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FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines | U. S. Food & Drug Administration.

For Immediate Release: January 04, 2021.

Statement From:

Commissioner of Food and Drugs - Food and Drug Administration

Stephen M. Hahn M.D.

Director - Center for Biologics Evaluation and Research (CBER)

Peter Marks M.D., PhD.

Two different mRNA vaccines have now shown remarkable effectiveness of about 95% in preventing COVID-19 disease in adults. As the first round of vaccine recipients become eligible to receive their second dose, we want to remind the public about the importance of receiving COVID-19 vaccines according to how they’ve been authorized by the FDA in order to safely receive the level of protection observed in the large randomized trials supporting their effectiveness.

We have been following the discussions and news reports about reducing the number of doses, extending the length of time between doses, changing the dose (half-dose), or mixing and matching vaccines in order to immunize more people against COVID-19. These are all reasonable questions to consider and evaluate in clinical trials. However, at this time, suggesting changes to the FDA-authorized dosing or schedules of these vaccines is premature and not rooted solidly in the available evidence. Without appropriate data supporting such changes in vaccine administration, we run a significant risk of placing public health at risk, undermining the historic vaccination efforts to protect the population from COVID-19.

The available data continue to support the use of two specified doses of each authorized vaccine at specified intervals. For the Pfizer-BioNTech COVID-19 vaccine, the interval is 21 days between the first and second dose. And for the Moderna COVID-19 vaccine, the interval is 28 days between the first and second dose. 

What we have seen is that the data in the firms’ submissions regarding the first dose is commonly being misinterpreted. In the phase 3 trials, 98% of participants in the Pfizer-BioNTech trial and 92% of participants in the Moderna trial received two doses of the vaccine at either a three- or four-week interval, respectively. Those participants who did not receive two vaccine doses at either a three-or four-week interval were generally only followed for a short period of time, such that we cannot conclude anything definitive about the depth or duration of protection after a single dose of vaccine from the single dose percentages reported by the companies.  

Using a single dose regimen and/or administering less than the dose studied in the clinical trials without understanding the nature of the depth and duration of protection that it provides is concerning, as there is some indication that the depth of the immune response is associated with the duration of protection provided. If people do not truly know how protective a vaccine is, there is the potential for harm because they may assume that they are fully protected when they are not, and accordingly, alter their behavior to take unnecessary risks.

We know that some of these discussions about changing the dosing schedule or dose are based on a belief that changing the dose or dosing schedule can help get more vaccine to the public faster. However, making such changes that are not supported by adequate scientific evidence may ultimately be counterproductive to public health.

We have committed time and time again to make decisions based on data and science. Until vaccine manufacturers have data and science supporting a change, we continue to strongly recommend that health care providers follow the FDA-authorized dosing schedule for each COVID-19 vaccine. 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Assessment of Preventative Measures Practice among Umrah Pilgrims in Saudi Arabia, 1440H-2019 | Environmental Research and Public Health.

[Open Access] [Received: 21 November 2020 / Revised: 22 December 2020 / Accepted: 23 December 2020 / Published: 31 December 2020]

Abstract.

Background: Annually, approximately 10 million pilgrims travel to the Kingdom of Saudi Arabia (KSA) for Umrah from more than 180 countries. This event presents major challenges for the Kingdom’s public health sector, which strives to decrease the burden of infectious diseases and to adequately control their spread both in KSA and pilgrims home nations. The aims of the study were to assess preventative measures practice, including vaccination history and health education, among Umrah pilgrims in Saudi Arabia.

Methods: A cross sectional survey was administered to pilgrims from February to April 2019 at the departure lounge at King Abdul Aziz International airport, Jeddah city. The questionnaire comprised questions on sociodemographic information (age, gender, marital status, level of education, history of vaccinations and chronic illnesses), whether the pilgrim had received any health education and orientation prior to coming to Saudi Arabia or on their arrival, and their experiences with preventative practices.

