UKHSA To Move COVID/Flu Jabs Forward Due To Concerns Over BA.2.86 - UKHSA Assessment (Sept 8th) - Large Care Home Outbreak (n=28)

[Michael Coston]

UKHSA To Move COVID/Flu Jabs Forward Due To Concerns Over BA.2.86

Credit ACIP/CDC

#17,468

As I mentioned in my last post (see NYC Statement On Detection Of COVID BA.2.86 In Wastewater), while we lack much in the way of solid information on BA.2.86, it's getting a lot of attention from public health entities.

Today, the UK has announced an early start to their fall COVID/Flu jab campaign - which normally begins in October - due to the unknowns surrounding the emerging BA.2.86 variant.​

The press release from the UK HSA follows:

Flu and COVID autumn vaccine programmes brought forward

Precautionary measure taken to protect those most vulnerable from illness during winter following the identification of COVID-19 variant BA.2.86.

From:Department of Health and Social Care, UK Health Security Agency, and Maria Caulfield MP Published 30 August 2023

Vaccinations are now set to start on 11 September 2023 in England with adult care home residents and those most at risk to receive vaccines first
Eligible people urged to come forward for their jab as soon as they’re invited

This year’s autumn flu and COVID-19 vaccine programmes will start earlier than planned in England as a precautionary measure following the identification of a new COVID-19 variant.

The precautionary measure is being taken as scientists from the UK Health Security Agency (UKHSA) examine the variant BA.2.86, which was first detected in the UK on Friday 18 August 2023.

According to the latest risk assessment by UKHSA, BA.2.86 has a high number of mutations and has appeared in several countries in individuals without travel history.

While BA.2.86 is not currently classified as a variant of concern, advice from UKHSA suggests that speeding up the autumn vaccine programme will deliver greater protection, supporting those at greatest risk of severe illness and reducing the potential impact on the NHS.
​
From Department of Health and Social Care, UK Health Security Agency, and Maria Caulfield MP Published30 August 2023
l impact on the NHS.

The decision means those most at risk from winter illness - including people in care homes for older people, the clinically vulnerable, those aged 65 and over, health and social care staff, and carers - will be able to access a COVID vaccine in September.

The annual flu vaccine will also be made available to these groups at the same time wherever possible, to ensure they are protected ahead of winter.

Vaccinations are now set to start on 11 September 2023, with adult care home residents and those most at risk to receive vaccines first. NHS England will announce full details of the accelerated roll-out soon, and those who fall into higher-risk groups are being encouraged to take up the jab as soon as they’re invited.

There is no change to the wider public health advice at this time.

Health Minister, Maria Caulfield said:​

As our world-leading scientists gather more information on the BA.2.86 variant, it makes sense to bring forward the vaccination programme.​

It is absolutely vital the most vulnerable groups receive a vaccine to strengthen their immunity over winter to protect themselves and reduce pressure on the NHS.​

I encourage anyone invited for a vaccination - including those yet to have their first jab - to come forward as soon as possible.​

Chief Executive of the UK Health Security Agency, Dame Jenny Harries said:​

As we continue to live with COVID-19 we expect to see new variants emerge.​

Thanks to the success of our vaccine programme, we have built strong, broad immune defences against new variants throughout the population. However, some people remain more vulnerable to severe illness from COVID-19. This precautionary measure to bring forward the autumn programme will ensure these people have protection against any potential wave this winter.​

There is limited information available at present on BA.2.86 so the potential impact of this particular variant is difficult to estimate. As with all emergent and circulating COVID-19 variants - both in the UK and internationally - we will continue to monitor BA.2.86 and to advise government and the public as we learn more. In the meantime, please come forward for the vaccine when you are called.​

For operational expediency and in line with public health recommendations, wherever possible flu and COVID-19 vaccines should be administered at the same time.

The vaccination campaign was previously due to commence in early October 2023. This is because the best protection is usually provided by getting vaccinated with as short a gap as possible before exposure to circulating influenza and COVID-19 viruses.

The advice from the Joint Committee on Vaccination and Immunisation (JCVI) for this autumn, is to offer the vaccine to those at high risk of serious disease from COVID-19 and who are therefore most likely to benefit from vaccination.

