‘New studies are needed’: Switzerland refuses to authorise AstraZeneca COVID-19 vaccine
Swiss regulators have said that data submitted by AstraZeneca was not sufficient for it to authorise use of the Anglo-Swedish firm’s COVID-19 vaccine and “new studies” were needed.
The Swissmedic regulatory authority said it had been examining information from AstraZeneca but that was “not yet sufficient to permit authorisation”. “To obtain more information about safety, efficacy and quality, additional data from new studies are needed,” it said in a statement.
Switzerland has so far given the green light to COVID-19 vaccines made by Pfizer-BioNTech and Moderna. It had been expected to authorise the AstraZeneca jab soon, after the neighbouring European Union last week gave the vaccine the go ahead.
But while the EU granted approval for use in all people over the age of 18, several European countries have advised against giving the jabs to people over 65, citing lack of evidence that it was effective among the elderly.
Swissmedic said a meeting of its external advisory body on Tuesday had confirmed its interim assessment of the AstraZeneca vaccine data. “The data currently available do not point to a positive decision regarding benefits and risks,” it said.
“To obtain a conclusive assessment, the applicant will among other things have to submit additional efficacy data from a Phase 3 trial under way in North and South America, and these will have to be analysed. “As soon as the results have been received, a temporary authorisation according to the rolling procedure could be issued at very short notice,” it added.
Although the European Medicines Agency recommended the AstraZeneca jab for adults of all ages last week, several countries have advised against administering it to older people.
Germany has said it will not advise over 65s to get it, Italy also recommended alternatives for people aged over 55 and Poland has authorised its use for under-60s only.
In France, where President Emmanuel Macron said last week that the AstraZeneca jab was “quasi-ineffective,” a lab will start producing a rival vaccine by US firm Moderna.
And another French lab will begin making the Pfizer-BioNTech vaccine in April, said Industry Minister Agnes Pannier-Runacher.
French pride has also taken a hit after its pharma giant Sanofi said its COVID vaccine would not be ready until later this year.
Further adding to global supply, China said it plans to provide 10 million doses of COVID-19 jabs to the WHO-backed international vaccine distribution program Covax.
AstraZeneca’s COVID-19 vaccine works better if there is a three month time lag between the first and second doses the latest trial results show. The original human clinical trials found the vaccine was 62 per cent effective when the second dose was given 28 days after the first. The new research shows efficacy climbs to 91.7 per cent when there is a three month time lag between doses.
And, it found just a single dose of the vaccine offered considerable protection.
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A cheap, blood-thinning drug could kill off COVID-19
Australian researchers have turned a cheap 100 year blood thinning drug into a nasal spray that could block COVID-19, stop it spreading and treat the illness.
The team of Melbourne scientists, which includes Victoria’s chief health officer Brett Sutton, is seeking funding to test the product, containing the blood thinning medication heparin, on people in hotel quarantine — to see if it works.
It comes as human trials begin to gauge whether AstraZeneca’s COVID-19 injection also works as a nasal spray.
Australia’s leading science research body, the CSIRO, had tested the vaccine as a nasal spray in ferrets — ahead of the human trials — and was waiting for the publication of promising results showing its impact on stopping infection spread.
“We’re confident. We have preclinical studies which are impressive at the moment,” CSIRO’s Rob Grenfell told News Corp.
“We also understand that our colleagues in the UK are conducting various ways of administering, in particular the AstraZeneca vaccine to demonstrate … whether or not it can actually cause what we call nasal neutralisation,” he said.
Another COVID-19 busting nasal spray being developed by Australian company ENA was also in preclinical trials.
And, Melbourne-based pharmaceutical company Starpharma hoped to roll out a nasal spray in Europe next month that is 99.99 per cent effective against COVID-19 when applied before or after exposure.
Nasal spray formulations would work as an accompaniment to COVID-19 vaccinations.
In the case of heparin, Australians would still receive COVID-19 vaccines but the nasal spray would be used three times a day during virus outbreaks, long haul travel and by frontline health and quarantine workers to provide immediate protection by blocking the virus entering the body through the nose.
And, unlike vaccines, heparin would work to block even mutated forms of the COVID-19 virus.
The medication is off patent, so would cost just $10 per bottle to produce and likely retail for $20 a bottle.
“The concept is that the intra-nasal heparin will, in fact, prevent the virus from locking onto the ACE2 receptor (in the nasal passage), and prevent it from being internalised and replicating and be associated shedding and spreading,” Monash University pharmacy expert Professor Michelle McIntosh said.
“We’ve been able to show in a petri dish that this concept works. And we have commenced some animal studies,” she said.
