Moderna reveals detailed plans for COVID-19 clinical trial Sep 18, 2020 0 2743 12345 AFPWashingtonUS biotech firm Moderna, one of two companies currently holding phase 3 trials in the United States for a COVID-19 vaccine, took the unusual step on Thursday of publishing its trial protocols after calls for more transparency.The race for a vaccine has taken a political turn in the run-up to the November 3 election, with President Donald Trump regularly promising to have one brought to market by October, raising questions about possible pressure on the Food and Drug Administration (FDA) to move quickly.Experts and even officials from his own administration say the outcome of ongoing trials cannot be predicted, and that they are unlikely to yield actionable results before the end of the year or early 2021.Available doses would be very limited in the first few months and given to priority populations such as senior government officials, essential workers and the elderly.Moderna said it had recruited 25,296 participants of its goal of 30,000, of whom 28 percent were from minority communities.Having a sufficient number of black and Hispanic participants, in particular, is seen as crucial to obtain a statistically representative results for these groups, which have been disproportionately hit by the pandemic.Among the participants, 10,025 have already received their second dose, which has to be injected 28 days after the first.The protocol of a trial is the document negotiated with the FDA, marked “confidential,” which describes in detail how the testing will be conducted.This includes, most crucially, the conditions under which a committee of independent experts can look at the data and stop the trial because the medicine is either working or is too dangerous.“This has the key information for stopping rules, interim analyses and efficacy assumptions. Applaud their transparency,” Eric Topol, an independent expert who has been sounding the alarm on the need to guard against political interference, told AFP.The other ongoing phase 3 trial in the United States is being led by Pfizer. RELATED ARTICLES WHO warns of ‘alarming’ virus spread in Europe Sep 18, 2020 0 1101 US sends top-level diplomat to Taiwan, angering China Sep 18, 2020 0 532 Navalny aides say Novichok found on hotel water bottle Sep 18, 2020 0 1099 EU parliament demands tough Russia sanctions over Navalny AFP Brussels The European Parliament on Thursday demanded tough EU sanctions on Russia over the poisoning of opposition leader Alexei Navalny, accusing the Kremlin of trying to assassinate him to silence dissent. .. Coronavirus epicentre Wuhan re-opens for international flights AFP Beijing China’s Wuhan, ground zero for the coronavirus outbreak sweeping the globe, has re-opened for international flights, ending an eight-month moratorium since the deadly disease first emerged. China .. Czechs struggling with record COVID-19 spike PRAGUE: The Czech Republic is struggling to stem a massive spike in coronavirus infections after clocking a record daily rate of infection on par with neighbouring Germany, which has a population that is eight times .. 17 countries initiate OSCE human rights investigation in Belarus DPA Vienna Belarus will be subject to an international investigation into human rights abuses and election fraud, according to a mechanism triggered by 17 mostly European countries on Thursday. The group, which .. New York City delays return to school again NEW YORK: New York City postponed again on Thursday the return of in-classroom teaching for a large number of pupils, highlighting the difficulty of getting children back to school amid anxiety among teachers about .. Biden faces US voters at town hall as campaign heats up AFP Washington White House hopeful Joe Biden on Thursday holds his first extended face-to-face with real voters since winning the Democratic nomination, a town hall where he will likely savage President Donald Trump’s ..