SARS CoV-2 Sublineage BA.2.86
SARS CoV-2 Sublineage BA.2.86
Risk Assessment Summary for SARS CoV-2 Sublineage BA.2.86
August 23, 2023, 10:10 AM EDT
CDC has detected a new SARS-CoV-2 variant labeled BA.2.86. CDC is continually monitoring for new variants and studying their potential impact on public health.
All viruses, including the virus that causes COVID-19 (SARS-CoV-2), change over time. These viruses with changes are called “variants.” These changes can affect how contagious a virus is, how well it responds to treatment, and how severely it affects people. Last week, a new variant of SARS-CoV-2 called BA.2.86 was detected in samples from people in Denmark and Israel. At least two cases have been identified in the United States. This variant is notable because it has multiple genetic differences from previous versions of SARS-CoV-2.
Current Risk Assessment
Based on what CDC knows now, existing tests used to detect and medications used to treat COVID-19 appear to be effective with this variant. BA.2.86 may be more capable of causing infection in people who have previously had COVID-19 or who have received COVID-19 vaccines. Scientists are evaluating the effectiveness of the forthcoming, updated COVID-19 vaccine. CDC’s current assessment is that this updated vaccine will be effective at reducing severe disease and hospitalization. At this point, there is no evidence that this variant is causing more severe illness. That assessment may change as additional scientific data are developed. CDC will share more as we know more.
If licensed/authorized by the FDA and recommended by the CDC, updated vaccines will be available as early as mid-September at your local pharmacy or doctor’s office.
What can you do to protect yourself and others as we learn more?
At this time, we don’t know how well this variant spreads, but we know that it spreads in the same way as other variants. That means you can still take the following actions to protect yourself and others from infection:
- Get your COVID-19 vaccines, as recommended
- Stay home if you are sick
- Get tested for COVID-19 if needed
- Seek treatment if you have COVID-19 and are at high risk of getting very sick
- If you choose to wear a mask, wear a high-quality one that fits well over your nose and mouth
- Improve ventilation
- Wash your hands
Scientific Understanding of BA.2.86 as of August 23, 2023
What follows is a scientific assessment of BA.2.86’s risk profile based on what CDC knows now.
Human cases: As of August 23, 2023, 9 BA.2.86 variant sequences have been reported globally: Denmark (3); South Africa (2); Israel (1); United States (2) and United Kingdom (1). One of the cases in the United States is in a person detected through CDC’s Traveler-based Genomic Surveillance. The identification of these cases in multiple geographies is evidence of international transmission. Notably, the amount of genomic sequencing of SARS-CoV-2 globally has declined substantially from previous years, meaning more variants may emerge and spread undetected for longer periods of time. It is also important to note that the current increase in hospitalizations in the United States is not likely driven by the BA.2.86 variant. This assessment may change as additional data become available.
Severity: It is too soon to know whether this variant might cause more severe illness compared with previous variants. CDC is closely monitoring hospitalization rates to identify any potential early signals that the BA.2.86 variant is causing more severe illness. At this time, locations where this variant have been detected have not experienced increases in transmission indicators (e.g., cases, emergency department visits) or hospitalizations out of proportion to those seen in neighboring locations. However, it is early in the emergence of this variant and too soon to evaluate impacts based on these indicators.
Transmission: With only nine sequences detected, it is too soon to know how transmissible this variant is. Detection across multiple continents suggests some degree of transmissibility. This is notable since scientists have not detected transmission of most other highly diverged lineages, which can arise in immunocompromised persons with prolonged infections.
Wastewater Detection: A U.S. wastewater sample that was collected as part of routine monitoring in the National Wastewater Surveillance System (NWSS) has preliminarily indicated the presence of the BA.2.86 variant. Scientists are investigating this sample and will continue to closely monitor wastewater for further or more widespread evidence of BA.2.86. NWSS is one of multiple monitoring systems CDC uses to detect variants within the United States, and is meant to be used with other COVID-19 public health data to better understand COVID-19’s spread. Learn more about wastewater monitoring in the United States.
Viral Genomics: BA.2.86 is a newly designated variant of SARS-CoV-2 that has a number of additional mutations compared with previously detected Omicron variants. Specifically, the genetic sequence of BA.2.86 has changes that represent over 30 amino acid differences compared with BA.2, which was the dominant Omicron lineage in early 2022. BA.2.86 also has >35 amino acid changes compared with the more recently circulating XBB.1.5, which was dominant through most of 2023. This number of genetic differences is roughly of the same magnitude as seen between the initial Omicron variant (BA.1) and previous variants, such as Delta (B.1.617.2).
Immune Impacts: The large number of mutations in this variant raises concerns of greater escape from existing immunity from vaccines and previous infections compared with other recent variants. For example, one analysis of mutations suggests the difference may be as large as or greater than that between BA.2 and XBB.1.5, which circulated nearly a year apart. However, virus samples are not yet broadly available for more reliable laboratory testing of antibodies, and it is too soon to know the real-world impacts on immunity. Nearly all the U.S. population has antibodies to SARS-CoV-2 from vaccination, previous infection, or both, and it is likely that these antibodies will continue to provide some protection against severe disease from this variant. This is an area of ongoing scientific investigation.