Those eligible for vaccination are encouraged to take up the offer of the vaccine as soon as they are called to ensure they head into winter with the best protection.


https://afludiary.blogspot.com/2023/08/ukhsa-to-move-covidflu-jabs-forward-due.html​

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[Michael Coston]

UK HSA: Situational Assessment For SARS-COV-2 Variant BA.2.86

#17,654


Now that 90% of the world's nations are no longer reporting COVID hospitalizations and deaths (see No News Is . . . Now Commonplace), and with the WHO moving to monthly(not weekly) epidemiological reports, we find ourselves facing an uncertain fall - and an emerging BA.2.86 variant - with far less real-time data than we'd like.

The decision to declare `victory' over the pandemic, and `move on' by treating COVID as if it was equivalent to the `flu', was motivated by widespread (and understandable) pandemic fatigue, economic concerns, and political necessities.​

Of course, for it to work, the SARS-CoV-2 virus would have to cooperate. While it's true we've seen far fewer hospitalizations and deaths over the past 6 months, Long COVID continues to plague, and sometimes permanently disable, millions of those infected.

AHA: COVID-19 May Trigger New-Onset High Blood Pressure​

Study: SARS-CoV-2 Infection and Viral Fusogens Cause Neuronal and Glial Fusion that Compromises Neuronal Activity​

JAMA: Additional Evidence Of A Post-COVID/Diabetes Link​

Nature: Long-term Cardiovascular Outcomes of COVID-19​

And as the SARS-COV-2 virus evolves and mutates, the number of pharmacological treatment options continue to dwindle (see ECDC: SARS-CoV-2 Variant Mutations Conferring Reduced Susceptibility to Antiviral Drugs and Monoclonal Antibodies), and vaccines become less effective.

While a `milder' Omicron lineage has reigned for the better part of two years, the SARS-CoV-2 virus continues to evolve, as it circulates in both human and non-human hosts (deer, mink, rodents, etc.).

The emergence of a dominant post-Omicron lineage at some point may not be inevitable, but given the mutability of the virus, it is a pretty good bet.​

Whether that is happening right now is up for debate. BA.2.86 represents the biggest antigenic leap we've seen with COVID since Omicron burst onto the scene in the fall of 2021, but our collective switch to a politically expedient `Don't test, don't tell' strategy deprives us of badly needed data.

Right now, we don't know how well this variant is transmitting, the extent of its spread, or much of anything at all about its severity (or lack, thereof). BA.2.86 could turn out to be a flash in the pan, unable to compete with more transmissible XBB variants.​

Conversely, BA.2.86 might be a contender. Or possibly a springboard for one of its descendants. Even it doesn't currently have the `right stuff' to conquer the world, it demonstrates that big leaps in COVID's evolution are still possible.

Although governments and public health entities are quick to point out there is `no evidence' that BA.2.86 poses an immediate threat, they are also generating technical documents (see here, here. here & here) at a furious pace, and the UK is altering fall vaccination campaigns (see UKHSA To Move COVID/Flu Jabs Forward Due To Concerns Over BA.2.86) with a sense of urgency we haven't seen in nearly 2 years.​

Yesterday, for the second time in less than two weeks, the UK's HSA released a technical assessment on what is known (and not known) about the emerging BA.2.86 variant (see below). As you'll see, there are far more questions than answers.

I'll have a brief postscript after the break.

Research and analysis​

Situational assessment for SARS-CoV-2 variant V-23AUG-01 (BA.2.86)

Updated 1 September 2023

Applies to England

Part 1. Context and UK cases

As of 10am, 31 August 2023, 25 BA.2.86 genome sequences are available on the international genomic data-sharing platform, GISAID. These originate in 8 different countries:

• 10 in Denmark
• 4 in Sweden
• 4 in USA
• 2 in Portugal
• 2 in South Africa
• 1 in Canada
• 1 in Israel
• 1 in UK

Two further UK cases, one in England and one in Scotland, have been identified and genome sequence data will be available on GISAID shortly. This is a dynamic situation changing daily.

Sample dates, where known, range from 24 July 2023 (Denmark, South Africa) to 22 August 2023 (USA) (Figure 1).

The first UK case was reported in the previous risk assessment, published 18 August 2023. All UK cases were identified through hospital testing and have no known recent travel history through routinely collected data.

