Sanofi, GSK to supply vaccine doses to WHO-backed alliance

PARIS (Reuters) – French drugmaker Sanofi and Britain’s GlaxoSmithKline will supply 200 million doses of their COVID-19 candidate vaccine to a global inoculation scheme backed by the World Health Organization.

There is no internationally-approved treatment against COVID-19, which has killed more than 1.16 million people, and the two companies’ vaccine is still undergoing phase 1 and 2 trials, from which first results are expected by late November or early December.

They said on Wednesday they had signed a statement of intent with vaccine alliance GAVI, which is coordinating the global scheme, known as COVAX.

COVAX, which aims to deliver 2 billion vaccine doses around the world by the end of 2021, has already sealed agreements this year with AstraZeneca and Novavax.

It aims to discourage national governments from hoarding COVID-19 vaccines and to focus vaccinating the most high-risk people first in every country.

More than 180 nations including China have joined the plan but some, including the United States, have opted to stick with their own supply deals.

Sanofi and GSK signed a $2.1 billion deal with Washington during the summer to supply it with more than 100 million doses of the same vaccine, which they hope to present for regulatory approval next year.

The companies also have similar agreements with the European Union, Britain and Canada.

Their candidate vaccine uses the same recombinant protein-based technology as one of Sanofi’s seasonal influenza vaccines. It will be coupled with an adjuvant, a substance that acts as a booster to the vaccine, made by GSK.

Sanofi is also working on another vaccine project with U.S. company Translate Bio that will use a technology known as messenger RNA (mRNA) which instructs cells in the body to make coronavirus proteins that then produce an immune response.

Clinical trials for this project are expected to start in the fourth quarter.

COVAX is co-led by GAVI, the WHO and the Coalition for Epidemic Preparedness Innovations (CEPI).

(Reporting by Vishwadha Chander in Bengaluru, Matthias Blamont in Paris; Editing by Shounak Dasgupta and John Stonestreet)

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Inspired by Her Cancer Struggle, Kan. Teacher’s Class Brings Holiday Cheer to Pediatric Patients

Inspired by Her Cancer Struggle, Kan. Teacher’s Class Brings Holiday Cheer to Pediatric Patients

Angela Holtgraves’ special education students began the Stocking Project in 2017 upon learning of Holtgraves’ own cancer battle

When the holiday season rolls around, hundreds of pediatric cancer patients in Kansas will receive stockings stuffed with toys — and it’s all thanks to teacher Angela Holtgraves and her students.

Holtgraves, 34, is a special education teacher, and for the last three years, has spearheaded a special initiative called Stocking Project with her students to spread goodwill and holiday cheer to those who need it most.

“It’s a nice way for us to help others,” she tells PEOPLE in this week’s issue. “This is their way of being able to show the world, ‘I might have a disability, but I can still do some pretty incredible things.’”

For Holtgraves, a mom of two based in Olathe, cheering up young oncology patients at Kansas City’s Children’s Mercy Hospital is personal; she overcame a breast cancer diagnosis at 28, and one of her students was a leukemia survivor. Sharon Houser, the teacher with whom she started the Stocking Project, also has a daughter who is a young breast cancer survivor.

Holtgraves’ students at Shawnee Mission North High School had previously done projects to give back — including making hygiene bags for homeless people — but when they learned of her history with cancer in 2017, switched gears to refocus their efforts.

Courtesy Angela Holtgraves Angela Holtgraves

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Together, they came up with the Stocking Project, which went with Holtgraves when she began teaching at Olathe West High School in 2018.

The group’s initial goal that first year was to create 20 stockings. Instead, they filled 75 in just two weeks, a number that has continued to grow each year for a total of nearly 600.

PEOPLE’s second annual Kindness Issue is dedicated to highlighting the ways, big and small, that kindness can make a difference and change lives. Click here and pick up the issue, on stands Friday, Oct. 30, for more stories on the impact of kindness from Priyanka Chopra Jonas, Sterling K. Brown, Heather Locklear and other stars, as well as everyday people practicing kindness in their communities. To share the story of someone who’s done something exceptionally kind, email [email protected]

Holtgraves estimates that she and her students have raised more than $50,000 in donated goods, helped along with gifts from companies like Russell Stover and Sephora, as well as local businesses.

