The UK has reported 54,095 new cases of COVID-19 on Sunday, as well as a further 75 deaths within 28 days of a positive test, according to the latest government figures.
It follows 60,578 new cases and a further 259 deaths reported on Saturday, and 69,007 new cases and 91 deaths reported last Sunday.
In total more than 17.7 million people in the UK have tested positive for COVID-19, and more than 158,000 people have died within 28 days of a positive test.
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The most recent data says that as of Thursday 3 February, there have been more than 452 million virus tests conducted in the UK.
As of the same date there are 14,634 patients in hospital with COVID-19, 478 of whom are in ventilation beds.
As of Saturday there have been more than 138 million vaccinations given in total, including more than 52 million first doses, 48 million second doses, and 37 million booster or third doses.
It comes as a director of the World Health Organisation (WHO) said Europe is entering the "plausible endgame" of the coronavirus pandemic.
Dr Hans Kluge, WHO regional director for Europe, said the region had recorded 12 million new COVID-19 cases in the last week, with 30% of all cases since the pandemic began being reported this year.
But, he said, "for now, the number of deaths across the region is starting to plateau".
Professor Sir David Spiegelhalter, chairman of the Winton Centre for Risk of Evidence Communication at Cambridge University has confessed he didn't take the virus "seriously enough" at the start of the pandemic.
He added that he had a naturally optimistic personality "and that's why I'm very glad I'm not a government adviser".
"The pandemic has been a net lifesaver for younger people, if you look at people between 15 and 30 in 2020, 300 fewer died than would normally have died and that includes the 100 that died from COVID sadly," Sir David said.
"So that's 300 fewer families mourning the death of a young person because of the pandemic.
"Now that's because young people were essentially locked up, they couldn't go out driving fast, they couldn't go out and get drunk, and they couldn't get into fights and whatever, and so all these lives were saved."
However, the professor said that this doesn't necessarily mean he advocates for lockdowns, because "on the flip side of that you have a big increase in mental health problems".
STATEN ISLAND, N.Y. After a surge of coronavirus (COVID-19) cases due to the omicron variant, many parents of K-12 students across the United States say that schools should offer a mix of in-person and online instruction in the winter season, a new survey by the Pew Research Center found.
The survey found that 53% of parents say schools should provide the mix of both types of instruction while 37% say schools should be fully in-person only, and 9% say schools should be fully remote.
When asked what factors schools should consider about offering in-person instruction this winter, many parents said schools should consider that students would fall behind academically (67%) or that their emotional well-being will be negatively impacted (61%) if they stay remote. Some parents (52%) also said they wouldnt be able to work if their kids are home for remote learning.
Other factors if kids went to school in-person include the risk to students or teachers of getting COVID-19 (43%) and spreading it (39%), and the financial cost to school systems to follow health guidelines to keep schools open safely (26%).
While a majority of parents think schools should offer a mix of in-person and remote instruction this winter, just 16% say this is the type of instruction their children are currently getting, according to the survey.
About 71% of parents said their kids are getting in-person instruction only, and 5% say their child is only learning remotely.
According to Pew, The analysis is based on a survey of 2,241 U.S. parents of children in K-12 schools who live in their household. The data was collected as part of a larger survey of 10,237 adults conducted Jan. 24-30, 2022.
In New York City, public schools have stayed open for in-person instruction for the 2021-2022 school year, even as cases rose because of the omicron variant.
As part of that effort to keep schools open safely, the city launched its Stay Safe and Stay Open plan that would double the number of students randomly tested at school, provide rapid at-home tests which reduced both the number of students who need to quarantine if exposed to COVID-19, as well as limit classroom and school closures.
Under this plan, students who are exposed to COVID-19 at school are required to take two rapid at-home tests over the course of five days. If the tests come back negative and students dont have COVID-like symptoms, they can continue to attend school as normal.
Since it was enacted, the number of classroom closures has been seemingly nonexistent. The DOE hasnt reported full or partial classroom closures in the city and therefore, no school investigations or closures have been reported.
Ahead of the midwinter break, New York City education officials announced last week it would update the coronavirus policy to increase the number of students tested in the citys weekly in-school random surveillance testing program.