Results: Pilgrims (n = 1012) of 41 nationalities completed the survey. Chronic diseases were reported among pilgrims (n = 387, 38.2%) with cardiovascular diseases being the most reported morbidity (n = 164, 42.3%). The majority of pilgrims had been immunized prior to travel to Saudi Arabia (n = 770, 76%). The most commonly reported immunizations were influenza (n = 514, 51%), meningitis (n = 418, 41%), and Hepatitis B virus vaccinations (n = 310, 31%). However, 242 (24%) had not received any vaccinations prior to travel, including meningitis vaccine and poliomyelitis vaccine, which are mandatory by Saudi Arabian health authorities for pilgrims coming from polio active countries. Nearly a third of pilgrims (n = 305; 30.1%) never wore a face mask in crowded areas during Umrah in 2019. In contrast, similar numbers said they always wore a face mask (n = 351, 34.6%) in crowded areas, while 63.2% reported lack of availability of face masks during Umrah. The majority of participants had received some form of health education on preventative measures, including hygiene aspects (n = 799, 78.9%), mostly in their home countries (n = 450, 44.4%). A positive association was found between receiving health education and practicing of preventative measures, such as wearing face masks in crowded areas (p = 0.04), and other health practice scores (p = 0.02).

Conclusion: Although the experiences of the preventative measures among pilgrims in terms of health education, vaccinations, and hygienic practices were at times positive, this study identified several issues. These included the following preventative measures: immunizations, particularly meningitis and poliomyelitis vaccine, and using face masks in crowded areas. The recent COVID-19 pandemic highlights the need for further studies that focus on development of accessible health education in a form that engages pilgrims to promote comprehensive preventative measures during Umrah and Hajj and other religious pilgrimages. View Full-Text


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Pakistan: IDB will provide $60m to Pakistan for Polio vaccination | Radio Pakistan.

[January 06, 2021]

Islamic Development Bank will provide financing of 60 million dollars to Pakistan for Polio vaccination.

An agreement to this effect was signed between Secretary Economic Affairs Division Noor Ahmed and IDB representative in Islamabad today (Wednesday). 

IDB representative said the bank is committed to support the vulnerable populations of the member countries from the pandemic and other fatal diseases.


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India: Administer pulse polio drops to children on Jan 17: DC | Deccan Herald.

[JAN 07 2021]

All children within five years of age will be administered with pulse polio drops in the district on January 17, said Deputy Commissioner Annies Kanmani Joy.

She was presiding over a preliminary meeting on the preparations for pulse polio drive in the district, at DC's office hall in Madikeri, on Wednesday.

She directed the departments of Panchayat Raj, Public Instructions, Women and Child Welfare and Regional Transport to provide necessary cooperation to the Health and Family Welfare Department in making the pulse polio drive a successful one.

The booths will be opened at schools, bus stands and other public places. Vehicle arrangements will be made by the regions transport department, for the staff.

Annies also insisted that the departments concerned should ensure uninterrupted power supply on the day of the pulse polio drive.
District Health Officer Dr K Mohan said that all necessary precautionary measures will be taken by the department while conducting the pulse polio drive, in the wake of the Covid-19 pandemic.

He further said, "There are 39,820 children within five years of age in the district. As many as 4,400 children are from urban areas and 35,420 are from rural areas. There are 10,463 children from migrating families, who will also be included in the programme."

As many as 464 boothswill be set up for the drive and 48 transit teams and six mobile teams have been formed towards the same, while 1,964 staff members and 86 supervisors have been deployed.

As many as 928 staff members will carry out door-to-door visits to administer pulse polio drops to children.

The DHO requested the public to get their children to the pulse polio booths.

The health workers will wear face masks and hand gloves while administering drops, apart from taking other precautionary measures towards checking the spread of Covid-19, he added.

District RCH officer Dr Gopinath said that the pulse polio drive will be held on January 17 at booth level. On January 18,19 and 20, the health department staff will visit houses in urban areas and on January 18 and 19 in rural areas to administer pulse polio drops to children who are left out during the drive on January 17.

Family Welfare Officer Dr Anand, World Health Organisation representatives Sudhir Nayak, DDPI P S Machado, Women and Child Welfare Department Deputy Director Ningaraju and Madikeri City Municipal Council Commissioner S V Ramdas were present during the meeting.

'Dry run prior to Covid-19 vaccination'

A dry run will be conducted in the district on January 8, as preparation for the Covid-19 vaccination drive, said Deputy Commissioner Annies Kanmani Joy.