“The sense of pride they get is everything,” she says.

Angela Holtgraves’ students

RELATED: Ava Sambora Praises Mom Heather Locklear for Helping Her Cope with Anxiety: ‘She is Selfless’

Each year, Holtgraves typically dedicates a day in December to filling the stockings, which are broken down by age group and sex, including male, female and gender-neutral patients, with about 20 items each.

Because of COVID-19, however, this year’s plan

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24 Hour Fitness wants California to ease COVID restrictions

24 Hour Fitness Chief Operating Officer Karl Sanft gave state and local officials a guided tour of the chain’s downtown Sacramento location Wednesday, highlighting the facility’s COVID-19 provisions while asking policymakers to consider easing capacity restrictions.

Mayor Darrell Steinberg asked questions of Sanft and his staff as they made their way through the 48,000-square-foot facility, which is next to Golden 1 Center in the Downtown Commons. City Council members Angelique Ashby and Eric Guerra, Assemblyman Jim Cooper and Danielle Stumpf from the California Department of Health and Human Services also participated in the tour.

“It’s more important than ever to take care of your physical health and your mental health,” Steinberg said. “I’ve said oftentimes over the past seven or eight months that COVID-19 is the pandemic, but mental health and mental illness might be the epidemic because this has been an extraordinarily difficult time for people.”

Sanft said 24 Hour Fitness is adapting after its industry and so many others were decimated by the coronavirus pandemic. He noted the company has closed more than 140 gyms since filing for Chapter 11 bankruptcy is June, including the Carmichael location on Arden Way.

“The impact to the business has been tragic,” Sanft said. “… The impact on our team members and members alike has been nothing short of tragic.”

Sanft said protocols put in place at 24 Hour Fitness locations have been effective. He pointed to the fitness center’s touchless check-in system, social distancing measures and safety-first approach to reopening amid the pandemic. General manager Tony Cigliutti said staff and members undergo temperature checks and health screenings before entering the facility. Masks are required at all times and areas including the swimming pool, steam room and sauna are closed.

The downtown location is currently limited to a capacity of 102 members under red-tier restrictions, 10% of the building’s normal capacity. Sanft is asking state and local leaders to increase that number to 25%, saying the building is big enough to safely accommodate 250 members while maintaining proper social distancing.

“We believe that we can operate at higher levels of occupancy,” Sanft said. “Our request, candidly, is 25%” within the red tier.

24 Hour Fitness provided data showing nearly 9.5 million people have checked in at 24 Hour Fitness locations across the country since the pandemic began in March. From June 12 to Oct. 15, 44 employees and 38 members of 24 Hour Fitness tested positive for COVID-19, but none of those cases were contracted at 24 Hour Fitness facilities, the company said.

“What’s really interesting about the fitness industry is, unlike many other businesses, everybody checks in,” Sanft said. “So it’s really simple for us to not only know who was here, but know who was here at the same time.

“Contact tracing is very easy for us to do. Across the clubs that we operate in the 13 states where we do business, we have yet to have a COVID case be traced back to one of our clubs, so

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COVID-19 activity intensifying in Washington

SEATTLE (AP) — State health officials say a new COVID-19 report shows an increase in cases and hospitalizations throughout Washington.

If not brought under control, officials said the spike could jeopardize progress toward reopening schools, strain the health care system and increase risks during the holiday season.

In an updated situation report released Wednesday, the state Department of Health said the virus is spreading faster in Western Washington than Eastern Washington, but is rising on both sides of the Cascades.

Estimates show each new COVID-19 patient is infecting 1.34 others, on average, in Western Washington. In Eastern Washington the average infection rate is 1.12. The goal is a number well below one, which would mean COVID-19 transmission is declining, officials said.

“High rates in the community increase the chance that someone at your gathering — even people you know well and trust —could have COVID-19,” Deputy Secretary of Health Lacy Fehrenbach said in a news release. “If we act now, we can get these increases in control in time for the holidays.”