It anticipates students and staff are now more likely to engage in activities and settings with less stringent health and safety measures. in response, the DOE is increasing the number of students who will be PCR tested for COVID-19 in schools starting Monday.
Starting Feb. 7, schools will test the larger of either 10% of the schools student enrollment in grades 1-12, up to a cap of 250 students; or 20% of the schools unvaccinated student population.
This change, the DOE said, will allow schools with a high number of vaccinated students to test a larger group every week.
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Fourmore Mainers have died and another 1,095coronavirus cases reported across the state, Maine health officials said Saturday.
Saturdays report brings the total number of coronavirus cases in Maine to 181,010,according to the Maine Center for Disease Control and Prevention. Thats up from 179,915 on Friday.
Of those, 133,351have been confirmed positive, while 47,059were classified as probable cases, the Maine CDC reported.
Three men and a woman have succumbed to the virus, bringing the statewide death toll to 1,804.
Two were from Androscoggin County, one from Kennebec County and one from Somerset County.
Of those, one was 80 or older, two were in their 70s and one in their 60s.
The number of coronavirus cases diagnosed in the past 14 days statewide is 14,112. This is an estimation of the current number of active cases in the state, as the Maine CDC is no longer tracking recoveries for all patients. Thats down from 14,224 on Friday.
The new case rate statewide Saturday was 8.18 cases per 10,000 residents, and the total case rate statewide was 1,352.43.
The most cases have been detected in Mainers younger than 20, while Mainers over 80 years old account for the largest portion of deaths. More cases have been recorded in women and more deaths in men.
So far, 4,019 Mainers have been hospitalized at some point with COVID-19, the illness caused by the new coronavirus. Of those, 339 are currently hospitalized, with 83 in critical care and 36 on a ventilator. Overall, 47 out of 379 critical care beds and 245 out of 328 ventilators are available.
The total statewide hospitalization rate on Saturday was 30.03 patients per 10,000 residents.
Cases have been reported in Androscoggin (18,232), Aroostook (8,615), Cumberland (37,861), Franklin (4,451), Hancock (5,296), Kennebec (17,441), Knox (4,284), Lincoln (3,815), Oxford (8,849), Penobscot (20,308), Piscataquis (2,274), Sagadahoc (3,776), Somerset (7,610), Waldo (4,473), Washington (3,161) and York (30,592) counties. Information about where an additional two cases were reported wasnt immediately available.
An additional 440 vaccine doses were administered in the previous 24 hours. As of Saturday, 978,717 Mainers are fully vaccinated, or about 76.4 percent of eligible Mainers, according to the Maine CDC.
As of Saturday afternoon, the coronavirus had sickened 76,379,284 people in all 50 states, the District of Columbia, Puerto Rico, Guam, the Northern Mariana Islands and the U.S. Virgin Islands, as well as caused 901,703 deaths, according to the Johns Hopkins University of Medicine.
More articles from the BDN
Just getting on the ice on Sunday felt like a victory.
Tahli Gill of Australias mixed doubles curling team had her bags packed and a flight booked to return home. Any hopes of finishing her Olympic run had seemingly been dashed by a series of positive coronavirus tests.
Yet, after a whirlwind of developments on Sunday, Gill and her partner, Dean Hewitt, notched Australias first-ever wins in curling. The pair beat Switzerland, 9-6.
I only had time to pull out my uniforms, Gill told reporters after the match, recounting the dizzying turn of events that led to health officials delivering an unexpected reprieve that sent her scrambling to make the game. I only played with one glove!
She had been excluded from her final two matches after a series of positive tests on Saturday, Australian Olympic officials said. Gill had alternated between positive and negative tests in recent days, which she had blamed on the residual effects of contracting the virus in December.
The call came late on Sunday when Chinese officials decided that Gills CT levels, a measure of how much viral material is detected, were within an acceptable range.
It was a sudden turn after Australian Olympic officials said that discussions with the health authorities and the International Olympic Committee went late into Saturday without success. By Sunday, Australian officials said, they were making plans to get Gill and Hewitt home after Gill had been moved into an isolation hotel.