Therapeutics: Examination of the mutation profile of BA.2.86 suggests that currently available treatments like Paxlovid, Veklury, and Lagevrio will be effective against this variant. Monitoring is ongoing and CDC will update this document as human data on the impact of this variant on therapeutics become available.
Diagnostics (tests): Based on BA.2.86’s mutation profile, the anticipated impact on molecular and antigen-based is low.
NATIONAL DATA OPT-OUT SERVICE
The national data opt-out service was introduced on 25 May 2018 following recommendations by the National Data Guardian who in her independent review of data security, consent and opt-outs (2016) said: 'A patient should be able to state their preference once (online or in person), confident in the knowledge that this will be applied across the health and social care system.'
The Patient Data Choices Project is a collaboration between NHS Digital and the Royal College of General Practitioners and has delivered a series of events and portfolio of resources to inform primary care teams on the national data opt-out so that they can confidently and accurately advise patients and carers on their data sharing options, and to support primary care teams to uphold the national data opt-out within their own practice.
- People will be able to set an opt-out online, through a supported telephone service (like the eReferral service) or by submitting a paper request
- Children under 13 and those who lack capacity may not be able to set an opt-out themselves. In such cases individuals who have a formal, legal relationship to act on behalf of the patient (i.e. somebody who has parental responsibility, a legal power of attorney or court appointed deputy) will be able to set a proxy opt-out on their behalf. This is to enable equality of opportunity for everyone to be able to opt out and will also reduce the burden on GP practices
- The national data opt-out choice is set by the individual and does not require any action by the person’s General Practice
Routes to set an opt-out - online
The preferred route for people to set a national data opt-out preference is through the nhs.uk website, which has information about the national data opt-out to help people make an informed choice. To set an opt-out online, the individual is required to verify their identity by providing their name, date of birth, NHS number or postcode. They will then be presented with their mobile phone number and/or email from the Patient Demographic Service (PDS) so that a secure one-time password can be sent to them. This ensures the patient is in control of the process.
If a person cannot confirm their identity they can use the telephone service to guide them through the service or set a choice on their behalf. The website is available 24 hours a day, seven days a week, from 25 May 2018.
Routes to set an opt-out - Supported telephone service
People can set their national data opt-out choice using a telephone service on 0300 303 5678. When calling this service patients will need to confirm their identity by providing their NHS number, name and date of birth. If the patient does not know their NHS number the contact centre may ask for their postcode to confirm a match. The patient will also need to have an email or mobile phone number recorded on PDS to receive a verification passcode.
Calls to this number should cost no more than calls to a normal personal or business geographic landline number (numbers starting with 01 or 02), whether calling from a landline, or mobile phone.
The telephone service is available 9am to 5pm, Monday to Friday, excluding English bank/ public holidays.
Routes to set an opt-out – Non-digital (Paper)
Patients can also obtain a form to fill in and post to register a national data opt-out preference. The form can be obtained via the nhs.uk website or the national telephone service. To use the non-digital route a patient can either use their NHS number, or two forms of identification one to confirm name and the other to confirm address. When a patient updates their choices through the non-digital paper route they will receive confirmation, and can choose to receive this by letter or email.
Cannot be set via GP
The national data opt-out choice CANNOT be set by the GP or other member of the practice staff and is not stored or implemented through the use of codes in the GP system. National data opt-outs are held by NHS Digital on a central repository on the Spine.
In order to ensure that identifiable data for patients with a restricted access setting against their PDS record (also known as a Sensitive flag) is not released for secondary purposes, a national data opt-out has been set for all patients with such a restricted access setting. The process for setting this flag on PDS has been updated so that a national data opt-out can be set or un-set as part of this process. See the ‘Restricting access to a patient’s demographic record’ section below.
Children and People with Lasting Power of Attorney
Patients can set their national data opt-out choice from the age of 13 through any of the available routes. This age is based on the minimum age in data protection legislation and is not based on any assessment of competence. Any national data opt-out set by a parent or guardian prior to age 13 will remain in place unless and until the patient reviews and changes it.
For children under the age of 13 a national data opt-out can be recorded by someone with parental responsibility. Once a young person passes the age of 13 the person with parental responsibility will no longer be able to set a national data opt-out.
Someone with legal authority to act on behalf of an individual e.g. Lasting Power of Attorney (LPA) or court appointed deputy can set a national data opt-out choice on behalf of that individual. For example a daughter with LPA could set a choice for her elderly parent with dementia. Anyone who wishes to set a national data opt-out on behalf of someone else will need to use the ‘by post’ forms or speak to the telephone service.
To set an opt-out on behalf of someone else, they will need to supply their own name, address, postcode and a signed declaration of parental responsibility to act on behalf of the individual for whom they are setting a choice. They will also need either the name and NHS number for the person for whom they are setting the choice, or name and two identification documents (one for name and one for address).