TUCSON, Ariz. As part of the federal government's "Operation Warp Speed," the Tucson clinic conducting part of Moderna's COVID-19 vaccine trial is now accelerating the number of patients it is enrolling.
The person coordinating this groundbreaking study is Yvonne De Los Reyes.
In her 15th year with Quality of Life Medical & Research Centers, De Los Reyes calls it the most important study of her career.
"People are losing their life every day," said De Los Reyes. "People are losing loved ones. At some point, at the end of this trial, hopefully we'll make an impact on people's lives, the world."
RELATED: Moderna's promising COVID-19 vaccine, explained
In the past two weeks, she has set up the vaccine trial at QLMC on the east side of Tucson. It is a huge undertaking.
De Los Reyes is in charge of recruiting participants, coordinating staff, lab tests, collecting the data, plus lots of paperwork to document each patient.
"And it's got to be precise," said De Los Reyes.
Quality of Life continues to ask for volunteers, especially Latinos and Native Americans. Those are groups who have been hit hard by the coronavirus.
More than 3,000 people have already volunteered in Tucson.
De Los Reyes says if you haven't been contacted yet, have patience.
"We're going to eventually get to them," she said. "But we also want to make sure the integrity of the study is being conducted properly."
National news reports this week say enrolling participants in Moderna's trial at the nearly 90 clinics across the country, has been slower than expected.
But QLMC already has more than 200 people enrolled, including KGUN 9 Anchor Pat Parris. He received the first of two injections last week.
QLMC is enrolling an additional 25 participants each day.
They'll soon pass Moderna's goal of 300 participants screened and randomized into the Tucson portion of the clinic trial.
But Dr. Jack McGettigan, the owner of QLMC, wants a thousand participants. A goal shared by Yvonne.
"That's the overall goal," she said. "It's a lot of patients, a lot of work, but at the end of the day it'll be worth it."
De Los Reyes says participants are reporting very little in the way of reactions to the first dose. A second dose is given 28 days later.
Two other major pharmaceutical companies are about to begin clinical trials in the United States. De Los Reyes is hopeful Quality of Life Medical & Research will also run those trials in Tucson.
If and when a coronavirus vaccine is rolled out, there will be people who refuse to take it for various reasons, but a Stanford Law School professor says such refusal will have consequences.
Hank Greely will appear on "TMZ Live" Thursday ... he's an expert in public health law and says people who refuse to take the vaccine could -- repeat COULD -- be denied the right to enter their workplace or their school.
Fact is ... there will probably be 3 groups of people who will refuse the vaccine -- the anti-vaxxers, the people who want to turn the vaccine into a political issue, and people who are afraid to take the vaccine because they worry it was rushed and not properly tested.
If the FDA, NIH and others show the phase 3 studies were thorough and established both safety and efficacy, Professor Greely says it will be hard for people to make the case they can refuse the vaccine and not be barred from work or school.
It's dicier, the good professor says, if phase 3 studies are less than thorough.
Professor Greely, whose focus includes legal and social issues related to advances in biosciences ... couched everything with the preface good lawyers always use ... "It Depends."