When word started trickling in of a possible reprieve, Hewitt said he was reluctant to believe it. Dont do this to us, please! he said of the tantalizing possibility of returning. Are you serious?
The news was true.
It was just crazy, mate, Hewitt said after the game on Sunday. The excitement in the room was unbelievable.
That excitement, Hewitt said, fueled their play on Sunday. You dont realize what youve got until its gone, he said. The win? That was a bonus.
THORNTON, Colo. It's been nearly two years since the start of the pandemic in Colorado. One man who made a miraculous recovery after contracting the virus is reflecting on the last year.
On February 8, 2021, Jaime Gonzalez-Tolentino was admitted to the hospital during a battle with the virus and was given a 1% chance of survival. Nearly a year later he and his family share this story of a miraculous recovery.
Gonzalez contracted a severe case of the coronavirus in 2021 after suffering a stroke and battling Pneumonia just a few years earlier. He was in a coma, intubated, and put on an ECMO machine that provides heart and lung support. The days in the hospital turned into months.
"They told me, you know, he has a 1% chance. I mean, there was just, they didn't have any hope for him," said Jaime's oldest son, Jesus. "It was hard, especially me being the oldest. And, you know, how are you going to tell your siblings, your younger siblings that his dad is going to, is going to die?"
Despite all odds against them, his family did not lose hope and did what they could to help. Jaime's oldest son suggested a rare steroid treatment. With few options left one doctor agreed to try it.
She took a leap of faith on us because we told her that we were people of faith that we believe God was going be there for us," said Jesus.
On Easter Sunday, April 4, 2021, which also happened to be Jaime's youngest son's birthday, a miracle happened: the dad-of-three woke up after a couple of months in a coma.
Jaime says he remembers that moment, being surrounded by his family and mother. He says seeing their excitement gave him the same feeling and motivation to push forward.
Gonzalez spent exactly 100 days hospitalized before making it home on May 20, 2021. Since then, Jaime has been able to resume his normal life with a few restrictions like having to use an oxygen pack.
He says doctors at his latest appointment have told him that his health is progressing and his lungs are improving. His message to those who hear his story is, "Life is beautiful and is something that should be enjoyed by everyone."
WATERLOO, Ontario (StudyFinds.org) COVID-19 has disrupted countless lives around the globe and still serves as a daily, unavoidable stressor. Now, researchers from the University of Waterloo are revealing just how detrimental the pandemic has been for multi-child families.
To start, the study finds that within a multi-child family, one child typically tends to be more affected by the pandemic than their siblings experiencing more stress, anxiety, anger, and depression. Unfortunately, this development appears to create a negative feedback loop of poor parenting decisions. Stressed out parents trying to navigate these uncertain timesend up reacting harshlyto the child in need of additional support.
Our study shows that parents tend to be most reactive and least positive to the child showing the highest levels of mental health difficulties, says lead study author Dillon Browne, a professor of clinical psychology, in auniversityrelease.
Struggles with mental health among family members exacerbate each other in a feedback loop, he continues. Our study suggests that the direction of influence appears to go from the childs mental health to parenting, not parenting to child mental health.
Data was collected on over 500 caregivers and 1,000 siblings for this study. More specifically, caregivers with at least two children (ages 5-18) filled out surveys asking about their COVID stress,overall family functioning, and mental health on numerous occasions during a two-month tracking period.
Understanding childrens mental health difficulties during COVID-19 requires a family system lens because of the numerous ways thepandemic affects the familyas a unit. Comprehensive interventions for childrens mental health require an examination of caregiver, sibling, and whole-family dynamics, explains Prof. Browne, who also holds the Canada Research Chair in Child and Family Clinical Psychology.
In light of these results, study authors believe countless families and households will likely benefit from some familytherapy sessions. Moreover, individual psychotherapy sessions for both children and adults may be a useful tool as the world continues to endure the ongoing pandemic.
A lot of research studies have pointed to mental-health challenges associated with the pandemic for children and parents. This work adds insight into how pandemic-related disruption goes beyond the individual and infiltrates the relational environment of the family unit, Prof. Brown concludes.