The first UK case was mildly unwell and the second UK case (England) did not have respiratory symptoms. The third UK case (Scotland) was symptomatic. The samples for the 2 new cases were sequenced through routine surveillance of hospital test-positive cases.

A number of additional countries have also made formal or informal announcements of BA.2.86 detection in wastewater. There is no internationally consistent repository for wastewater genomic data.

Figure 1 is a bar showing sequences grouped by week of sample collection (GISAID upload date is used where sample collection date is not available in one case). Total number of sequences per country are shown in the figure legend.​

One sequence from both Denmark and USA, and 2 sequences from South Africa have collection dates available on GISAID from the week beginning 23 July 2023.

There was one sequence each from Denmark, Israel, and USA with a collection date from the week beginning 20 July 2023. One sequence from USA and Sweden, and 3 sequences from Denmark have a collection date in the week beginning 6 August 2023.

Three sequences from the UK, 3 from Sweden, 2 from Portugal and 4 from Denmark have a collection date from week beginning 14 August 2023.

One sequence from USA and one sequence from Denmark have a collection date from week beginning 20 August 2023. There was one sequence from Canada with a submission date from the week beginning 27 August 2023.​

​

Figure 1. Epicurve of BA.2.86 genome sequences on GISAID, including additional 2 new UK cases ​

Part 2. Variant Technical Group assessment

Meeting and assessment 29 August 2023. The UK Health Security Agency (UKHSA) is aware of new data since this date and continues to assess all available information.

Through the limited available global genomic surveillance, the variant is present in multiple countries on multiple continents, detected at a low prevalence amongst clinical cases or in wastewater. Although an increasing number of countries are reporting detection, there is as yet no clear signal of growth within any of these individual countries.

The BA.2.86 phylogeny shows one sublineage within which most European cases are located but does not otherwise have a high degree of substructure. The time of most recent common ancestor (tMRCA) is estimated at 3 June (range 29 April, 1 July) assuming exponential growth.

BA.2.86 is an outlier in terms of geographic dispersion when compared to other nodes in the SARS-CoV-2 global phylogeny in 2023 with similar tMRCA and which are still circulating. However, it is not the most extreme outlier. This analysis does not incorporate countries detecting BA.2.86 through wastewater.

The group considered hypotheses of a mass gathering event seeding multiple countries, an ongoing outbreak in a country without surveillance, or widespread community transmission undetected by surveillance. All 3 possibilities were still considered plausible, though widespread high-level community transmission is not best supported by the phylogeny.

No conclusions can be drawn about the fitness of the variant based on this data, and a full range of options – from less fit than other circulating variants, to a large jump in fitness – are still possible, given the available data.

There is no laboratory data available. Two samples are in culture in the UK and we are also in contact with international partners. Neutralisation and other phenotypic data is still likely to be one to 2 weeks away at minimum in the UK.

The extant UKHSA variant of concern definition requires us to demonstrate (or confidently predict) a detrimental change in biological properties, as well as a growth rate compatible with displacement or maintenance. At present there are a wide range of possibilities for the fitness and growth of the variant and there remains uncertainty about the impact of the mutations present.​

BA.2.86 does not, therefore, meet this definition of a variant of concern. The Variant Technical Group discussed whether the current surveillance context required an updated approach to designating and acting on variants. However, any such updated definition of a variant of concern would include a higher level of confidence on positive growth than is available at present for BA.2.86.

Sources and acknowledgements

• Variant Technical Group
• Analysis submitted by:
• UKHSA Genomics Public Health Analysis Team
• UKHSA COVID vaccines and epidemiology team
• Public Health Scotland
• Andrew Rambaut
• Erik Volz

(Continue . . . .)



Without better data, it is impossible to say how much of a threat BA.2.86 poses, now or in the immediate future. We will simply have to wait and see.

But even without a new lineage, COVID is back on the ascendant here in the United States, and in many other countries around the globe. It still kills thousands of people every month, and even mild infection is well worth avoiding if you can.​

The U.S. and UK, and other countries will be rolling out a new vaccine this fall, and while it remains to be seen how effective it may be against BA.2.86 infection, it is still expected to reduce hospitalizations and deaths.