The commissioner of the US Food and Drug Administration assured physicians and other healthcare providers that vaccine and therapeutics approvals for the COVID-19 pandemic will be based on good science and sound data.Nothing else will be used to guide our decisions, said Stephen Hahn, MD, speaking at a virtual meeting held by the Reagan-Udall Foundation on 10 August.Hahn delivered prepared remarks along with American Medical Association president Patrice Harris, MD; Harris then fielded questions for Hahn from attendees. Much of Hahns presentation and Harris subsequent questions focused on FDAs projected process to approve vaccines for SARS-CoV2, the virus that causes COVID-19.Vaccine decisions will be deliberativeHahns remarks frequently turned to reassurances about FDAs plans to run a rigorous approval program despite the press of the pandemic. Because of the speed with which we need to make decisions, there has been discussion about whether FDA will compromise any of our scientific principles in reviewing data and making decisions about new products, said Hahn.Let me assure you that we will not cut corners All of our decisions will continue to be based on good science and the same careful, deliberative processes which we have always used when reviewing medical products.Hahn also announced a new initiative termed the Pandemic Recovery and Preparedness Plan (PREPP) that he said will help systematically review FDAs actions to date and identify lessons learned.The commissioner said that the US has made significant progress on many fronts during the pandemic. Yet with cases continuing to rise, it is evident that further action is needed for our country to chart a course for recovery, he said: We all know in medicine that a look back on our actions can help us in improving care and service delivery. This is the important part of the PREPP goal for FDA. Our goal is both to make needed adjustments to the ongoing COVID-19 response as well as improve our capacity to respond to public health emergencies in the future.Hahns discussion at the Reagan-Udall Foundation event followed a 7 August Viewpoint article in JAMA authored by Hahn, together with Anand Shah, MD, FDAs deputy commissioner for medical and scientific affairs, and Peter Marks, MD, who heads the Center for Biologics Evaluation and Research (CBER). That editorial also promised unwavering regulatory safeguards for the FDA COVID-19 vaccine approval process in the face of public anxiety about the safety and effectiveness of vaccines developed on expedited timelines.Hahn and his coauthors cited a recent poll showing that nearly a third of US adults were uncertain whether they would take a COVID-19 vaccine when it becomes available; one in five said they would not receive a vaccine.The BLA path versus an EUA They also noted that the most likely pathways through FDA for a vaccine would either be the traditional biologics license application (BLA) review or an emergency use authorization (EUA). Sponsors are still advised to file for review via traditional market authorization, however, considering that any vaccine would be intended for widespread use.In anticipation of an influx of vaccine candidates, FDA is adding members to the Vaccines and Related Biological Products Advisory Committee, where Hahn and his colleagues said transparent discussion will be needed before any authorization or licensure, to make sure the public has a clear understanding of the evidence underpinning any recommendations.During the Reagan-Udall event, Harris and attendees had several questions about the specifics of the vaccine approval process, including under what circumstances the agency might issue an emergency use authorization (EUA). Asked Harris, What type of evidence would you have to have in a phase 3 trial to be able to make an EUA?We would have to be very secure about the safety of a vaccine, Hahn responded. We would have to see the evidence of clinical efficacy. Were not going to back away from what weve said with respect to these data. Weve set a floor of 50% for efficacy, he said, referencing the figure given in a June 2020 guidance. (RELATED: FDA issues COVID-19 vaccine guidance, setting 50% effectiveness threshold, Regulatory Focus 30 June 2020)Hahn noted that the streamlined nature of the EUA process means the timetable may be tightened up for coronavirus vaccine approval, but we wont stray from the vaccine requirements delineated in the guidance.Will an EUA carve out sub-populations?The potential exists that EUAs might be carved out for sub-populations in a clinical trial in whom high efficacy is seen, said Hahn. I cant pre-judge the data, he added, but one could imagine a situation where we had very robust safety and efficacy data and could make an EUA determination.The threshold of 50% reduction in COVID-19 cases established in the guidance, he said, should be seen in every subgroup in order to make this generalizable. Whether decisions would be made for individual subgroups, he said, is a complete unknown at this point, because we dont have the data in front of us.Regarding safety, Hahn said that current and projected Phase 3 trials will fall within the usual practice of requiring a patient pool of 3,000-5,000 for determining vaccine safety, since FDA foresees these trials enrolling 30,000 patients or more, with about half that number receiving active vaccines.However, Hahn and his colleagues noted in the JAMA piece that FDA recognizes that there could be rare adverse events not detected in a trial of 15,000 to 20,000 patients, so postmarketing surveillance will be critical. The officials said that a discussion will need to take place prior to authorization or licensure of a vaccine about postmarket surveillance, with an eye to building the proper pharmacovigilance framework.He emphasized that FDA is asking for clinical endpoints, not immunological endpoints, from the vaccine trials, since the presence of antibodies alone has not yet been shown to be protective of becoming ill with COVID-19.
