Teens sought for Novavax COVID-19 vaccine trial in Lakeland, Fla.

 A Maryland-based vaccine development company has expanded its clinical COVID-19 vaccine trial to teenagers in Lakeland.

Novavax, which still awaits emergency use authorization for its two-dose COVID-19 vaccine from the U.S. Food and Drug Administration, is in phase 3 of its clinical trials.

It received $1.6 billion from Operation Warp Speed in July 2020 for coronavirus vaccine development.

It uses Accel Research Sites in Lakeland, formerly Meridian Research, to conduct some of its trials.

“This will determine the efficacy. This is how well does it actually work in real life and real time?” said Dr. James L. Andersen, principal investigator at Accel Research Sites in Lakeland.

One hundred and sixty four adults participated in the Lakeland-based clinical trial, with 90% of them still remaining in the trial, according to Dr. Andersen.

Now, that group has expanded to 12-17 year olds. Parental consent is required.

“This will also help with school enrollments, decreased propagation to adults and so forth,” said Dr. Andersen.

Participants are monitored for two years and paid $150 each for four total doses, and are reimbursed for follow-up appointments, according to Dr. Andersen.

Two-thirds of the participants receive the vaccine, while the rest get placebos. Months later, they switch.

“Everybody who got the active vaccine will get a placebo and everybody who got a placebo will get a vaccine so eventually everybody will be vaccinated,” said Dr. Andersen.

Novavax reports a 89.3% efficacy rate from its U.K. phase 3 clinical trials.

Dr. Andersen’s message to weary parents – these vaccines have already been tested.

“Phase three trials, there are no guinea pigs. Guinea pigs are long before this. There are animal studies first, then phase one studies that are human volunteers,” said Dr. Andersen.

Moderna, Pfizer and Johnson & Johnson are also conducting trials involving children.

Moderna’s trials include children as young as 6 months old.

Lakeland’s teen Novavax trial requires roughly 30 teenagers and will begin administering shots next week.

To learn more visit the clinical trials website.

https://www.wfla.com/community/health/coronavirus/teenagers-sought-for-novavax-covid-19-vaccine-trial-in-lakeland/

HHS Loosens Rules for Prescribing Buprenorphine

 Primary care doctors and other health professionals will be able to more easily prescribe buprenorphine for opioid use disorder under guidelines released Tuesday by HHS.

"We are seeing a startling rise in opioid addiction and mental health issues during COVID-19, and addressing these underlying issues is critical to moving forward as a country," Assistant Secretary for Health Rachel Levine, MD, said on a phone call with reporters. "We want to incorporate this as a routine part of healthcare, so primary care physicians can more easily take care of a patient who presents in their office with opioid use disorder."

In addition to physicians, the exemption will be available to physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives.

Under the new guidelines, providers will be exempt from requirements under the Controlled Substances Act that they undergo 8 hours of training and make counseling available to patients. Providers will be limited to prescribing buprenorphine to a maximum of 30 patients at a time, and will be required to notify the Substance Abuse and Mental Health Services Administration (SAMHSA) of their intent to prescribe the drug, Levine said.

"The opioid epidemic has ended too many American lives," she continued. "More than 90,000 drug overdose deaths are predicted to have occurred in the U.S. in the 12 months ending in 2020. This is the highest number of overdose deaths ever recorded in a 12-month period, according to provisional data from the CDC."

The new guidelines are similar to those announced by the Trump administration in January, which eliminated some "X waiver" requirements for buprenorphine prescribing. Under those loosened requirements, physicians could prescribe buprenorphine to up to 30 patients, as long as they only treated patients in the state in which they were authorized to practice.

Providers wishing to prescribe buprenorphine to more patients can do so if they meet more stringent requirements, including training, as outlined by SAMHSA.

Physicians using that exemption must put an "X" on the prescription, clearly state that the prescription is being written for opioid use disorder, and maintain separate charts for patients being treated for opioid use disorder, according to a Jan. 14 press release. HHS also said it would establish an interagency working group to monitor the implementation and results of the guidance, as well as the impact on diversion.