Since I consider even a little protection preferable to none, I plan to roll up my sleeve (for both COVID and Flu vaccines) this fall. I'll also be adding some extra layers of protection; wearing a KN-95 face mask, using hand sanitizers, and avoiding crowds whenever possible.​

Some people may consider that excessive, or premature. But as a Floridian, I've learned that when a CAT 1 hurricane is predicted to make landfall, it is prudent to prepare for a CAT 2 or CAT 3 storm.

If the worst doesn't happen, I don't feel foolish.​

I feel lucky.


https://afludiary.blogspot.com/2023/09/uk-hsa-situational-assessment-for-sars.html


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[Michael Coston]

UK HSA SARS-CoV-2 Variant Technical Briefing #53 - Details BA.2.86 Outbreak In Care Home (n=28)




#17,662

After early concerns over the large evolutionary leap taken by COVID variant BA.2.86, last week we unexpectedly saw the UKHSA Move COVID/Flu Jabs Forward Due To Concerns Over BA.2.86, after reporting only a couple of UK cases.

Since then, we've seen a number of reports and risk assessments (see here, here, and here) which have tempered initial concerns somewhat, calling into question both BA.2.86' transmissibility, and its degree of immune evasion.​

But the reality is that epidemiological data remains frustratingly scarce, and laboratory tests - while useful - don't always translate into real-world results. And of course, BA.2.86 (and its myriad of viral cronies) continue to evolve.

Today the UK has released a new technical briefing; one that provides details on a care home outbreak with at least 28 confirmed cases due to BA.2.86, which they began investigating in late August.

While citing limited data, they state that this `. . . is an early indicator that it (BA.2.86) may be sufficiently transmissible to have impact in close contact settings'.​

This early signal was likely the impetus behind the UK's decision to move up COVID jabs by nearly a month. Care home residents were among the earliest, and hardest hit, populations when COVID emerged in 2020.

First stop, a brief summary/update from the UK HSA.

UKHSA publishes latest BA.2.86 analysis in new technical briefing

The UK Health Security Agency (UKHSA) has published SARS-CoV-2 variant surveillance and assessment technical briefing 53. It contains the latest epidemiological and genomic analysis of the emergent BA.2.86 variant.

As of 4 September 2023, 34 confirmed cases of BA.2.86 had been identified in England. Of these, 5 were hospitalised and no deaths due to COVID-19 have been reported amongst these cases.

Multiple unlinked cases in different regions without reported travel history suggests a degree of community transmission within the UK. However, there is currently not enough data to conclude what the extent of this transmission might be. It is also too early to draw conclusions on the impact the variant may have on the UK population due either to its clinical or immune escape properties.

Of the 34 cases in England, 28 cases were from a single outbreak at a care home in Norfolk. Specialists from UKHSA have been working with Norfolk County Council to offer infection control advice and support.

Staff and residents of the care home were asked to undergo polymerase chain reaction (PCR) testing by local health protection officials when an unusually high number of people became unwell. Positive samples were sent for whole genome sequencing at UKHSA laboratories, where BA.2.86 was confirmed in the majority of samples.

Based on the information from this incident, it is too early to draw any conclusions about how BA.2.86 will behave in the wider UK population, but it is an early indicator that it may be sufficiently transmissible to have impact in close contact settings. UKHSA scientists are investigating this and will publish further analysis in future technical briefings. This variant has been detected in a number of countries globally.

Dr Renu Bindra, Incident Director, UKHSA said:​

While BA.2.86 has a significant number of mutations to the viral genome compared to other currently circulating COVID-19 variants, the data so far is too limited to draw firm conclusions about the impact this will have on the transmissibility, severity or immune escape properties of the virus.​

UKHSA scientists are working with international partners to culture the samples and analyse the evidence as it becomes available. However, it is likely to be some time before we have enough data to make a confident assessment.

Specialists from UKHSA have been working with Norfolk County Council to offer infection control advice and support following a confirmed outbreak of BA.2.86 in a care home.​

It is clear that there is some degree of widespread community transmission, both in the UK and globally, and we are working to ascertain the full extent of this. In the meantime, it remains vital that all those eligible come forward to receive their autumn vaccine as soon as it is offered to them.​

The Department of Health and Social Care (DHSC) announced last week that the autumn vaccine programme will be brought forward to 11 September as a precautionary measure following the emergence of BA.2.86.​

Next, some excerpts from a much longer technical briefing, but you'll want to follow the link to read it in its entirety. I'll have a bit more after the break.

