#AceNewsReport – Jan.16: CBP officers immediately noted the vaccination card’s poor print quality, unclear logos of the Centers for Disease Control and Prevention (CDC) and U.S. Health and Human Services (HHS), and uneven borders. While fake vaccination cards are selling for as much as $200, the CDC reminds people that an actual vaccination is free.
#AceDailyNews says according to to Philadelphia CBP Report: Officers Intercepts Fake #COVID19 Vax Card – One of 30K Seized Nationally: On Saturday, U.S. Customs and Border Protection officers were conducting routine international parcel inspections for dangerous, illegal, or prohibited products when they encountered an obviously counterfeit COVID-19 vaccination card.
The fake vaccination card was shipped from Bulgaria to an address in Stamford, Conn. Officers discovered the card was concealed inside of a greeting card which was inside of a shipping envelope. The contents were manifested as “documents.”
Since the start of the COVID-19 pandemic, CBP officers across the nation have seized more than 30,000 counterfeit coronavirus vaccination cards from nearly 1,200 seizures. Locally, the Baltimore Field Office, which includes the Area Port of Philadelphia, has seized a combined 1,520 fake vax cards from 41 seizures.
“Coronavirus continues to pose a serious health and safety threat to American citizens, as do unscrupulous vendors who peddle counterfeit COVID vaccination cards and the unvaccinated people who buy them,” said Joseph Martella, Area Port Director for CBP’s Area Port of Philadelphia. “Customs and Border Protection officers are extremely skilled at detecting cleverly concealed contraband and we will continue to intercept dangerous and illicit products that could harm consumers, our economy and our nation.”The fake vax card was found in a greeting card.
CBP’s border security mission is led at ports of entry by CBP officers from the Office of Field Operations. CBP officers screen international travelers and cargo and search for illicit narcotics, unreported currency, weapons, counterfeit consumer goods, prohibited agriculture, and other illicit products that could potentially harm the American public, U.S. businesses, and our nation’s safety and economic vitality.
#AceNewsReport – Jan.15: The FBI’s Miami Field Office and HHS-OIG are investigating the case: Trial Attorneys Jamie de Boer and Dermot Lynch of the Criminal Division’s Fraud Section are prosecuting the case.
#AceDailyNews DOJ Court Report: A Florida man pleaded guilty today in the Southern District of Florida to a $6.9 million conspiracy to defraud Medicare by paying kickbacks and bribes to obtain doctors’ orders for medically unnecessary lab tests that were then billed to Medicare. The defendant exploited the #COVID19#pandemic by bundling #COVID19 testing with other forms of testing that patients did not need, including genetic testing and tests for rare respiratory pathogens.
According to court documents, Christopher Licata, 45, of Delray Beach, admitted that, as owner of Boca Toxicology LLC (dba Lab Dynamics), he bribed patient brokers who would refer Medicare beneficiaries and doctors’ orders authorizing medically unnecessary genetic testing to Licata’s laboratory.
Licata and these patient brokers entered into sham agreements to disguise the true purpose of these payments. Once the COVID-19 pandemic began, Licata exploited patients’ fears of COVID-19 by bundling COVID-19 tests with more expensive, medically unnecessary testing, including respiratory pathogen panel testing and, at times, genetic testing for cardiovascular diseases, cancer, diabetes, obesity, Parkinson’s, Alzheimer’s and dementia. In total, Licata caused his laboratory to submit over $6.9 million in false and fraudulent claims to Medicare for these medically unnecessary tests.
Licata pleaded guilty to one count of conspiring to commit health care fraud. He is scheduled to be sentenced on March 24 and faces a maximum penalty of 10 years in prison. A federal district court judge will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors.
Assistant Attorney General Kenneth A. Polite Jr. of the Justice Department’s Criminal Division; Special Agent in Charge George L. Piro of the FBI’s Miami Field Office; and Special Agent in Charge Omar Pérez Aybar of the U.S. Department of Health and Human Services Office of the Inspector General (HHS-OIG) made the announcement.
In May 2021, the Attorney General established the COVID-19 Fraud Enforcement Task Force to marshal the resources of the department in partnership with agencies across government to enhance efforts to combat and prevent pandemic-related fraud. The Task Force bolsters efforts to investigate and prosecute the most culpable domestic and international criminal actors and assists agencies tasked with administering relief programs to prevent fraud by, among other methods, augmenting and incorporating existing coordination mechanisms, identifying resources and techniques to uncover fraudulent actors and their schemes, and sharing and harnessing information and insights gained from prior enforcement efforts. For more information on the department’s response to the pandemic, please visit https://www.justice.gov/coronavirus.
The Fraud Section leads the Health Care Fraud Strike Force. Since its inception in March 2007, the Health Care Fraud Strike Force, which maintains 15 strike forces operating in 24 federal districts, has charged more than 4,600 defendants who have collectively billed federal health care programs and private insurers for approximately $23 billion. In addition, the HHS Centers for Medicare and Medicaid Services, working in conjunction with the HHS-OIG, are taking steps to increase accountability and decrease the presence of fraudulent providers.
#AceHealthReport – Jan.12; The previous record was 1.03 million cases on Jan. 3. A large number of cases are reported each Monday due to many states not reporting over the weekend. The seven-day average for new cases has tripled in two weeks to over 700,000 new infections a day.
The record in new cases came the same day as the nation saw the number of hospitalized COVID-19 patients also hit an all-time high, having doubled in three weeks, according to a Reuters tally.
There were more than 136,604 people hospitalized with COVID-19, surpassing the record of 132,051 set in January last year.
While the Omicron variant is potentially less severe, health officials have warned that the sheer number of infections could strain hospital systems, some of which have already suspended elective procedures as they struggle to handle the increase in patients and staff shortages.
The surge in cases has disrupted schools, which are struggling with absences of staff, teachers and bus drivers.
Chicago canceled classes for a fourth day as the district and teachers failed to agree on how to deal with increased infections.
New York City suspended service on three subway lines as a large number of workers were out sick, according to its Twitter account. Companies’ plans for workers to return to office have also been derailed.
Deaths are averaging 1,700 per day, up from about 1,400 in recent days but within levels seen earlier this winter.
A redesigned COVID-19 vaccine that specifically targets the Omicron variant is likely needed, Pfizer Inc’s (PFE.N) CEO said on Monday, adding his company could have one ready to launch by March.
#AceHealthReport – Jan.10: Xi’an, capital city of northwest China’s Shaanxi Province, has basically stopped the spread of COVID-19 in communities one month after the resurgence of the epidemic hit the city, thanks to stringent containment measures such as city-level lockdown and rounds of mass nucleic acid testing.