On Tuesday's call, Levine noted that the new guidance includes other providers in addition to physicians. "I'm confident this evidence-based and patient-centered step has the potential to save thousands of lives," she said.

The American Medical Association (AMA) praised Tuesday's announcement. "The AMA is pleased that HHS will support physicians to prescribe buprenorphine by removing daunting regulatory barriers and easing stigma facing patients with opioid use disorder," AMA Opioid Task Force Chair Patrice Harris, MD, said in a statement. "Patients are struggling to find physicians who are authorized to prescribe buprenorphine; onerous regulations discourage physicians from being certified to prescribe it."

"With this change, office-based physicians and physician-led teams working with patients to manage their other medical conditions can also treat them for their opioid use disorder without being subjected to separate, burdensome, and stigmatizing requirements," continued Harris, who is also immediate past president of the AMA.

"Physicians should become educated about managing patients with opioid use disorder to help stem the nationwide overdose epidemic and ease the persistent health disparities facing these patients ... Going forward, the AMA is supporting legislation to remove the waiver requirements altogether and will advocate for that in Congress," she said.

https://www.medpagetoday.com/psychiatry/addictions/92298

Here's Who Might Want to Avoid the J&J COVID Shot

 Patients with a prior history of an episode of an immune-mediated syndrome characterized by thrombocytopenia and thrombosis, such as heparin-induced thrombocytopenia, should avoid the Johnson & Johnson COVID-19 vaccine in the immediate aftermath of their illness, CDC staff said in a call with clinicians Tuesday.

Because the etiology of thrombosis and thrombocytopenia syndrome (TTS) appears similar to heparin-induced thrombocytopenia, patients with a similar immune-mediated syndrome should be offered another FDA-authorized COVID-19 vaccine for at least 90-180 days after their illness resolves.

While women under age 50 can receive any authorized COVID-19 vaccine, they have an increased risk of TTS associated with the Johnson & Johnson vaccine. CDC staff noted they should "be aware of the rare risk of TTS" and may opt for one of the other authorized vaccines, such as the mRNA vaccines from Pfizer and Moderna.

However, there were no such caveats for patients with risk factors for venous thromboembolism (VTE), or a prior history of thromboses not associated with thrombocytopenia. CDC staff noted the biologic mechanisms for VTE and arterial thrombi were different from the "underlying immune mechanism" for heparin-induced thrombocytopenia.

Therefore, these patients were unlikely to be at increased risk for TTS, they said.

Pregnant women can also receive the Johnson & Johnson COVID-19 vaccine. While thrombosis risk is higher during pregnancy and postpartum, as well as with hormonal contraception, "experts believe these factors do not make people more susceptible to TTS," CDC staff noted.

Sara Oliver, MD, of the CDC, urged people taking aspirin or anticoagulants as part of their routine medications to not stop taking them prior to the Johnson & Johnson COVID-19 vaccine, nor should people start taking these medications prior to receiving Johnson & Johnson or any other COVID-19 vaccine.

Clinicians asked whether patients with a history of stroke or risk factors for stroke should avoid the vaccine. Oliver said because the phenomenon appears to be immune-mediated, "people who have a history of other embolic events, including stroke, do not appear to be at increased risk for developing" TTS, and there were no recommendations for people with a history of stroke to avoid this vaccine.

Similarly, those with other risk factors, such as smoking or obesity, did not appear to be at increased risk of developing these rare blood clots.

Oliver added that CDC has partnered with the American Society of Hematology about diagnosis of TTS and treatment-specific recommendations for patients.

https://www.medpagetoday.com/infectiousdisease/covid19vaccine/92304

Nursing home families still in the dark after Gov. Cuomo’s COVID disaster

 Gov. Andrew Cuomo’s now-notorious decision to force nursing homes to accept COVID-positive patients was based neither on science nor common sense. Even back then, we knew as much — and rushed to remove our 89-year-old father, Norman Arbeeny, from his nursing home in Brooklyn. Already infected, he died at home on April 21, 2020.

We need answers: substantive, accurate accounting.