Recent growth in cases is widely distributed across the state. Several larger counties including Clark, Pierce, Snohomish and Thurston are seeing steady growth in cases. After increases through Oct. 7, King County case counts began to decline, possibly because of decreased testing in that time period.

Health officials say the trends can be reversed if everyone wears a mask around people they don’t live with and limits the number, size and frequency of gatherings.

Since the pandemic began, more than 104,000 COVID-19 cases have been confirmed in the state. The state dashboard shows 2,337 people with confirmed cases in the state have died.

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Minnesota cautions against traditional Halloween

MINNEAPOLIS — Minnesota health officials are warning against traditional Halloween festivities amid the recent rise in coronavirus cases statewide.

Officials say that instead of traditional trick-or-treating and indoor haunted houses, people should look to lower risk activities like carving pumpkins and decorating homes or holding virtual gatherings.

he state’s infectious diseases director said Wednesday that warmer weather this weekend may encourage outdoor gatherings, but cautioned against disregarding health guidelines with virus infections rising steadily.

Officials reported 1,916 new coronavirus cases and 19 new COVID-19 deaths. Daily case counts statewide have exceeded 2,000 three times in the past two weeks, and the state has reported more than 1,000 new daily cases for the last 21 days.

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HERE’S WHAT YOU NEED TO KNOW ABOUT THE VIRUS OUTBREAK:

— US plans to buy initial antibody doses from Eli Lilly

— Task force member Giroir: Cases, hospitalizations, deaths up in US – not just testing

— President Emmanuel Macron announces second national lockdown in France starting Friday. German officials agreed four-week partial lockdown.

— Belgium and Czech Republic top Europe’s highest number of coronavirus cases per 100,000 citizens, ahead of hotbeds France and Spain.

— Love blossoms amid pandemic for two TikTok creators in Los Angeles, using goofy dance videos, heartfelt vlogs and affirmations.

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— Follow AP’s coronavirus pandemic coverage at http://apnews.com/VirusOutbreak and https://apnews.com/UnderstandingtheOutbreak

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HERE’S WHAT ELSE IS HAPPENING:

DES MOINES, Iowa — Medical professionals in Iowa are expressing concerns that a surge in coronavirus infections and hospitalizations could overwhelm medical facilities if no action is taken to slow the virus’ spread.

Hospitals had 596 coronavirus patients Wednesday, the highest number so far for the state. The 113 patients admitted in the past 24 hours also was the most since the virus surfaced in Iowa last March.

Doctors and hospital officials say they are talking about how to transfer COVID-19 patients between hospitals and enacting surge plans that could turn non-hospital facilities into spots to handle any overflow.

One hospital CEO said that “what we know is if the last four weeks are indicative of what happens over the next four weeks, we will have the system overwhelmed.”

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WELLINGTON, New Zealand: The Marshall Islands has reported its first cases of the coronavirus after two people who flew from Hawaii to a U.S. military base tested positive.

The small Pacific nation had been among the last places in the world to have no reported cases of the virus.

The Office of the Chief Secretary says a 35-year-old woman and a 46-year-old man tested positive this week after flying directly from Honolulu to the base on Kwajalein Atoll. The office says that the two cases weren’t connected and that both people are in quarantine. The office says all businesses and government operations will continue as normal.

Home to about 78,000 people, the Marshall Islands maintains close military and civilian ties with the U.S. under a compact of free association.

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RICHMOND, Va. — Virginia’s governor and top health officials say the state’s

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Federal family separation policy amounts to ‘torture’

The U.S. government’s policy of separating migrant children from their families at the southern border is “cruel, inhuman,” and “rises to the level of torture,” according to a new academic article authored by a slate of doctors throughout the country.

The paper, published Tuesday in the medical journal Pediatrics, found that the controversial anti-immigration practice meets the UN’s three criteria to be defined as torture for children: It causes “severe pain and suffering,” it’s purposeful and it’s state-sponsored.

“Targeted physical and psychological abuse is inflicted on children,” the authors wrote, adding that the suffering is severe given their age and stage of development. “It is a purposeful strategy of the state to use children to reduce border crossings by their parents.”