Thestudyis published in the journalDevelopmental Psychology.
A statistician has said he was "overly-optimistic" at the start of the COVID-19 pandemic.
Professor Sir David Spiegelhalter, chairman of the Winton Centre for Risk of Evidence Communication at Cambridge University confessed he "didn't take it seriously enough".
He added that he had a naturally optimistic personality "and that's why I'm very glad I'm not a government adviser".
"The pandemic has been a net lifesaver for younger people, if you look at people between 15 and 30 in 2020, 300 fewer died than would normally have died and that includes the 100 that died from COVID sadly," Sir David said.
"So that's 300 fewer families mourning the death of a young person because of the pandemic.
"Now that's because young people were essentially locked up, they couldn't go out driving fast, they couldn't go out and get drunk, and they couldn't get into fights and whatever, and so all these lives were saved."
However, the professor said that this doesn't necessarily mean he advocates for lockdowns, because "on the flip side of that you have a big increase in mental health problems".
Sir David, who has been a regular commentator on the pandemic, admitted he had an "optimistic" disposition during the pandemic.
Speaking on BBC Radio 4's Desert Island Discs, he said: "I think it's very important that we have to acknowledge that we can never take an objective view about evidence, we always bring our, I think, personalities into it, and mine is unfortunately very optimistic and that's why I'm very glad I'm not a government adviser, I don't think I'd be very good at it because I do tend to hope for the best and sort of expecting the best as well.
"I was terribly over-optimistic at the start of the pandemic and didn't take it seriously enough."
'Could he have been caught earlier?'
Sir David was knighted in 2014 for services to medical statistics, including leading the statistical team for the public inquiry into high rates of deaths among babies following heart surgery at Bristol Royal Infirmary.
He also discussed his work as an expert witness to the public inquiry into serial killer doctor Harold Shipman.
Shipman was jailed for life in January 2000 for murdering 15 patients while working in Manchester but official predictions are that he killed between 215-260 people during a 23-year-period in West Yorkshire.
He said: "I was part of the team that was asked to say 'well, could he have been caught earlier if people had been looking at the data?'.
"We looked at the statistical methods that were used in industrial quality control, where you monitor whether a process is going out of kilter by seeing whether you're getting more failures than you would expect and, in Harold Shipman's case, it was looking for when more people were dying in his practice than you would expect.
"And we adapted the methods used in industrial quality control and showed that, actually Shipman could have been caught much earlier and if someone had been looking at the data and had blown the whistle you might have been able to save 200 lives."
Jerusalem, February 6, 2022- An additional grant of US$3.75 million was allocated to the ongoing West Bank and Gaza COVID-19 Emergency Response. The additional financing will continue to support the Palestinian Authority's response to the threat posed by the COVID-19 pandemic while ensuring continuity of essential health services and contributing to long-term resilience.
The grant will be contributed from the Health Emergency Preparedness and Response (HEPR) Multi-donor Trust Fund administered by the World Bank. It is a flexible mechanism for rapid financing to support countries and territories to improve their capacities to prepare for, prevent, respond to, and mitigate the impact of epidemics on populations.
"*COVID-19 continues to pose a high risk of morbidity and mortality, as well as a burden to healthcare systems. Due to low capacity of testing in the Palestinian territories, the number of COVID-19 cases are underestimated. Still, the numbers of new infections reported daily continue to reach new highs. The additional financing will support the original project by providing immediate response to COVID-19, but also contributing to long-term resilience,*" said Kanthan Shankar, World Bank Country Director for West Bank and Gaza.
Beyond strengthening the overall healthcare services and clinical capacity in immediate response to COVID-19 under the framework of the parent project, the new grant focuses on procuring supplies and equipment that could be utilized to promote resilience to future pandemics and health shocks. These include medicines for the treatment of health emergencies and chronic conditions as well as emergency medical devices and equipment including defibrillators, vital-signs monitors, emergency trolleys, patient beds, mobile blood banks, ultrasound machines, generators, and more.
