Boris Johnson has promised bereaved families will have their voices heard, as he published wide-ranging terms of reference for the public inquiry into the governments handling of the Covid-19 pandemic.
The prime minister bowed to pressure last year and announced the inquiry, which will be chaired by the retired judge Lady Hallett.
The government has now published its draft terms of reference. These cover the public health response, including how decisions were made, and a wide range of other issues from shielding to lockdowns, the procurement of personal protective equipment to the closure of schools.
Hallett will also examine the economic response, including the furlough scheme, and how the NHS and wider health and social care system responded.
Announcing the draft terms of reference, Johnson said: The importance of the inquiry working to understand the experiences of those most affected by the pandemic including bereaved families as well as looking at any disparities evident in the impact of the pandemic and our response.
Hallett will hold a four-week consultation on the draft terms of reference. They include the necessity to produce a timely report, although the very broad remit suggests merely taking evidence may be a very lengthy process.
The inquiry is asked to produce a factual narrative account of the response to the pandemic and then to identify any lessons to be learned, thereby to inform the UKs preparations for future pandemics.
In doing so, the inquiry will listen to the experiences of bereaved families and others who have suffered hardship or loss as a result of the pandemic. It will not investigate individual cases of harm or death in detail, and Hallett will not be asked to apportion blame for any failures she identifies.
The families of people who have died from Covid-19 have long campaigned for a full public inquiry. Johnson initially rejected those calls, before announcing one in May 2021. But he stipulated the inquiry would not begin its work until this year, when the government hoped the worst of the pandemic would be over.
At the time, Johnson said it would take a frank and candid look at how the pandemic was managed.
An investigation by the health and science select committees has already pointed to a number of failures in the governments response, including the pace at which Covid testing was ramped up, and the decision to discharge patients from hospitals into care homes without testing.
The committees took dramatic testimony from Johnsons former chief aide Dominic Cummings, who claimed the prime minister consistently failed to grasp the seriousness of the pandemic in its early stages.
Becky Kummer, a spokesperson for Covid-19 Bereaved Families for Justice, said: The inquiry is a one-off and historic opportunity for the terrible suffering and loss of the past two years to be learned from, [and] to ensure these tragedies are not repeated in the future. The government finally publishing the draft terms of reference is a huge step forward, and we look forward to feeding into the consultation on them.
Sadly, todays announcement comes far too late. We will never know how many lives could have been saved had the government had a rapid review phase in summer 2020, as we called for at the time.
The COVID-19 vaccine is an important measure to help protect you, your family and the community.
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Further information on COVID-19 vaccine safety, possible side effects and how to report any side effects.
Last reviewed: 01-03-2022
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JERUSALEM, Jan 4 (Reuters) - A fourth dose of COVID-19 vaccine boosts antibodies five-fold a week after the shot is administered, Israeli Prime Minister Naftali Bennett said on Tuesday, citing preliminary findings of an Israeli study.
"A week into the fourth dose, we know to a higher degree of certainty that the fourth dose is safe," Bennett said at Sheba Medical Center, which is giving second booster shots in a trial among its staff amid a nationwide surge in Omicron variant infections.
"The second piece of news: We know that a week after administration of a fourth dose, we see a five-fold increase in the number of antibodies in the vaccinated person," he told reporters.
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"This most likely means a significant increase against infection and ... hospitalisation and (severe) symptoms," Bennett said in English.
Israel has played a leading role in studying the effects of COVID-19 vaccines, as the fastest country to roll out two-dose inoculations to a wide population a year ago and one of the first to give third shots as boosters.
It is now administering fourth doses to people over 60, health workers and immunocompromised patients.
The World Health Organization has said more people worldwide should be vaccinated with first doses before others receive boosters.
Launched on Dec. 27, the Sheba trial administered a fourth dose of the Pfizer (PFE.N) and BioNTech (22UAy.DE) vaccine to 150 medical personnel whose level of antibodies had dropped greatly since they received their third doses four to five months ago.
A separate group is set to receive Moderna's vaccine for their fourth dose this week, Sheba said.
The mild side effects some participants have so far reported have not differed from those reported following a third dose. They include pain, fever and headaches, the hospital said.