The authors concluded their article with a call to action, asking that pediatricians, child health care professionals and child advocacy organizations to work together across disciplines, to stop the torture of children in the U.S. and around the world.

This they said, would include training child health care professionals how to identify, document and educate others on the effects of this trauma and for the American Academy of Pediatrics (AAP) to lead a global call for family reunification.

UCSF family medicine Dr. Coleen Kivlahan, one of the paper’s co-authors, said there’s been an active discussion for years among pediatricians and family medicine doctors about what should be done to care for those separated at the border. The paper’s authors are comprised of doctors who have treated patients at the border and some like Kivlahan, who, as co-chair of the UCSF Health and Human Rights Initiative, works with migrant families who have relocated to the Bay Area.

Kivlahan said doctors have long struggled with how to legally define what was happening to the children — who were taken from their families during early developmental stages, and kept in cages without proper food, warmth or proper hygiene.

But the laws against child abuse are related to the caregiver or the parent, Kivlahan explained, and that didn’t apply at the border.

“That’s why we called this torture,” said Kivlahan. “We talked to these doctors from all over the world, and they agreed: (The policies) didn’t meet the diagnosis of child abuse, they met the diagnosis of torture,” given that the acts were carried out by federal officials.

The practice of removing children from their families stemmed from the Trump administration’s “zero tolerance” immigration policy launched in eary 2018 — a series of punitive actions taken against people caught crossing the border illegally. The polices, intended to deter illegal immigration, garnered widespread outrage from both sides of the aisle, prompting Trump to sign an executive order in June 2018, to end the family separation portion.

But several news and advocacy outlets, including the Southern Poverty Law Center, reported that family separations continued long after the executive order.

The article states that in 2019 over 851,000 people were apprehended on the border, including 473,682 families and 76,020 unaccompanied minors.

The paper’s authors include six

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New Adjuvant RT Standard for Cervical Cancer

Image-guided intensity-modulated radiation therapy (IG-IMRT) for cervical cancer achieved disease control similar to three-dimensional conformal radiation therapy (3D-CRT) but with substantially less gastrointestinal (GI) toxicity, a potentially practice-changing clinical trial showed.

Patients who received adjuvant IG-IMRT had a 4-year GI toxicity-free survival rate of 78% compared with 57% for the 3D-CRT arm. Grades 2 and 3 GI toxicity rates were significantly reduced with IG-IMRT. Pelvic relapse-free survival did not differ significantly between the two groups (73% with IG-IMRT and 68% with 3D-CRT).

“We observed that there was a clear benefit of image-guided IMRT in toxicity-free survival,” said Supriya Chopra, MD, of Tata Memorial Center in Mumbai, India, during the virtual American Society for Radiation Oncology (ASTRO) annual meeting. “This is one of the few studies in radiation oncology looking at late toxicity as a time-to-event factor, and you can see that at even extended follow-up the difference between IG-IMRT and 3D-CRT persists. This [toxicity benefit] is at no cost of extra relapses, as 3D-CRT and IMRT have similar pelvic relapse-free survival.”

“Image-guided IMRT should represent the new standard of care for postoperative pelvic RT in women with gynecological cancers,” she concluded.

Vishal Gupta, MD, of Mount Sinai Medical Center in New York City, agreed that “this very important study” should make IG-IMRT the standard of care for cervical cancer and possibly other gynecologic malignancies.

“A prior North American study showed that IMRT only improved short-term GI toxicity,” Gupta told MedPage Today via email. “The Indian study’s results show that long-term GI toxicity is also improved, which provides a much more convincing argument that IMRT should now be considered the standard of care for these patients.

“It will likely be interpreted that uterine cancers would also benefit from IMRT over 3D-CRT. Uterine cancers are much more common in the U.S. so this study will likely impact many patients.”

Postoperative irradiation is standard practice for both cervical and endometrial cancers. However, long-term survivors often have high GI symptom and toxicity burdens, Chopra noted. The phase III NRG Oncology-RTOG 1203 trial, which compared IMRT and conventional four-field pelvic irradiation in patients with cervical or endometrial cancer, showed an improvement in patient-reported outcomes at 5 weeks and 1 year with IMRT but no difference at 3 years.