She has issued necessary directions to the DHO and officials of the medical education department in this matter. The officials were told to disseminate necessary information to the health workers in this regard.

The district officials should coordinate with the tahsildars to conduct the practice sessions of Covid-19 vaccination. "There should be no room for any ambiguity," said the deputy commissioner.

DHO Dr K Mohan said that the dry run will be conducted at the District Government Hospital, Community Health Centres in Kushalnagar and Virajpet and at the Primary Health Centre in Kakotuparambu in Virajpet taluk.


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Kashmir: Doda Administration braces for Intensified Pulse Polio Immunization | Kashmir Reader.

[January 7, 2021]

DODA: District Administration Doda has braced up for Intensified Pulse Polio Immunization(IPPI) being conducted on January 17, 2021.

Acting upon the directions of Deputy Commissioner (DC), Dr Sagar D Doifode, Additional Deputy Commissioner, Kishori Lal Sharma convened a meeting of District Task Force Committee to review the arrangements for the intensified pulse polio immunization (IPPI) programme. The meeting was informed that during the NID program 70790 children in the 0 to 5 year age group would be administrated polio drops.

It was apprised that a total 523 Booths have been set up in the district immunization on January 17, while in next two days drops would be given by conducting Door to Door campaign. “In case of inclement weather conditions, the door to door campaign would be extended for 7 days to cover all the children.

It was also given out that 105 supervisors would oversee IPPI booths, while the services of 2124 health workers along with supervisory teams, Anganwadi workers and Asha workers and employees of education department have also been sought for proper execution and monitoring of the immunization process.

It was further informed that 46 areas have been identified as hard to reach for which adequate deployment of officials from different departments has been made.

Meanwhile, The ADC Doda also took stock of the preparedness and action plan devised for the effective implementation of the Covid vaccine drive in the district.

The meeting discussed in detail the present status of the availability of logistical support, man power, vaccination points, besides the training and mock drills being conducted in the district.

The meeting was attended by PO ICDS; Chief Education Officer, District Immunization Officer, Dy CMO and officials of the concerned committee.


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UK: Even as the Covid crisis accelerates, paramedics like me see people taking risks | The Guardian.

[Wed 6 Jan 2021 08.00 GMT] Jake Jones writes:

It’s half past midnight on my last night shift of 2020, the working year I’ll never forget. We’re sat in our ambulance outside A&E with a patient with Covid symptoms, waiting for an isolation cubicle, and we’ve been here for almost three hours.

I keep apologising: the patient smiles graciously, tells us it’s not our fault, makes a joke about her nasal oxygen cannula being like a moustache. A doctor has been out to speak to her, and a nurse has taken bloods, both in the back of the ambulance. Other crews arrive and join the queue. At one point, four ambulances on blue lights appear within 10 minutes; their patients will take precedence since they require immediate care. Yet even these patients are being assessed in the ambulances initially because space inside the hospital is so limited.

Every so often, our radio dispatcher reminds us about the backlog of calls waiting across our area. There are patients with time-critical problems – strokes, heart attacks, severe breathing difficulties – and in these instances, the delay in response might be catastrophic. Until we can offload our current patient, however, there’s nothing we can do. We’re stuck here waiting – frustrated, drained, powerless to help. This is our new routine.

As infections have rocketed and Covid-related deaths have begun to follow suit, I’ve witnessed from the inside a health service under unsustainable pressure – a pressure that, at least in the short term, will only get worse. What’s concerning is the increase in patients now requiring hospital. With cases still rising, and the lag between transmission and peak symptoms, it’s hard to see how the demand will be met in the coming weeks.

Our role in the emergency ambulance service has once again become a tougher, more streamlined version of its normal self. Like canaries in a mine, we’re sent into corona-filled environments. We put on our PPE and assess patients to determine where they sit on the Covid spectrum. Some we leave at home with self-care advice; others we transport to hospital for supplemental oxygen. In the most serious cases, we give the hospital advance warning and they search for a space where they can administer high-level interventions such as CPAP (continuous positive airway pressure) or ventilator support. When we’ve finished with each patient we remove our PPE and clean, clean, clean.

