Remdesivir as First COVID-19 Treatment Recommended for EU Authorization

European Medicines Agency’s human medicines committee has recommended granting a conditional marketing authorization to remdesivir in European Union for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen. This was announced through a press release by the agency today.

Remdesivir (sold under the name Veklury) is the first medicine against COVID-19 to be recommended for authorization in the European Union. The request for approval came after the agency under an exceptionally short timeframe pushed for a rolling review procedure. Rolling reviews are only used during public health emergencies to assess data as they become available.

By late April the European Medicines Agency began assessing data on quality and manufacturing, non-clinical data, preliminary clinical data and supporting safety data from compassionate use programmes, to see if the drug can be helpful.

The final approval request was based on latest data from the US National Institute of Allergy and Infectious Diseases (NIAID) study, plus supporting data from other studies on remdesivir.

The US NIH study evaluated the effectiveness of a 10-day course of remdesivir in over 1,000 hospitalized patients with COVID-19. Remdesivir was compared with placebo and the main outcome of effectiveness was patients’ time to recovery.

The results showed that the patients treated with remdesivir recovered after about 11 days, compared with 15 days for patients given placebo. The drug was only effective in people with severe COVID-19 symptoms.

In patients with mild to moderate disease the time to recovery was 5 days for both the remdesivir group and the placebo group. For patients with severe disease (90% of the study population), time to recovery was 12 days in the remdesivir group and 18 days in the placebo group.

No difference was seen in time to recovery in patients who started remdesivir when they were already on mechanical ventilation or ECMO (extracorporeal membrane oxygenation). Data on the proportion of patients who died up to 28 days after starting treatment are currently being collected for final analysis.

Given this data the European Medicine Agency considered the balance of benefits and risks of using this drug to treat COVID-19 patients with pneumonia requiring supplemental oxygen.

The Agency recommends that the treatment should start with a 200-mg infusion on the first day, followed by one 100-mg infusion a day for at least 4 days and no more than 9 days.

The Agency will continue to evaluate further studies for the effectiveness and safety of remdesivir.  The company which will be given approval will have to submit the final reports of the remdesivir studies to the Agency by December 2020, and further data on the quality of the medicine, as well as the final data on mortality, by August 2020.

The New UK COVID-19 Vaccine

In other news, the Imperial College London has started first human trial for their new coronavirus vaccine. This was announced in a press release by the institution.

The first participant has already been given the first dose and is reported to be in good health with no safety concerns after being injected on 19 June. A second booster dose of the vaccine will be administered within four weeks.

The institute is looking forward to recruiting at least 300 people in the first phase of the vaccine trial which is the second vaccine to enter human trials in England.

Previously researchers at the University of Oxford began testing their vaccine in April and have currently an enrolled strength of 1000 participants in the study.

Drug company AstraZeneca, which is the commercial partner of University of Oxford for this vaccine, has already begun production of the vaccine with the aim of building up stockpiles to be ready for deployment if it is approved for use later in the year.

In the Imperial corona vaccine trial, 15 healthy volunteers are expected to be given the vaccine to initiate the first phase of the trial. The Imperial vaccine is an RNA vaccine that uses synthetic strands of RNA based on the genetic material of the coronavirus (Sars-CoV-2) that causes Covid-19.

The vaccine works by providing human muscle cells with the genetic information to make the “spike” protein on the surface of Sars-CoV-2. This protein in turn triggers an immune response and provide immunity against an infection from the virus in the future.

If the first phase is successful and the vaccine is safe, then a second phase of the trial involving 6,000 people is expected to go ahead in October.

Imperial College has received more than £41m in funding from the UK government and £5m in donations to develop this vaccine. The educational institute has also created a social enterprise called VacEquity Global Health to develop and distribute its vaccine across the UK and worldwide if the trials are successful.

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