Week's news analysis

The pandemic accelerates so are trials
on Covid-19 treatments

By The Editor - 28 october 2020

While the Covid-19 pandemic shows no sign of decrease and accelerates on the contrary dramatically in many parts of the world, urging governments to set up more restrictive measures, several drugmanufacturers raise hopes for potential coronavirus vaccines or treatments in the coming weeks or months.

- End of October, AstraZeneca and the University of Oxford announced that their Covid-19 experimental vaccines produced an immune response in both old and young adults, while triggering lower adverse responses among the elderly. The news that older people get an immune response from the vaccine is positive as the immune system weakens with age and older people are those most at risk of dying from the virus.

Meanwhile, October 23, the FDA gave AstraZeneca the green light to recommence its Phase 3 Covid-19 vaccine trial in the US. The trial was paused globally on September 6 after an unexplained illness in a study participant. While trials had recommenced in the UK on September 14 following the go-ahead from regulators (as well as in Brazil, South Africa and Japan in the following weeks), it was not the case in the US. AstraZeneca said results are anticipated later this year, depending on the rate of infection within the communities where the clinical trials are being conducted.

Moreover the European Medicines Authority (EMA) started a rolling review of AstraZeneca's vaccine at the beginning of October, marking the first Covid-19 vaccine to enter this process. This means that the committee has started evaluating the first batches of data from earlier trials.

- Johnson & Johnson's vaccine candidate JNJ-78436735 also resumed its trials after having suffered a similar setback as AstraZeneca, with an unexplained illness resulting in a pause to its Phase 3 trial earlier this month. However, on October 23 the company said it was preparing to resume recruitment in the US, in the pivotal Phase 3 ENSEMBLE trial of its investigational Janssen Covid-19 vaccine in the United States. The first batches of its Covid-19 vaccine could be available as soon as in January, for emergency use.

- Roche and partner Atea Pharma joined hands to develop oral treatment for Covid-19. The companies will develop, manufacture and distribute AT-527, Atea's investigational oral direct-acting antiviral, to people around the globe. AT-527 acts by blocking the viral RNA polymerase enzyme needed for viral replication, and is currently being studied in a Phase 2 clinical trial for hospitalised patients with moderate Covid-19. A Phase 3 clinical trial, expected to start in Q1 2021, will explore the potential use in patients outside of the hospital setting. AT-527 also holds the potential to be the first oral treatment option for Covid-19 patients that are not hospitalised. Roche agreed to pay $350 million in cash upfront for the deal.

- Meanwhile, October 22, Remdesivir became the first drug to gain full clearance in the US for Covid-19. Gilead Sciences announced that Veklury (remdesivir) had been approved by the FDA to treat hospitalised Covid-19 patients aged 12 years and older and weighing at least 40 kg. The antiviral was previously authorised by the agency for emergency use only. The FDA's decision rose questions from the WHO, which found "little or no effect" on mortality from Gileads'antiviral so far.

- Last but not least, according to Pfizer and partner BioNTech, the earliest they will apply for FDA emergency-use authorisation (EUA) for their Covid-19 vaccine programme would be in the third week of November.

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