#CoronavirusNewsDesk – Brutal Lockdown in community due to spread of #COVID19 basically blocked in China’s Xi’an according to Xinhua Headlines: Published On Jan.09:
XI’AN, Jan. 9 (Xinhua) — Xi’an, capital city of northwest China’s Shaanxi Province, has basically stopped the spread of COVID-19 in communities one month after the resurgence of the epidemic hit the city, thanks to stringent containment measures such as city-level lockdown and rounds of mass nucleic acid testing.
As notable progress has been made to control the epidemic, Xi’an will gradually lift closed-off management based on the judgment and research conducted by national and provincial experts.
The virus spread in communities had been basically cut off, Xu Mingfei, vice mayor of Xi’an, told a press conference on Jan. 5. Xu said that all the new cases found over the previous rounds of nucleic acid testing were among the people who were quarantined at designated places (centralized quarantine) or at home.
Daily cases in Xi’an with a population of 13 million began to drop since the start of this year and slipped to two-digit numbers quickly, with 30 new cases, all in centralized quarantine, reported on Saturday.
The city, a popular tourist destination known for the Terracotta Warriors, registered 1,989 locally transmitted confirmed cases as of Saturday since Dec. 9, 2021.
The viral genome sequencing of the new cases has identified them as strains of the highly contagious Delta variant, which are highly homologous with imported cases from an inbound flight on Dec. 4, 2021, according to the provincial center for disease control and prevention.
STRICT CONTAINMENT MEASURES
Many positive patients didn’t show obvious symptoms in the initial stage, and they tended to ignore their physical condition, which led to community transmission and clustered cases, local officials have said.
The number of confirmed cases in Xi’an rose by more than 150 per day for a week in late December, and the virus has spread to other cities and provinces.
To curb the spread of the virus, the city has launched several rounds of mass nucleic acid testing, with thousands of sample collecting venues set up.
Mass nucleic acid testing can help health authorities identify the infected cases and put them under quarantine early. Meanwhile, it is conducive to adopting precise control measures and relieving public stress, said Li Qun, director of the health emergency center of the Chinese Center for Disease Control and Prevention.
As the trajectories of the positive cases in Xi’an were complex and involved a wider area, and some could not be traced to known sources, the megacity imposed closed-off management for communities and villages since Dec. 23 last year.
“The strict containment measures introduced are based on the epidemic situation to prevent transmission within the city and spreading elsewhere,” said Lei Zhenglong, a member of the Xi’an taskforce team sent by the State Council for epidemic control.
JOINT EFFORTS AGAINST EPIDEMIC
During a recent tour to Shaanxi Province for investigation and research on prevention and control of the epidemic, Vice Premier Sun Chunlan said that Xi’an saw a sharp decline in daily-reported new COVID-19 cases and had basically blocked the spread of COVID-19 in communities. However, Sun warned that the epidemic containment is still at a crucial stage, and urged efforts to prevent the rebound of the epidemic.
As of 6 p.m. Jan. 6, the city arranged 431 venues for centralized quarantines, putting 45,760 people under quarantine.
“The quarantined personnel have overcome the inconvenience to themselves and their families for the safety of all. They are also heroes,” said vice mayor Xu.
Ma Hui, one of the residents in isolation, recorded his life in a quarantined site in short videos. “Despite some inconvenience at the beginning, the room is warm, and we receive necessities and even snacks,” said Ma, 40, in a video.
Community workers and volunteers have devoted themselves to sending free groceries to residents in lockdown. People can also place orders online, and items will be distributed and delivered to each household by community staff and volunteers.
A volunteer arranges packed vegetables in Yanta District of Xi’an, capital of northwest China’s Shaanxi Province, Jan. 5, 2022. (Xinhua/Zhang Bowen)
The city government has taken measures to help people under closed-off management overcome inconvenience brought about by containment measures.
For example, responding to people’s difficulty in accessing medical services, the city government has dispatched buses to shuttle those who need emergency treatment at hospitals to prevent the risk of cross-infection, said vice mayor Xu.
In Yanta District, the worst-hit district, several officials, including the Party chief of the Yanta District, have been removed from posts due to dereliction of duty.
As notable progress has been made to control the epidemic, Xi’an will gradually lift closed-off management based on the judgment and research conducted by national and provincial experts, Lyu Yongpeng, deputy director of the city’s health commission, said on Saturday.
As of Saturday, a total of 262 patients had been discharged from hospitals after recovery.
(Video reporters: Wu Hongbo, Yang Yimiao, Lin Juan, Liang Aiping and Zhao Yingbo; Video editors: Zhang Qiru, Zhu Jianhui) ■
#AceHealthReport – Jan.06: This is a temporary measure while COVID-19 rates remain high across the UK. Whilst levels of COVID-19 are high, the vast majority of people with positive LFD results can be confident that they have #COVID19
The UK Health Security Agency (UKHSA) announces temporary changes to confirmatory PCR tests.
Lateral flow tests are taken by people who do not have COVID-19 symptoms. Anyone who develops 1 of the 3 main COVID-19 symptoms should stay at home and self-isolate and take a PCR test. They must self-isolate if they get a positive test result, even if they have had a recent negative lateral flow test – these rules have not changed.
The new approach reflects similar changes made this time last year in January 2021, when there was also a high prevalence of infection meaning it was highly likely that a positive LFD COVID-19 result was a true positive. This meant confirmatory PCRs were temporarily paused and reintroduced in March 2021 following a reduction in prevalence.
The UK’s testing programme is the biggest in Europe with over 400 million tests carried out since the start of the pandemic. Since mid-December, 100,000 more PCR booking slots have been made available per day and capacity continues to be rapidly expanded, with delivery capacity doubled to 900,000 PCR and LFD test kits a day.
Under this new approach, anyone who receives a positive LFD test result should report their result on GOV.UK and must self-isolate immediately but will not need to take a follow-up PCR test.
After reporting a positive LFD test result, they will be contacted by NHS Test and Trace so that their contacts can be traced and must continue to self-isolate.
There are a few exceptions to this revised approach.
First, people who are eligible for the £500 Test and Trace Support Payment (TTSP) will still be asked to take a confirmatory PCR if they receive a positive LFD result, to enable them to access financial support.
Second, people participating in research or surveillance programmes may still be asked to take a follow-up PCR test, according to the research or surveillance protocol.
Finally, around one million people in England who are at particular risk of becoming seriously ill from COVID-19 have been identified by the NHS as being potentially eligible for new treatments. They will be receiving a PCRtest kit at home by mid-January to use if they develop symptoms or if they get a positive LFD result, as they may be eligible for new treatments if they receive a positive PCR result. This group should use these priority PCR tests when they have symptoms as it will enable prioritised laboratory handling.
