Adjuvanted Flu Vaccine Showed 'Encouraging' Results

Peter Russell

May 31, 2019

New figures showed "encouraging" effectiveness for the newly licensed adjuvanted trivalent influenza vaccine (aTIV) offered to people aged 65 years and over during the 2018-19 flu season.

Public Health England (PHE) estimated that aTIV, given to the majority in this age group, provided approximately 62% protection against the flu strains circulating during the winter. That compared with 49.9% for those aged 65 and over who received all types of influenza vaccine.

Vaccine uptake in 2018 to 2019 in England for those aged 65 and older was 72%, slightly lower than that seen in 2017 to 2018.

Influenza A(H1N1)pdm09 was the main strain circulating, although influenza A(H3N2) also circulated later on, PHE said.

Low to moderate levels of influenza activity were seen during the season, according to PHE's Surveillance of influenza and Other Respiratory Viruses in the UK , although impact on secondary care in terms of hospitalisations and ICU admissions was high.

Overall, the flu vaccine offered to those eligible for immunisation reduced the likelihood of visiting the GP because of flu by approximately 44%, PHE said.

Vaccine uptake in 2018 to 2019 was lower than the 2017 to 2018 season for those aged 6 months to under 65 years who had one or more underlying clinical risk factors (48.0%), and pregnant women (45.2%). Vaccine effectiveness for those aged 18 to 64 was 44.2%.

People aged 18 to 64 in an at-risk group were offered the quadrivalent vaccine during the 2018-19 season.

Roll out continued of the childhood live attenuated influenza vaccine (LAIV) programme across the UK which reached its sixth season. The programme targeted 2 to 3-year-olds in primary care and all children of school year reception, 1, 2, 3, 4, and 5 across the UK.

Uptake levels in school-age children varied by country, at 60.8% in England up to year 5 and 69.9% in all primary school children in Wales, 72.9% in Scotland and 75.9% in Northern Ireland. 

Provisional vaccine effectiveness of LAIV in children aged 2-17 years of age showed "significant" effectiveness during the season, the report found, with protection put at 48.6%.

During the 2019-20 season, all primary school children across the UK will be eligible for LAIV when availability is extended to school year 6.

Vaccine uptake for health care workers in 2018 to 2019 increased to 70.3%, up from 68.7% in 2017 to 2018.

Dr Richard Pebody, PHE's head of flu, said: "We're pleased that the adjuvanted vaccine, which was offered to older adults for the first time this year in England provided encouraging protection against the main circulating strains this winter. The flu vaccine programme demonstrates the value of vaccination throughout the life course.

"We’re pleased that more parents have been taking up the offer of vaccination for their children – and encourage anyone who is eligible to do so every winter. It’s the best defence we have against this unpredictable virus."

Prof John Edmunds from the Centre for the Mathematical Modelling of Infectious Diseases, London School of Hygiene & Tropical Medicine, said: "The UK switched to an adjuvanted flu vaccine last year for the elderly, as the traditional (unadjuvanted vaccine) tends to give lower levels of protection in this key at-risk group.  Hence, it is very encouraging news that relatively high levels of protection appear to have been achieved with this new vaccine. 

"However, flu vaccine effectiveness does vary from year to year, depending on how well the vaccine is matched with the circulating strains.  So, although this is good news, we would need to see data over a number of years before we could make firm conclusions about the effectiveness of this vaccine."

Change of Mind Over Letermovir

The National Institute for Health and Care Excellence (NICE) overturned a previous negative assessment to recommend letermovir (Prevymis, Merck, Sharpe & Dohme) for the prevention of cytomegalovirus (CMV) reactivation and disease after an allogeneic haematopoietic stem cell transplant (HSCT) in adults.

Current practice largely focusses on monitoring viral levels and giving antivirals to asymptomatic patients to prevent disease progression (pre-emptive therapy).

An appraisal committee considered the lack of any licensed treatments for preventing CMV reactivation after HSCT, as well as clinical trial evidence showing that letermovir was effective in reducing CMV infection as well as the need for pre-emptive therapy.

The recommended dose of letermovir is 480 mg once daily for 100 days.

The drug's list price is £3723.16 for 28×240 mg tablets, although the drug was being offered to the NHS at a discount.

In draft guidance, NICE said it was now able to recommend letermovir after considering new data from the company.

Final guidance is expected on 31st July 2019.

Therapeutic Hypothermia for Stroke

Therapeutic hypothermia should not be used for acute ischaemic stroke because the technique was associated with serious complications, NICE ruled.

In final guidance, it said evidence failed to show any meaningful improvement in outcomes for patients undergoing this treatment, which involves maintaining body temperature at 33C to 36C for at least 12 to 24 hours.

Worse neurological outcome, pneumonia, and bleeding were the key safety outcomes assessed by the appraisal committee.

Percutaneous Mitral Valve Leaflet Repair 

The routine NHS use of percutaneous mitral valve leaflet repair for mitral regurgitation was supported by adequate clinical evidence on efficacy and safety, NICE said in final guidance.

In final guidance, it said the technique should only be performed in specialist centres and by a multidisciplinary structural heart team that should typically include an interventional cardiologist, an expert in transoesophageal echocardiography, an expert in heart failure, a cardiac anaesthetist, a cardiac surgeon, and a specialist nurse.

Additionally, the procedure should only be carried out by clinicians with specialist training, and while supervised by an experienced mentor for at least the first 20 procedures, NICE said.

Anal Fistula

The use of collagen paste to close an anal fistula with the aim of promoting healing could not be recommended because of a lack of evidence to support use of the technique, NICE said.

In final guidance it called for further research to focus on patient selection, the type of fistula treated, how the internal fistula opening was closed, and long-term outcomes including recurrence and the need for reoperation.

The technique would be reviewed again in 2022.

Restrictions on MS Drug 

The Medicines and Healthcare products Regulatory Agency (MHRA) announced restrictions on the use of alemtuzumab (Lemtrada, Genzyme) in May pending an urgent safety review following reports of serious cardiovascular events and immune-mediated reactions, including autoimmune hepatitis.

Strengthened requirements were introduced to monitor vital signs and liver function before and during treatment.

It said all patients on alemtuzumab for multiple sclerosis should be alerted to the risks and symptoms.

Advice on Tofacitinib

The MHRA imposed temporary restrictions on the use of the 10 mg twice-daily dose of tofacitinib (Xeljanz, Pfizer) after the European Medicines Agency temporarily advised doctors not to prescribe the 10 mg twice-daily dose to patients at high risk of pulmonary embolism.

The recommendation stemmed from results of a study evaluating the safety of tofacitinib 5 mg twice daily and tofacitinib 10 mg twice daily in comparison with a tumour necrosis factor (TNF) inhibitor in patients with rheumatoid arthritis aged 50 years or older who had one or more cardiovascular risk factors.

Pending results of a European safety review, the 10 mg twice-daily dose of tofacitinib, which is authorised for patients with ulcerative colitis, must not be used in patients at high risk of pulmonary embolism, the MHRA said.

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