New York: Johnson & Johnson is beginning a huge final study to try to prove if a single-dose COVID-19 vaccine can protect against the virus.
The study starting Wednesday will be one of the world's largest coronavirus vaccine studies so far, testing the shot in 60,000 volunteers in the U.S., South Africa, Argentina, Brazil, Chile, Colombia, Mexico and Peru.
A handful of other vaccines in the U.S. including shots made by Moderna Inc. and Pfizer Inc. and others in other countries are already in final-stage testing. Hopes are high that answers about at least one candidate being tested in the U.S. could come by year's end, maybe sooner.
U.S. health officials insist the race for a vaccine isn't cutting corners.
We want to do everything we can without sacrificing safety or efficacy we're not
going to do that to make sure that we end up with vaccines that are going to save lives, Dr. Francis Collins, director of the National Institutes of Health, told reporters.
But many vaccine specialists question whether the Food and Drug Administration will stick to that goal under intense pressure from the Trump administration. President Donald Trump has consistently presented a faster timeline for a new vaccine than experts say is adequate to fully test the candidates.
Meanwhile, testing of still another experimental vaccine, made by AstraZeneca, remains on hold in the U.S. as officials examine a safety question, even though studies have resumed in other countries.
Earlier this week, Vice President Mike Pence urged state governors to "do your part to build public confidence that it will be a safe and effective vaccine.
And Dr. Anthony Fauci, the top U.S. infectious disease expert, added in the call to governors that he is confident in a tried and true process that has checks and balances built in, including an independent board evaluating the progress of each vaccine trial, as well as the integrity of the FDA. A recording of the call was provided to The Associated Press.
Senators were scheduled to question FDA Commissioner Stephen Hahn, Fauci and other administration officials later Wednesday about the pandemic response.
Even if the FDA were to allow emergency use of a vaccine by year's end, supplies would be limited and given first to vulnerable groups such as health workers. Most Americans aren't likely to receive a vaccine until sometime next year.
The Centers for Disease Control and Prevention wants states to get ready now to roll out vaccinations, which will present enormous logistical challenges. On Wednesday the CDC was set to announce distribution of 200 million in congressionally approved funds to help begin setting up operations.
Health and Human Services Secretary Alex Azar said the COVID-19 vaccine campaign will build on longstanding cooperation between the federal government and the states on immunizations.
J&J's vaccine is made with slightly different technology than others in late-stage testing, modeled on an Ebola vaccine the company created. Unlike the other three vaccines that started late-stage testing in the U.S., it requires only one shot, not two.
Despite a later start to testing than some of its competitors, Dr. Paul Stoffels, J&J's chief scientific officer, told reporters that the study was large enough to yield answers possibly by early next year.
Let the Truth be known. If you read VB and like VB, please be a VB Supporter and Help us deliver the Truth to one and all.
Bhatkal: The Karnataka unit of the All India Ideal Teachers Association (AIITA) has welcomed the Karnataka government’s decision to strictly ban school children from dancing to obscene songs during educational and cultural programmes in government, aided, and private schools across the state.
AIITA Karnataka State President M. R. Manvi congratulated the government for taking what he termed an important step to preserve the sanctity of education.
“Such decisions to safeguard the dignity of school children and uphold the values of education are the need of the hour. This rule should not be limited to government schools alone but must be strictly implemented in all private educational institutions as well,” he said.
He further urged the government to address other concerns within school programmes.
“The government should not only prohibit obscene dances in the name of school anniversaries, but also ensure that plays and dialogues that incite religious hatred are avoided. Schools should be centres of harmony, not platforms for spreading hatred,” he added.
According to a recent circular issued by the Department of School Education and Literacy, obscene dances are adversely affecting the mental health and moral values of students.
In this regard, schools have been advised to use songs that promote nationalism, positive thinking, the greatness of Kannada culture, and value-based traditions instead of inappropriate content during programmes.
The circular also emphasises that students should be dressed in decent attire.
AIITA also backed the department’s warning that disciplinary action would be taken against head teachers if such guidelines are violated. The association has further demanded that district Deputy Directors of Public Instruction strictly monitor the implementation of these rules.