Since the heavily mutated Omicron variant was first detected in November, WHO data shows it has spread quickly and emerged in at least 128 countries. Case numbers have surged to all-time records, but hospitalisation and death rates are largely lower than at other phases in the pandemic.
In Israel, daily infections have increased by more than 10 times over the past month. Severe illness has also climbed but at a far slower pace, according to Health Ministry data.
Around 60% of the country's 9.4 million population are fully vaccinated.
Some research has indicated that even if Omicron escapes antibodies, a key part of the immune system's second line of defence - its T-cells - are still highly effective at recognising and attacking the variant, preventing most infections from progressing to critical illness.
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Reporting by Jeffrey HellerEditing by Peter Graff and Catherine Evans
Our Standards: The Thomson Reuters Trust Principles.
Doctors with the Florida chapter of the American Academy of Pediatrics are speaking out against recent COVID-19 vaccine guidance from the Florida Department of Health and state surgeon general Dr. Joseph Ladapo. The recommendation says healthy children may be better off not getting the shots.
State health officials say kids ages five to 17 with underlying conditions are the "best candidates" for COVID vaccines but they argue other kids have little to no risk of developing severe illness.
RELATED: Florida's new COVID vaccine guidance for "healthy" kids 5-17
It's true that children aren't nearly as likely to go to the hospital or die from COVID as adults. But Dr. Mobeen Rathore, professor and associate chair of the department of pediatrics at the University of Floridas College of Medicine in Jacksonville, said he and other physicians have still treated children for COVID who were otherwise healthy.
We see these sick children who don't need to be that sick if they would have gotten the vaccine, he said. And you know, tell that to a parent whose child is in the ICU or is very ill or intubated or very sick, Oh, you know, most children don't really get very sick with this, and see the reaction you get.
I think that's really sad that we feel that its ok for some children to get sick, get hospitalized and die of this disease, when we could clearly prevent that.
The state also points to a recent study from New York that found the Pfizer vaccine's effectiveness reduced dramatically in children in just a couple months amid the omicron surge. That variant proved to evade vaccines more successfully than others in all age groups.
Kids younger than 12 receive doses that are a third of the size of doses that teens and adults get, and authors of the study suspect that could have contributed to the sharp decline in effectiveness at preventing infection.
But they found the shots still were successful at protecting kids against severe disease. Thats why they continue to recommend vaccination (read "Conclusions and Relevance" section of report).
Rathore said state officials fail to acknowledge that in their guidance.
You know they have picked and choosed (sic) some stuff but ignored others, he said.
Health News Florida asked the department of health why it would use a study that concluded all kids should get vaccinated to defend its guidance.
Spokesman Jeremy T. Redfern replied, The researchers conclusions are their assessment of the data. The Surgeon General disagrees."
"Disagreements on conclusions are normal during the scientific process, and it is what helps science progress," he went on. Remember: Dr. Ladapo is a physician, but he is also a research scientist. He spends a lot of time reviewing the relevant scientific literature.
Rathore said Ladapo's interpretation of the data from that study concerns him.
The question is do we increase the dose of the vaccine, do we increase the schedule, meaning give more vaccine shots the answer is not to stop giving the vaccine, he said.
Ladapos guidance cautions the risks from COVID vaccines may outweigh the benefits for kids without underlying conditions. He focuses on myocarditis, which occurs when the heart muscle becomes inflamed. Some symptoms include chest pain and irregular heartbeat.
The state points to a study that found more cases of myocarditis occurred after COVID vaccination than expected, especially in adolescent males. But Rathore said state officials don't put things in perspective.
You know millions and millions of doses of this vaccine have been given and myocarditis has not come out as a major issue, he said. I won't say it doesn't happen, it does, but I think any risk the vaccine may pose because of myocarditis is so small compared to the benefit the vaccine provides.
That study found 1,626 cases that met the definition of myocarditis among more than 192.4 million people vaccinated. That's .0008%.
Researchers also provided context (read 'Discussion' section of report), saying young men are more likely to get myocarditis in general, and that symptoms in people who got it after getting vaccinated resolved faster than in typical myocarditis, which is usually caused by viral infection.
The Centers for Disease Control points out people are much more likely to get myocarditis from COVID infection.
A report published last September recorded about 150 cases of myocarditis per 100,000 COVID-19 patients, and found COVID patients risk for developing the condition was about 16 times higher than non-COVID patients.
