1/3 of parents want to vaccinate 5- to 11-year-olds 'right away'

 One-third of parents want to vaccinate their 5- to 11-year-olds “right away” when the coronavirus vaccine is approved for their age group, according to a new report from the Kaiser Family Foundation. 

The report found that 34 percent of parents polled will get their 5- to 11-year old children vaccinated immediately, with most of the interviews conducted before Pfizer released their clinical trial results for the age group in September. 

Thirty-two percent of respondents say they would want to “wait and see” before getting young children vaccinated, 7 percent would do so if it was required and 24 percent would “definitely not” get their kids vaccinated.

The percentage of those who would get their children vaccinated right away has gone up from a July survey by Kaiser, when 26 percent of parents said they would get their 5- to 11-year olds vaccinated right away when the vaccine was approved. 

The Pfizer vaccine is only authorized for those 12 and older. Forty-eight percent of those surveyed said they have had their 12- to 17-year old children vaccinated. 

The results follow a previous poll from Axios-Ipsos Coronavirus Index that showed parents are split on whether to get their young children vaccinated once it is approved for the age group.

The poll found 44 percent of respondents with kids ages five to 11 would get their children vaccinated while 42 percent would not. 

The Kaiser Family Foundation survey was conducted between Sept. 13 and Sept. 22. The group surveyed 1,519 people and reports a margin of error of plus or minus 3 percentage points.

https://thehill.com/policy/healthcare/574739-one-third-of-parents-want-to-vaccinate-5-to-11-year-olds-right-away-report

Troops move to block Pentagon vaccine requirement in court

 Two service members filed a potential class action lawsuit against Defense Secretary Lloyd Austin to attempt to block him from requiring all troops receive a COVID-19 vaccine.  

Army Staff Sgt. Dan Robert and Marine Corps Staff Sgt. Hollie Mulvihill, who filed the complaint Aug. 17 in the U.S. District Court of Colorado, also want the Pentagon to create a vaccine exemption for those previously infected with the coronavirus as they already have “natural immunity.”

The two, who are both based in North Carolina, argue that the Defense Department’s vaccine mandate “is in open violation” of the rights of service members and is unconstitutional.

Austin is named as a defendant in the lawsuit as are Health and Human Services Secretary Xavier Becerra and Janet Woodcock, acting commissioner of the Food and Drug Administration (FDA).

The Pentagon chief in late August ordered service members to “immediately begin” receiving the COVID-19 vaccine, with the military services setting the deadlines for the requirement.

The Pentagon has also made clear it would only require a COVID-19 vaccine that had full FDA approval, which the Pfizer shot received on Aug. 23.

But Robert and Mulvihill, who filed their complaint days prior to the FDA decision, base their argument on the Pfizer vaccine’s previous emergency-use authorization standing.

They also say they should be exempt from the mandate because they already caught and recovered from COVID-19.

More than 372,000 coronavirus cases — 244,300 of which were service members — have been reported among U.S. military personnel, with 5,274 hospitalizations and 515 deaths, according to Defense data.

As of Wednesday, 58 troops, sailors and airmen have died from the illness.

https://thehill.com/policy/defense/574790-troops-move-to-block-pentagon-vaccine-requirement-in-court

NYC teachers ask Supreme Court to block vaccine mandate

 A group of New York City public school teachers who refuse COVID-19 inoculation have asked the Supreme Court to block a vaccine mandate set to take effect Friday.

The teachers, who expressed various reasons for refusing to vaccinate, are united in their view that New York City’s public health measure runs afoul of the law. 

“Thousands of school teachers will lose their livelihoods if they are without pay and cannot work anywhere else, their ability to serve the children of New York City, and, of course, their ranking as teachers,” their lawyer Vinoo Varghese told The Hill. 

The teachers’ request was submitted to Justice Sonia Sotomayor, who handles emergency matters arising from New York, after their legal bid was rebuffed by lower federal courts over the past week.

The dispute arose after New York City officials in August announced that public school employees would be required to get vaccinated against the coronavirus in the interest of protecting the health of those who populate America’s largest school system.

The policy initially provided teachers the ability to opt-out of the vaccine requirement by agreeing instead to undergo weekly COVID-19 screenings. That option was later withdrawn for teachers, however, even as firefighters and police officers continue to be able to opt-out of receiving jabs.  

Part of the teachers’ legal complaint is that school employees are being treated differently than other city workers. 

“There is no rational and non-discriminatory basis for treating applicants differently than other municipal workers,” the teachers wrote in their Supreme Court filing. 

The New York-based challenge follows a recent legal fight over another mandatory school vaccine policy. 

In that case, a group of Indiana University students sought to block the school’s requirement that students be vaccinated against COVID-19 before attending classes this fall. Justice Amy Coney Barrett, who handles emergency matters from Indiana, denied their request without comment.

https://thehill.com/policy/healthcare/574782-new-york-city-school-teachers-ask-supreme-court-to-block-vaccine-mandate

Gilead's Kite Applies to FDA for Earlier Use of Yescarta in Large B-cell Lymphoma

 Kite, a Gilead Company (Nasdaq: GILD), today announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Yescarta® (axicabtagene ciloleucel) to expand its current indication to include the treatment of adults with relapsed or refractory large B-cell lymphoma (LBCL) in the second-line setting.

