NYC Begins COVID Vaccine Push For 5-11 Kids, With Public Schools To Host Pop-Up Clinics

 Mayor Bill de Blasio has announced New York City will be ready to vaccinate 5- to 11-year-olds starting Thursday, and public schools will launch vaccine drives next week.

The Centers for Disease Control and Prevention gave final clearance on Tuesday for the use of the Pfizer vaccine for young children between 5 to 11 years old, following the emergency use authorization granted by the Food and Drug Administration last week. The mayor said the final details of the city's rollout would arrive once the CDC sketches out its final guidance for health care providers.

The New York State Department of Health also said Wednesday that providers can begin administering vaccinations. "Providers can start administering pediatric doses for 5-11 year-olds today, as long as they have pediatric doses on hand and are administering the vaccines according to the FDA’s Emergency Use Authorization and the CDC’s COVID-19 vaccine provider agreement," said DOH spokesperson Jill Montag in a statement.

De Blasio said waiting for the CDC guidance will help thousands of local providers administer the vaccine properly to children, and the city will dispense the shots to eligible kids at city-run sites as early as Thursday. The state vaccination website was still not accepting appointments for the newly-eligible age groups as of Wednesday morning. The city vaccination website still had Pfizer listed for 12 years old and up and was not taking appointments for younger children.

“Tomorrow's going to be a historic day for this city in our fight against COVID as we reach our youngest New Yorkers, so city-run sites will be ready, up and running, ready to go,” de Blasio said at his press briefing Wednesday.

Next week, every public school with an eligible population will host a one-day vaccination drive to reach a broader swath of families. Parents or guardians will need to accompany their children.

Unlike the vaccination push for adults that centered on large-scale sites and community clinics, state and city officials have repeatedly invoked family pediatricians as critical to rolling out the vaccine for younger kids.

“We have been gearing up for the last few weeks,” said Dr. Warren Seigel, chair of the New York State American Academy of Pediatrics. “We're very excited about this. This is a huge milestone in the fight against COVID-19.”

Some pediatricians have already warned of limited initial supply: Tribeca Pediatrics, a large chain with three dozen locations around New York City and New Jersey, said in an email to parents that appointments would be limited to three facilities until they could roll out to more clinics. South Slope Pediatrics in Brooklyn also said they couldn’t schedule appointments until they get more information from the city’s health department about when they will receive their first delivery of doses and the overall shipping schedule.

“I would tell families to hang in there. Just like when we started the COVID vaccine for adults, we got better at it as days went on,” Seigel said. “We will be ready as soon as everybody gets their shipment.”

Here are some answers to other frequently asked questions.

Does the vaccine cost money or require insurance?

No - the vaccine is free. You don't need insurance or proof of legal status either.

What are the details of the dosage?

Kids between 5 to 11 years old will receive a dose that's about a third the size of what’s given to adults.

Can my child get Moderna or J&J instead?

No, only Pfizer has been authorized for kids between 5 and 11 years old.

When can I get my child vaccinated at a city site? At their school?

The city-run vaccination sites hope to begin inoculations Thursday, though the website wasn't booking appointments for younger kids as of Wednesday. Starting next week, the Department of Education will hold vaccination sites on one day at every public school in the city with eligible students.

What about state-run vaccination sites?

As of Wednesday morning, the state-run vaccination site was not accepting appointments for 5- to 11-year-olds yet. But Hochul is arranging #VaxtoSchool pop-up clinics around the state.

What about pharmacies and pediatricians?

Some national pharmacies like CVS and Walgreens are booking appointments for next week. Many pediatricians in New York City said they were awaiting supplies before making appointments.

Do I need an appointment for the city-run sites?

Dr. Dave Chokshi, the city's Health Commissioner, said walk-ins are available, but parents should consider making an appointment.

"I do strongly recommend particularly in the initial days that parents book an appointment because we do expect that some sites will be particularly busy as people come in to get their child vaccinated in the early days, and we want to make that a smoother process," Chokshi said.

My kid turns 12 years old in between the first and second shots. What happens then?

“Once you hit 12, then you get the adult dose. So the dosage is based on the age of the child at the time of the vaccine,” said Dr. Warren Seigel, the chair of the New York State American Academy of Pediatrics. According to testimony delivered Tuesday to the CDC, Pfizer's clinical trial only gave out child-size doses to its recipients even if they turned 12 between their first and second shots.

