Remdesivir approved by US FDA but WHO trial reports little impact on survival
Last month, the US Food and Drug Administration approved the antiviral remdesivir for the treatment of COVID-19 in adults and children over 12 years of age weighing at least 40 kilograms and who require hospital admission. Remdesivir should only be administered in a hospital or a healthcare setting able to provide acute care comparable to inpatient hospital care. (Further information). According to preliminary results from a World Health Organization Solidarity trial, however, remdesivir has little or no impact on survival, initiation of ventilation and length of hospital stay. This trial followed 11,266 adults at 405 hospitals in 30 countries and is awaiting peer review.
Convalescent plasma for moderate COVID-19 does not reduce severe disease
Results of an open-label, parallel arm, phase 2, randomised controlled trial of convalescent plasma to treat moderate COVID-19 disease was published in the BMJ last month. The trial, involving 464 patients from 39 hospitals in India, found that use of convalescent plasma was not associated with a reduction in progression to severe COVID-19 or all-cause mortality. More here.
Trial of COVID-19 vaccine reports death in Brazil
The phase 3 clinical trial of ADZ1222, a vaccine developed by AstraZeneca and the University of Oxford, reported the death of a volunteer in Brazil last month. Following assessment of the case no concerns about safety of the trial were found and the independent safety monitoring committee and the Brazilian regulator have recommended that it continues. A few days later a spokesperson at AstraZeneca was reported as saying that its vaccine triggers the immune response similarly in older and young adults. Meanwhile on the vaccines front, J&J also paused its large, late-stage trial last week after a study participant became ill, while Pfizer announced that it hoped to seek authorisation for its COVID-19 vaccine mid-November. As of 19 October, the World Health Organization reported that there are 44 candidate COVID-19 vaccines under clinical evaluation.
WHO states position on herd immunity
Attempts to reach herd immunity through exposing people to a virus are scientifically problematic and unethical, the World Health Organization said last month. At a media briefing, WHO Director General Tedros Adhanom Ghebreyesus said that not enough is known about immunity to COVID-19. He explained that herd immunity is a concept used for vaccination; measles requires about 95% of a population to be vaccinated and the remaining 5% will be protected, whereas for polio the threshold is around 80%. Until we better understand COVID-19 immunity, it will not be possible to know how much of a population is immune and how long that immunity lasts for. “Letting the virus circulate unchecked therefore means allowing unnecessary infections, suffering and death,” Dr Tedros said.
UK pharmacists authorised to administer unlicensed COVID-19 vaccines
Pharmacists in the UK will be able to administer an unlicensed COVID-19 vaccination when one becomes available, following changes to the Human Medicine Regulations that came into effect last month. The Pharmaceutical Journal reported that the amendments to law followed a government consultation on the delivery of COVID-19 and influenza vaccines by a wider workforce.
FIP’s “Transforming vaccination globally and regionally” programme offers two new episodes
“Empowering pharmacists to deliver vaccination at health-system level”, episode 2.2 of the FIP “Transforming vaccination globally and regionally” programme, will take place on 3 November at 14:00 CET, and will focus on the FIP Development Goal 7: Advanced integrated services. This will cover change management principles in the context of integrating advanced practice services into everyday practice and ensuring that vaccination by pharmacists in all settings and jurisdictions is consistent with best evidence and practice guidelines. Join here free of charge.
Episode 2.3 “Removing policy barriers to pharmacist vaccinations”, on 5 November at 14:00 CET, will look at FIP Development Goal 13: Policy development. Join here free.