In line with the reduced self-isolation approach announced on 22 December, anyone who tests positive will be able to leave self-isolation 7 days after the date of their initial positive test if they receive 2 negative LFD results, 24 hours apart, on days 6 and 7.
Rapid lateral flow tests are most useful at identifying COVID-19 in people without any symptoms. The tests are over 80% effective at finding people with high viral loads who are most infectious and most likely to transmit the virus to others.
Analysis by NHS Test and Trace shows LFD tests to have an estimated specificity of at least 99.97% when used in the community. This means that for every 10,000 lateral flow tests carried out, there are likely to be fewer than 3 false positive results. LFD tests identify the most infectious people. These people tend to spread the virus to many people and so identifying them remains important.
Secretary of State for Health and Social Care Sajid Javid said:
We have built a world-leading testing system and our testing capacity is the largest in Europe. This has helped save lives and protect millions of people from COVID-19. It forms a crucial line of defence alongside vaccines and antivirals.
As Omicron cases continue to rise the demand for tests has grown rapidly across the globe. We’re putting plans in place to manage the demand for PCR tests in the UK so we can ensure that those who most need tests can continue to access them.
Chief Executive of UKHSA, Dr Jenny Harries, said:
While cases of COVID-19 continue to rise, this tried-and-tested approach means that LFDs can be used confidently to indicate COVID-19 infection without the need for PCR confirmation.
It remains really important that anyone who experiences COVID-19 symptoms self-isolates immediately. They should also order a PCR test on GOV.UK or by phoning 119.
I’m really grateful to the public and all of our critical workers who continue to test regularly and self-isolate when necessary, along with other practical and important public health behaviours, as this is the most effective way of stopping the spread of the virus and keeping our friends, families and communities safe.
Yesterday the Prime Minister announced the government will provide 100,000 critical workers in England with free lateral flow tests to help keep essential services and supply chains running.
Critical workers will be able to take a test on every working day and the provision of precautionary testing will be for an initial 5 weeks. This will help to isolate asymptomatic cases and limit the risk of outbreaks in workplaces, reducing transmission while COVID-19 cases remain high.
The full range of critical workers have been identified by the relevant departments and government will contact these organisations directly on the logistics of the scheme this week. Roll-out will start from Monday 10 January.
Tests will be separate from public sectors who already have a testing allocation with UKHSA, such as adult social care or education, and separate to those delivered to pharmacies and homes, so those channels will not be impacted by the new scheme.
We are now distributing around 600,000 packs of LFD tests (each containing 7 tests) on GOV.UK directly to homes every day (more than 50% higher than last week).
#AceNewsReport – Jan.06: The news is filled with images of long lines at in-person #COVID19 testing sites and reports of limited supplies of at-home test kits. It’s not a surprise that, according to the U.S. Food and Drug Administration, fake and unauthorized at-home testing kits are popping up online as opportunistic scammers take advantage of the spike in demand.
#CoronavirusNewsDesk says how to avoid buying fake #COVID19 tests online according to Division of Consumer and Business Education, FTC: January 4, 2022: By Colleen Tressler
Using these fake products isn’t just a waste of money, it increases your risk of unknowingly spreading COVID-19 or not getting the appropriate treatment. So, if you’re shopping online for COVID test kits and related items:
Check out a seller before you buy, especially if you’re buying from a site you don’t know. Search online for the website, company, or seller’s name plus words like “scam,” “complaint,” or “review.”
Compare online reviews from a wide variety of websites. You can get a good idea about a company, product, or service from reading user reviews on various retail or shopping comparison sites. Think about the source of the review. Ask yourself: Where is this review coming from? Is it from an expert organization or individual customers?
Pay by credit card. If you’re charged for an order you never got, or for a product that’s not as advertised, contact your credit card company and dispute the charge.
To provide estimates of coronavirus (COVID-19) positivity over the Christmas period, we have published headline results in a shortened version of our usual release.
In England, the percentage of people testing positive continued to increase; we estimate that 2,024,700 people in England had coronavirus (COVID-19) (95% credible interval: 1,951,200 to 2,096,300), equating to around 1 in 25 people.
In Wales, the percentage of people testing positive continued to increase; we estimate that 76,500 people in Wales had COVID-19 (95% credible interval: 65,100 to 89,200), equating to around 1 in 40 people.
In Northern Ireland, the percentage of people testing positive increased; we estimate that 47,500 people in Northern Ireland had COVID-19 (95% credible interval: 37,800 to 58,600), equating to around 1 in 40 people.
In Scotland, the percentage of people testing positive continued to increase; we estimate that 135,400 people in Scotland had COVID-19 (95% credible interval: 117,400 to 154,800), equating to around 1 in 40 people.
In England, COVID-19 infections increased across all age groups and were highest among those aged two years to school Year 6 and those aged 25 to 34 years; the high infections for those aged two years to school Year 6 are more likely to be compatible with the Delta variant, whereas the high infections for those aged 25 to 34 years are more likely to be compatible with the Omicron variant, as shown by separateanalysis.
COVID-19 infections increased across all regions of England, with the highest infection levels seen in London (1 in 15) and the lowest in the North East of England (1 in 45).
COVID-19 infections compatible with the Omicron variant continued to increase rapidly across England, Wales, Northern Ireland and Scotland, and Omicron is now the most common variant in England and Scotland.
Figure 1: COVID-19 infections compatible with the Omicron variant continued to increase rapidly across England, Wales, Northern Ireland and Scotland in the week ending 23 December 2021
Modelled percentage of positive cases compatible with the Delta variant, and compatible with the Omicron variant, based on nose and throat swabs, daily, 12 November to 23 December 2021, UK
All results are provisional and subject to revision.
These statistics refer to infections occurring in private households, and exclude infections reported in hospitals, care homes and/or other communal establishments.
Omicron variant-compatible positives are defined as those that are positive on the ORF1ab-gene and N-gene, but not the S-gene. Delta variant-compatible positives are defined as those that are positive on the ORF1ab, N-gene and S-gene, as well as gene patterns N+S and ORF1ab+S.
Data should be treated with caution. Not all cases positive on the S-gene will be the Delta variant, but some cases with pattern ORF1ab+N will also be the Delta variant where the S-gene was not detected for other reasons, such as low viral load.
#AceHealthReport – Jan.04: Lauterbach, a member of the center-left Social Democrats (SPD), said that the windows of his office in the western city of Cologne were smashed.
#CoronavirusNewsDesk says according to DW News Report: People angry over #COVID19 curbs have been held responsible for damaging the offices of two German lawmakers on New Year’s Eve — including the constituency office of German Health Minister Karl Lauterbach who criticised an apparent vandalism attack on his local constituency office German media reported on Sunday.