Recently we’ve been to many patients who have almost certainly contracted the virus through household-mixing. Incredibly, we’re still going to people who are socialising outside their households, confirmed Covid-positive patients who need to be told to wear a mask, and individuals with week-long symptoms who haven’t got themselves tested yet and don’t seem to have heard of self-isolation. After the year we’ve had, and everything we know about the virus, this is the most demoralising aspect of the whole process.

The question I’m asked most often is how the current crisis compares with last spring. The simple answer is: it’s worse. True, we have a better understanding of how the virus is spreading – yet we seem to have missed the opportunity afforded by that knowledge to get ahead of transmission and intervene decisively. There was a distinct change of atmosphere three weeks ago, when things suddenly seemed to slip out of control, so why has the response been so delayed?

There is now a sense of fatigue among staff. Sickness rates are high and there’s little appetite to work extra shifts, even at enhanced rates. During the first wave, I remember feeling energised by having a clear sense of purpose – the intrinsic momentum that comes from being needed. This time around, after a year that’s been physically and emotionally exhausting, I just feel spent. There’s now a genuine fear among my colleagues about what’s coming next, and the psychological effects of this are starting to show.

Most disheartening for me is the lack of solidarity, in some quarters if not all. Don’t worry; I’m not asking for applause. I’d settle for a return to the sense of apprehension that characterised the early stages of the first lockdown, and the helpful constraint it had on people’s behaviour. I never expected to feel nostalgic about those strange days, but how relieved I’d be to return to their empty streets now. The full lockdown may have been a brutal instrument, but within a fortnight of its imposition, ambulance call rates began dropping, and we started to move back towards a measure of control. The metaphor I’d use would be of a dam: imposing, unapologetic and not without unwelcome consequences. But decisively effective.

Unfortunately, the current situation feels much more porous. This is not just the result of a lack of political strategy; it’s about a failure of personal responsibility and the effects that individual actions can have at a communal, societal level. Every time someone socialises outside their household, or visits a relative, or has a friend round, it’s as if they’re drilling a hole in the dam. Just a small hole: what difference could one visit make? But if enough people drill enough holes, what you’re left with is not a dam, but a colander – and a health service that simply cannot cope.

All these thoughts go through my mind as we wait with our patient, feeling guilty that with so much work out there, we’re unable to contribute. Then, seemingly from nowhere, there’s a space. We take our patient inside, transfer her to a hospital bed and plug in the oxygen. We return to the ambulance and clean everything in sight. Then we push the button to make ourselves available and get ready to do the whole thing again.


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Afghanistan: Weekly Humanitarian Update (28 December 2020 – 3 January 2021) | ReliefWeb.

[Situation Report] [Source: OCHA] [Posted: 6 Jan 2021] [Originally Published: 6 Jan 2021] [Origin: View original]

South: 8,898 people recommended to receive humanitarian assistance.

Fighting between Afghan National Security Forces (ANSF) and a non-state armed group (NSAG) continued in Hilmand, Kandahar, Uruzgan and Zabul provinces.

Sporadic armed clashes continued in Shah Joi, Tarnak Wa Jaldak, Mizan and Arghandab districts in Zabul province.
In Hilmand province, fighting between the ANSF and an NSAG was reported in Nahr-e-Saraj, Lashkargah, Nad-e-Ali and Nawa-e-Barakzaiy districts. Airstrikes were also reported in Nawa-e-Barakzaiy and Nahr-e-Saraj and clearing operations of improvised explosive devices (IEDs) in the same districts are reportedly ongoing.

In Kandahar province, the security situation remained volatile mainly in Zheray, Panjwayi, Arghandab, Shah Wali Kot, Arghestan and Shorabak districts. Several roadside IEDs were reportedly discovered and diffused in the Zala Khan area, Panjwayi district. The overall presence of IEDs continued to hinder civilian movements.

In Uruzgan province, the security situation deteriorated in Gizab district with ongoing clashes between an NSAG and ANSF. In Dehrawud district, one child was reportedly killed and another injured by an IED detonation.