HOLLYWOOD, FLORIDA - AUGUST 07: Lisa Taylor receives a COVID-19 vaccination from RN Jose Muniz as ... [+] she takes part in a vaccine study at Research Centers of America on August 07, 2020 in Hollywood, Florida. Research Centers of America is currently conducting COVID-19 vaccine trials, implemented under the federal government's Operation Warp Speed program. The center is recruiting volunteers to participate in the clinical trials, working with the Federal Government and major Pharmaceutical Companies, that are racing to develop a vaccine to potentially prevent COVID-19. (Photo by Joe Raedle/Getty Images)
As Russia debuts its new Covid-19 vaccine, Sputnik V, and begins to inoculate some of its citizens without extensive testing regarding its safety or efficacy, concern regarding the pressure to get a vaccine safely to market here in the United States via Operation Warp Speed has many people concerned, and rightfully so.
While vaccine trials typically take many years until a viable vaccine comes to market, the reality is that these are not normal times. But the process to produce a safe and effective vaccine also shouldnt be compromised. With respect to the debut of the Russian vaccine, its important not to be just first, but to be safe and effective by investing in sound Phase 3 trials. Simply put, we dont want to expose people to a vaccine until it is thoroughly tested and we have the data to support its widespread distribution. First and foremost, we do not want vaccinate children and older persons if there is any concern that it could potentially do harm.
But bringing a vaccine to market in such a short period of time requires appropriate monitoring and transparencyakin to a check and balance to maintain public confidence in the regulatory process.
One such approach is the introduction of the SAVE ActThe Safe Authorization for Vaccines during Emergencies Act. It represents bipartisan legislation that aims to improve public confidence in a potential Covid-19 vaccine by increasing the transparency of the vaccine approval process. The legislation is especially timely, as Phase 3 trials in the US began for several vaccine candidates last month.
Sponsored by U.S. Senators Maggie Hassan (D-NH), Mike Braun (R-IN), and Lisa Murkowski (R-AK), its legislative goal is to simple: increase transparency of the approval process by providing the public data and facts during the approval process itself, helping to improve confidence that Americans will accept a vaccine when it is finally approved.
As we work to get a potential vaccine approved, produced, and distributed as quickly as possible, its critically important that the public is confident that the federal government followed the necessary protocols to ensure that the vaccine is safe and effective,Senator Hassansaid in a recent press release. This bipartisan bill would ensure that key oversight mechanisms of the vaccine approval process stay in place, and that recommendations provided during this process are publicly available, even during an expedited vaccine approval process. We will push for this bills inclusion in the upcoming COVID-19 relief package.
The SAVE Act would essentially define the current operating rules and processes within the CDC and FDA for review of vaccine candidates. It would also spell out the requirements that the CDCs Advisory Committee on Immunization Practices (ACIP) and FDAs Vaccine and Related Biological Products Advisory Committee each must satisfy in order to produce recommendations regarding the safety and efficacy of vaccine candidates seeking emergency use authorization (EUA). It would also make sure that public recommendations regarding safety related to specific groups for immunization are issued by these two committees.
When a COVID-19 vaccine comes to market, Americans need to be confident it is safe and effective for their families, saidSenator Braun. The SAVE Act makes the vaccine approval process transparent so Americans can see CDCs and FDAs rigorous review process for themselves as a vaccine gets closer to market.
This bill makes sure that federal regulators do their part to ensure that a safe and effective vaccine will be deployed to the public in a timely manner.It also ensures that the regulatory approval process for any potential COVID-19 vaccine is efficientand not slowed down by regulatory hurdles that have nothing to do with safety and effectiveness, added Senator Braun.
Senator Murkowski emphasized that my focus right now is providing all Americans with the resources and support they need to address the impacts of the COVID-19 pandemic, including supporting efforts to help develop a vaccine. Equally important, is that a vaccine is safe and effective, and that people trust it.
Our bill works to ensure that the vaccine approval process is clear and transparent, giving Americans the confidence they will need in making decisions once we have a successful vaccine, she added.
While its important to understand that such bipartisan legislation would not compromise the speed of the current vaccine approval process, it would guarantee that transparent committee meetings occurbut if they dont for some reasonthe Secretary of Health and Human Services (HHS) would be required to provide and explanation for such a decision.