“So there is a lack of clarity on the long-term impact of postoperative IMRT,” said Chopra.

In an attempt to resolve the uncertainty, investigators at three clinical sites within Tata Memorial Center enrolled patients with cervical cancer treated with either type III hysterectomy with intermediate- or high-risk features or type I/II hysterectomy necessitating adjuvant chemoradiation therapy. The trial design excluded patients with positive para-aortic lymph nodes or another indication for extended-field RT, a history of multiple prior abdominal surgeries or irradiation, or any medical condition that would predispose them to bowel toxicity.

Following surgery, patients were randomized to 3D-CRT or IG-IMRT. Follow-up occurred at 3-month intervals for 2 years, then every 6 months thereafter. The primary endpoint was freedom from grade ≥2 GI toxicity at 4 years,

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Advisory Panel Balks at Neovasc Reducer for Refractory Angina

More than 10 hours of testimony and debate failed to convince a US Food and Drug Administration (FDA) expert advisory panel that existing evidence reasonably supports a premarket approval (PMA) application for the Neovasc Reducer device.

The Reducer is intended for people suffering from refractory angina pectoris despite guideline-directed medical therapy, who are unsuitable for revascularization by coronary bypass grafting or percutaneous coronary intervention.

The FDA’s Circulatory System Devices Panel advisory committee generally agreed in a 14-to-4 vote that the evidence provides reasonable assurance the Reducer is safe, but took a dim view on assurances of its effectiveness in a vote of 1 to 17.

On the question of a benefit/risk ratio, the vote was 3 yes, 13 no, and 2 abstentions. The panel did not vote on the approval of the PMA itself but heard several impassioned pleas from patients calling for its approval in the United States.

“People talked about the urgent need and the patients need hope, but we shouldn’t give them false hope,” Richard Page, MD, University of Vermont Medical Center, South Burlington, said. “We need to provide them something we truly believe is going to be effective and that was not proven today.”

Erik Magnus Ohman, MD, Duke University School of Medicine, Durham, North Carolina, who voted no on all three counts, said, “I voted no for efficacy because I couldn’t link ischemia, which is objective, with a device that we put in permanently when nearly half the patients had very little treatment benefit.”

The primary data set in support of the PMA was from the phase 2 COSIRA study, in which 18 of 52 patients treated with the Reducer and 8 of 52 patients treated with a sham procedure had improved by at least two Canadian Cardiovascular Society (CCS) classes, the primary efficacy outcome, at 6 months (34.6% vs 15.4%, P = .024). 

In 28.8% of the Reducer group and 57.7% of the control group, no change in CCS was seen.

“This is an angina study and for 50 years the standard for angina for success or magnitude of success in minimizing or preventing angina has been a quantitative exercise test, but that’s not what we’re talking about here,” Jeffrey Borer, MD, SUNY Downstate Health Sciences University in Brooklyn, New York, said. “We’re talking about a subjective endpoint and I think that’s a real problem and just magnifies all the other problems that have been discussed.”

Several panelists questioned whether the trial truly enrolled patients with CCS class 3 or 4 angina with limited options, given that 27% of Reducer patients and 25% of controls were on none or one antianginal medication. Information was also not provided about compliance or whether patients were on therapeutic or maximally tolerated doses.

Others pointed out the potential for a placebo effect and that patients were largely satisfied with treatment despite the marked discrepancy in results. Also, the trial lacked a formal blinding assessment for investigators.

Wayne Batchelor, MD, Inova Heart & Vascular Institute, Fairfax, Virginia, took issue

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Iowa doctors say virus spread risks overwhelming hospitals

DES MOINES, Iowa (AP) — Iowa’s number of coronavirus cases, deaths and hospitalizations continued to surge higher Wednesday as medical professionals have begun to express concern that hospitals could be overwhelmed with patients if no action is taken to slow the virus spread.

Iowa hospitals had 596 coronavirus patients Wednesday, by far the highest number so far in Iowa. The 113 patients admitted in the past 24 hours also was the highest seen since the virus surfaced in Iowa in March. The number of patients needing intensive care unit services has also trended upward in the past month.