During the reporting period, interagency assessment teams recommended 1,908 people displaced by conflict to receive humanitarian assistance in Hilmand and Kandahar provinces. Also, interagency assessment teams in Tirinkot and Gizab districts, Uruzgan province identified 6,990 people affected by conflict to receive humanitarian assistance in the coming days. Furthermore, humanitarian activities resumed in Suri district, Zabul province and on 1 January humanitarian assistance was delivered to people in need. From 28 December 2020 to 3 January 2021, about 3,000 people were reached with assistance in Lashkargah city(Hilmand), Kandahar, Zaranj (Nimroz), and Suri district (Zabul).

North-east: 13,286 people received humanitarian assistance.

Fighting between ANSF and NSAGs intensified in the north-east mainly in Eshkashem, Raghestan and Yaftal-eSufla districts, Badakhshan province. On 25 December 2020, two civilians were reportedly injured in Raghestan district and Yaftal-e-Sufla district in Badakhshan province due to ongoing fighting.

Humanitarian assistance including cash for food and winter support reached 13,286 people affected by conflict in Badakhshan, Takhar and Kunduz provinces. Assessment teams identified 532 people displaced by conflict in Baghlan and Kunduz provinces to receive humanitarian assistance in the coming days.

East: 22,499 people received humanitarian assistance.

Clashes between ANSF and an NSAG continued and the number of security incidents affecting civilians increased compared to the previous week.

Interagency assessment teams identified 4,277 people to receive immediate humanitarian assistance. A total of 22,499 people received humanitarian assistance — among them are 609 newly displaced people, 1,022 people in protracted displacement, 400 farmers in need of food security/livelihood support and 20,468, people who received unconditional seasonal support/food rations in response to COVID-19. Some 7,340 returnees, IDPs and people from host communities were reached with emergency outpatient health services and 7,966 children were vaccinated to protect them against polio and measles. This week, 6 mobile health teams provided nutrition support to people affected by conflict and natural disasters in Nangarhar and Kunar provinces. Among 7,074 children under five screened, 242 children suffered from severe acute malnutrition (SAM) and 772 children suffered from moderate acute malnutrition (MAM). The severe cases were admitted to the therapeutic feeding centres for treatment.

West: Two cases of polio identified in Hirat.

On 28 December 2020, a civilian was reportedly killed in a suicide attack in Kushk district, Hirat province. On 3 January, two cases of polio were identified among IDPs displaced from Ab Kamari district in Badghis province to Hirat city.

A total of 2,600 people affected by conflict received humanitarian assistance including food, household items, water, sanitation and hygiene supplies in Badghis, Ghor and Farah provinces. Needs assessments of people affected by conflict continued in Badghis, Ghor, Hirat and Farah provinces.

Centre: 8,596 people received cash assistance for winter.

The security situation in the Centre remained unstable mainly in Logar, Kabul, Maidan Wardak, Khost and Paktya provinces with continued reports of IED attacks.

On 31 December 2020, the Afghanistan National Disaster Management Authority (ANDMA) provided cash assistance, food and household items to 28 people who were affected by avalanches in Kiti district, Daykundi province on 29 December. On 2 January, 63 people affected by natural disasters were reached with humanitarian assistance in Yakawlang district of Daykundi province. This week, 8,596 people received cash assistance for winter in Ghazni, Kapisa, Paktika, Bamyan and Logar provinces. Needs assessments continued for vulnerable people in need of winter assistance across the central part of the country.

North: 3,332 IDPs received humanitarian assistance.

Armed clashes between ANSF and an NSAG continued in Balkh, Faryab, Sar-e-Pul, Jawzjan and Samangan provinces.

Interagency assessment teams identified 1,743 people affected by conflict to receive humanitarian assistance in the coming days in Balkh, Faryab, Jawjan and Sar-e-Pul provinces. A total of 3,332 people affected by conflict received humanitarian assistance in Faryab, Sar-e-Pul and Jawzjan provinces. In addition, 647 people including vulnerable families from host communities, IDPs in protracted displacement and returnees received basic health assistance through mobile health teams in Sar-e-Pul province.

For further information, please contact:
Linda Tom, Public Information Officer, OCHA Afghanistan, toml@un.org, Cell: +93 79300 11 10
For more information, please visit: unocha.org | reliefweb.int
facebook.com/UNOCHAAfghanistan | twitter.com/OCHAAfg

UN Office for the Coordination of Humanitarian Affairs:
To learn more about OCHA's activities, please visit https://www.unocha.org/.


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