The operation will also seek to reduce limitations to access to healthcare experienced by rural and marginalized communities. For instance, women in remote areas often find it difficult to access health services due to distance to health facilities and lack of transportation. Mobile clinics financed through the additional financing will ensure equitable access to quality care for populations that are often left behind. The World Bank will continue to strengthen resilience and pandemic preparedness in the health system through technical and operational engagement with the Ministry of Health and other partners in the sector.
Mary Koussa
+(972) 2-2366500
mkoussa@worldbank.org
Serene Jweied
+1 (202) 473-8764
sjweied@worldbankgroup.org
The test kits alone, the city estimated, caught 25,000 cases. School attendance hovered around 70 percent in early January, as children were out sick or kept home by their parents to try to avoid infection.
While Omicron often causes milder illness in adults, it sometimes has a more severe impact on children, particularly those too young to be vaccinated, creating new challenges for health care workers. Hospitalization rates for children rose more quickly than in previous waves, mirroring trends elsewhere.
Still, of the 181 children that Cohen Childrens Medical Center in Queens admitted with Covid-19 in the recent wave, only one, an unvaccinated 17-year-old boy, died, a spokesman said. From Jan. 1 to Jan. 27, three children under 18 died of Covid-19 in the city, bringing the citys total death toll in that age group during the pandemic to 32, according to data from the American Academy of Pediatrics.
Although Omicron is receding quickly, the wave is not totally gone. There were 2,633 people with Covid-19 in city hospitals on Feb. 2, fewer than half than at the Omicron peak, but still more than four times as many as before the variant was first detected in December.
Even with the numbers declining, medical workers on the front lines say staffing shortages remain acute.
At SUNY Downstate, employees from across departments pitched in when the emergency room was taking in four times its regular number of patients in early January. Vaccines and new treatments helped limit severe cases. But there were too many patients flooding the entire health system at once to load balance, or transfer patients, between Downstate and other hospitals that were also being hit hard.
Still, strategies that had been developed after earlier waves helped, said Patricia A. Winston, the hospitals senior vice president for operations. Those included regular check-in calls with state and city officials and the Greater New York Hospital Association, a trade group that followed the situation across medical centers.
Before, it was like, you were in this by yourself, Ms. Winston said. Now you talk to each other and work together and figure out how to strategize. Even if you cant move somebody, you have someone to talk to.
Background
In January 2020, the Government of India based on the recommendation of the Drugs Controller General ofIndia(DCGI) and National Technical Advisory Group on Immunization (NTAGI) started the rollout of the COVID-19 vaccine in the country. Two vaccines, ChAdOx1 nCoV-19 coronavirus vaccine (recombinant), i.e., COVISHIELD produced by Serum Institute of India and COVAXIN developed indigenously by Bharat Biotech, were given emergency use authorisation (EUA) by the DCGI.
In this cohort study, we assessed the incidence, pattern and severity of adverse events following immunization (AEFI) observed among the healthcare workers of a large tertiary care institute in eastern U.P., India vaccinated with ChAdOx1 nCoV-19 Coronavirus vaccine (recombinant) within 30 minutes of vaccination by direct observation.
Out of the total 834 healthcare workers who were vaccinated with the first dose of the vaccine, around 10% experienced any AEFI within the directly observed period. The most common AEFI was pain/tenderness at the injection site experienced by 59.3% of those who experienced any AEFI followed by headache/dizziness (35.3%), itching/rashes at the injection site (8.1%), nausea/vomiting (5.8%) and fever/chills (4.7%). The majority (95.3%) of the AEFIs observed were of minor severity with no serious AEFIs observed as per the WHO severity classification.
ChAdOx1 nCoV-19 Coronavirus vaccine (recombinant) is proven to be safe based on our findings as the majority of AEFIs observed were of minor grade only. However, the vaccine beneficiaries should be strictly observed for a minimum of 30 minutes at the vaccination site to look for any serious AEFI with arrangements to manage the same.
