearing face coverings. 

The report also offers resources on opening cooling shelters for local organizations and clinical best practices for managing cases of heat stroke. 

https://thehill.com/changing-america/sustainability/climate-change/3517379-hhs-report-warns-of-extreme-heat-risks-in-coming-months/

AbCellera Sees Strong Trading Volume on Insider Buying

 Shares of AbCellera Biologics Inc. (NASDAQ:ABCL - Get Rating) saw strong trading volume on Thursday following insider buying activity. 64,282 shares were traded during mid-day trading, a decline of 97% from the previous session's volume of 2,225,388 shares.The stock last traded at $8.51 and had previously closed at $7.96.Specifically, major shareholder Holdings Ltd. Thermopylae acquired 64,545 shares of the firm's stock in a transaction dated Monday, June 6th. The stock was acquired at an average price of $7.50 per share, for a total transaction of $484,087.50. Following the purchase, the insider now owns 55,580,303 shares of the company's stock, valued at approximately $416,852,272.50. The transaction was disclosed in a filing with the SEC, which can be accessed through this link. Also, CFO Andrew Booth acquired 85,000 shares of the firm's stock in a transaction dated Thursday, May 12th. The stock was bought at an average price of $5.79 per share, with a total value of $492,150.00. Following the purchase, the chief financial officer now directly owns 138,500 shares in the company, valued at approximately $801,915. The disclosure for this purchase can be found here. Over the last ninety days, insiders acquired 1,758,013 shares of company stock valued at $11,272,517. 45.80% of the stock is currently owned by corporate insiders.

https://www.marketbeat.com/instant-alerts/nasdaq-abcl-volume-advance-2022-06/

Preclinical Study Backs Seelos' Gene Therapy for Dementia with Lewy Bodies

 Seelos Therapeutics announced in vitro data on Thursday supporting its gene therapy, SLS-004, which is intended for the treatment of dementia with Lewy bodies (DLB).

Dementia with Lewy bodies, also known as Lewy body dementia, is a type of progressive dementia associated with declines in cognition, motor ability and independent functioning. It's also associated with cholinergic dysfunction, which can affect many aspects of brain functioning, including sleep and sensory processing.

DLB is the third most common type of dementia after Alzheimer’s disease (AD) and vascular dementia. The condition is caused by the buildup of Lewy bodies in the brain, which are mainly made up of alpha-synuclein proteins.

Seelos is hoping to make a difference for people with DLB using its gene therapy program, SLS-004, which utilizes CRISPR-dCas9. The company tested SLS-004 in cholinergic neurons from the areas of the brain cortex that are usually affected by DLB.

The preclinical study results showed that a single dose of SLS-004 was associated with a 19% downregulation of mRNA and a 40% reduction of alpha-synuclein, following a two-week period showing the drug’s potential to reduce the presence of Lewy bodies.

 "This current in vitro study extends the existing CRISPR program for Parkinson's disease to DLB as both disorders are synucleinopathies although affecting different neurons in separate regions of the brain. Our team's observation of a meaningful efficacy with a new CRISPR technology focused on cholinergic neurons in striatum for DLB is exciting indeed, as it reinforces our earlier findings in a Parkinson's disease model," Raj Mehra, Ph.D., Seelos chairman and CEO, said in a press release. "Results producing statistically significant reductions in mRNA and alpha-synuclein are clinically meaningful. We plan to advance into additional preclinical studies in DLB and Parkinson's and expect additional data in the second half of this year."

SLS-004 modulates the expression of the SNCA gene, which has been implicated in the pathology of Lewy bodies in Parkinson’s disease and AD, as it encodes for alpha-synuclein. In previous studies of SLS-004, the therapeutic was able to produce a 30% downregulation of SNCA overexpression in dopaminergic neurons in a PD patient. The reduction was sufficient to ameliorate disease-related cellular phenotypes. Seelos plans to announce additional data from its Parkinson’s disease model in the second half of 2022.

Armed with new data supporting SLS-004’s development, Seelos plans to advance studies of SLS-004 in DLB in preclinical models and will disclose further developments of the therapy in the future.

Seelos also announced in May that it had received a notice of allowance in the U.S. for an additional patent for its candidate SLS-007, a peptide inhibitor designed to inhibit alpha-synuclein protein aggregation in patients with PD. The patent now covers the methodology for treating several neurodegenerative diseases, including AD, Parkinson’s disease, DLV and multiple system atrophy.