A grim milestone: 100,000 COVID deaths in Germany
Vandals also targeted the offices of parliament member Marco Wanderwitz, a center-right Christian Democrat (CDU) lawmaker for the eastern state of Saxony. The windows of Wanderwitz’s office in the town of Zwönitz were heavily damaged.
Marco Wanderwitz’s office in Zwönitz was severely damaged on New Year’s Eve
Minister: ‘These people do not represent society’
The federal health minister told German news agency dpa on New Year’s Day that he assumed that the renewed attack was from people angry at coronavirus restrictions.
His office in Cologne was also attacked on December 10 with slogans such as “Minister of Sickness,” “Murderer” and “Psycho Lauterbach.”
And on January 1, he said: “These people do not represent society, where really the overwhelming part is sticking together and trying to do everything against the pandemic.”
The perpetrators of these attacks “represent a very small splinter group,” Lauterbach added.
Democracy under attack
Meanwhile, Wanderwitz told Redaktionsnetzwerk Deutschland (RND) that the incidents show that far-right radicalization during the COVID pandemic is putting democracy in great danger.
“The Free Saxons, a right-wing radical collection, associated with the NPD and AfD, have for months been poisoning society in Saxony,” the lawmaker said, referencing the far-right National Democratic Party (NPD) and far-right Alternative for Germany (AfD).
Saxony and other eastern German states have been hit hard by spiking COVID cases, but also have some of the lowest vaccination rates in the country. The state has also seen heated protests that have only grown more aggressive after the Bundestag passed a vaccine mandate for some professions in December.
Politicians such as CDU Secretary-General Paul Ziemiak, the Greens’ Michael Kellner and the newly installed Parliamentary State Secretary for the east of Germany Carsten Schneider (SPD) all expressed solidarity with Wanderwitz.
“There is no justification for [the violence]. This attack is not a form of protest, rather simply criminal,” Ziemiak wrote on Twitter
Kellner echoed those sentiments, writing in his own message on Twitter that “violence has no place in the democratic debate.”
German authorities are now investigating and have asked for any potential witnesses in both cities to come forward.
This report was written in part with material from news agency dpa.
#AceHealthReport – Jan.02: Researchers working at Belgium’s Princess Elisabeth Polar Station in Antarctica have contracted Covid-19, even though all personnel have been inoculated and any new arrival has to follow rigorous safety protocols.
#CoronavirusNewsDesk says according to RT News Report: Remote Antarctic station hit with #COVID19 outbreak: Two-thirds of the station’s staff of 25 have been infected with the coronavirus, Belgium’s polar secretariat confirmed to local media earlier this week. But how the virus could have reached the remote station, located some 220km (137 miles) from the Antarctic coast, remains a mystery.
“All those present have received two doses of vaccine, and one person has even received a booster shot,” said Alain Hubert, the facility’s executive operator and head of security measures. All staff members also have to undergo a series of PCR tests on their long journey to the station.
Those en route there take one PCR test in Belgium before leaving for South Africa and another five days after their arrival. They self-isolate for 10 days in Cape Town, then undergo two further tests: one before leaving for Antarctica and another five days after arriving at the station.
Nonetheless, even such strict control measures were apparently not stringent enough, as the first Covid-19 case was reported at the station in mid-December among a group of new arrivals. The person in question was immediately placed in isolation, but two others were soon revealed to have contracted the coronavirus as well.
All three infected researchers were evacuated on December 23, but this measure did not stop the virus from spreading further. A virologist contacted by the polar secretariat said the variant that has infected personnel at the station might be Omicron – the highly transmissible strain recently discovered in South Africa.
There are two emergency doctors and all the necessary equipment at the station to treat anyone who falls ill, according to the media. In the meantime, the polar secretariat has placed all personnel under quarantine and put a halt to any new arrivals until the Covid-19 cluster there dissipates. Explorers venturing on two new expeditions had been expected on January 12, but their arrival has now been delayed.You can share this story on social media:
Developed by Pfizer, Paxlovid is an antiviral medicine with a combination of active ingredients, PF-07321332 and ritonavir, that works by inhibiting a protease required for virus replication. This prevents it from multiplying, keeping virus levels low and helping the body to overcome the viral infection. Ritonavir slows the breakdown of the second ingredient PF-07321332 in the body, thereby increasing its effectiveness.
The two active substances of Paxlovid come as separate tablets that are packaged together and taken together, twice a day by mouth for 5 days. PF-07321332 is a new antiviral, meaning that it has not been approved for use before. However, ritonavir has been used alongside some HIV medicines for many years to ‘boost’ their activity, which is similar to what it is doing for PF-07321332.
In a clinical trial in high-risk adults with symptomatic COVID-19 infection, a five day treatment course of Paxlovid reduced the risk of COVID-19 related hospitalisation and death within 28 days by 89% when compared to a placebo group when treatment was started within 3 days of the onset of COVID-19 symptoms. The number of hospitalisations and deaths were 0.8% (3 out of 389) in the Paxlovid group compared with 7% (27 out of 385) in the placebo group. Similar favourable results were seen in patients when treatment was started within 5 days of the start of symptoms.
Based on the clinical trial data, Paxlovid is most effective when taken during the early stages of infection and so the MHRA recommends its use as soon as possible and within five days of the start of symptoms. It has been authorised for use in people aged 18 and above who have mild to moderate COVID-19 infection and at least one risk factor for developing severe illness. Such risk factors include obesity, older age (>60 years), diabetes mellitus, or heart disease.
It is too early to know whether the omicron variant has any impact on Paxlovid’s effectiveness but the MHRA is proactively working with the company to establish this.
Dr June Raine, MHRA Chief Executive, said:
“Today we have given our regulatory approval for Paxlovid, a COVID-19 treatment found to cut COVID-19 related hospitalisations and deaths by 89% when taken within three days of the start of symptoms.
“We now have a further antiviral medicine for the treatment of COVID-19 that can be taken by mouth rather than administered intravenously. This means it can be administered outside a hospital setting, before COVID-19 has progressed to a severe stage.
“I hope the announcement today gives reassurance to those particularly vulnerable to COVID-19, for whom this treatment has been approved. For these individuals, this treatment could be life-saving.”
Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines, said:
“The Commission on Human Medicines and its COVID-19 Therapeutics Expert Working Group has independently reviewed the data and endorses the MHRA’s regulatory approval of Paxlovid.
“Based on this data, it is clear Paxlovid is another safe and effective treatment to help us in our fight against COVID-19. As it is deployed, we will monitor its effectiveness and safety in the real-world, including any drug interactions, as we do with all medicines. Any side effects should be reported to the MHRA using the Yellow Card scheme.”
Health and Social Care Secretary Sajid Javid, said:
“The UK has been a world leader at finding and rolling out COVID-19 treatments to patients. This is further proved by the MHRA being one of the first in the world to approve this life-saving antiviral.