As of June 30th, 2021, coronavirus disease 2019 (COVID-19) has been reported in more than 180 million individuals, and there have been more than 3 million deaths worldwide [1]. Various strategies such as tracking, tracing, testing, quarantine, and lockdown were implemented to combat the pandemic in many countries [2]. Currently, the strategy of mass vaccination against COVID-19 is being implemented in most of the countries across the globe to overcome this global catastrophe. In the absence of any definitive anti-SARS-CoV-2 therapy, mass vaccination against the viral disease may be the only mean for containing this ongoing pandemic.
In India, the COVID-19 vaccination drive was initiated on January 16th, 2021 after approval of two COVID-19 vaccines by the Drugs Controller General of India (DCGI) for restricted emergency use in the country [3]. The priority populations to be vaccinated in the first phase of this drive were the healthcare workers (HCWs) and the frontline workers (FLWs). In the first quarter of the vaccination, HCWs were administered the ChAdOx1 nCoV-19 vaccine/COVISHIELD (AstraZeneca/Serum Institute of India) or BBV152 vaccine/COVAXIN (Bharat Biotech). COVISHIELD is based on a replication-deficient simian adenoviral vector coding the whole length spike glycoprotein (S) of SARS-CoV-2 while COVAXIN is based on the inactivated SARS-CoV-2 platform [4]. Randomized controlled trials (RCTs) have reported an acceptable safety profile for both the vaccines [5, 6]. It is very important to improve the vaccination coverage of the COVID-19 vaccines to achieve the national goal of herd immunity. However, several adverse events associated with COVID-19 vaccines have been reported, including anaphylaxis, transverse myelitis, and deep vein thrombosis [6-8]. Misinformation through the mass media has been the basis of substantial anxiety among people about the safety of the vaccine since the initiation of the vaccination drive [9]. Moreover, there have been very few large-scale research studies on monitoring the adverse events following immunization (AEFI) associated with the COVID-19 vaccines in the Indian population.
We aimed to evaluate the incidence, pattern and severity of AEFIs associated with the ChAdOx1 nCoV-19 vaccine (AstraZeneca/Serum Institute of India) among the HCWs vaccinated at a single center situated in a tertiary care institute of North India during the first phase of vaccination so as to provide a basis to ensure safety of this vaccine during the future national vaccination against COVID-19.
A prospective, single-center cohort study using complete enumeration method was conducted from February 1st, 2021 to April 30th, 2021 at the COVID-19 Vaccination Centre, SSL Hospital, Banaras Hindu University, Varanasi, U.P., North India. The study subjects were all the HCWs who were taking the first dose of the ChAdOx1 nCov-19/COVISHIELD vaccine during the time period. As per the government policy, adult HCWsof any age were eligible for the COVID-19 vaccination. Among those who received the vaccination, HCWs who did not give consent for participation in the study were excluded.
Information about the ChAdOx1 nCov-19 vaccine and vaccination was notified to all the HCWs of the institute through the head of respective departments by asking the list of HCWs from them for uploading on the COWIN website. Written informed consent was obtained from the HCWs priorly while screening for the vaccination at the vaccination centre before the actual vaccination. For those who consented to undergo vaccination, the vaccination schedules were set from 10 AM to 4 PM daily except Sundays. The vaccination was conducted by dividing the space of the vaccination centre into three sections so that preliminary screening and registration, vaccinations, and AEFI monitoring could be performed simultaneously. The HCWs were asked to fill a preliminary form before vaccination that captured their previous history of vaccination, history of COVID-19 infection, and any known allergies. The vaccine was administered in the deltoid region by the well-trained auxiliary nurse midwife (ANMs)/nurses, and adverse events were directly observed and monitored for 30 minutes at the vaccination centre. Definition of adverse event was considered as defined by the World Health Organization (WHO), i.e., any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the usage of the vaccine. Theevent may be any unfavorable or unintended sign, abnormal laboratory finding, symptom or disease [10]. Every HCWwas directly observed for at least 30 minutes by one of the investigators who are specialized in identifying the adverse events and thosedeveloping any severe or serious AEFI were kept till they were stabilized. After discharge from the vaccination centre, vaccinated HCWs were advised to report any further AEFI in the WhatsApp groups created by the investigators for monitoring the AEFIs on day-to-day basis.If any of the HCW reported any AEFI in the group, he/she was given appropriate advice by the investigators. In case of any emergency arising subsequent to vaccination after the period of direct observation, they were advised to directly call one of the investigators whose number was displayed at the vaccination centre who counselledthem regarding the AEFI including prescribing Paracetamol and Ibuprofen for fever and/or body aches. The HCWs were also advised appropriately regarding whether to visit the outpatient clinic of the department of internal medicineor the emergency room (ER) if the adverse events persisted.
