With two vaccines approved for restricted use, can placebos be used in trials?

When the standard of care is available only to a section of the population, the priority groups at the moment, then it is not standard of care for the rest of the population. Therefore, it is ethical to continue with a placebo in the population outside the priority groups, as long as that non-priority status … Continue reading With two vaccines approved for restricted use, can placebos be used in trials?

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How the new coronavirus variant quickly accumulated 17 mutations

Immunocompromised patients experiencing prolonged infection with novel coronavirus when treated with convalescent plasma might trigger a strong selective pressure on the virus due to high concentration of antibodies. This might lead to the generation of large number of mutations. The new SARS-CoV-2 variant — B.1.1.7 — that was first seen in Kent and Greater London … Continue reading How the new coronavirus variant quickly accumulated 17 mutations

Ethics of denying COVID-19 vaccine to placebo group participants once EUA is granted

Offering the vaccine right away to those in the placebo group will first require unblinding the study. Unblinding the study and offering the vaccine to the placebo group will make it almost impossible to gather further information on vaccine efficacy, thus making full licensure challenging.

Eight Indian generic drug companies join international coalition, pledge to make COVID-19 drugs

A coalition of 18 pharma companies located in India, China, Bangladesh and South Africa that manufacture generic drugs have pledged to work together to accelerate access to millions of doses of new interventions for COVID-19 for low- and middle-income countries. A coalition of 18 pharma companies located in India, China, Bangladesh and South Africa that … Continue reading Eight Indian generic drug companies join international coalition, pledge to make COVID-19 drugs

WHO supported Solidarity trial finds remdesivir ineffective but WHO prequalifies it anyway

Even as WHO supported Solidarity Therapeutics Trial found remdesivir to be ineffective in reducing mortality and duration of hospital stay, the global body prequalified the drug the same day the results of the trial were posted on the preprint server. And Gilead Sciences, which was aware of the Solidarity trial results, signed a $1 billion … Continue reading WHO supported Solidarity trial finds remdesivir ineffective but WHO prequalifies it anyway

Remdesivir, other repurposed drugs ineffective, says WHO’s Solidarity trial

WHO's Solidarity Therapeutics Trial, the largest randomised control trial carried out in the world during the pandemic, has found that four repurposed drugs — remdesivir, interferon, hydroxychloroquine and lopinavir/ritonavir regimes — for the treatment of COVID-19 are not effective. WHO's Solidarity Therapeutics Trial, the largest randomised control trial carried out in the world during the … Continue reading Remdesivir, other repurposed drugs ineffective, says WHO’s Solidarity trial

FDA grants emergency use authorisation for convalescent plasma, experts express concern

FDA grants emergency use authorisation for convalescent plasma even in the absence of evidence from randomised, controlled trial. Mr. Trump, FDA Commissioner and Secretary of Health and Human Services made a false claim that convalescent plasma reduces mortality by 35%., while the preprint does not make any such claim. First it was with hydroxychloroquine, and … Continue reading FDA grants emergency use authorisation for convalescent plasma, experts express concern

SARS-CoV-2-specific T cell immunity prevents recurrent severe COVID-19 disease

The immune system elicits robust, broad and highly functional memory T cell responses once a person is infected with novel coronavirus. T cells were found even in the absence of detectable antibodies specific to SARS-CoV-2. This indicates a previously unanticipated degree of population-level immunity against COVID-19. Natural exposure or infection with the novel coronavirus may … Continue reading SARS-CoV-2-specific T cell immunity prevents recurrent severe COVID-19 disease

Gilead to begin testing inhaled remdesivir for early-stage treatment

Gilead plans to begin a Phase-1 clinical trial in August of an inhaled version of remdesivir for early-stage COVID-19 treatment outside of hospital settings. The drug is currently approved for daily intravenous administration in the hospital. With an approval from the U.S. FDA in hand, Gilead hopes to begin a Phase-1 clinical trial in August … Continue reading Gilead to begin testing inhaled remdesivir for early-stage treatment

Antibodies from convalescent plasma protects against COVID-19

The researchers found passive transfer of neutralising antibodies isolated from convalescent plasma into Syrian hamsters protect the animals against the disease when exposed to the virus and also protects hamsters against heavy viral exposure. A team of scientists led by Dennis R. Burton from the Scripps Research Institute has discovered neutralising antibodies present in the … Continue reading Antibodies from convalescent plasma protects against COVID-19