Senator Hassan has made it a priority to push for funding and safety measures in the ramp up to a potential vaccine candidate. Along with 27 other colleagues, last month she called for Congress to provide at least 5.6 billion dollars in federal funding to support and develop Covid-19 vaccine infrastructure. In early May, during a Senate Health, Education, Labor, and Pensions Committee hearing, Senator Hassan asked Dr. Anthony Fauci what is necessary to mass produce and distribute a Covid-19 vaccine candidate. In early April, she also called on the Trump administration to look into concerns related to domestic supply chain for hypodermic needles and syringes necessary to administer a potential Covid-19 vaccine.
Gaining the confidence of the public in a potential COVID-19 vaccine is mission critical if we want to ensure a high rate of vaccination; yet currently, many Americans are unsure if they are willing to get it if one becomes available. Its clear to me that ensuring proper review of data will help ensure that any vaccine that enters the market is safe and effective, and will also lead to a higher level of public confidence in the vaccine, said Dr. Joseph Sakran, Director of Emergency General Surgery at Johns Hopkins Hospital.
Senator Hassans bipartisan bill allows for emergency authorization of vaccine products while combining someofcornerstone pieces that exist during normal licensure.This will also allow healthcare workers to instill the necessary confidence patients often need when they look to us for advice, added Sakran.
William A. Haseltine, PhD, Chair and President, ACCESS Health International and a Forbes Healthcare contributor, explained that legislation is required to assure that any Covid-19 vaccine approved for use in the United States, including emergency use authorization, meet the FDA requirements for a vaccine to be used for young children, and older adults. Otherwise, vaccines of unknown safety and efficacy may be approved for political, electoral, or economic reasons independent of either their known safety and efficacy.
While the technology behind Sputnik V is reported to resemble Astra Zenecas vaccine candidate,using human adenovirus vectors as opposed to Astras monkey vectorslack of effective testing of this vaccine may result in compromised safety and efficacy when administered to large groups. Whats clear is: if issues develop related to lack of efficacy or safety of this vaccine, it could undermine public confidence in Operation Warp Speeds vaccine candidate and other vaccines, resulting in further vaccine hesitancy. In effect, failure of Sputnik V could poison the entire field of vaccine candidates.
Regarding the new Sputnik V vaccine, do its benefits outweigh its risks? At this time, we dont know exactly how many people in Russia received it so far, but Russian elites or military involved in earlier trials are most likely the recipients of the new vaccine. The Russians, and their partners in Saudi Arabia and the United Arab Emirates (UAE), plan to produce 500 million doses of their vaccine, as they conduct essentially live Phase 3 trials on their vaccine, according to a report today by NBC News. Its also vital to understand that a targeted global distribution of the vaccine could impact the Russians sphere of influence, which could certainly affect or change the optics of the upcoming election in November.
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One-third of Americans wouldnt get COVID-19 vaccine even if its free, poll says FOX13 Memphis
The West Virginia Department of Health andHuman Resources (DHHR) reportsas of 10:00 a.m., on August 13, 2020, there have been 339,349 total confirmatory laboratory results receivedfor COVID-19, with 8,151 total cases and 153 deaths.
CASESPER COUNTY: Barbour (29), Berkeley (720), Boone (112),Braxton (8), Brooke (70), Cabell (431), Calhoun (6), Clay (18), Doddridge (6),Fayette (160), Gilmer (17), Grant (131), Greenbrier (92), Hampshire (84),Hancock (112), Hardy (62), Harrison (238), Jackson (165), Jefferson (302),Kanawha (1,020), Lewis (28), Lincoln (96), Logan (276), Marion (195), Marshall(130), Mason (67), McDowell (62), Mercer (216), Mineral (125), Mingo (195),Monongalia (962), Monroe (20), Morgan (31), Nicholas (39), Ohio (271),Pendleton (42), Pleasants (14), Pocahontas (42), Preston (125), Putnam (204),Raleigh (276), Randolph (212), Ritchie (3), Roane (19), Summers (16), Taylor(60), Tucker (11), Tyler (15), Upshur (38), Wayne (214), Webster (4), Wetzel(44), Wirt (7), Wood (266), Wyoming (43).