“We are also leading the whole of Europe in the number of antivirals we’ve bought per person – with over 2.75 million courses of this antiviral secured for NHS patients by the Antivirals Taskforce.
“The booster campaign, testing and antiviral defences ensure our country is in the strongest possible position to deal with the threat posed by Omicron as we head into the new year.”
Paxlovid may interact with certain other medications. Before it is prescribed, the MHRA is therefore advising that patients’ current medications should be carefully reviewed, and appropriate advice given on adjustments that may be needed to their current medications. Additional tests may also be needed for its safe use. More information is provided in the patient information leaflet.
Paxlovid is not a substitute for vaccination against COVID-19. Vaccination and having a booster after the first course remains the best way to avoid hospitalisation due to COVID-19 for most people. The government and the NHS will confirm how this COVID-19 treatment will be given to patients in due course.
The Medicines and Healthcare products Regulatory Agencyis responsible for protecting and improving the health of millions of people every day through the effective regulation of all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
TheCommission on Human Medicines (CHM) advises ministers on the safety, efficacy and quality of medicinal products. The CHM is an advisory non-departmental public body, sponsored by the Department of Health and Social Care.
The MHRA’s Conditional Marketing Authorisation for Paxlovid is valid in Great Britain only. An emergency use authorisation has been granted for Northern Ireland to ensure access across the whole of the United Kingdom. Both authorisations were made on the basis of the same rigorous evaluation.
#AceHealthReport – Dec.30: The number of people in hospital with the virus increased by 80 to 679 – the highest since the start of December – with 36 in intensive care.
#CoronavirusNewsDesk says according to media news report #COVID19 in Scotland has recorded a high number of infections: First Minister Nicola Sturgeon said the Omicron variant was spreading “rapidly” and now accounts for 80% of all cases.
She said further “steep increases” in infections are expected in the coming days and weeks.
However, no changes are to be made to restrictions in Scotland, with curbs expected to remain until 17 January.
Ms Sturgeon also said a decision about whether to reduce the 10-day self-isolation period would be made in the coming week.
Talks are also being held with the sports sector about the impact of the restrictions on large events like football matches.
Ms Sturgeon said: “There simply isn’t an easy trade-off between protecting health and protecting the economy.
“If Covid continues to spread rapidly, the economic impact in the form of staff absences and diminished consumer confidence will be severe. We’re already seeing those impacts. So doing nothing won’t help business.”
The data is jumping around a bit just now – in part because of reporting delays over Christmas but also strains in the system as more people come forward for tests.
Almost 16,000 daily positive cases is probably in tune with the central estimates of modellers but we could still see a sharp rise over the next few days as the data starts to catch up. It may be that the worst-case scenario has been avoided because people have adapted their behaviour even before restrictions were brought in.
For the first time in five days there is information on the numbers of people in hospital with Covid. It shows a small rise, but not a huge spike. Good news, but remember the early Omicron cases would largely be in young people who are less likely to become severely ill. We are still to see the impact of mixing across generations over Christmas.
Early data from London, which is a little ahead of the rest of UK, show hospital admissions with Omicron are lower – even in older age groups – and that the number of people needing intensive care is even less. It also appears that many cases are incidental, with patients admitted for something else and then testing positive.
But the experts continue to warn that even if Omicron is milder, a small proportion of a large number has the potential to cause major disruption for the NHS. Health and social care staff are exempt from 10-day isolation if they have a negative PCR test, but staff absences remain high, and it only takes a small increase in Covid patients for other care to be put on hold.
We still don’t know when the peak of this wave will hit, and how good boosters will be at protecting the most vulnerable. Scientists will say it is still too early to draw any firm conclusions from the data.
Ms Sturgeon also said ministers were “weighing the risks and benefits” of shortening the isolation period for Covid patients.
The first minister said consideration was being given to matching this, and to potentially easing the requirement for household contacts to isolate – something which is not required in England for double-vaccinated household contacts.
She said any decision would be made in the coming week, and come into effect from 5 January.
Nicola Sturgeon gave the Covid update to a virtual session of the Scottish Parliament
The Scottish Conservatives have repeatedly called for the rules to be changed, saying they are causing staff shortages for key services.
A total of 3,316 NHS staff were absent in the week to 28 December for Covid-related reasons, the highest level of absences since March and close to double the 1,771 recorded at the end of November.
At Holyrood, Tory leader Douglas Ross called for immediate action, saying that “the first minister’s message on these essential changes is yet again to tune in next week”.
#AceHealthReport – Dec.30: The eight temporary “Nightingale” units will each house about 100 patients, with building starting this week: There are also plans to identify sites for a further 4,000 beds if needed.
Health Secretary Sajid Javid said he hoped the new hubs “will not have to be used” but that it was right to prepare for all scenarios.
The hubs were described as a “back up insurance policy” by Chris Hopson, chief executive of NHS Providers – the membership organisation for NHS trusts in England.
An email seen by the BBC from Leeds Teaching Hospitals NHS Trust to its staff said that the hubs could be “activated in extremis”.
Trusts have been tasked with identifying other places, such as gyms and education centres, which could be converted to accommodate up to 4,000 patients if required.
NHS braces for potential wave
This is not a revival of the Nightingale hospitals set up at the height of the pandemic in the spring of 2020.
Back then, large venues such as conference centres were pressed into service for an anticipated surge in seriously ill Covid patients.
But they were little used as major hospitals preferred to hold on to staff to deal with Covid pressures rather than lend them to the Nightingales.
This time temporary structures will be set up in the grounds of hospitals so staff, equipment and emergency departments are close at hand.
Only those patients who are close to being discharged and need minimal support will be cared for at these facilities.
Creating extra surge capacity is a familiar policy in winter months. But this is on a much bigger scale.
NHS England says its precautionary and the newly created structures may not be needed.
But the fact they are doing it suggests that, while Omicron may not make people as seriously ill as Delta, the NHS is braced for significant numbers in a potentially major new wave of Covid admissions.
They will be staffed by a mix of consultants, nurses, and other clinical and non-clinical staff.
Mr Hopson said he “recognises that this will add further stretch to an already hard pressed NHS”.
As well as the new Nightingale surge hubs, up to 4,800 people a day will receive support via hospice beds or hospice teams.
The NHS will also be increasing its use of virtual wards where patients are monitored via remote technology.
GPs also have access to pulse oximeters – devices that can read blood-oxygen levels, allowing Covid-19 patients to monitor at home.
The network of emergency Nightingale hospitals set up in spring 2020 to cope with the first wave was closed down in April this year.
In England, seven Nightingale hospitals were built, starting with the 4,000-bed facility at London’s ExCel centre. Another was set up in Belfast, while Scotland and Wales had their own temporary hospitals.