The study questionnaire, developed by the investigators, captured the basic socio-demographic characteristics, history of COVID-19 infection in past, drug and medical history and 10 common adverse events following vaccination. If the HCW did not report any severe/serious AEFI within the direct observation period, he was discharged from the vaccination centre. The questionnaire was pilot tested on 20 HCWs, data of whom were excluded from the actual study,to assess its validity and reliability and suitable changes were made in it based on findings of the pilot study before administering it to the actual study participants.
The AEFI surveillance survey comprised questions about 10 common adverse events and a provision of free-text reporting for any other adverse events not listed in the questionnaire. Solicited local AEFIs included tenderness, pain at rest, redness, and swelling at the injection site. Solicited systemic AEFIs included fatigue, headache, malaise, arthralgia, chills, fever and nausea or vomiting. The severity of the local and systemic AEFIs was graded as per WHO guidelines for classifying AEFIs based on severity [11].Ifany of the HCWs visited the outpatient clinics or ERs due to AEFIs, the adverse event was reported to the national COVID-19 vaccination management system on the COWIN portal according to the government's policy.
The data were entered into excel sheets and analyzedusing SPSS software version 25.0 (IBM Corp., Armonk, NY, USA). The categorical variables were summarized using absolute frequencies and proportions and the quantitative variables were summarized by their means with the standard deviations.
This study was approved by the Institutional Ethical Committee (IEC) of the Institute of Medical Sciences, BHU, Varanasi (Approval letter No. Dean/2021/EC/2524 dated 12-02-21). All participants provided their written consent prior to taking part in the study. Participation was completely voluntary, and participants were able to withdraw from the study anytime without any consequence. Confidentiality of data was maintained.
A total of 836 HCWs, out of the 840 HCWswho received the first dose of COVISHIELD vaccine during the study period, gaveconsent for participation in thestudy andwere monitored for AEFIs at the vaccination center of SS Lal Hospital, BHU, Varanasi, UP.Their background characteristics are mentioned in Table 1.
A total of 86 (10.3%) out of the 836 HCWs reported to experience one or more AEFIs within 30 minutes of vaccination with COVISHIELD vaccine (Figure 1). Out of the 836 HCWs vaccinated with the first dose of COVISHIELD, one (0.12%) developed anaphylaxis.
The most common AEFI was pain/tenderness at the injection site experienced by about two-thirds (59.3%) of the HCWs who reported to have any AEFI followed by headache/dizziness in one third (34.9%), itching/rashes at the injection site (8.1%), nausea/vomiting (5.8%) and fever/chills (4.7%) and the least common AEFIs were increased lacrimation (1.1%) and altered sensorium (1.1%) (Table 2).
Out of the 86 HCWs experiencing any AEFI, 82 (95.3%) had minor grade AEFIs, 4 (4.7%) had severe AEFIs and none had any serious AEFI as per WHOs severity classification for AEFIs (Figure 2).
Since the beginning of the development of vaccines against COVID-19, concerns have been raised and apprehensions were observed in the populations and sub-groups globally over the adverse events and risks associated with these vaccines. Some adverse events may not have been reported in the clinical trials due to their lower frequency, smaller number of people participating in the trials and other restrictions in the trials. Thus, post-vaccination monitoring of the adverse reactions is important to inform the public and policymakers of the safety and possible severe reactions of the vaccine.
In the present study, we have presented the incidence, pattern and severity of AEFIs within 30 minutes of vaccination observed among the healthcare workers (HCWs) of a tertiary care institute of Northern India vaccinated with ChAdOx1 nCoV-19/COVISHIELD vaccine. As per WHOs safety surveillance module manual for COVID-19 vaccines, in the context of COVID-19 vaccination, surveillance systems need to be prepared for identifying and responding to both adverse events following immunization (AEFIs) and adverse events of special interest (AESIs) as well as other safety events that may cause public concern, including incidents of substandard or counterfeit vaccines [12].