As case surveillance continues at thelocal health department level, it may reveal that those tested in a certaincounty may not be a resident of that county,or even the state as an individual in question may have crossed the stateborder to be tested. Such is the case of Jackson,Mineral, Nicholas and Ohio counties in this report.
Please note that delays may be experiencedwith the reporting of information from the local health department to DHHR.
On August 12, 2020, DHHR announced thatboth confirmed and probable deaths will be reported on the dashboard, per CDCguidelines. Probable deaths are defined as decedents who had no knownpositive laboratory test for COVID-19 but whose death certificate listsCOVID-19 as a cause of death or contributing factor, or decedents who weresymptomatic and had a known exposure to COVID-19.
Confirmed and probable cases have beenreported in this report since April but will now be combined for the purpose ofthis report. Data is published daily at 10 a.m. on thedashboard located at www.coronavirus.wv.gov.
For the Fryson brothers, the year had begun on a hopeful note. They had finally reunited with their mother, Beatrice McMillian, after years of being in foster care.
Ms. McMillian had secured rental assistance for an apartment so she could move out of a homeless shelter. The older brother, Kasaun, was embarking on adulthood, working at Whole Foods and attending community college.
The younger brother, EJ, was living with his mother and doing well in high school. Then, in April, Ms. McMillian died of Covid-19. Her death shattered everything the family had gained. Mr. Fryson, 22, headed to court to try to become his 16-year-old brothers guardian and keep him from returning to foster care. He needs someone, and Im going to be that person, said Mr. Fryson.
When the coronavirus pandemic killed thousands of people in New York City, it made orphans of an unknown number of children. At least eight children have been placed in foster care because their parents died from the virus, according to the city Administration for Childrens Services.
The total number is likely higher. Children in families with more money or wider support systems usually handle guardianship issues privately.
The sudden loss has thrust some young adults like Mr. Fryson into the unexpected role of surrogate parent, fighting to keep what is left of their families together.
Your physical home is gone, your emotional home is gone. Then, youre going to be put with someone youve never known in your life, said Karen J. Freedman, the founder and executive director of Lawyers for Children, which represents children in foster care, including some whose parents died in the pandemic. That is a terrifying process for any child.
Jessica Barrera, 16, faced the prospect of losing her home this spring. Her father died of tuberculosis in March, just as the virus was erupting in New York. Jessicas mother, Maria Arizaga, who worked in a bakery, was worried about how to care for Jessica and her older brother, Luis.
Her parents had emigrated from Ecuador, and did not have close family in Brooklyn, where they lived.
At the funeral, Ms. Arizaga turned to a family friend, Cesar Cevillo, and remarked that her children would now belong to him. It was the kind of brief, emotional remark that a grieving person might whisper in the moment, and Mr. Cevillo politely nodded.
Only weeks later, Ms. Arizaga died of Covid-19. Her son, Luis, began desperately looking for an adult to be a guardian to Jessica so that she would not be placed in foster care. At 19, he was about two years too young to be considered for the role.
The last time I spoke to my mom on the phone, she said, If anything happens to me, just take care of your sister, OK? Mr. Barrera said. I had to be the responsible one for my sister.
He turned to Mr. Cevillo, who had just recovered from the coronavirus himself. Mr. Cevillo then asked his sister, Laura, to help.
Ms. Cevillo, who has her own teenage daughter, said she had to establish remote learning for Jessica, take her to the doctor and make sure she was eating tasks that Luis, who worked at a supermarket and attended college, could not handle on his own. He also had to plan a trip to Ecuador, where he and his sister took their parents ashes in July.
Ms. Cevillo said it had not been easy trying to comfort and care for teenagers who have lost two parents within weeks of each other, but she said she did not want to give up. I was sad because these children were alone, she said.
A judge granted temporary guardianship, which will likely be extended at a hearing on Friday. But the judge will have to ultimately decide who will be Jessicas permanent guardian.
David Villar, 17, feared he was headed to foster care after his father died of Covid-19 in March, just two years after his mother died of a heart attack at home, where he had tried to save her with cardiopulmonary resuscitation.