How long is the vaccine effective in my child?

It’s too soon to say, Seigel said. “We don't even have the vaccines in the arms of those children. So we can't really comment on how long this is going to work,” he said. “But we do know that with the holidays coming up, this is the best time to get your children their COVID vaccines as well as update all their other vaccines so that we can all have a good holiday season.”

Pfizer plans to follow each of the trial participants for at least six months.

What are some possible side effects?

Seigel said the side effects are similar to what some adults have experienced after getting the vaccinations, but the rates have been slightly lower among 5- to 11-year-olds in their clinical trials. Kids in Pfizer's trial experienced half as much fever, and the rate of fatigue was 20 percentage points lower. The side effects might be milder because the dose is smaller or because the kids are younger.

https://gothamist.com/news/nyc-begins-covid-vaccine-push-5-11-kids-public-schools-host-pop-clinics

Eligible NYC Kids Can Snag $100 Incentive For Getting COVID Vaccine At City-Run, School Sites

 The young New Yorkers who are now eligible for the Pfizer COVID vaccine are also now eligible for a lucrative array of incentives -- including $100 prepaid debit cards at city-run sites, Mayor Bill de Blasio said Thursday.

“Good news! Kids are eligible for the $100 vaccine incentive. So we really want kids to take advantage, families take advantage of that,” de Blasio said at his press briefing. “Everyone could use a little more money around the holidays. But most importantly, we want our kids and our families to be safe.”

(UPDATE: Kids who get vaccinated at public schools next week will also be eligible for the $100 prepaid debit card incentive, according to the Department of Education.)

The Centers for Disease Control and Prevention gave final clearance on Tuesday for the use of smaller doses of the Pfizer vaccine for children between 5 to 11 years old, following the emergency use authorization granted by the Food and Drug Administration last Friday. Like adults, kids must take two shots -- three weeks apart -- to be fully vaccinated

The $100 incentive is available to anyone who gets their first vaccine dose at a city-run vaccination site or public school site, which De Blasio said would begin doling out doses to the newest age group on Thursday. Other providers like pharmacies and pediatricians were given the green light by the state Health Department on Wednesday.

By noon at the city-run Flatbush YMCA vaccination site in Brooklyn, five kids under the age of 12 had turned up.

Children were handed a fire hat, coloring book and as many stickers as they could handle. They were also invited to play with a small fluffy therapy dog after getting the shot. Parents could also collect their kids' $100 prepaid debit cards. Providers there said some children were scared and cried, but rebounded quickly.

Other kid-friendly incentives include tickets to New York City Football Club or Brooklyn Cyclones games, tickets to the Statue of Liberty and access to Luna Park and the Cyclone at Coney Island. The Brooklyn Nets are giving away game tickets at the Barclays Center vaccination site, and the American Museum of Natural History offers an admission voucher for up to four visitors.

This week, the city expects to receive its initial order of more than 330,000 pediatric doses, which carry about a third of what is given to people older than 12, city Health Commissioner Dr. Dave Chokshi said at a City Hall press briefing.

“The health department has been working with about 1,500 pediatricians and family doctors to prepare for this phase of our historic vaccination campaign. City-wide we expect to receive our full initial order: that's over 330,000 doses over the next few days,” Chokshi said.

Next week, every public school with an eligible population will host a one-day vaccination drive (update: kids can also get the $100 prepaid debit card incentive at the school sites). Parents or guardians will need to accompany their children to these school sites. De Blasio acknowledged the city is looking at allowing parents and guardians to submit written consent instead of having to attend the school vaccination drive in person with their child or be available on the phone before the child is inoculated.

Anyone with questions about the vaccine for kids or adults can call 212-COVID-19 to speak with medical providers from the city’s Test and Trace Corps.

https://gothamist.com/news/eligible-nyc-kids-can-snag-100-incentive-getting-covid-vaccine-city-run-sites

Opiant Fast Tracked for Nasal Nalmefene, for Treatment of Opioid Overdose

 

• Fast Track Designation further underscores the potential for OPNT003 to represent a major advance in the treatment of opioid overdose as opioid overdose deaths surge1
  
  

• This designation enables early and frequent communication with the FDA, in addition to the potential for a rolling submission of NDA application2
  

Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ: OPNT), a company advancing medicines to better treat addictions and drug overdose, today announced that the U.S. Food and Drug Administration (“FDA”) has granted fast track designation for OPNT003, nasal nalmefene, its investigational treatment for opioid overdose.

