WHO enlists more COVAX participants, clears 2nd rapid test

At a World Health Organization (WHO) media briefing today that began with the director-general's wishes of a full and swift recovery from COVID-19 for US President Donald Trump and First Lady Melania Trump, officials announced more progress with the COVAX initiative and rapid testing.

In other developments, the European Medicines Agency (EMA) said it is looking into reports of kidney injury in people taking remdesivir, an experimental treatment for COVID-19, and the Coalition for Epidemic Preparedness Innovations (CEPI) announced the launch of a new centralized lab network to do head-to-head evaluations of COVID-19 vaccine candidates.

More COVAX participants, another rapid test

The global COVID-19 total is growing by about 2 million cases each week, and the world is at another critical moment in its response, WHO Director-General Tedros Adhanom Ghebreyesus, PhD, said today. However, he noted that countries are in four different situations, which range from intense transmission to holding steady with few cases after avoiding large earlier outbreaks.

Also, he said 168 countries have now joined the COVAX Facility, a WHO-led effort to pool the risk of supporting vaccine development and for securing doses equitably for countries across all income levels. Tedros added that 25 more countries have said they will join the initiative soon.

In another development, Tedros said the WHO has just approved a second rapid antigen test. WHO records show that the second rapid test cleared for emergency use listing is the Panbio rapid test made by Abbott. On Sep 22 it approved the first rapid test, produced by SD Biosensor. Earlier this week, the WHO announced a massive effort to supply low- and middle-income countries with 120 million rapid tests made by the two companies over the next 6 months.

When asked about US COVID developments, including Trump's illness, Mike Ryan, MD, who leads the WHO's health emergencies program, said the agency doesn't comment on the behaviors of individuals or criticize specific countries. "We are a community and we will get through this together," he said. "This is not a time to turn on each other."

EMA probes remdesivir reports

The EMA said in a statement today that its safety committee is reviewing reports of acute kidney injury in some patients with COVID-19 who were being treated with the antiviral drug remdesivir. The EMA had conditionally approved the drug for treatment of COVID-19 in those ages 12 and older with pneumonia who require supplemental oxygen.

When Gilead, the maker of remdesivir, applied for marketing authorization, it had evaluated renal toxicity in animals with the understanding that more information was needed to better understand the impact of the drug on kidneys. The EMA said so far there's no causal link between the drug and reports of acute kidney injury, which can result from other factors such as diabetes and COVID-19 infection.

At today's WHO briefing, officials said they are reviewing the situation and are in close contact with the EMA regarding its investigation. The US Food and Drug Administration (FDA) granted an emergency use authorization (EUA) for remdesivir for those ages 12 and up on May 20.

Network to compare vaccine candidates

With 320 COVID-19 vaccines and development, with 41 of them in clinical trials, CEPI today announced the launch of a new centralized lab network to standardize evaluation and allow for head-to-head comparisons, steps that can help researchers identify the most successful candidates.

In a statement, CEPI said the network is available to all vaccine developers and that network labs are located in Canada, the United Kingdom, Italy, the Netherlands, Bangladesh, and India. The labs in Canada and the UK are providing the assays, reagents, and controls. The current testing will cover evaluation of vaccine through phase 2 studies, and CEPI said it has also put out a proposal for labs to assess phase 3 clinical trial samples.

CEPI noted that similar efforts have been conducted for HIV and flu vaccines, but the collaboration for assessing and comparing COVID-19 vaccines has been done at an unprecedented speed and scale.

Global hot spots

India, as it has for the past several weeks, continues to report the world's highest daily case total. It added 81,484 more cases, with its deaths nearing the 100,000 mark.

In Europe, where many countries are experiencing a second spike in cases, Poland reported a daily record high of 2,292 cases, as Madrid became the first of Europe's capitals to go on lockdown again and Italian officials ordered people in Rome and the surrounding Lazio region to wear facemasks at all times, including outdoors, to curb the rise in cases.

Elsewhere, cases in the WHO's Middle East region rose by 5% last week, with deaths rising by 4%, the regional office said on Twitter. Jordan and the United Arab Emirates are among countries reporting steady rises, and Tunisia's health ministry said today the country had a record daily high of 1,308 new cases on Sep 30 and that officials will impose a night curfew on two of its governorates, Reuters reported.

The global COVID-19 total today climbed to 34,448,691 cases, and 1,025,315 people have died from their infections, according to the Johns Hopkins online dashboard.

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