Rathore said the virus can also cause other rare but serious complications in kids, such as multisystem inflammatory syndrome or long COVID.
He is urging all kids ages five and older to get vaccinated.
You know, the health of our children and all of our citizens is paramount and vaccines are really the best tool, if you will, in our toolkit, Rathore said.
Another tool is natural immunity to the virus. State health officials say a large number of kids already have built up protection against COVID, citing the CDCs seroprevalence survey that uses antibodies present in blood samples to estimate how much of the population has had the virus.
Rathore said existing immunity is important to protect the community, but is not enough to end the pandemic long-term.
As with vaccine-acquired protection, data shows natural immunity to COVID wanes over time. Since scientists don't expect the virus to go away anytime soon, families have a choice moving forward: get their kids a shot to boost that immunity, or risk them getting sick again.
Key Findings
This months KFF COVID-19 Vaccine Monitor explored how the recent omicron surge impacted the economic stability of U.S. families and workers. Four in ten workers (42%) say they had to miss work at least once in the past three months because of a COVID-19 related concern or sickness. This includes one in four workers (26%) who say they had to miss work to quarantine following a COVID-19 exposure, one in five who missed work because they tested positive for COVID-19, and one in eight (13%) who missed work because their place of employment was closed or reduced hours due to COVID-19 concerns. Additionally, three in ten parents (28%) say they had to miss work in the past three months because they had to stay home with a child who had to quarantine, or their childs school went virtual due to COVID-19 concerns.
Lower-income workers are more likely than those with higher incomes to report missing work in the past three months due to COVID-related concerns, particularly when it comes to workplace closures. Six in ten workers with household incomes less than $40,000 report missing work for COVID concerns during the past three months, compared to less than four in ten of higher income workers. In particular, one-third of lower-income workers (35%) say they missed work because their workplace was closed or had reduced hours, compared to fewer than one in ten among workers with higher incomes. Half of Hispanic workers (47%) say they have had to miss work in the past three months due to COVID-19-related issues as did four in ten White workers (42%) and more than one-third (35%) of Black workers.
Among the 42% of workers who had to miss work due to COVID-19 concerns or sickness, six in ten (62%) say missing work had a major impact or minor impact on their familys stress level and four in ten (44%) say it has impacted their familys finances. About one in five say missing work had a major impact on the level of stress in their family (22%) or on their familys finances (19%).
Overall, about one in ten workers say that they had to miss work due to COVID-related concerns in the past three months, and that missing work had a major impact on their familys stress or finances. Individuals living in households with lower incomes are more likely to report that missing work had a major negative impact on their family. One-fourth of workers in households with incomes less than $40,000 report missing work for COVID-concerns and say that this had a major impact on their familys finances or the level of stress in their family, compared to less than one in ten in households with higher levels of income. One in five Hispanic adults (18%) report loss of work that had a major negative impact, as do about one in eight Black adults and one in ten White adults.
One way to protect employees health and reduce the spread of COVID-19 in workplaces is for employers to offer their employees paid time off. About half of workers (52%) say their employer provides paid time off if they get sick from COVID-19 while less than half report receiving paid time off if they need to quarantine (44%), or to stay home with a child (35%) who cant attend school or daycare because of COVID-related concerns. Slightly more than one-third of all employees say their employer offers paid time off to get vaccinated or boosted (37%) or to recover from vaccine side effects (36%).
While half of all workers report paid time off if they are sick from COVID-19, getting time off to recover from COVID is less common among those in households with lower incomes. One-third (32%) of workers in households with incomes below $40,000 report getting paid time off if they get sick from COVID-19 compared to more than half (57%) of those earning $40,000 or more. Similarly, three in ten (28%) lower-income workers report having paid time off if they need to quarantine following a COVID-19 exposure compared to half of higher-income workers. About one-third of lower-income workers report being unaware if they receive paid time off in either of these instances.
Among those who report missing work due to COVID-19 concerns or sickness in the last three months, less than half report that their employer offers paid time off if they get sick from COVID-19 (48%), if they need to quarantine because of a COVID-19 exposure (42%), or if their child has to stay home from school or daycare (27%).