In July, the Company reported positive results from a confirmatory pharmacokinetic (“PK”) study comparing OPNT003 to intramuscular nalmefene injection3. The characteristics OPNT003 exhibited in this study, coupled with nalmefene’s five-fold higher affinity compared to naloxone4, demonstrate its promise as a potential new treatment. OPNT003 is currently being studied in an ongoing pharmacodynamic (“PD”) study comparing it to nasal naloxone5. Both PK and PD data will form the basis of a New Drug Application (“NDA”) submission using the 505(b)(2) regulatory pathway.

https://finance.yahoo.com/news/opiant-receives-fda-fast-track-200500779.html

bluebird bio Completes Planned Business Separation

 Company to focus on gene therapies for severe genetic diseases

Three near-term programs positioned to deliver significant commercial and patient impact

Spotlight investor call on bb1111 product candidate for sickle cell disease scheduled for November 18

bluebird bio, Inc. (NASDAQ: BLUE) today announced the company has completed the tax-free spin-off of its oncology programs and portfolio into 2seventy bio, Inc., an independent, publicly-traded company. bluebird bio will continue its work focused on severe genetic disease, with three near-term opportunities to bring transformative gene therapies to patients and their families in the U.S. 2seventy will begin regular-way trading on the NASDAQ under the stock ticker symbol "TSVT" on November 5, 2021. bluebird bio will continue to trade under the stock ticker symbol "BLUE."

"Over more than a decade, bluebird bio has set the standard for gene therapy and with more than 485 patient years of experience, we have amassed the largest and deepest ex-vivo gene therapy data set in the world," said Andrew Obenshain, chief executive officer, bluebird bio. "As a dedicated severe genetic disease company, we are prepared to unlock the full value of our pipeline through the anticipated launch of three, first-in-class therapies for patients with sickle cell disease, β-thalassemia and cerebral adrenoleukodystrophy, and to realize the potential of gene therapy to transform lives for patents and their families now and in the future."

bluebird bio is led by an experienced team composed of tenured bluebird leaders and recent additions, focused on executing against a clear strategy to develop and commercialize the company’s lentiviral vector gene therapies and to deliver with increased fiscal discipline.

In September 2021, bluebird announced that it had submitted a biologics licensing application to the U.S. Food and Drug Administration for betibeglogene autotemcel (beti-cel) for patients with β-thalassemia who require regular red blood cell transfusions. The BLA filing for elivaldogene autotemcel (eli-cel, Lenti-D®) for patients with cerebral adrenoleukodystrophy (CALD) is on track for the end of 2021.

https://finance.yahoo.com/news/bluebird-bio-completes-planned-business-110000723.html

Walensky Flip-Flops: Says CDC Not Examining Changing Definition Of 'Fully Vaccinated'

 Authored by Zachary Stieber via The Epoch Times,

The Centers for Disease Control and Prevention is not examining changing the definition of “fully vaccinated,” its director said Wednesday.

“The definition of ‘fully vaccinated’ is one dose of the Johnson & Johnson vaccine and two doses of the either Pfizer vaccine or the Moderna vaccine,” Dr. Rochelle Walensky, the director of the agency, or the CDC, told reporters during a virtual briefing.

“And we’re not examining changing that definition anytime, at this point,” she added.

Walensky was questioned about the definition because federal health officials recently decided to let tens of millions of Americans get booster COVID-19 vaccine shots, including everybody who has gotten a Johnson & Johnson jab.

Additionally, a federal COVID-19 vaccine mandate for many private businesses was published this morning. It and many mandates across the country include the “fully vaccinated” term.

The federal requirements will follow the CDC’s guidance, Jeffrey Zients, the White House COVID-19 response team’s coordinator, told reporters.

The rule developed by the Department of Labor will apply to every business that has 100 or more employees.

Walensky sounded a different tune last month when she said that the definition of “fully vaccinated” had not been changed but “we will continue to look at this.”

“We may need to update our definition of ‘fully vaccinated’ in the future,” she added.

Those comments were a shift from earlier remarks Walensky delivered in September. She said at the time that federal health officials were not considering changing the definition of ‘fully vaccinated.'”

Israel recently adjusted its definition to include three doses of the messenger RNA-based vaccines and other countries like Australia have mulled making a similar change.