SARS-CoV-2 variant surveillance and assessment: technical briefing 53

Updated 8 September 2023
Applies to England

This report has been published to share the detailed variant surveillance analyses which contribute to the variant risk assessments and designation of new SARS-CoV-2 variants. This specialist technical briefing contains early data and analysis on emerging variants and findings have a high level of uncertainty.

Unless stated otherwise, this technical briefing uses a data cut-off of 4 September 2023 to allow time for analyses.

During periods when technical briefings are being published by the UK Health Security Agency (UKHSA), the routine variant prevalence and growth rate reports will be included in the technical briefing.

Situational assessment BA.2.86 (Variant Technical Group of 5 September 2023)​

1. There is a continued slow accumulation of cases globally including cases reported from new countries. The rate of detection of new sequenced cases cannot be used as an indicator of growth due to limited and lagging genomic surveillance globally.
2. BA.2.86 is now more globally dispersed than other lineages of similar age in 2023. This may have been the result of international seeding from one or more unknown sources through mass travel. However, with apparent established transmission chains now in many countries, these seeding events are now unlikely to be the key driver of spread.
3. The data suggest established community transmission of BA.2.86 within the UK. This is based on the detection of multiple unlinked cases in different regions of the UK, without identified travel links, and phylogeny (the relationship between cases as determined by viral genomic data). This finding does not confirm that BA.2.86 has a growth advantage within the UK compared to other circulating variants.
4. A single care home outbreak was investigated due to a high attack rate and found to be BA.2.86. This cannot be used to make an assessment of the variant’s fitness butin contrast to recent laboratory data suggesting lower infectivity in vitro, this is an early indicator that the variant may be sufficiently transmissible to have impact in close contact settings.
5. Pseudovirus neutralisation data is available from several laboratories. Whilst this data has limitations, antigenic cartography based on mouse sera is mostly consistent with the antigenic distances estimated from the mutational profile. The potential UK population impact after several vaccines and waves cannot be extrapolated from the available data.
6. Some early indicators of increasing COVID-19 transthis is mission in the UK were noted and behavioural, immunological and virological factors may all be contributing. We cannot confirm that BA.2.86 is contributing to any increase given available data.
7. There is an insufficient number of cases to make an assessment of outcome or severity. In the UK, the current surveillance systems do not support an assessment of comparative severity between variants but trends in severity and outcomes can be monitored over time through hospital data. It is likely that any such signal will take weeks to be visible and confirmed through sequencing.

Data summary​

BA.2.86​

As of 4 September 2023, there are 34 BA.2.86 sequenced cases in England, with cases located in East of England, London, and North West England. Of 34 total cases in England, 5 were hospitalised (2 have unknown hospitalisation status), and no deaths due to COVID-19 have been reported. These cases include 28 sequenced as part of an investigation of an outbreak in a care home which reported a high attack rate.​

Cases in Scotland are reported by Public Health Scotland. There are no cases reported by Wales or Northern Ireland.​

The global situation is dynamic with new cases identified daily. As of 5 September 2023, there are 33 sequences from human cases identified as BA.2.86 available in GISAID from 9 countries. The earliest collection date is 24 July 2023, and the most recent collection date is 26 August 2023. Of the 33 sequences, 2 are from the UK. The remaining UK sequence data will be uploaded to GISAID shortly, including those from the outbreak cluster described in this briefing. There are also multiple reports of BA.2.86 detected in wastewater in other countries though limited sequence data is available.​

Virus was successfully isolated from the first UK case and passage 1 isolate has been shared with UKHSA; UKHSA and academic partners will undertake assessment using sera from UK studies.​

(Continue . . . )



Quite obviously, despite recent reassuring reports, there is still a lot we don't know about the threat from BA.2.86. Its impressive attack rate in a highly vaccinated care home population is of obvious concern, but the lack of deaths is encouraging.

Because surveillance and reporting of COVID cases, hospitalizations, and deaths has become so unreliable, it may be some time before we get a good handle on what we may be facing this fall.​

In the meantime we are likely to be subjected to a roller coaster ride of conflicting information. Opinions and assessments may help guide us, but it will be the virus that has the final say.


https://afludiary.blogspot.com/2023/09/uk-hsa-sars-cov-2-variant-technical.html