The drug is currently being evaluated in preclinical studies to establish target engagement and pharmacokinetic and pharmacodynamic profiles. Like SLS-004, data from the study is also anticipated in the second half of 2022.

https://www.biospace.com/article/seelos-therapeutics-study-backs-gene-therapy-for-dementia-with-lewy-bodies/

Ensysce’s Novel Opioid Appears Impervious to Abuse

 Against the backdrop of a global opioid crisis, Ensysce Biosciences is developing solutions that make opioids safer, and virtually impossible to abuse.

Rather than reformulate opioids, Ensysce is modifying the chemical structure of the opioid so it only takes effect when swallowed and shuts down when more than a few pills are taken. Its candidate, PF614, is a prodrug of oxycodone and is currently in Phase II clinical trials. Its analgesic profile is equivalent to that of oxycodone except that it has a 12-hour half-life once ingested – longer than other marketed opioids.

“Opioids are wonderful products to eliminate pain, but they also create – in some individuals – a sense of euphoria,” Lynn Kirkpatrick, Ph.D., CEO of Ensysce Biosciences told BioSpace. “Therefore, people take them when they aren’t needed to control pain, which leads to abuse and the current opioid crisis.” To put numbers to that, nearly 50,000 people die of opioid overdoses each year in the United States, and more than 10 million people misuse opioids, according to DrugAbuseStatistics.org.

“When some want to achieve that euphoria faster and for it to be more intense, they start chewing it, snorting it or injecting it,” Kirkpatrick continued. “Our chemistry reduces one’s ability to abuse PF614 by any of those means.”

To that end, Ensysce has two technology platforms.

For the first, “We use the body’s own enzymes to start the activation process,” she said. “Trypsin, which everybody has in their body to digest meat, breaks off part of the PF614 molecule to start activation. The rest of the chemistry releases the opioid over time. In the body, trypsin is only found in the small intestine, so you can’t abuse PF614 by injecting it into your arm or chewing it to activate it any faster, or snorting it. Those methods won’t deliver the effects any faster than swallowing it, so we could possibly deliver PF614 in a glass of water for people who have problems swallowing.” This platform is called TAAP – trypsin abuse protection.

Many people who truly need opioid pain medication currently refuse them because of fears of becoming addicted. Physicians then prescribe non-steroidal anti-inflammatory drugs or other pain products, which are less effective and may come with dangerous toxicities if taken for a period of time. PF614 with TAAP™ offers a safer alternative that is difficult to be abused.

“We also have another layer of safety, MPAR – the multi-pill abuse resistance platform – which nobody else delivering opioids has,” she said. This is a combination product that includes a small amount of a trypsin inhibitor. Therefore, if a patient takes another dose, either by accident or on purpose, there’s more trypsin inhibitor to block activation of the pills, thus preventing overdose and reducing the possibility of respiratory depression (cessation of breathing). This failsafe platform protects forgetful patients and children who get into the medicine cabinet, as well as those who want to abuse the drug.

“The inhibitor starts to work immediately,” Kirkpatrick said. Ensysce is determining the proper dosage now, but if, for example, the prescription called for two pills twice per day, “if you take three or four, it diminishes what you would receive without its protection.” If the patient needs a larger dose, the physician would prescribe a higher-dose product.

PF614’s safety profile is similar to that of traditional opioids and can be abused less easily. This puts it in a prime position, assuming it gains regulatory approval, to be used in cases of severe pain in which people need to take opioids for a period of time, such as for acute pain after surgery or to treat chronic indications such as osteoarthritis lower back pain when non-steroidal anti-inflammatory drugs (NSAIDs) and similar medications aren’t potent enough.

The U.S. Food and Drug Administration has granted Fast Track designation to PF614 because of the large unmet need in combatting the opioid crisis. There are applications beyond the opioid crisis, too. TAAP and MPAR can be applied to approximately half of all prescription drugs, Kirkpatrick hypothesized. Ensysce is exploring their development for therapeutic molecules it is creating to treat ADHD and opioid use disorder.

“We’re moving our first product to commercialization as quickly as we can,” she said. “For opioids, you have to conduct human abuse liability studies (sometimes called liking trials) to determine how well a drug abuser would like your product. We are starting those initial studies in May. We believe our product won’t be liked as much as equivalent doses of conventional opioids, because we know there’s no trypsin in the blood or the nose. This is the only kind of pharmaceutical study where companies hope the study participant hates the drug.” 

https://www.biospace.com/article/currently-in-phase-ii-ensysce-s-novel-opioid-appears-impervious-to-abuse/

Novavax Delayed Again, Moderna's Bivalent Vaccine and More Breakthrough Cases

 Sadly, the COVID-19 pandemic is still with us, despite the accessibility of effective vaccines and treatments. Here’s a look at some of the latest COVID-19 news.