But he is now with his sister, Giannie Done, who has been given guardianship. Ms. Done, 21, said she felt obligated to care for her brother. He didnt have anybody. I wanted him to know Im his sister, and Im here for him, she said.
Ms. Done, who works as a sales representative at AT&T, said she is learning how to be a guardian, but knows she is not a mother to David. Hes not a child; hes my little brother, she said. I just want him to respect me.
David had been adopted out of foster care and briefly returned when his father went through another illness. He assumed he was going back again. I didnt know where I would go to, he said, adding that he was grateful to his sister.
Updated August 12, 2020
Now, its official, he said, laughing about the paperwork that awarded Ms. Done guardianship.
Like Ms. Done, Mr. Fryson was determined to prevent his brother, EJ, from having to return to foster care.
The brothers went into the care of the state in 2013, after their father died of prostate cancer. Their mother, Ms. McMillian, was in prison, serving a sentence for manslaughter.
But Ms. McMillian, who killed her boyfriend in a domestic dispute in 2009, was a fierce protector from prison, Mr. Fryson said. She monitored the welfare of her sons in phone calls to foster parents and agencies. She pushed to get her sons moved into a more suitable home when they told her they were having problems with one foster mother, Mr. Fryson said.
Her sons visited her at Bedford Hills Correctional Facility, and went to a nearby sleep-away camp during the summer so they could spend more time with her.
When Mr. Fryson learned his mother had coronavirus and would be hospitalized, he immediately went to the homeless shelter where his family was staying in Kips Bay and got his brother. Doctors ordered them to quarantine for two weeks in his apartment on the Lower East Side, so they were unable to visit their mother before she died in the hospital.
The funeral was a blur, Mr. Fryson said. It wasnt really much of a funeral. You cant see the person. They wont let you see the body. You just stand at the box for 10 minutes, he said.
He reached out to Lawyers for Children, which had represented them in the past. The group referred him to a private lawyer, Philip Katz, who said a judge recently awarded Mr. Fryson custody, although there are still complications.
Mr. Fryson cannot have overnight visitors for long stays at the supportive housing building where he lives, so EJ sometimes has to bunk with relatives. Mr. Fryson has applied to move into a larger apartment in the building so the brothers can live together full time.
Mr. Fryson said his mother would have wanted them to stay together. She was a good mom, he said.
Governor Cuomo Announces New Record Number of COVID-19 Tests Reported Yesterday | Governor Andrew M. Cuomo Skip to main content August 12, 2020
Albany, NY
87,776 COVID-19 Tests Reported Yesterday; 0.79 Percent of Tests were Positive
7 COVID-19 Deaths in New York State Yesterday
Confirms 700 Additional Coronavirus Cases in New York State - Bringing Statewide Total to 422,703; New Cases in 36 Counties
Governor Andrew M. Cuomo today announced that 87,776 COVID-19 tests were reported to New York State yesterdaya new record high for tests in a single day. The governor also updated New Yorkers on the state's progress during the ongoing COVID-19 pandemic. The number of new cases, percentage of tests that were positive and many other helpful data points are always available at forward.ny.gov.
"We're continuing to move forward protecting New Yorkers, slowing the spread and saving lives as the COVID-19 pandemic rages throughout much of the country and threatens the reduction in the numbers we've achieved here at home," Governor Cuomo said. "New York is reaching new heights in its ability to track and trace the virus, and that's evidenced by the record number of testsnearly 88,000that were reported yesterday. As we prepare for the fall, I urge everyone to wear masks, socially distance and wash their hands, and I urge local governments to enforce state guidance on reopening."