During Wednesday’s briefing, Walensky was also questioned on whether there will be discussion on recommending a single mRNA-based vaccine dose for young children who have natural immunity, or immunity from prior infection, against the CCP (Chinese Communist Party) virus.

Pfizer’s vaccine was granted emergency use authorization for 5- to 11-year-olds by drug regulators last week and recommended to the entire age group by the CDC on Tuesday.

Some experts have called for the CDC to adjust its recommendations for people with natural immunity, especially children.

Walensky said data from Pfizer’s trial indicates that the vaccine is safe and effective in young children, adding “we absolutely recommend two doses of vaccines for these children.”

“We do know that after nearly all infectious diseases you have some protection from getting that infection again, but we don’t really know how long that lasts or how robust it is,” she added.

https://www.zerohedge.com/covid-19/walensky-flip-flops-says-cdc-not-examining-changing-definition-fully-vaccinated

NIH Officials Allowed EcoHealth Alliance To Self-Police Risky Gain-Of-Function Experiments In Wuhan

 A cache of newly released communications reveals that the National Institutes of Health (NIH) allowed nonprofit genetic engineering firm EcoHealth Alliance to police its own risky research on bat coronaviruses in Wuhan, China.

According to FOIA documents obtained by WhiteCoatWaste, The Intercept, and the House Energy & Commerce Committee, NIH officials were concerned about risky research being done at the Wuhan Institute of Virology on a US grant.

As The Intercept notes:

Detailed notes on NIH communications obtained by The Intercept show that beginning in May 2016, agency staff had an unusual exchange with Peter Daszak, the head of EcoHealth Alliance, about experiments his group was planning to conduct on coronaviruses under an NIH grant called “Understanding the Risk of Bat Coronavirus Emergence.” The notes were taken by congressional staff who transcribed the emails.

EcoHealth was entering the third year of the five-year, $3.1 million grant that included research with the Wuhan Institute of Virology and other partners. In a 2016 progress report, the group described to NIH its plans to carry out two planned experiments infecting humanized mice with hybrid viruses, known as “chimeras.”

NIH staff members Jenny Greer - a grants management specialist, and Erik Stemmy - a program officer in charge of COVID research, both expressed concern over the risky experiments - telling EcoHealth that their experiments "appear to involve research covered under the pause," referring to an Obama-era moratorium on gain-of-function research that could be reasonably assumed to make MERS and SARS viruses more transmissible in mammals.

One of EcoHealth's experiments involved using genetic engineering to create chimeric MERS viruses, while another experiment used bat-virus-derived chimears related to SARS. According to the report, the researchers infected humanized mice with the altered viruses.

Disturbingly, after the two NIH staff members voiced concerns over Gain-of-Function research, the agency allowed EcoHealth to dictate its own definition of GoF, exonerating itself of doing 'risky' research. The NIH inserted several obscure reporting requirements suggested by EcoHealth that moved the goalposts of what constitutes GoF.

Of note, The Intercept writes that while the experiments demonstrate a lack of oversight and present dangers to public health, "none of the viruses involved in the work are related closely enough to SARS-CoV-2 to have sparked the pandemic," according to several scientists contacted by the outlet.

In December 2017, GoF research resumed - as long as it adhered to newly created "Potential Pandemic Pathogen Care and Oversight," or P3CO. That said, language crafted by EcoHealth CEO Peter Daszak helped the nonprofit evade oversight once again.

In July 2018, NIAID program officers decided that the experiments on humanized mice — which had been conducted a few months earlier — would get a pass from these restrictions as long as EcoHealth Alliance immediately notified appropriate agency officials according to the circumstances that the group had laid out.

While it is not unusual for grantees to communicate with their federal program officers, the negotiation of this matter did not appropriately reflect the gravity of the situation, according to Jesse Bloom, a virologist at the Fred Hutchinson Cancer Research Center. “The discussions reveal that neither party is taking the risks sufficiently seriously,” said Bloom. “MERS-CoV has killed hundreds of people and is thought to pose a pandemic risk, so it’s difficult to see how chimeras of MERS-CoV with other high risk bat coronaviruses shouldn’t also be considered a pandemic risk.” -The Intercept

"It’s absolutely outrageous," said Pasteur Institute virologist, Simon Wain-Hobson. "The NIH is bending over backward to help people it’s funded. It isn’t clear that the NIH is protecting the U.S. taxpayer."

