A larger scale clinical trial of nebulised interferon beta-1a as a treatment for COVID-19 has been launched in the UK, after a pilot study found it reduced the risk of developing severe disease or dying by almost 80%.
In the phase II study, patients given interferon beta were more than twice as likely to recover as those in the placebo group. They also had significant reductions in breathlessness, and the average time they remained in hospital was reduced by a third, from 9 days to 6.
The phase III study will involve 600 subjects in 20 countries, and will enrol COVID-19 patient who need supplementary oxygen. The trial of the nebulised form of interferon beta is expected to complete by early summer 2021. If results mirror those from the phase II study, marketing authorisation is expected to follow soon afterwards.
- A new trial has found the arthritis drug tocilizumab no better than standard care for severe COVID-19, and the trial was stopped early because of an increased number of deaths among those receiving the drug. These results contradict earlier observational studies that suggested the biologic therapy tocilizumab could be beneficial because it blocks part of the immune system (interleukin 6) that can ‘go into overdrive’ in some patients with COVID-19. Researchers say their new placebo-controlled trial raises questions about an anti-inflammatory approach to the treatment of COVID-19 beyond corticosteroids.’
Public Health England has clarified advice on giving the same type of COVID-19 vaccine for the first and second doses after some reports suggested they could be administered interchangeably.
Patients should be given the same type of vaccine for both first and second doses unless the same vaccine was not available or there was no record of which vaccine had been used for the first dose.
Head of Immunisation at PHE, Mary Ramsay said ‘every effort should be made to give patients the same vaccine, but where this is not possible it is better to give a second dose of another vaccine than not at all.’
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has issued a statement urging adherence to the dosing schedules for the available COVID vaccines, after the UK Government announced that the priority should be to maximise the number of people receiving a first dose rather than ensuring that both doses should be given to fewer patients. UK chief medical officers announced on 30 December that the second doses of COVID vaccines should be given towards the end of 12 weeks rather than within the previously recommended 3-4 weeks.
EFPIA said: ‘The biopharmaceutical industry supports adherence to the dosing that has been assessed in clinical trials and any changes from the tested and approved dosing and vaccination schedules should follow the science’.
The European Medicines Agency has said that the gap between the first and second doses of the Pfizer-BioNTech vaccine should not exceed 42 days. However, Andrew Pollard who led the clinical trials for the Oxford-AstraZeneca vaccine said extending the gap between doses made ‘biological sense’. ‘Generally a longer gap between vaccine doses leads to a better immune response,’ he said.
A history of anaphylaxis is no longer a contraindication to the Pfizer/BioNTech COVID-19, according to the MHRA. Healthcare professionals had been warned not to give the vaccine to any patients with a history of severe allergy to food or medicines after three cases of anaphylaxis occurred on the first day of the COVID-19 vaccination programme but the MHRA has now withdrawn that advice.
Patients with a history of systemic allergic reactions can now receive any COVID-19 vaccine unless they are allergic to any of the vaccine components.
Pregnant and breastfeeding can also be vaccinated following an update to the prescribing information for the Pfizer/BioNTech vaccine. It is now considered that the benefits of vaccination outweigh the potential risks. The advice to avoid pregnancy for two months after vaccination has also been withdrawn.
The NMC has announced an extension to the COVID-19 temporary register to include overseas-trained nurses whose applications to join the permanent register are in progress. Registrar Andrea Sutcliffe said the need for as many people as possible to provide skilled care and support in hospitals, nursing homes and in the community has never been greater.’ The NMC will therefore be inviting an additional 2,000 nurses who have trained overseas to join the temporary register, which opened in March 2020 to allow thousands of former nurses to return to nursing.
The RCN welcomed the move, saying ‘these measures are vital to expand the nursing workforce… the level of vacant nurse jobs in England was high before the pandemic and nursing staff have been stretched even further in the last 10 months’ but added that the UK must end its over-reliance on overseas nursing staff by investing in domestic education and support for nursing students.
The NMC has also announced that it will reintroduce emergency education standards to enable final year nursing students to opt-in to support the COVID-19 response through extended – paid – clinical placement.