Science back then told us that a COVID-positive patient was infecting about three others. Meanwhile, Cuomo claimed a year ago — falsely, we now know — that some 6,000 COVID patients were sent into nursing homes. So we extrapolated then that the total extra nursing home death tally could be as high as 18,000.

Yet as recently as a few months ago, the Cuomo administration was still wrongly reporting only approximately 6,500 deaths. In reality, 9,000 COVID-positive patients were discharged into nursing homes; the true nursing home death toll as a result of Cuomo’s order is closer to a staggering 15,000.

In January 2021, state Attorney General Letitia James proved grieving families like ours correct with a report concluding that the Cuomo administration had concealed the true count of COVID deaths in nursing homes by up to 50 percent. Even the “corrected” tally fails to include patients like our father, who caught COVID in a nursing home but died at home.

Government omission is betrayal of trust.

This is the Empire State’s latter-day Watergate. Only in this cover-up, thousands died. Cuomo’s betrayal will require an all-of-government response from our statewide elected officials, lest public confidence never be repaired. Obviously, we can’t rely on Cuomo. Our attorney general has taken some action, and our US senators, Chuck Schumer and Kirsten Gillibrand, are focused on federal pandemic relief.

That leaves one powerful statewide official who has been missing in action.

State Comptroller Thomas DiNapoli is independently elected and has the authority to audit and hold accountable state and local government. His mission is transparency and to seek the truth wherever it leads. Unfortunately, DiNapoli has declined to assert this power during the pandemic. In fact, he has conducted not one audit of any substantive COVID-related issue, let alone of the nursing home scandal that resulted in the deaths of thousands of New Yorkers.

In May 2020, during the height of the COVID pandemic, after the governor had issued and rescinded his deadly nursing home directive, DiNapoli decided to audit equine health and safety. One of DiNapoli’s latest audits is of parking fine collections in the Big Apple. This week, he did officially request that the attorney general investigate the governor’s grotesque book deal, for which we commend him.

However, he punted the nursing home investigation back to James, stating that nothing prevents her from investigating potential criminal violations and that a referral from his office is unnecessary. Even an unnecessary yet symbolic referral would have been a meaningful response for the thousands of New Yorkers who lost loved ones in nursing homes. And why hasn’t he done any of his own audits into any of these matters?

If DiNapoli wants to get in the game and do his job to seek the truth, he needs to probe the origins of the March 25, 2020, nursing home order, including all communications of outside parties who took part. He also needs to uncover whether the 600 nursing homes were equipped to accept COVID-positive patients and, if not, why.

We need to know who tallied the state Department of Health’s nursing home COVID death count data, and exactly what the agency knew when. We also need the number of nursing home discharges who, like our father, caught COVID in a nursing home but later died at home.

Along the way, DiNapoli should look into the credible claims that Cuomo lined up COVID testing for family and other connected people during the initial months of the pandemic. The taxpayers deserve to know these names.

Last March, I cried on the phone with the state Health Department to be approved for a COVID test, while the well-connected were getting house calls. The state comptroller’s audit authority is vast and powerful and needs to be used to seek the truth.

DiNapoli needs to do his job and make sure our father and thousands of other New Yorkers’ deaths will finally be counted.

–– ADVERTISEMENT ––

Daniel and Peter Arbeeny are fifth-generation residents of Cobble Hill, Brooklyn.

https://nypost.com/2021/04/27/nursing-home-families-still-in-the-dark-after-cuomos-covid-disaster/

Sanofi lands 3rd Covid vax manufacturing partner as it pushes forward its own jab

 As the demand for mRNA-based Covid-19 vaccines persists, Sanofi is jumping into the fray.

The French drugmaker has entered an agreement with Moderna to manufacture the company’s Covid-19 vaccine. The agreement marks the third different company Sanofi has paired with to manufacture a Covid-19 vaccine, since their own effort to develop a pandemic inoculation faced significant setbacks.

The company will perform fill-and-finish at its Ridgefield, NJ site to complete up to 200 million doses of the vaccine. That will begin in September.

“Since the beginning of the pandemic, we have been mobilizing on multiple fronts and we showed solidarity across the industry,” CEO Paul Hudson said in a statement. “We are one of the few pharmaceutical companies to leverage many industrial partnerships to improve equitable global supply and access to Covid-19 vaccines, while in parallel, also continuing to develop our 2 Covid-19 vaccine programs.”

