The phased supply of the new adjuvanted flu vaccine for people aged over 65 years is causing problems with the usual smooth running of the pharmacy flu service

Illness caused by the flu virus puts significant strain on the healthcare system in any winter – so improving flu vaccine uptake rates is always a key priority.

As a letter this year from the chief medical officer to NHS staff points out: “Last season’s higher level of flu activity is an important reminder that flu can have a significant impact and is highly unpredictable. This year saw record flu vaccination levels, with nearly one-and-a-half million more people getting the vaccination than last year. We should strive to further improve vaccine uptake rates in all eligible cohorts.”¹

That may be easier said than done in pharmacy, with stock of the new adjuvanted trivalent influenza vaccine (aTIV) issued as a phased delivery during September (40 per cent of orders), October (20 per cent of orders) and November (40 per cent of orders). Such a process was always likely to present logistical challenges to pharmacies – and so it proved.

Numark member George Wickham, who owns a group of pharmacies in Devon, describes this year’s flu season as difficult to predict. “It has been a messy year with all the changes in schedules and the deliveries,” he says. It was hard for contractors to predict what was needed when ordering aTIV in the spring, he points out, when orders needed to be made quickly after the announcement on the vaccine schedule was made.

“We ordered less vaccine overall than last year, because we thought we were more likely to be left with vaccine than not having enough – so we are predicting a slight reduction in numbers.”

Pharmacies who did not order enough aTIV in time earlier in the year are not able to source extra supplies.

Supply problems for pharmacy

When PM spoke to George in September, he thought it likely that the phased delivery of the aTIV vaccine may cause the over-65s some problems in getting their vaccines at certain times of the month. “I think people may fnd themselves making two or three journeys to either the GP or ourselves to get vaccinated. They may fnd when they turn up that the vaccine isn’t available.”

Many pharmacies tend to use a supply of vaccines within a couple of weeks, and then have two or three weeks to wait before the next delivery. These patients might go to their GP for a vaccination in the meantime.

A further issue has been that some GPs have received batches of adjuvanted trivalent vaccine before pharmacies. Turning away patients because supplies had ran out has been damaging to patients’ confdence in the pharmacy service and the credibility of the service itself. Many pharmacists have expressed their concerns and frustration.

One of the main differences this year has been communicating this new system to patients. “Unfortunately, some patients are not going to get the vaccination as easily as they did in the past, but hopefully next year things will be better,” says George.

The potential for a greater physical response at the site of injection and a greater febrile response from aTIV could also reignite the myth among older patients of “catching the flu” from vaccination, George warns, which could affect uptake of the vaccination in the over-65 age group.

Why the change?

The aTIV vaccine Fluad, manufactured by Seqirus, was approved this year by the MHRA for the first time in the UK, although it has a well-established safety and tolerability profile based on its use in Europe and other countries including Canada and the US over 20 years. The main ingredient of the adjuvant (MF59), which strengthens and lengthens the immune response, is squalene oil.

According to the Joint Committee on Vaccination and Immunisation (JCVI), the vaccine offers increased protection from flu in people aged 65 years and over, compared to existing non-adjuvanted flu vaccines.²

Public Health England predicts that the introduction of the aTIV is likely to be “highly cost effective” due to “large reductions in GP consultations and hospitalisations”.

“Based on the existing evidence and in the context of the UK programme, PHE analysis strongly supports the preferential use of “Based on the existing evidence and in the context of the UK programme, PHE analysis strongly supports the preferential use of adjuvanted trivalent vaccine in older people,” it says. Widening its use for adult at-risk groups and healthcare workers may also be beneficial in the future, it adds.³

Service specifications

For the 2018-19 season, community pharmacists are able to vaccinate adults in at-risk groups and those working in care homes or domiciliary care. Hospice workers and social care workers have been added to the list this year. Pharmacies offering off-site flu vaccination, such as in a care home or in a patient’s home, should inform their local NHS England team.⁴

A three-phased prioritisation approach should be taken to vaccinating patients aged 65 years and over with aTIV:

• First priority should be given to those aged 75 years and over or those in a care home
• Second priority should be given to those aged 65-74 years in a clinical risk group
• Third priority should be given to those aged 65-74 years NOT in a clinical risk group.