Novavax Vaccine Decision Delayed

After the U.S. Food and Drug Administration’s vaccines advisory panel voted to recommend Novavax’s COVID-19 vaccine for an emergency use authorization (EUA), most everyone expected a fast decision by the agency. But like almost everything about the Novavax vaccine in the U.S., there’s been a snag. The agency reports it plans to review changes to the company’s manufacturing process before it authorizes the vaccine. Novavax informed the agency regarding changes to its manufacturing process on June 3, only a few days before the adcom meeting. The company has had problems with manufacturing processes in the past.

“FDA will carefully review this and any additional information submitted by the firm as part of its ongoing assessment and prior to authorizing the vaccine for emergency use,” FDA spokesperson Abby Capobianco stated. 

Manufacturing problems have delayed production around the world. Company CEO Stanley Erck recently said those problems were resolved and “are well behind us.” Novavax has distributed more than 40 million doses as of March 2022 in Asia, Europe and elsewhere. The Serum Institute of India manufactured the shots for Novavax, which is based in the U.S.

HIV Appears to Increase Susceptibility to COVID-19 Even After Vaccination

A study by Johns Hopkins University found that the risk of COVID-19 infection in HIV patients was 28% higher even after receiving the first two primary doses. Researchers evaluated the risk of COVID-19 infection in 113,994 vaccinated patients, of whom 33,029 had HIV and 80,965 who did not. The participants received either two doses of the Pfizer-BioNTech or Moderna vaccines (93%) or one dose of the Johnson & Johnson vaccine (7%) at least 14 days earlier. The study was conducted through December 31, when the Delta and Omicron variants were predominant. Seventy percent of the participants were 55 years or older and male (92%).

The study found the overall risk of COVID-19 was only 3.8% but was nonetheless 28% higher in participants with HIV. The rate post-vaccination was highest in J&J recipients, followed by Pfizer-BioNTech, with Moderna at the lowest risk level. 

Moderna Expects to Have Omicron-Specific Booster Available by Late Summer

Moderna is evaluating a bivalent COVID-19 vaccine that contains the original Spikevax vaccine and a newer version, mRNA-1273.214 that contains an Omicron-specific vaccine, the company announced Thursday. In a Phase II/III trial, it demonstrated superior antibody response against Omicron. Moderna expects to submit data to regulators soon with expectations of it becoming available in late summer.

The data generated so far found that levels of neutralizing antibodies against Omicron in people receiving the bivalent shot were 1.75 times higher than in people who received a booster of Spikevax. The study, however, did not evaluate the efficacy of the modified booster shot.

“I think the data clearly shows this is a superior booster,” Stephen Hoge, Moderna’s president, said. 

Breakthrough Cases an Increasing Problem

Breakthrough cases of COVID-19 are defined by the CDC as when a fully vaccinated individual gets infected with the virus. Early in the pandemic after vaccines were developed, these were rare, but they have grown increasingly common. This appears to be due to the gradual waning of immunity over time and the rise of variants, particularly the Omicron subvariants, that are much better at evading immunity. The vaccines are still very effective at preventing severe disease, hospitalization or death. Experts also suggest that the sheer volume of COVID-19 cases also increased the risk for the vaccinated.

In June 2021, breakthrough cases represented only 12% of cases. By October, breakthrough cases were about 33%. Between April 2021 and April 2022, breakthrough cases rose from 3% to more than 60%. People who have received booster shots are at lower risk, but the risk of breakthrough cases there has also risen, although more slowly. Public health officials expect it to increase, particularly in older people and the more susceptible as they get further from their original shots.

Last month, Dr. Anthony Fauci, the White House’s chief medical advisor and director of the National Institute for Allergy and Infectious Diseases, told CBS  News, “As long as you have vulnerable people in the population, even though the unvaccinated are going to be much more at risk, even vaccinated with underlying conditions and a high degree of susceptibility to severe disease will account for those deaths.”

According to data analysis by ABC News, 80% to 90% of deaths in vaccinated Americans are in people over the age of 65. The CDC has strengthened its recommendation that people over the age of 50 and the immunocompromised over the age of 12 should receive a second booster shot.

https://www.biospace.com/article/covid-19-roundup-novavax-s-vaccine-decision-delayed-by-fda/