Today's data is summarized briefly below:
Of the 87,776 test results reported to New York State yesterday, 700, or 0.79 percent, were positive. Each region's percentage of positive test results reported over the last three days is as follows:
REGION
SUNDAY
MONDAY
TUESDAY
Capital Region
0.8%
1.2%
0.7%
CentralNew York
0.6%
0.4%
0.8%
Finger Lakes
0.7%
0.6%
0.7%
Long Island
1.2%
0.8%
0.9%
Mid-Hudson
0.9%
0.7%
1.0%
Mohawk Valley
0.5%
1.3%
0.5%
New York City
0.9%
0.9%
0.8%
North Country
0.2%
0.4%
0.1%
Southern Tier
0.4%
0.6%
0.3%
WesternNew York
0.8%
1.3%
0.5%
The Governor also confirmed 700 additional cases of novel coronavirus, bringing the statewide total to 422,703 confirmed cases in New York State. Of the 422,703 total individuals who tested positive for the virus, the geographic breakdown is as follows:
County
Total Positive
New Positive
Albany
2,624
10
Allegany
80
0
Broome
1,150
7
Cattaraugus
168
0
Cayuga
161
4
Chautauqua
258
0
Chemung
177
1
Chenango
218
0
Clinton
129
0
Columbia
548
2
Cortland
96
1
As schools worldwide struggle with reopening, the latest data from the WHO/UNICEF Joint Monitoring Programme (JMP) reveal that 43 per cent of schools around the world lacked access to basic handwashing with soap and water in 2019 a key condition for schools to be able to operate safely in the midst of the COVID-19 pandemic.
Global school closures since the onset of the COVID-19 pandemic have presented an unprecedented challenge to childrens education and wellbeing, said Henrietta Fore, UNICEF Executive Director. We must prioritize childrens learning. This means making sure that schools are safe to reopen including with access to hand hygiene, clean drinking water and safe sanitation.
According to the report, around 818 million children lack basic handwashing facilities at their schools, which puts them at increased risk of COVID-19 and other transmittable diseases. More than one third of these children (295 million) are from sub-Saharan Africa. In the least developed countries, 7 out of 10 schools lack basic handwashing facilities and half of schools lack basic sanitation and water services.
The report stresses that governments seeking to control the spread of COVID-19 must balance the need for implementation of public health measures versus the associated social and economic impacts of lockdown measures. Evidence of the negative impacts of prolonged school closures on childrens safety, wellbeing and learning are well-documented, the report says.
Access to water, sanitation and hygiene services is essential for effective infection prevention and control in all settings, including schools," said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. "It must bea major focus of government strategies for the safe reopening and operation of schools during the ongoing COVID-19 global pandemic.
Other key findings from the report include:
The report identifies several resources necessary for COVID-19 prevention and control in schools, including 10 immediate actions and safety checklists. It builds on guidelines on the safe reopening of schools issued by UNESCO, UNICEF, WFP and the World Bank with practical advice for national and local authorities on how to prepare for safe school reopening and keep children safe when they return to school. The guidelines include several WASH-related protocols on hygiene measures, use of personal protective equipment, cleaning and disinfection, as well as providing access to clean water, handwashing stations with soap, and safe toilets.
UNICEF and WHO are committed to achieving equitable access to adequate WASH services worldwide. The agencies recently launched a joint initiative, Hand Hygiene for All, to support the most vulnerable communities with the means to protect their health and environment. It brings together international partners, national governments, public and private sectors, and civil society to ensure affordable products and services are available, especially in disadvantaged areas.
###
For further information, please contact:
Sara Alhattab, UNICEF Headquarters (working out of Jordan), Tel: +962 7 80180363, salhattab@unicef.orgWHO Media Enquiries: Tel: +41 22 791 2222, mediainquiries@who.int
About UNICEF
UNICEF works in some of the worlds toughest places, to reach the worlds most disadvantaged children. Across more than 190 countries and territories, we work for every child, everywhere, to build a better world for everyone.
Follow UNICEF onTwitterandFacebook
About WHO
The World Health Organization directs and coordinates international health within the United Nations system. Working with its 194 Member States, WHOs mission is to promote health, keep the world safe and serve the vulnerable.
For more information about WHO, visit www.who.int.
FollowWHOonTwitterandFacebook
About the Joint Monitoring Programme
The WHO/UNICEF Joint Monitoring Programme (JMP) for Water Supply, Sanitation and Hygiene is responsible for monitoring global progress towards the Sustainable Development Goal (SDG) targets and indicators relating drinking water, sanitation and hygiene (WASH). The JMP produces national, regional and global estimates of progress on WASH in households, schools and health care facilities.
