WHO discontinues hydroxychloroquine, lopinavir/ritonavir trial for COVID-19 treatment
UNTV News • July 6, 2020 • 521
The World Health Organization (WHO) announced on Saturday that it was discontinuing hydroxychloroquine and lopinavir/ritonavir arms for its Solidarity Trial, citing little or no reduction in the mortality of hospitalized COVID-19 patients.
The WHO said the decision was in light of the evidence from the Solidarity Trial interim results.
“These interim trial results show that hydroxychloroquine and lopinavir/ritonavir produce little or no reduction in the mortality of hospitalized COVID-19 patients when compared to standard of care. Solidarity trial investigators will interrupt the trials with immediate effect,” the WHO said in a press release.
But the organization said this decision applies only to hospitalized patients and does not affect the possible evaluation in other studies of hydroxychloroquine or lopinavir/ritonavir in non-hospitalized patients or as pre- or post-exposure prophylaxis for COVID-19.
The Solidarity Trial was established by the WHO in March to find an effective COVID-19 treatment for hospitalized patients. It was originally designed to have five trial arms, including standard or usual care provided to COVID-19 patients, remdesivir, lopinavir/ritonavir combined, lopinavir/ritonavir combined with interferon beta, and hydroxychloroquine or chloroquine.
By enrolling patients in multiple countries, the Solidarity Trial aims to rapidly discover whether any of the drugs slow disease progression or improve survival. (Reuters)
The “hybrid” coronavirus variant which Vietnam officials thought was a combination of strains first identified in the U.K. and India does not meet the definition of a new variant, the World Health Organization’s Vietnam representative told Nikkei newspaper Thursday.
“There is no new hybrid variant in Vietnam at this moment based on WHO definition,” Dr. Kidong Park, the global health body’s Vietnam representative, said in an online interview.
Dr. Park said the variant detected is a delta variant which was first detected in India and has appeared in other countries.
Park added that there is no alarming alert from WHO, as of the moment but still stressed the dangers of the delta variant since it is highly contagious.
The WHO representative clarified the matter after Vietnamese authorities expressed alarm and announced that a newly discovered variant could have contributed to the COVID-19 outbreaks in the country. AAC
The World Health Organization (WHO) on Tuesday, June 1, validated CoronaVac COVID vaccine produced by China-based pharmaceutical firm Sinovac for emergency use.
This gives the assurance that the vaccine meets international standards for safety, efficacy, and manufacturing.
“The world desperately needs multiple COVID-19 vaccines to address the huge access inequity across the globe,” said Dr. Mariângela Simão, WHO Assistant Director General for Access to Health Products.
“We urge manufacturers to participate in the COVAX Facility, share their know-how and data, and contribute to bringing the pandemic under control,” she added.
WHO’s Emergency Use Listing (EUL) is a prerequisite for COVAX Facility vaccine supply and international procurement.
It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
The EUL assesses the quality, safety, and efficacy of COVID-19 vaccines, as well as risk management plans and programmatic suitability, such as cold chain requirements through the product evaluation group composed of regulatory experts from around the world.
In the case of the Sinovac-CoronaVac vaccine, the WHO assessment included on-site inspections of the production facility.
Given Sinovac-CoronaVac’s easy storage requirements, it is very manageable and particularly suitable for low-resource settings.
Based on available evidence, WHO recommends the vaccine for use in adults 18 years and older, in a two-dose schedule with a spacing of two to four weeks.
Vaccine efficacy results showed that the vaccine prevented symptomatic disease in 51 percent of those vaccinated and prevented severe Covid-19 and hospitalization in 100 percent of the studied population.
Few older adults (more than 60 years) were enrolled in clinical trials, so efficacy could not be estimated in this age group.
Nevertheless, WHO is not recommending an upper age limit for the vaccine because data collected during subsequent use in multiple countries and supportive immunogenicity data suggest the vaccine is likely to have a protective effect in older persons.
WHO recommends that countries using the vaccine in older age groups conduct safety and effectiveness monitoring to verify the expected impact and contribute to making the recommendation more robust for all countries.
MANILA, Philippines — The Department of Health (DOH) has yet to receive an official statement from the World Health Organization (WHO) on the community transmission of new variants of novel coronavirus disease (COVID-19) in the Philippines, the agency’s spokesperson said Friday.
“We still not have received from WHO an official statement to inform us that there is this, based on their assessment that there is already community transmission among these variants that we have already detected in the country,” Health Undersecretary Maria Rosario Vergeire said in an online briefing.
Vergeire, however, said they have assumed such transmission due to reports about individuals who have tested positive for COVID-19 variants.
“But of course, there has been this assumption already even before dahil nakikita naman ho natin na talagang tumataas ang bilang ng mga taong naa-identify natin with these variants,” she said.
WHO country representative Dr. Rabindra Abeyasinghe earlier said they are seeing “some degree of community transmission” of the variants that were first detected in South Africa and the United Kingdom.
Abeyasinghe said there was reason to believe that there was community transmission of the said variants in several parts of the Greater Manila Area based on evidence and the number of cases.
The linkages among cases could not be traced yet and that it was uncertain whether these variants were now the dominant variants in the said areas.
“We have a challenged in the fact that the Philippines has limited capacity for genome sequencing. We have only capacity to do about 700 samples on a weekly basis,” Abeyasinghe said.
“We are engaging with the government to see how we can expand that capacity. With limited capacity, it’s difficult for us to judge exactly how widespread these variants are and how their distribution is,” he added.
The WHO said it has sent a team of experts to assess the possible community transmission of new COVID-19 variants in Metro Manila and nearby provinces.
Following this pronouncement, the DOH reminded the public to protect themselves by complying with health protocols and to get vaccinated against COVID-19.
“Kahit ano pang variant ang meron tayo dito sa ating bansa, pareho pa rin kailangan nating gawin. di porket may community transmission… ay talagang naman pong matatakot na tayo ng husto,” she said.
“Kailangan lang lang po ay lalabanan natin by doing and complying with the heath protocols at kung eligible na po kayong magpabakuna, magpabakuna na po tayo,” she added. – RRD (with details from Correspondent Aiko Miguel)
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