In February, Sanofi announced that it would support manufacturing for 12 million doses a month of J&J’s vaccine at its manufacturing site in France. Before that, the company signed on to provide 125 million doses of the Pfizer-BioNTech vaccine for the EU, stepping up as some countries worried if they’d receive enough doses and Italy threatened legal action.

Its own attempt at a Covid-19 vaccine, alongside GlaxoSmithKline, hit a major setback in December, after the companies announced the shot failed among adults older than 49 years old in an early study. A low immune response “likely due to sufficient concentration of the antigen” was to blame, according to researchers. The 2 companies had anticipated getting hundreds of millions of the vaccine on the market to help parts of the world in dire need of pandemic help, and relied on a slower but more proven technology.

That vaccine candidate uses the same recombinant protein-based technology as 1 of the company’s seasonal flu vaccines. In February, Sanofi announced the start of a Phase II study with an improved antigen fomulation, and a total of 720 participants. The earliest that vaccine would be available would be Q4 2021. It previously was looking to head to Phase III trials in December 2020.

https://endpts.com/sanofi-lands-3rd-covid-19-vaccine-manufacturing-partner-as-it-works-to-push-forward-its-own-jab/

Solid majority of advisers vote to keep Roche's Tecentriq in mTNBC

 Kicking off three days of reexamining anti-PD(L)-1 accelerated approvals, the FDA’s Oncologic Drugs Advisory Committee started slowly on Tuesday. After a more than hour-long technical delay, members voted 7-2 to keep alive the accelerated approval for Genentech’s Tecentriq (atezolizumab) plus Abraxane (nab-paclitaxel) in metastatic triple negative breast cancer (mTNBC) while additional confirmatory trials are ongoing.

But technical glitches at the hearing kept discussions among the committee’s cancer experts to only a few questions for Genentech, and the audio cut out before the committee members offered any of their typical explanations after their votes.

Triple-negative breast cancer (TNBC) is notoriously difficult to treat, representing 10-20% of breast cancers, with a median survival after diagnosis of just 12 to 18 months and a 5-year survival rate of 15%, explained Charlie Fuchs, a Yale cancer specialist who joined Roche in January.

The good: With limited other treatment options, Tecentriq initially won its accelerated approval in combination with nab-paclitaxel for adult patients with mTNBC whose tumors express PD-L1 in March 2019 based on a median progression-free survival (PFS) of 7.4 months, which compared with 4.8 months for those on placebo in combo with nab-paclitaxel.

The bad: The confirmatory trial did not pan out, and even showed a worrisome sign as the placebo outperformed the treatment combo in terms of overall survival.

Laleh Amiri-Kordestani, division director at the Office of Oncologic Diseases, presented for the FDA on Tuesday and also noted that the overall survival results in the initial trial (on which the accelerated approval is based) may be due to chance alone, and that the benefit seen in the first trial was not corroborated in a similar population in the confirmatory trial.

The ugly: She also called the overall survival results in the confirmatory trial “concerning.” Those results led to an alert from the agency and a label update in December because of the “possibility of detriment” in overall survival.

Presenting for Genentech, Steve Chui, global development lead in oncology, spelled out both the benefit from the initial trial and how the confirmatory trial did not show a PFS benefit. He also explained how the results from the confirmatory trial showed 101 of those on placebo and paclitaxel had a median of 28.3 months of overall survival, compared with 22.1 months for 191 of those on atezolizumab and paclitaxel.

Looking to the future, Chui pointed to conversations from December with FDA on other possible confirmatory trials, including one that would use a different type of chemo along with Tecentriq in about 570 mTNBC patients, which is expected to see results in 2023. Other trials proposed won’t read out until 2023 or 2024.

The FDA said in its briefing documents that “it is not yet clear which of these trials are sufficiently designed to adequately confirm benefit,” and adcomm panelists questioned why one of the trials would use different chemotherapies if it’s a confirmatory trial for Tecentriq and nab-paclitaxel. But the majority of members still voted to keep the indication under an accelerated approval.