While some were alarmed by the results of the study conducted by the Mumbai authorities and the Tata Institute of Fundamental Research, others were optimistic. Mumbai's slums, where social distancing is nearly impossible, might now have some of the highest levels of immunity in the world -- only 23.5% of samples taken by India's National Center for Disease Control tested positive for antibodies in Delhi and 14% tested positive in New York, in a study sponsored by the New York State Department of Health.
Scientists believe it's likely that recovering from coronavirus leaves a person with some immunity, but it's not clear how strong it is or how long it lasts. Herd immunity is the idea that a disease will stop spreading once enough of a population becomes immune -- and is appealing because, in theory, it might provide some protection for those who haven't been ill.
If more than half of people in Mumbai's slums had contracted coronavirus, could they be approaching herd immunity -- without a vaccine?
One expert thought so.
"Mumbai's slums may have reached herd immunity," Jayaprakash Muliyil, chairman of the Scientific Advisory Committee of India's National Institute of Epidemiology, said, according to a Bloomberg report. "If people in Mumbai want a safe place to avoid infection, they should probably go there."
But others have been more cautious. David Dowdy, an associate professor in epidemiology at Johns Hopkins Bloomberg School of Public Health, said it was possible that the researchers had used a test that created false positives.
And Om Shrivastav, an infectious diseases expert in Mumbai, cautioned that, less than eight months into the virus' existence in society, it was too early to make any "decisive, conclusive statements."
The risk of a high death toll is exactly why India's health authorities say the country is not aiming for herd immunity. "Herd immunity can be achieved through immunization -- but that is in future," health official Rajesh Bhushan told reporters last month.
What is herd immunity?
Herd immunity works like this: Assume that each infected person infects three more people. If two of those three people are immune, then the virus is only able to make one person sick. This mean that fewer people are infected by the illness -- and over time, even people who aren't immune end up being protected as they are less likely to be exposed to the virus.
The level of immunity needed in a population depends on the disease. Scientists don't yet know what proportion of a population needs to be immune to achieve herd immunity for the novel coronavirus.
Building up the level of immunity in a population can happen in two ways. People can become immune by being vaccinated, or they catch the virus and develop natural immunity by recovering from it.
And that's where things get controversial.
Most other countries -- including India -- have taken a different approach. "Herd immunity in a country with the size of population of India cannot be a strategic choice, it can only be an outcome and that, too, at a very high cost," said the health official, Bhushan.
As Dowdy puts it: "We could very rapidly develop a population immunity to the coronavirus simply by exposing every single person in the population to the disease ... it's just that millions and millions of people are going to die in the process."
Can we build natural immunity?
The science around immunity to Covid-19 is still developing.
The fact that antibody levels decline over time doesn't necessarily mean that immunity doesn't last, Dowdy says. In other viruses, antibody levels decline over time, too, but the immune response is still able to ramp up again if a person is re-exposed to the virus.
According to Dowdy, our immunity to other coronaviruses tends to last a few years, rather than being life-long. "If those are a guide, then that's what we might expect from this new coronavirus," he said. "But it's hard to say. We don't have any data on this particular virus."
But for now, Tanoto says we don't know how much -- if at all -- these T cells are helping fight off Covid.
In reality, once there is herd immunity -- whether naturally or through vaccines -- it probably won't be the impenetrable shield some people might imagine.
Tanoto's co-author Nina Le Bert, a senior research fellow at Duke-NUS Medical School in Singapore, points out that it's rare to have complete immunity from infection. Instead, immunity often means that a person's body is able to respond fast enough to the virus so that it doesn't gain a foothold -- and doesn't develop enough to infect other people.
"That will be good enough, but that doesn't mean you don't get infected," Le Bert said.
Even if certain areas do achieve herd immunity, it might not last.
The virus could mutate, meaning people who previously had immunity are no longer immune to the new version of the virus, or a person's immunity to the virus might not last long, according to Kleczkowski, from the University of Strathclyde.
"Even if we reach herd immunity at some point in time, we might lose it again," he said. "I don't think it's a silver bullet."
Dowdy says that herd immunity "isn't a magic number" to solve coronavirus.
"It doesn't mean that the disease is going to go away. It means that if you gave it 1,000 years, it would go away."