A notable share of workers, especially among lower-income households, say they have gone to work amidst COVID-19 concerns because they couldnt afford to miss work. One in ten workers (11%) say they have gone to work when they had COVID-19 symptoms or had been exposed to the virus because they couldnt afford to take the time off, rising to about three in ten among those in lower-income households (those earning less than $40,000 annually). Fifteen percent of workers whose employer does not offer paid time if they get sick from COVID-19 say they have gone into work when they had COVID-19 symptoms or had been exposed because they couldnt afford to take the time off (compared to six percent of those whose employer offers paid time off).
Additionally, five percent of employed parents say they have sent their child to school or daycare when they had COVID-19 symptoms or had been exposed to the virus because they couldnt take the time off work.
Many workers also report being exposed to coronavirus at work with one-third of those who tested positive or had to quarantine saying their exposure happened at their workplace. Half (52%) say their exposure occurred outside of work while an additional 15% are unsure where they were exposed to coronavirus.
Overall, about three in ten U.S. adults say their household has had difficulty paying bills over the past three months, during the latest wave of coronavirus cases with the omicron surge. This includes one in five (17%) who say they have fallen behind in paying credit cards or other bills, and about one in ten who say they have had problems paying for food (13%), medical bills (12%), affording health insurance (11%), or have fallen behind in their rent or mortgage payments (9%).
The share of households who experienced economic impacts during the omicron surge is somewhat lower than the level measured at other points during the pandemic (July 2020 and February 2021) when there was a large number of cases of the virus in the U.S. but before there were vaccines widely available.
While the share of U.S. adults who reported difficulty paying bills or expenses wasnt as widespread as seen during previous coronavirus waves, members of racial and ethnic minority groups, as well as those with lower levels of income, are still reporting difficulty at higher rates.
Nearly half of Black adults (48%) and one-third of Hispanic adults (34%) report difficulty paying such bills, compared to a smaller share of White adults (22%). In addition, about half (47%) of those with household incomes less than $40,000 annually say they have had problems affording at least one of these expenses during the past 3 months, roughly four times the rate among those in families with incomes of at least $90,000 a year (12%).
Several vaccine candidates have been developed following the onset of the coronavirus disease 2019 (COVID-19) pandemic. Most countries throughout the world have rolled out extensive vaccination programs to vaccinate and protect individuals from severe infections and deaths associated with COVID-19.
However, the US Centers for Disease Control and Prevention (CDC) reported mild to moderate myocarditis/pericarditis cases post the second dose of mRNA vaccination on 17th May 2021.
Most of the patients who were found less than 50 years of age were reported to be presented with chest pain, fever, raised cardiac-specific troponin many days after vaccination followed by full recovery. In Israel, a higher risk of myocarditis was reported in younger men following the second BNT162b2 (BioNTech, Pfizer) vaccination. A self-controlled case series (SCCS) design in England reported an increased risk of myocarditis after first doses of BNT162b2, ChAdOx1 (Oxford, AstraZeneca), and mRNA-1273 (Moderna) vaccines.
A new study posted to the pre-print server medRxiv* used a cohort design for the estimation of adjusted hazard ratios (aHRs) for hospitalized or fatal myocarditis/pericarditis following the first and second dose of BNT162b2 and ChAdOx1 vaccines.
The study included individuals who were aged 12 years or above, were of known sex, were alive at the start of the vaccination program, and possessed at least one primary care record. The myocarditis and pericarditis outcomes were defined by ICD10 codes.
Estimation of aHRs for hospitalized or fatal myocarditis/pericarditis was carried out on 0-13 and 14+ days after the first and second dose of BNT162b2 and ChAdOx1-S vaccines. Follow-up began on 8th December 2020 and ended due to either death, outcome event, or the end date of the study (17th May 2021). Interactions with sex and age group were also examined. Furthermore, two sensitivity analyses, subgroup analysis in people with and without prior COVID-19, and analysis of myocarditis and pericarditis in a single post-vaccination period was carried out.
The results reported that 3,216,259 and 8,614,934 people had received the first and second doses of BNT162b2 while 19,336,909 and 15,925,122 people had received the first and second doses of ChAdOx1. Also, 1,459 pre- and 607 post-vaccination events were reported.