The sBLA filing is based on data from the ZUMA-7 study with the longest follow-up – over two years – of any Phase 3 CAR T-cell therapy trial. Top-line results from the primary analysis of ZUMA-7 were recently reported and showed superiority of Yescarta compared to standard of care (SOC) in second-line relapsed or refractory LBCL. With a median follow-up of two years, the study met the primary endpoint of event-free survival (EFS; hazard ratio 0.398, p <0.0001). This represents a clinically meaningful 60% reduction in risk of EFS events versus standard of care. The study also met the key secondary endpoint of objective response rate (ORR). The interim analysis of overall survival (OS) showed a trend favoring Yescarta; however, the data are immature at this time, and further analyses are planned for the future.

https://www.streetinsider.com/Corporate+News/Gileads+%28GILD%29+Kite+Submits+sBLA+to+FDA+for+Earlier+Use+of+Yescarta+in+Large+B-cell+Lymphoma/19007979.html

FDA posts guidance on mining real-world data from health records

 There is a lot of discussion about the power of drawing out insights from information hidden within electronic health records and insurance claims, but little regulatory guidance on how that should be undertaken.

Now, the FDA has published its first take on sourcing real-world data (RWD) from EHRs and medical claims, setting out its thinking on the approach that should be used to support regulatory filings for medicines.

The new guidance is the first of a series that have been promised by the US regulator to develop a framework for regulating RWD, which is increasingly being used by pharma companies to investigate how their medicines perform beyond the controlled environment of clinical trials.

The plan is in response to new legislation requiring the FDA to create a framework for evaluating real-world evidence (RWE) to support the approval of a new indication for an already-approved drug, or other post-approval study requirements, for example to provide confirmatory data after an accelerated approval.

In some respects the agency is playing catch-up in this area, as it has already approved the first new indication for a drug based on real-world evidence (RWE) alone – a filing to expand the breast cancer indication for Pfizer’s Ibrance (palbociclib) to include men in 2019.

It is becoming increasingly common for pharma companies to include some element of RWE in their marketing applications to back up clinical trial results.

The new guidance – entitled Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products – covers three key issues related to the use of RWD from EHRs and medical claims data.

First up is advice on how to select and validate data sources that appropriately address the study question in terms of study populations, exposure, outcomes of interest, and other factors.

It also focuses on the development and validation of definitions for study design elements, and maintaining the provenance and quality of data during  “accrual, curation, and transformation into the final study-specific dataset. ”

The guidance does not provide recommendations on study designs or statistical analyses, or any particular type of data source or study methodology, but instead seeks to set out general principles on RWD use.

“For all study designs, it is important to ensure the reliability and relevance of the data used to help support a regulatory decision, ” says the regulator.

The FDA stresses it is a preliminary document and is encouraging comments, which can be filed up to 60 days after publication.

https://pharmaphorum.com/news/fda-posts-guidance-on-mining-real-world-data-from-health-records/

Glaxo $4.2B bet on Merck KGaA cancer drug goes up in smoke after series of flops

 Merck KGaA and GlaxoSmithKline are ending a partnership for the oncology asset bintrafusp alfa which could have netted billions for the German pharma if successful.

But the data just didn’t pan out that way in multiple tests, most recently a phase 2 clinical trial in locally advanced or metastatic biliary tract cancer that was discontinued due to futility.

The companies announced their mutual parting effective today, September 30. Merck said the decision was “based on the clinical trial data generated to date,” specifically results from the INTR@PID Lung 037 study that failed to show the effect seen in earlier tests.

GSK did not pay out any milestone payments through the deal and will not do so in the future, either. Merck collected €300 million upfront in 2019 through the pact, with an additional €500 million in milestones and €2.9 billion in sales possible down the line.

So what does Merck do with bintrafusp alfa now? The therapy was once heralded as a future competitor to the mega-blockbuster Keytruda sold by U.S. competitor Merck & Co.

Merck KGaA said the company will use “advanced analytics” to comb through the vast data collected through the INTR@PID clinical program and better understand what happened—and how learnings can be applied to the field of immunotherapy.

The drug is a bifunctional immunotherapy designed to combine a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein. In plain English, bintrafusp alfa was supposed to control tumor growth by enhancing or restoring anti-tumor responses in the immune system. Merck and GSK hoped it could become a targeted treatment for difficult-to-treat cancers.

Merck and GSK had an expansive clinical program for bintrafusp alfa, including indications in non-small cell lung cancer, biliary tract cancer, cervical cancer, breast cancer and urothelial cancer.

https://www.fiercebiotech.com/biotech/merck-kgaa-gsk-cut-ties-bintrafusp-alfa-deal-had-4-2b-biobucks-line

Regeneron's Covid-19 antibody gets an in-patient boost

 Regeneron’s latest trial of its antibody cocktail Regen-Cov was intended to broaden the use of the treatment to patients hospitalised with Covid-19. And it looks to have succeeded, at least in some patients. In a phase 2/3 trial the combination of casirivimab and imdevimab met the primary endpoint of significantly reducing viral load within seven days of treatment. More importantly, it reduced the risk of death by 36% compared with placebo at day 29 for hospitalised Covid-19 patients not requiring high-flow oxygen or mechanical ventilation. However, this was not significant, as the trial was stopped early because of slow enrolment. And in an echo of the much larger Recovery trial, the greatest benefit was in seronegative patients – those who fail to mount an adequate response to infection – with the risk reduction here rising to 56%. Regen-Cov is not yet authorised for hospitalised patients, but the latest data could help support a nod here, at least in a seronegative population. This should give a much-needed option for in patients, but serostatus testing will have to become routine. 

https://www.evaluate.com/vantage/articles/news/snippets/regenerons-covid-19-antibody-gets-patient-boost