Since the closures some sites were used as rehab centres and other sites were kept open for vaccinations.
#AceHealthReport – Dec.30: Countries across Europe are imposing restrictions on social life during the holiday season in response to a growing number of #COVID19 cases.
#CoronavirusNewsDesk says French Prime Minister Jean Castex announced on Monday a series of new measures aimed at curbing the spread of #COVID19 These will come into force on January 3 and remain in place for at least three weeks as authorities fear hospitals could be overwhelmed by #Omicron-variant patients.
The maximum size of mass gatherings will be limited to 2,000 people indoors and 5,000 outdoors, with a complete ban on standing concerts. A mask mandate will be reintroduced in city centers. Consumption of food and drinks in cinemas, theaters, and sports venues, and during long-distance travel on public transport, will not be allowed.
Companies that can allow employees to work remotely will have to do so for at least three days a week, the government said.
France stopped short of preemptively shutting down schools, which are set to reopen next Monday, but will evaluate whether such a measure might be necessary during a special meeting on Wednesday. In mid-January, parliament is set to vote on a bill to introduce a vaccination pass.
Greece likewise announced on Monday new rules for the January 3-16 period. The restrictions include a midnight curfew for bars and restaurants, a ban on serving standing customers, and a limit of six people per table, Health Minister Thanos Plevris said. People visiting public spaces or using mass transport will be required to wear high-protection masks.
The measures come on top of existing regulations, which banned Christmas and New Year festivities and prohibited unvaccinated people from visiting public venues.
In Germany, the restrictions announced last week came into force on Tuesday. They introduced a cap of 10 people for private gatherings, which are allowed only for the vaccinated and the recovered. If one or more people have no proof of immunity, only two households are allowed to mix.
There is also a ban on large public gatherings, including outdoor New Year celebrations in popular streets and squares. The authorities have banned all firework displays in restricted areas to discourage violators, under the threat of fines.
As he was announcing the regulations, German Chancellor Olaf Scholz stressed that his government and the leaders of federal states had agreed to put them in place after Christmas because previous experience had shown that “Christmas and Easter haven’t been great drivers of infections.”
Spain’s northern region of Catalonia last week imposed a nightlife curfew, limited social gatherings to 10 people, and capped the capacity of many public venues to either 50% or 70%. The holiday measures, which are to remain in place until at least January 7, are more restrictive than in other parts of the country and caused mass protests in Barcelona on Christmas Eve.
Prime Minister Pedro Sanchez failed to convince regional leaders to have a unified set of measures beyond a mandate to wear masks outdoors. Contrasting Catalonia, the region of Madrid focused on ramping up testing.You can share this story on social media:
#AceNewsReport – Dec.29: In a complaint filed on Nov. 13, 2020, the United States alleged that Natural Solutions Foundation, along with trustees Ralph Fucetola and Dr. Rima Laibow, violated the Federal Food, Drug and Cosmetic Act (FDCA) by distributing a “nano silver” product that they claimed would prevent, treat or cure #COVID19
#AceDailyNews DOJ Court Report: A federal court permanently enjoined a New Jersey entity and its principals from distributing unapproved and misbranded drugs touted as a treatment for #COVID19
According to the complaint, which was filed at the request of the U.S. Food and Drug Administration (FDA), Natural Solutions operated various websites to market “Dr. Rima Recommends Nano Silver,” a product that purportedly contained silver particles in a solution.
The complaint further alleged that nano silver is not generally recognized by qualified experts as safe and effective to prevent, treat or cure COVID-19, and that the defendants’ claims were not supported by credible scientific evidence or studies. Additionally, the complaint alleged that the defendants’ nano silver products were misbranded drugs, because their labeling failed to bear adequate directions for use, as required by the FDCA.
“Marketing unproven products as treatments for COVID-19 endangers public health and violates the law,” said Acting Assistant Attorney General Brian M. Boynton of the Justice Department’s Civil Division. “The department will work closely with the FDA to stop anyone attempting to take advantage of the pandemic by selling unapproved, misbranded drugs.”
“The FDA will continue to aggressively pursue and hold accountable those who jeopardize public health,” said Acting Deputy Director Greg Noonan for the FDA’s Office of Dietary Supplement Programs. “Today’s consent decree demonstrates that we will use all of our authority to stop companies that prey on the public during a global pandemic by selling unapproved new drugs.”
The defendants agreed to settle the suit and be bound by a consent decree of permanent injunction. The order entered by the federal court permanently enjoins the defendants from violating the FDCA and requires that they institute a recall for the nano silver products they sold and destroy any such products in their possession. Before distributing any drug in the future, the defendants must notify FDA in advance, comply with specific remedial measures set forth in the injunction and permit FDA to inspect their facilities and procedures.
The enforcement action was prosecuted by Trial Attorney Brianna M. Gardner of the Civil Division’s Consumer Protection Branch, with assistance from Associate Chief Counsel for Enforcement Jaclyn Martínez Resly of the FDA’s Office of Chief Counsel.
On May 17, 2021, the Attorney General established the COVID-19 Fraud Enforcement Task Force to marshal the resources of the Department of Justice in partnership with agencies across government to enhance efforts to combat and prevent pandemic-related fraud. The Task Force bolsters efforts to investigate and prosecute the most culpable domestic and international criminal actors and assists agencies tasked with administering relief programs to prevent fraud by, among other methods, augmenting and incorporating existing coordination mechanisms, identifying resources and techniques to uncover fraudulent actors and their schemes and sharing and harnessing information and insights gained from prior enforcement efforts. For more information on the department’s response to the pandemic and efforts to stop COVID-19 fraud, please visit https://www.justice.gov/coronavirus.
#AceNewsReport – Dec.25: According to flight tracking firm FlightAware, 2,380 flights were called off and another 11,163 delayed globally on Christmas Eve. The figures for Christmas Day stood at 2,388 cancelations and 2,579 delays as of the afternoon. Another 747 flights scheduled for Sunday have been pulled as well.
US airports accounted for more than a quarter of all cancelations, with United Airlines and Delta being among the worst hit. There were 688 flights pulled across the US on Friday, and a further 980 called off so far over the peak travel weekend.
The majority of the cancelations came from five airlines, with China Eastern forced to call off more than 1,200 journeys over the weekend. Meanwhile, Air China, United, Delta, Jet Blue, and Lion Air have reported large numbers of pulled flights, according to FlightAware’s real-time tracker.
“The nationwide spike in Omicron cases this week has had a direct impact on our flight crews and the people who run our operation,”United said in a statement on Friday, adding that it was “notifying impacted customers” and working to rebook them.
Delta also apologized to customers, noting that it had “exhausted all options and resources – including rerouting and substitutions of aircraft and crews to cover scheduled flying.” The airline attributed the cancelations to both the Omicron variant and poor weather conditions.