The results indicated a lower incidence of myocarditis/pericarditis after the first dose as compared to before or without vaccination. Following the second dose, the aHRs for 0-13 days were found to be 0.77 and 14+ days were found to be 1.11 for BNT162b2 as compared with the duration between the first and second doses. For the second dose of ChAdOx1-S, the aHRs for 0-13 days were found to be 1.33 and 14+ days were found to be 1.38.
The aHRs for first dose analyses were observed to decrease with increasing age group while for second dose analyses the evidence was found to be inconsistent. Also, similar aHRs were produced by people with or without prior COVID-19 in the subgroup analysis. Splitting the combined outcome suggested that pericarditis might be the cause of elevated aHRs.
The current study, therefore, demonstrates lower fatality or incidence of myocarditis/pericarditis following the first dose of the ChAdOx1 and BNT162b2 vaccine. Also, significant evidence to support a higher incidence of these events after the second dose of these vaccines was not available. Therefore, the benefits of vaccination were considered more significant as compared to the risk of myocarditis/pericarditis.
medRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information.
COVID-19 vaccination challenge: what have we learned from the Brazilian process? The Lancet
Since our article in October 2021 there has been much change in the health and social care sector in relation to mandatory Covid-19 vaccines.
By way of background, all those working within a care home were required to be fully vaccinated (unless exempt) by 11 November 2021. A proposal to extend the scope of this regime was subject to government consultation. The consultation closed on 22 October 2021 with 65% of respondents indicating that they did not support the proposal. Despite this, just over two weeks later, the government confirmed that it would introduce regulations that require all staff who interact with patients and service users to deliver a Care Quality Commission (CQC) regulated activity, to be fully vaccinated against Covid-19 (with some limited exceptions). Among the organisations captured, were NHS services such as GP Practices and hospitals/clinics, along with those operating in the private sector. The new regulations were made on 6 January 2022 and were due to come into force on 1 April 2022. This timeline meant that unvaccinated staff were told they would require their first jab by 4 February 2022.
However, by 31 January 2022, the government announced its intention to revoke the regulations regarding mandatory vaccinations subject to undergoing a consultation. At the time it was suggested by some that the turnaround was due to the anticipated impact on the NHS workforce when the regulations were implemented. (A consideration which is said was not extended to the care home sector). The governments explanation focused on the less severe strain of Covid, Omicron, now being the dominant variant in England meaning that clinical evidence and risk factors in requiring mandatory vaccinations had now changed. After this announcement NHS England told employers to place on hold plans for dismissals (previously scheduled for 4 February) and redeployments.
The government consultation was held between 9 and 16 February 2022. In the report published on 1 March 2022, 90% of respondents supported the removal of the mandatory vaccination scheme in the health and social care sector. (With many organisations remaining committed to encouraging staff to voluntarily vaccinate). Shortly after, the government announced new regulations would come into force on 15 March 2022, which would remove the legal requirements for mandatory vaccines in care homes, which are still a requirement today, in addition to those which were due to come into force on 1 April 2022 for the wider sector.
So what does this mean? Whilst the revocation of the mandatory vaccine regulations has been welcomed by most, it has caused significant operational difficulties in an already overstretched and understaffed sector which is still recovering from the pandemic. Organisations have been required to devote substantial resources to planning and developing processes to comply with the regulations including in respect of staff dismissals (actual in care homes and planned in the wider sector). Staff members who were told in January 2022 that they were to be dismissed if they did not get vaccinated, are suddenly now able to continue on in their role. Whilst their employers were planning appropriately in line with the regulations, there are reports that these discussions have led many staff affected to consider leaving the sector in any event, particularly given the stresses experienced in the pandemic. In care homes, it is reported that the tens of thousands of staff who lost their jobs as a result of the regime, are unlikely to now return to the sector, having sought alternative employment (some within the NHS).
It is inevitable that the uncertainty and upheaval in the sector caused by these regulations will have an historic impact. Over the coming months, we will see whether the disruption to the delivery of health and care services and the impact on staffing, will lead to more care homes exiting the market and/or an increase in regulatory action by the CQC. The government figures show that 92% of the NHS workforce and 95% of care home staff are now double-vaccinated. The question remains whether achieving these vaccination levels has really protected service users and patients when considered alongside the cost to an already struggling sector. Has this regime in fact posed more risk to the delivery of care?
Article co-authored by Niamh O'Hanlon, Trainee Solicitor at CMS.
