In two major COVID-19 developments today, the World Health Organization (WHO) updated its mask guidance, urging countries with widespread transmission to encourage mask use in situations where physical distancing isn’t possible, and researchers from the United Kingdom stopped a large hydroxychloroquine trial after no benefit was found in hospitalized patients.
Today the global total climbed to 6,703,686 cases, and 393,383 people have died from their infections, according to the Johns Hopkins online dashboard.
Mask guidance for clinical settings, at-risk people, general public
At a media briefing today, WHO Director-General Tedros Adhanom Ghebreyesus, PhD, said the updated guidance has three main changes, plus new information on the construction of cloth face masks that was guided by research that it commissioned. He said the new recommendations come with strong caveats that masks alone won’t protect people from COVID-19 and that they should be used as part of comprehensive measures that also include physical distancing, hand hygiene, and other public health measures.
The recommendation for the general public applies to cloth face masks and would apply, for example, on public transport, in shops, or in other crowded environments, Tedros said.
Another new recommendation applies to anyone working in a clinical area of a health facility, not just those caring for patients who have COVID-19. The WHO recommends medical masks in any hospital clinical setting, such as a doctor making rounds in hospital wards that don’t have COVID-19 patients.
The third new piece of the guidance applies to people who have risk factors and live in community transmission areas, who should wear medical masks. Those groups include people ages 60 and older and those with underlying medical conditions.
Regarding cloth face masks, the WHO recommends that they be made with three different layers: an inner cotton absorbent one, a middle filtering one made from polypropylene, and an outer nonabsorbent layer made from, for example, a polyester polypropylene blend.
WHO officials today said the rationale for wearing a cloth face mask in certain settings is to provide a barrier that prevents the spread of droplets from people with asymptomatic or presymptomatic infections. Mike Ryan, MD, said the goal is source control, “more of an altruistic act.” And they emphasized that respiratory protection against COVID-19 is an area of research that will expand and that they expect recommendations will evolve over time.
UK researchers end large hydroxychloroquine study
In another key development today, researchers from Oxford University involved in large randomized clinical trial of different drugs for treating COVID-19 (the Recovery trial) today announced that they have stopped the hydroxychloroquine arm of the study after a review of the data found no benefit in hospitalized patients.
The latest announcement comes at the end of a week that saw a flurry of new developments surrounding the controversial drug, including yesterday’s retraction of a high-profile observational study due to questions about the validity of the data and the publication of a randomized controlled trial that found no benefits for preventing COVID-19 in people exposed to infected patients.
In a statement, chief investigators Peter Horby, MD, PhD, and Martin Landray, PhD, said the trial has moved at unprecedented speed and has enrolled more than 11,000 patient from 175 National Health Service hospitals across the United Kingdom. A data monitoring committee has been reviewing the data about every 2 weeks to look for evidence that would be strong enough to impact COVID-19 treatment. Yesterday, after a request from UK drug regulators, the panel reviewed unblinded data on the hydroxychloroquine arm of the trial.
“We have concluded that there is no beneficial effect of hydroxychloroquine in patients hospitalised with COVID-19,” they said. “We have therefore decided to stop enrolling participants to the hydroxychloroquine arm of the RECOVERY Trial with immediate effect. We are now releasing the preliminary results as they have important implications for patient care and public health.”
In the study, 1,542 patients were randomized to hydroxychloroquine and 3,132 were randomized to usual care. They found no significant difference in 28-day mortality, which was 25.7% for the drug and 23.5% for usual care, which a hazard ratio of 1.11 (95% confidence interval 0.98 to 1.26). They also found no benefits in the length of hospital stay or other outcomes. Horby and Landray said the team would publish full results as soon as possible.
Horby said hydroxychloroquine and chloroquine have garnered a lot of attention, despite the absence of good evidence. “Although it is disappointing that this treatment has been shown to be ineffective, it does allow us to focus care and research on more promising drugs,” he said.
Landray added that the preliminary results are quite clear. “This result should change medical practice worldwide and demonstrates the importance of large, randomised trials to inform decisions about both the efficacy and the safety of treatments,” he added.
At today’s WHO media briefing, Soumya Swaminathan, MD, the group’s chief scientist, said the WHO is aware of the Recovery trial announcement. The WHO-led Solidarity trial also had a large randomized controlled trial of treatments underway, including a hydroxychloroquine arm, which recently resumed after a pause to look for any potential safety signals.
She said WHO’s data committee will look at the UK group’s final analysis as it makes a decision on the next step, but for now, the trial will continue.
Donors pledge $8.8 billion for vaccine efforts
In another international development, the Global Vaccine Summit hosted virtually by the United Kingdom yesterday raised $8.8 billion from 32 donor governments and 12 foundations for childhood immunizations and to support the global battle against COVID-19.
At today’s WHO briefing, Tedros thanked donors for the funding, which will fully fund GAVI, the Vaccine Alliance, for its next 5-year cycle. “This is a vital investment in saving millions of lives from vaccine-preventable diseases,” he said.
According to a statement from GAVI, $567 million was raised for a new financing instrument to provide low- and middle-income countries with access to COVID-19 vaccines.
The group estimates that the money raised for routine childhood immunizations will help vaccinate 300 million children over the next 5 years. Of the money pledged, $3.6 billion will go toward buying the vaccine, more than double the amount available for GAVI’s last 5-year cycle. Also, about $6 billion will be invested in service delivery, though officials warned that COVID-19 disruptions could change the delivery cost projection.
In other COVID-19 vaccine developments, the Coalition for Epidemic Preparedness Innovations (CEPI) yesterday and today announced support for two more vaccine efforts, one an investment up to $383 million in a partnership with Astra Zeneca to create extra manufacturing capacity to make 300 million doses of its vaccine candidate. Today CEPI, CSL, and the University of Queensland announced a partnership to speed the development of a COVID-19 vaccine candidate that uses the university’s “molecular clamp” technology, expected to enter clinical trials in July.
