16, July 2020
Covid-19 vaccine developed by US biotech firm Moderna enters final stage trial 0
US biotech firm Moderna said Tuesday it would enter the final stage of human trials for its Covid-19 vaccine on July 27, to test how well it protects people in the real world.
The announcement came as the results from an earlier trial intended to prove the vaccine was safe and triggered antibody production were published.
The upcoming Phase 3 trial will recruit 30,000 participants in the US, with half to receive the vaccine at 100 microgram dose levels, and the other half to receive a placebo.
Researchers will then track them over two years to determine whether they are protected against infection by the virus. Or, if they do get infected, whether the vaccine prevents symptoms from developing.
If they do get symptoms, the vaccine can still be considered a success if it stops severe cases of Covid-19.
The study should run until October 27, 2022, but preliminary results should be available long before.
The announcement came shortly after the New England Journal of Medicine published results from the first stage of Moderna’s vaccine trial, which showed the first 45 participants all developed antibodies to the virus.
Moderna is considered to be in a leading position in the global race to find a vaccine against the coronavirus, which has infected more than 13.2 million people and killed 570,000.
But scientists caution that the first vaccines to come to market may not be the most effective or safest.
Encouraging results
Moderna had previously published “interim results” from the first stages of its trial, called Phase 1 in May.
The early results were called “encouraging” by Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases, which is co-developing the vaccine.
But some in the scientific community said they would reserve judgment until they saw the full results in peer-reviewed form.
According to the paper, 45 participants were split into three groups to test doses of 25 micrograms, 100 micrograms and 250 micrograms.
They were given a second dose of the same amount 28 days later.
After the first round, antibody levels were found to be higher with higher doses.
Following the second round, participants had higher levels of antibodies than most patients who have had Covid-19 and gone on to generate their own antibodies.
More than half the participants experienced mild or moderate side effects, which is considered normal.
The side effects included fatigue, chills, headache, body ache and pain at the injection site.
Three participants did not receive their second dose.
They included one who developed a skin rash on both legs, and two who missed their window because they had COVID-19 symptoms, but their tests later returned negative.
Amesh Adalja, an infectious diseases specialist at Johns Hopkins University, said it was encouraging that the participants developed high levels of an advanced class of antibodies.
He added, however: “You have to be very limited in how much you can extrapolate from a phase one clinical trial, because you want to see how this works when a person is exposed to the actual virus.”
The Moderna vaccine belongs to a new class of vaccine that uses genetic material – in the form of RNA – to encode the information needed to grow the virus’s spike protein inside the human body, in order to trigger an immune response.
The spike protein is a part of the virus that it uses to invade human cells, but by itself the protein is relatively harmless.
The advantage of this technology is that it bypasses the need to manufacture viral proteins in the lab, helping to ramp up mass production.
No vaccines based on this platform have previously received regulatory approval.
Early work using this technology backfired by making hosts more, not less, susceptible to infection, David Lo, a professor of biomedical sciences at University of California Riverside told AFP.
“One of the things we certainly want to look out for is whether there is a long term effect where the immune response… potentially develops an immunologic tolerance which would actually be detrimental to protection,” he said.
(AFP)
16, July 2020
US: Amid decline in poll numbers ahead of election, Trump replaces campaign manager 0
President Donald Trump shook up his campaign staff amid sinking poll numbers less than four months before the election, replacing campaign manager Brad Parscale with veteran GOP operative Bill Stepien.
“I am pleased to announce that Bill Stepien has been promoted to the role of Trump Campaign Manager,” Trump said Wednesday on Facebook. “Brad Parscale, who has been with me for a very long time and has led our tremendous digital and data strategies, will remain in that role, while being a Senior Advisor to the campaign.”
Trump and Parscale’s relationship had been increasingly strained, with the president annoyed by the publicity Parscale had garnered in the role. But the final straw appeared to be a Tulsa, Oklahoma, rally last month that drew an unexpectedly low crowd of about 6,200 people after Parscale had bragged that more than a million people had requested tickets. The president was furious.
The shakeup injected familiar turmoil to Trump’s 2020 campaign, which had so far largely avoided the regular staff churn that dominated the president’s 2016 campaign and his White House. It comes as Trump has been struggling in his reelection campaign against presumptive Democratic presidential nominee Joe Biden, with the nation facing health and economic crises during a pandemic that has killed more than 135,000 Americans.
The staff change was not expected to alter the day-to-day running of the campaign. News of the shuffle was delivered to Parscale on Wednesday afternoon by White House adviser and Trump son-in-law Jared Kushner.
Parscale, a political novice, ran Trump’s digital advertising in 2016 and was credited with helping bring about his surprise victory that year. Stepien has been in politics for years, working for former New Jersey Gov. Chris Christie and serving as Trump’s national field director in 2016.
Parscale had been increasingly sidelined in the weeks since the Tulsa rally and as the president’s public and private poll numbers have taken a hit amid the pandemic. Speculation had been rampant about who might be promoted to lead the operation, with names like former Trump strategist Steve Bannon floated.
Parscale is a close ally of Kushner, who wields ultimate control over the campaign. A Florida resident, he had not been a regular presence of late in the campaign’s Arlington, Virginia, headquarters, sparking some resentments among staffers.
Rather than parting ways completely, Parscale was retained in part because of the difficulty the campaign would have faced in rebuilding its digital advertising operation so close to the Nov. 3 general election. While the Republican National Committee owned most of the campaign’s data, voter modeling and outreach tools, Parscale ran most of the microtargeted online advertising that Trump aides believed were key in 2016.
Parscale’s digital advertising firm was among the campaign’s most significant vendors, and some in Trump’s orbit have alleged that the former campaign manager was profiting off the president’s reelection. Parscale has repeatedly denied the claims.
Trump has been pressed by allies in recent months to expand his political circle and more forcefully define his run against Biden. Last month, Trump announced a promotion for Stepien and returned former communications chief Jason Miller to his campaign, taking away some of Parscale’s clout and influence.
Biden also shuffled his campaign team, albeit much earlier in the cycle, amid a disastrous stretch in his primary run. For Biden, the moves marked genuine shakeups that expanded and changed how his campaign operated.
Biden elevated Anita Dunn, effectively displacing his first campaign manager, Greg Schultz, after a fourth-place Iowa finish and as he was already headed for a second embarrassing finish in New Hampshire. Dunn had joined Biden at the outset of his campaign after having served President Barack Obama as a top communications adviser.
With Dunn’s urging, Biden hired his current campaign manager, Jen O’Malley Dillon, in March after Dunn and others helped resurrect Biden in Nevada and South Carolina and put him on the path to the nomination. Schultz is now at the Democratic National Committee, helping lead the joint battleground strategy among the national party, the Biden campaign and state parties.
Source: AP