Meanwhile, German carrier Lufthansa told AP on Friday that it was canceling 12 transatlantic flights over the holiday period due to a “massive rise” in pilots calling in sick, and despite arranging for a “large buffer” of additional staff for the period.
The last-minute travel chaos added to the frustration for passengers looking to celebrate with their families over the holidays after pandemic precautions severely impacted Christmas in 2020. Airline social media feeds reflected this public anger, with several passengers weathering service delays to demand assistance and refunds.
@Delta HORRIBLE CUSTOMER SERVICE!! Flight was canceled yesterday and I’ve been trying to get a refund since yesterday! Hours spent being sent from person to person only to be offered an ecredit!! I want my money back and the sky Miles I used to upgrade my flight— Sonny Wigginton (@SonnyW08) December 25, 2021
According to figures released by the American Automobile Association earlier this month, airlines were expected to see an 184% increase in traffic between December 23 and January 2 from 2020. The US Transportation Security Administration expected to screen nearly 30 million people between December 20 and January 3.You can share this story on social media:
#AceHealthReport – Dec.24: News of the new super-vaccine comes as the latest COVID variant, Omicron, drives a fresh explosion in cases across the US, just weeks after it was first spotted in a California COVID patient on December 1. It now accounts for 73 per cent of all diagnoses across the country, with the figure as high as 90 per cent in states including New York and New Jersey.
#CoronavirusNewsDesk says according to MailOnline News Report: Army to Announce It Has Developed a Single Vaccine That Researchers at the Maryland-based facility expect to officially announce the completion of the vaccine in the coming weeks, Defense One first reported.
On Monday night, the United States confirmed its first Omicron death, a man in his 50s from Houston who was unvaccinated and had previously recovered from COVID before being infected again and dying.
The Army began working on the Spike Ferritin Nanoparticle COVID-19 vaccine (SpFN) in early 2020, with a final release date likely to emerge whenever the Army submits its trial results to the Food and Drug Administration. It also remains unclear whether SpFN will be a single or multiple-shot vaccine.
From the beginning, they worked to create a vaccine that would protect against all existing and potential variants of the viruses.
#AceHealthReport – Dec.22: Denmark became the first EU country to lift its Covid restrictions three months ago, but the emergence of the new variant has seen Europe revert back to tougher rules as cases and hospitalisations are on the rise again.
#CoronaNewsDesk says according to Mail Online News Report: #COVID19 ‘s icy grip on Europe: Winter infections soar on the continent as Belgium rages with anti-lockdown riots, Holland enforces brutal new curbs and Germany bans tourists in desperate bid to slow the march of #Omicron
Winter infections are soaring across Europe amid the rapid spread of the Omicron coronavirus variant
Denmark became first EU country to lift lockdown restrictions, but Europe now reintroducing tougher rules
Thousands of protestors marched through Brussels and clashed with police over tighter restrictions
Holland has announced that all non-essential stores, bars and restaurants will be closed until January 14
Germany has also confirmed Britain has been added to its list of high-risk countries as a ‘virus variant area’
Published: 15:56, 19 December 2021 |
The UK lifted its own lockdown restrictions earlier on July 19, but Health Secretary Sajid Javid today warned there are ‘no guarantees’ Christmas Day will go ahead without a lockdown as Boris Johnson desperately fends off alarming warnings from scientists.
He admitted ‘everything is under review’ after SAGE delivered a grim assessment that the number of infections could reach two million by the end of the month without tougher restrictions – floating a ‘circuit breaker’ ban on households mixing and closure of non-essential shops.
It came as France barred UK holidaymakers from entering the country without a ‘compelling reason’ this week, while Germany added Britain to its list of high-risk countries.
Meanwhile, protestors clashed with police in the Brussels earlier this month amid demonstrations against the tightening of restrictions across the continent.
#AceNewsReport – Dec.21: The implant can be read by any device using the near-field communication (NFC) protocol – technology used for contactless payments and keyless entry systems.
#AceDailyNews says according to Mail Online News Report: Epicenter say it is a small-sized ‘Microchip Implant That Stores Your Coronavirus Plague Vaccine Passport Under Your Skin’ and can be read for use of contactless payments and any other private data records in the future using NFC Protocol.
In a video shared by Epicenter, Hannes Sjöblad, chief distribution officer, has the chip in his arm and simply waves a smartphone over it to pull up his vaccination status.
‘Implants are very versatile technology that can be used for many different things, and right now it is very convenient to have #COVID19 passport always accessible on your implant, he said in a statement.
#AceHealthReport – Dec.15: Their view, having considered the views of the COVID-19 Vaccine Benefit-Risk Expert Working Group (EWG), NHS planners and others is that with the low rates of anaphylaxis, in the context of the considerable need for people to be boosted or vaccinated, the 15-minute wait after a vaccination with mRNA vaccine will cause more harm than it can avert because it will significantly reduce the number of people who can be vaccinated over a short period of time. The 15-minute wait should therefore be suspended for first, second and homologous or heterologous boost vaccinations with mRNA vaccine given the current situation, with this operationalised in line with the needs in each of the 4 nations.
#CoronavirusNewsDesk says that a tweet below confirms this report …..The Chief Medical Officers (CMOs) of the UK and lead Deputy Chief Medical Officers (DCMOs) for vaccines have considered whether, in the light of the very considerable need to speed up vaccination and boosting in response to Omicron variant, the 15-minute wait for some mRNA #COVID19 vaccines should be suspended….
The long-term decisions on the 15-minute wait, when the current need for extreme speed of vaccination and boosting is over, should rest with the Commission on Human Medicines (CHM), the Medicines and Healthcare products Regulatory Agency (MHRA) and the Joint Committee on Vaccination and Immunisation (JCVI). If Ministers agree then this should be a temporary measure on the grounds of public health need to protect as many citizens as possible over a short period of time. How the 15-minute suspension is operationally implemented should be determined by each nation.
The CMOs recognise that this will lead to a marginal increase in risk for a very small number of people, but substantially fewer than would be harmed by a slower vaccine rollout in the current public health emergency leading to some citizens not getting boosted or vaccinated prior to exposure to Omicron. This includes a consideration that any prior vaccination and particularly boosting is likely to lessen the likelihood of severe disease arising from Omicron variant infection.
Those with a history of allergic reactions should be managed in line with Green Book advice and everyone who is vaccinated should be given verbal and written advice on allergic reactions including what actions to take if they become unwell.
The background to this decision is laid out below.
We will copy this to the Chair of CHM and JCVI for information.
The current threat and response
Omicron is spreading extremely rapidly, with a doubling time of 2 to 3 days. If this is maintained, it will spread extremely rapidly through the population. Even if less severe than Delta, with the very high numbers involved modelling from several groups show this will cause substantial mortality, severe illness and pressure on the NHS. This constitutes a national health emergency.