Iowa doctors and hospital officials are preparing for a system overrun by COVID patients by talking about how to transfer patients between hospitals and enacting surge plans that could turn non-hospital facilities into spots to handle any overflow.

“What we know is if the last four weeks are indicative of what happens over the next four weeks we will have the system overwhelmed,” said Suresh Gunasekaran, CEO of University Hospitals and Clinics in Iowa City. “If hospitalizations continue to increase at the exact same rate they have been for weeks, the math itself tells you that you run out of beds.”

University hospitals, the state’s only academic medical center, is often where other hospitals send patients with complex intensive care needs. It is seeing a significant volume of COVID-19 patients from around the state, Gunasekaran said.


He said Iowans need to understand that the coronavirus patient surge often displaces the ability to care for patients with other complex needs stemming from problems such as heart disease, cancer or neurological conditions.

State public health officials reported 1,814 new confirmed cases Wednesday and an additional 22 deaths for a total of 1,680.

Over the past two weeks, the rolling average number of daily new cases has increased by 249, an increase of nearly 23%, according to researchers from Johns Hopkins University. Iowa has averaged about 1,400 new cases a day for the past week.

“My take away from this is that things are bad but also they can and will likely get much worse because the number of new cases is just staggering,” said Dr. Rosanna Rosa, an infectious disease doctor with UnityPoint Health.

A spokesman for the Iowa Department of Public Health said the state is in regular, often daily, contact with health systems, hospitals and regional medical coordination centers to assess hospital capacity, staffing and resources.

“At this time, hospitals are reporting that they are able to manage the increased number of patients, and are prepared to implement surge plans to expand capacity if necessary,” spokesman Alex Carfrae wrote in an email.

He said staffing shortages can occur during times of seasonal illness or viral outbreaks and hospitals have a variety of solutions to maintain adequate staffing levels.

Rosa said a better public health approach would be to make it clear to Iowans that these illnesses and deaths are preventable, a point made in a recent report from the White House Coronavirus

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Tennessee mulling independent review on COVID-19 vaccine

NASHVILLE, Tenn. (AP) — Tennessee is considering independently reviewing the safety and efficacy of a coronavirus vaccine once it is eventually approved by the federal government before distributing it to the public, Health Commissioner Lisa Piercey said Wednesday.

“It’s not off the table,” Piercey told reporters during the state’s weekly COVID-19 briefing.

Last week, Piercey announced the state had submitted its draft distribution plan for a coronavirus vaccine to the federal government. However, she has since warned that the plan will likely be amended as state officials learn more about when the state will start receiving the vaccine and how many doses are initially provided.

California was the first state to announce that it would hold off on distributing any COVID-19 vaccines until it had independently reviewed them. A handful of other states have since joined in that pact, including Nevada, Oregon and Washington. Meanwhile, New York Gov. Andrew Cuomo has appointed a similar independent group to review the quality of the vaccine.

Supporters of such independent reviews argue that doing so adds an extra layer of assurance to people interested in the vaccine. However, others counter that doing so could politicize the vaccine process.

Piercey said she didn’t “have a clear answer” when asked if an independent review could cause more alarm over the vaccine’s safety, but instead stressed “when we get to that bridge we’ll cross it but it’s definitely on our minds.”


Earlier this year, Gov. Bill Lee declined to say whether he would be vaccinated against COVID-19 when a vaccine becomes available. Instead, he said he’d determine if it’s “safe and effective and talk to my doctor.”

Tennessee is expected to get 2% of the national vaccine allocation, but the exact number is unclear. It’s also unknown when a COVID-19 vaccine will be available for distribution to the states.

Under the current draft plan, Tennessee will distribute the majority of the vaccines throughout its 95 counties based on population. Ten percent of the vaccines will be set aside as a reserve.

The health agency is seeking hospitals, pharmacies, clinics and other partners capable of storing and administering the vaccine. First responders will be the state’s top priority in receiving the vaccine during the initial distribution phases, with health care workers being the next top priority.

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