The incidence of AEFI was found to be 10.3% within the directly observed period among the studied population. We found that the most commonly reported AEFIs after the first dose of the ChAdOx1 nCoV-19/COVISHIELD vaccine were pain/tenderness at the injection site, headache and itching/rashes at the injection site. As per severity, most of the AEFIs were of minor grade (95.3%), only four healthcare workers experienced a severe AEFI. There were no serious events observed requiring hospitalization, and most AEFIs improved before discharging from the vaccination centre.
In an interim analysis of four clinical trials on the ChAdOx1 nCoV-19 vaccine, the most frequently reported adverse reactions were tenderness at the injection site (63.7%), pain at the injection site (54.2%), headache (52.6%), and fatigue (53.1%). The majority of the adverse reactions were mild-to-moderate in severity and usually resolved within a few days of vaccination [6, 13]. Compared to this report, a lower incidence and severity of local and systemic AEFIs were observed in our study.
In a study by Joshi et al. [14]conducted among 1634 Armed Forces Medical Services healthcare workers (HCWs) deployed in Northern India, who took the first dose of ChAdOx1 nCoV-19 Coronavirus vaccine (Recombinant) voluntarilyin January-February 2021, 105 vaccine recipients reported at least one AEFI symptoms following COVID-19 vaccination (incidence proportion 6.4%, 95% CI: 5.3%, 7.7%). All AEFIs reported were of minor grade which were managed by tablet paracetamol and subsided after 1-2 days with no severe or serious AEFI being reported among the vaccine recipients.
In a study by Menni et al. [15] from Kings College, London, U.K., systemic side-effects were reported by 33.7% of the participants and local side-effects were reported by 58.7% of the participants after the first dose of ChAdOx1 nCoV-19, both figures much higher than that observed in our study.
Huh et al. [16] reported that the incidence of anaphylaxis associated with vaccination tended to increase with time in Korea. As of March 26, 2021, according to the reports of adverse reactions after vaccination against COVID-19 in Korea, 96 suspected cases of anaphylaxis were reported among 771,284 individuals (0.01%) receiving the first dose of the vaccine [17]. However, in our study, only one HCW presented with an acute allergic reaction with breathlessness and hypotension, which was resolvedspontaneously. Moreover, no serious AEFIs requiring hospitalization or death were reported. These results also are consistent with the results of the ChAdOx1 nCoV-19 vaccination among HCWs inNepal, Afghanistan and South Korea [18-20]. Such mild-to-moderate AEFIs are acceptable during immunization against COVID-19.Results of our study would be helpful in addressing the vaccine hesitancy caused by the concerns about severe adverse events associated with the COVID-19 vaccine.
The main strength of the study was the very little chances of non-response bias as all the healthcare workers who received the COISHIELD vaccine were directly observed. However, the current studyonly reports after administration of the first dose of the vaccine, which limits the information about the incidence, pattern and severity of side effects reported after the second dose of vaccine and the information after the second dose of the vaccine is yet to be explored in the population under study. Being a single-center study, it also makes it difficult to generalize the findings; however, the findings of this study could provide a useful insight into the situation and may play an important role in reducing vaccine hesitancy among the public.
In conclusion, only 10.3% of the health care workers (HCWs) from a tertiary care institute of U.P., North Indiareceiving the first dose ofChAdOx1 nCoV-19/COVISHIELD experienced any AEFI. Mild-to-moderate pain or tenderness at the injection site and headache or dizziness were the most frequently reported AEFIs. Among the healthcare workers who experienced any AEFI, the majority (95.3%)hadminor AEFIs and there were no serious AEFIs that required hospitalization or resulted in death. To develop a novel vaccination strategy againstCOVID-19 and to improve its coverage, the sharing of accurate and abundant information regarding vaccine safety through post-vaccination surveillance of AEFIs is of utmost importance.