What to do if aTIV is not available

Most cases of seasonal flu occur between December and February, within an eight-to-10 week period – but the season can start earlier. The phased delivery of aTIV means less vaccine will be available at the start of the season. In a joint letter to general practice and community pharmacies, NHS England, the BMA and PSNC advise that with appropriate planning, all patients should be able to be offered protection before the flu season starts.

According to the letter, “previous patterns of immunisation suggest that not all of the 65-years-and-over group of patients are immunised early. Data from the weekly ImmForm surveys shows that in 2017/18, 60 per cent were immunised by the end of October, rising to around 70 per cent by the end of November and 72.6 per cent at the end of January”.⁵

Community pharmacy teams need to work as collaboratively as possible with colleagues in general practice to provide the best possible care for patients, says PSNC. To help overcome supply issues and guide patients to where supply is available, NHS England, PSNC and the BMA have produced guidance to ensure that GPs and community pharmacy teams signpost patients to local providers if they don’t have the recommended vaccine in stock.

PSNC advises pharmacists to consider:

• Using the prioritisation approach to inform flu vaccination activity (e.g. ensure the frst priority group gets vaccinated first)
• If an eligible patient presents at the pharmacy seeking vaccination, and the appropriate vaccine is available, vaccinate them there and then rather than asking them to return later in the season
• If the recommended vaccine is not available, the patient should be asked to return when the vaccine will be available
• Liaise with local GP practices and pharmacies to signpost people to where aTIV is available
• Ensure consistent messages are given about the flu programme and why specific vaccines are recommended.

Patients over 65 years should not be given the quadrivalent vaccine other than in exceptional circumstances – for instance, if there is no locally accessible supply of aTIV and no further supplies are expected.

PSNC warns any contractor who administers a vaccine other than the recommended one for the relevant age group may be asked by NHS England to justify their decision. “If, in NHS England’s opinion, the clinical justifcation is not satisfactory, the contractor may be deemed to be in breach of the terms of service for this service.”

Further guidance and information on this year’s flu vaccination service, including advice on vaccinating patients aged 65 years and over, use of QIV in exceptional circumstances and the contractual consequences of non-compliance, is available on the PSNC website.

Real threat

It is 100 years since the Spanish flu epidemic of 1918, described as one of the most devastating events in human history, killing 50-100 million people worldwide – up to five per cent of the population. The epidemic was the result of an H1N1 virus, which was unusually fatal in those between 20-40 years of age.

The threat of a pandemic remains real and research continues to try to develop a universal flu vaccine. Researchers from the University of Oxford recently published a study in Nature Communications showing pre-clinical success for a universal flu vaccine, using a mathematical model to look at the evolutionary dynamics of the infectious disease. It is hoped that such a vaccine would potentially give lifelong protection and the same model could be used to design protection against the common cold. 

References

1. The national flu immunisation programme 2018/19 (28 March 2018): assets. publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/ fle/694779/Annual_national_flu_programme_2018-2019.pdf
2. Joint Committee on Vaccination and Immunisation: gov.uk/government/groups/jointcommittee-on-vaccination-and-immunisation
3. gov.uk/government/publications/flu-vaccination-supporting-data-for-adult-vaccines/ summary-of-data-to-support-the-choice-of-influenza-vaccination-for-adults-inprimary-care
4. psnc.org.uk/services-commissioning/psnc-briefngs-services-and-commissioning/ psnc-briefng-041-18-changes-to-the-seasonal-influenza-vaccination-advancedservice-2018-19-august-2018
5. england.nhs.uk/wp-content/uploads/2018/08/flu-vaccs-2018-planning-letter.pdf