Semantics

In a June 8, 2016 response to NIH concerns, Daszak wrote that because EcoHealth's proposed chimeric viruses were 'significantly different' from SARS, the experiments weren't considered GoF, and should not be restricted.

He wrote that WIV1, the parent of the proposed chimeric SARS-based virus, "has never been demonstrated to infect humans or cause human disease," adding that previous research "strongly suggests that the chimeric bat spike/bat backbone viruses should not have enhanced pathogenicity in animals."

What's more, Daszak 'gave his group a way out' according to the report.

If the recombinant viruses grew more quickly than the original viruses on which they were based, he suggested, EcoHealth Alliance and its collaborators would immediately stop its research and inform their NIAID program officer. Specifically, he suggested a threshold beyond which his researchers would not go: If the novel SARS or MERS chimeras showed evidence of enhanced virus growth greater than 1 log (or 10 times) over the original viruses and grow more efficiently in human lung cells, the scientist would immediately stop their experiments with the mutant viruses and inform their NIAID program officer. -The Intercept

The NIH accepted that on its face - with Greer and Stemmy formally accepting it in a July 7 letter noting that the chimeric viruses were "not reasonably anticipated" to "have enhanced pathogenicity and/or transmissibility in mammals via the respiratory route."

According to virologist Jesse Bloom, EcoHealth's argument that their research did not pose a risk of infection is in contradiction to their justification for the work.

"The entire rationale of EcoHealth’s grant renewal on SARS-related CoVs is that viruses with spikes substantially (10-25%) diverged from SARS-CoV-1 pose a pandemic risk," said Bloom. "Given that this is the entire rationale for the work, how can they simultaneously argue these viruses should not be regulated as potential pandemic pathogens?"

House GOP

Also interested in the latest release is the House Committee on Energy and Commerce, who wrote a letter to NIH Director Francis Collins looking for answers.

Summarizing key points is Twitter user @gdemaneuf, with entire letter embedded below.

https://www.zerohedge.com/covid-19/nih-officials-allowed-ecohealth-alliance-self-police-risky-gain-function-experiments-wuhan

Sangamo's Fabry gene therapy clears early clinical test

 Sangamo Therapeutics has posted clinical data on a therapy it hopes will shake up the Fabry disease market. The gene therapy showed encouraging safety and efficacy signs in the small study, prompting Sangamo to start preparations for a phase 3 clinical trial. 

Today, Fabry patients receive enzyme replacement therapies (ERTs) such as Sanofi’s Fabrazyme and, in some ex-U.S. markets, Takeda’s Replagal. However, the biweekly infusions are a burden, leading gene therapy developers including Avrobio and Freeline to try to develop one-shot treatments for the disease.

Sangamo showed its hand Thursday, presenting data on the first four patients to receive ST-920 across two dose cohorts. The gene therapy, also known as isaralgagene civaparvovec, uses an AAV vector to get a copy of the GLA gene to the liver, thereby driving production of an enzyme needed by Fabry patients. 

All four patients experienced increased enzyme activity, ranging from two- to 15-fold above mean normal. Two of the patients were on ERT at baseline. Investigators have withdrawn ERT from one of the patients and plan to stop treatment of the second subject. One patient had elevated levels of lyso-Gb3, a Fabry biomarker, at baseline. Their lyso-Gb3 levels fell by around 40% after treatment.

The effects of the gene therapy on enzyme activity and lyso-Gb3 appear to be durable so far. The first patient to receive ST-920 had maintained elevated enzyme activity for one year as of the September cutoff. Lyso-Gb3 in the patient with an elevated level at baseline remained down and stable 32 weeks after treatment with ST-920.

Sangamo also highlighted changes relevant to quality of life. Three patients reported improvements in their ability to sweat, which Sangamo said could lift a limit on their ability to tolerate strenuous tasks and exercise. Safety and tolerability look clean at this stage, with no treatment-related adverse events higher than Grade 1.

The phase 1/2 clinical trial is continuing, with Sangamo recently dosing the first patient in the third dose cohort, but attention is already starting to turn to further development. Sangamo has started phase 3 planning. 

https://www.fiercebiotech.com/biotech/sangamo-s-fabry-gene-therapy-clears-early-clinical-test-firing-starting-gun-preparations