While some protection by any level of vaccination against severe disease is likely, data to date show that 2 doses of any available vaccine is not sufficient to prevent symptomatic disease.
There is therefore a need to boost as much of the population as possible before the peak of the Omicron wave, or provide first vaccination to those with no prior protection. It is likely that this will significantly reduce the number of people becoming ill, hospitalised and dying. Given the speed of the current wave this will need to be undertaken very rapidly.
The mRNA vaccines have shown better ability to boost and are therefore the basis for the current booster campaign. In the CovBoost study antibody responses to mRNA vaccine boost were also much quicker than for other vaccine modalities (typically 7 to 10 days).
Basis of the 15-minute wait
All currently deployed vaccines have proven safe with low rates of severe side effects. As with all vaccines occasional cases of anaphylaxis have been reported, and the rates are slightly higher (but still very low) in the case of mRNA vaccines from Pfizer/BioNTech and Moderna but still overall very rare. For mRNA vaccines there have been 2 fatal Yellow Card reports of anaphylaxis linked to primary course vaccination and no deaths from anaphylaxis linked to booster vaccination reported in the UK to date.
We extract below some of the key points from the COVID-19 vaccine benefit-risk expert working group (EWG) analysis on booster vaccination:
a) Anaphylaxis following mRNA COVID-19 vaccination is a very rare but a potentially life-threatening event.
b) The EWG has previously stated that occurrence of anaphylaxis, where the first 2 doses of the same vaccine have been previously administered with no allergic reaction, would be extremely unlikely and agreed that the 15-minute observation time can be waived for homologous boosters (where the booster is the same vaccine as the first 2 doses) where no allergic reaction occurred on the first 2 doses.
c) The overall reporting rate of anaphylaxis with booster doses (0.26 per 100,000) was below that of reporting for the first 2 doses, with Moderna (1.47 per 100,000) and Pfizer (1.23 per 100,000). There had been 28 reports of anaphylaxis events with Pfizer booster doses (12 on a homologous i.e. Pfizer boosters, after Pfizer first/second dose; and 16 on heterologous schedule (i.e. Pfizer booster after AZ or Moderna or where primary dose was unspecified first and second doses).
d) Five of the 28 anaphylaxis Pfizer reports met the case definition criteria for anaphylaxis; of which 4 were heterologous, the fifth case was homologous, but the patient had received concurrent flu vaccine which is a potential co-suspect in the case. There were 9 reports of anaphylaxis events with Moderna booster doses, all reports on a heterologous schedule.
e) Within the 15-minute waiting time 17 events were reported and outside the 15-minute waiting time, 14 events were reported, but within the same day. The exact timings were not always specified, for instance – several said’<1 day’ or ‘after a few minutes’ or ‘outside the vaccination centre’. Six reports indicated an onset time of 5 minutes or less from vaccination.
f) There were no fatal reports, however 18 of the reports stated adrenaline was administered and 8 were hospitalised. It was noted that several had pre-existing allergies to a variety of allergens.
Reports with the Yellow Card database are under constant review and subject to change. This can include of receipt of additional information on reports, including additional reactions or details which may lead to identification of duplicated information. As such numbers of events may fluctuate.
The CMOs take these data as read. They demonstrate a real, but very rare, absolute risk with 2 reports of fatalities. It is not clear whether the 15-minute wait contributed to the non-fatal outcomes. The 15-minute wait was observed in the reports with fatal outcomes.
The risks of the 15-minute wait in the current situation
Initial analysis from NHS England from England, which is likely to be similar to other nations, implies that under the conditions of a system working at full capacity (as is needed now) the 15-minute wait reduces throughput by 23%. This leads to over 500,000 people not getting a vaccine in the initial period who would otherwise have done so.
Even allowing for the relatively crude initial calculations here, the absolute number of people put at risk because they cannot get vaccinated due to the 15-minute wait (in the high tens of thousands or higher) is much greater than the more precisely calculated number who get anaphylaxis.
Since the mortality rate for COVID-19 is non-trivial (although not yet calculated for Omicron) the probability of harm through delay is, in the view of the CMOs substantially in excess of the probability of benefit from maintaining 15-minute waits under the current situation.
The CHM has also agreed that the 15-minute observation period for primary course, third doses and booster doses of mRNA vaccines could be waived on a temporary basis during the emergency response to the Omicron variant. They will keep this under close review.
CMO for England, Professor Chris Whitty
CMO for Northern Ireland, Professor Sir Michael McBride
CMO for Scotland, Professor Gregor Smith
CMO for Wales, Dr Frank Atherton
DCMO lead for vaccination (England), Professor Jonathan Van Tam
DCMO lead for vaccination (Northern Ireland), Dr Naresh Chada
DCMO lead for vaccination (Scotland), Professor Nicola Steedman
DCMO lead for vaccination (Wales), Professor Gillian Richardson
Fully vaccinated 12 to 15 year olds are now able to access a NHS COVID Pass letter for international travel
Follows government decision to extend the vaccination programme to include offer of both doses of vaccine to all 12 to 15 year olds
Children remain exempt from certification in domestic settings and at the UK border
This will allow those children who have had both doses of an approved vaccine to travel to countries, including Spain and Canada, which now require 12 to 15 year olds to be fully vaccinated in order to gain entry, avoid isolation, or access venues or services.
Proof of vaccination will initially be provided via a letter service including an internationally recognised 2D barcode, with a digital solution via NHS.UK to be rolled out early next year. The letter service can be accessed by calling 119 or via NHS.UK.
Health and Social Care secretary Sajid Javid said:
From today, I can confirm the NHS COVID Pass is being rolled out to 12 to 15 year olds for international travel, allowing even more people to be able to prove their vaccination status for travel where it’s needed.
The move will enable families to plan holidays in 2022 with greater confidence, as parents can be reassured they will be able to evidence their child’s vaccination status once they have had both doses of the vaccine.
It can take up to 7 days to receive a COVID Pass letter.
Children will remain exempt from domestic certification policy in England and will not require an NHS COVID Pass to gain entry to venues.
Chief Executive of NHSX, Matthew Gould, said:
This is another example of the NHS COVID Pass service responding to the changing situation, while maintaining the integrity of the NHS COVID Pass itself.
The vaccination programme will be extended to offer all children aged 12 to 15 a second dose of an approved vaccine no sooner than 12 weeks after the first dose following the government’s acceptance of JCVI advice on 29 November.
In the last year the NHS COVID-19 vaccination programme has delivered over 100 million life-saving doses, preventing at least 24 million infections, hundreds of thousands of hospitalisations and almost 130,000 deaths.