Prior to the discussion of atezolizumab, Julia Beaver, chief of medical oncology at FDA’s Oncology Center of Excellence, opened the meeting by explaining how accelerated approvals only need to be “reasonably likely to predict clinical benefit,” and that of the 151 accelerated approvals for oncology drugs, 35 have been for PD-(L)1 antibodies, including the three under scrutiny this week, and a total of 10 have been withdrawn.

Those withdrawals have come as the treatment landscape may have changed or because follow-up trials have failed to confirm benefits.

https://endpts.com/tech-glitches-overshadow-fda-oncology-adcomm-as-a-solid-majority-of-advisers-vote-to-pull-roches-tecentriq-in-mtnbc/

Ceding to Pressure, Biogen Will Offer Early Access to Tofersen for ALS in July

 In a reversal of course that may come too late for Lisa Stockman Mauriello, Biogen will open a compassionate use program for Amyotrophic Lateral Sclerosis (ALS drug), tofersen. The program will begin in mid-July, after the completion of the pivotal phase III VALOR study, but before the data reads out. 

During a time when Americans have come face-to-face with their own mortality, Stockman Mauriello’s petition to receive access to tofersen through the “Right-to-Try” drew the attention of the nation. 

Tofersen, developed by Biogen with collaborator Ionis Pharmaceuticals, is an antisense oligonucleotide (ASO) which targets a mutation in the superoxide dismutase 1 (SOD1) gene, believed to be the genetic driver in a familial form of the disease called SOD1-ALS.

In phase one of the two-part program, access to tofersen will be granted on an individual basis to SOD1-ALS patients with an ALS Functional Rating Scale - Revised (ALSFRS-R) slope decline greater than or equal to 2 points per month. Then, if safety and efficacy data are positive, Biogen will offer the drug to the broader SOD1-ALS population in Fall, 2021.

Stockman Mauriello suffers from a particularly devastating AD5 variant of SOD1-ALS, which typically kills patients within 12 months of the diagnosis. The New Jersey mother of three began exhibiting symptoms in August of 2020, which may put the start date of Biogen’s program out of reach for her.

“We are pleased our efforts have contributed to some people with ALS getting access to tofersen faster than they would have otherwise. Unfortunately, it still falls short for ALS A5V patients like me who are deteriorating rapidly. For us, this is a death sentence because we most likely will not make it to mid-July when the tofersen expanded access trial will start, and if we do, we will be in such bad shape that we may not see any benefit,” stated Stockman Mauriello this morning. 

Yesterday, Biogen denied Stockman-Mauriello’s fifth request for compassionate use of tofersen.

While finally ceding to the pressure of over 100,000 petitioners and vocal criticism from the ALS community, Biogen did not compromise on its primary ethical argument.

BioSpace originally reported that the neurodegenerative disease leader was uncomfortable offering Tofersen more broadly while a control group of patients was still receiving a placebo in the 2:1 randomized trial. As of mid-July, Biogen stated that these patients will have transitioned to active therapy.

“We do not believe it is fair to ask participants in this study to continue to receive placebo while other SOD1-ALS patients are offered access to tofersen, but we do believe that access could be provided as soon as the placebo-controlled study has ended. However, until the safety and efficacy have been established, we will prioritize early access for a subset of the most rapidly progressing patients with this rare, severe disease,” Biogen said in a statement announcing the early access program.

Former Biogen senior vice president of corporate affairs, Daniel McIntyre, weighed in on the matter.

“The effort to support Lisa Mauriello has never been about simply giving her tofersen to the detriment of others. It’s true that the research sponsor’s first obligation is to those in the trial, which is why Lisa has asked to be randomized in the same manner as those participating in the VALOR trial,” McIntyre told BioSpace. “This started together as help for Lisa but not ONLY for Lisa, and arguments focused on trial participants on placebo does a disservice to both Lisa and other members of the ALS community who are seeking a more transparent, humane and accountable system that works for everyone.” 

https://www.biospace.com/article/ceding-to-pressure-biogen-will-offer-early-access-to-tofersen-in-july/