The team working on the heparin spray includes researchers from the Peter Doherty Institute the Murdoch Children’s Research Institute, University of Melbourne, St Vincent’s Hospital, Northern Health, Monash University and the CSIRO.
They needs $4 million for clinical studies, which would see the nasal spray tested on 100 people in hotel quarantine in Melbourne and at the Howard Springs centre near Darwin.
The trials would focus on whether the spray blocks the virus and stops infected people shedding the virus.
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A Different Type of Secession Is Already Happening in the USA
Lately, there has been so much frustration with the last election and the direction of our country that some Trump supporters have been talking about “secession.” Many conservatives and libertarians are asking if it makes sense for certain states to leave the union the way South Carolina left in 1860, after the election of Abraham Lincoln as president of the United States.
Whether it makes “sense” or not, we can be assured that it will not happen. Although the South Carolina state legislature voted in November of 1860 to initiate the process of secession, no state legislature would do that today. This is because most modern state legislatures, even conservative ones, do not have many members who are angry enough at the federal government to support seceding from it.
Never forget that many individual state legislators are professional politicians. They may disagree with some of the policies that flow from Washington D.C., but they are not angry enough to vote for secession, and that is what is required to secede, anger. While an official secession will not happen, there will be a different type. In fact, it has already started in our country.
Instead of state legislatures, dominated by urban dwellers, voting for secession, Americans who live in rural and some suburban areas are executing a secession of their own. They are disassociating themselves from the lifestyles, cultural mores, laws, and self-inflicted wounds exhibited in our large cities.
Of course, rural Americans are already living in areas removed from large cities, but geography is only one of the many differences. An even more striking distinction involves political ideology and attitudes on an array of issues like criminal justice.
Citizens living outside of ultra-progressive urban areas do not accept what is going on in large cities. Surely, the thinking is, “I am not one of them. They are different from me. We do not agree on basic things, like what laws should govern human conduct.”
This mental disassociation did not exist in previous times of crisis in our country. There was much more national unity in December of 1941 or even September of 2001. At that time, rural Americans and city dwellers still had many shared values and followed the same laws. Clearly, the similarity in culture and politics between rural and urban Americans is dying, and the pace of its death march is quickening.
This same type of disassociation is also felt by many Americans living in suburban areas. They recognize their way of life is incompatible with that exhibited in large cities. This results in suburban dwellers venturing into cities less often. Once there, they feel unsafe and unwelcome. According to the FBI, crime rates in our urban areas are significantly higher than in suburban and rural areas.
More crime is not the only difference Americans notice in large cities. There are also different laws regarding decency, civility, and cleanliness. Unfortunately, manners and traditional customs are rarely, if ever, practiced.
Many horrific things can happen to you in a large city without warning. You can be struck from behind in a “Knockout Attack” or wounded by a stray bullet. You can be surrounded by violent demonstrators who scream at you and call you evil because of your wealth, race, religious views, or political beliefs. This is not a place that feels comfortable or feels like home.
Over the past few decades, millions of Americans who support traditional American values, and even some who value safety, have already left our large cities. They are disgusted with the political corruption, high taxes, racial politics, homelessness and, over the past year, the excessive Covid-19 lockdown orders.
People leaving are also those who value their second amendment rights. They do not want to be charged with a crime if they have to defend their home. Who can forget what happened to Mark and Patricia McCloskey in St. Louis?
On June 28, 2020, their neighborhood was overrun by protesters and a mob was descending on the McCloskey’s home. The couple waved firearms in front of their home to encourage the protesters to leave. No gun was ever fired at any of the trespassers. Incredibly, Mr. and Mrs. McCloskey were charged with the unlawful use of a weapon even though they feared for their lives. If convicted, they could face up to four years in prison and a fine of $10,000.
As this trend continues and cities like St. Louis, Detroit, San Francisco, Seattle, Portland, Washington D.C., and New York City decline even more, these areas will simultaneously become more similar. They already have much in common politically. Future cooperation will likely continue on issues such as drug legalization, the treatment of homelessness, gun control, permissive law enforcement, and providing a sanctuary and support for illegal aliens. With so much commonality, these cities will forge even closer bonds in the days ahead.
With unworkable policies and massive bureaucracies, these cities will need greater and greater subsidies from productive, tax-paying citizens living in rural and suburban America. Urban areas have been failing financially for many years, but as the policies become more progressive, the costs are escalating even higher.
In large cities, politicians spend vast sums of money on enormous municipal government systems which include inefficient departments featuring payrolls that are too large and too expensive. Other characteristics include broken infrastructure, rampant homelessness, and an overly generous municipal pension system.
How much longer will productive taxpayers living in rural and suburban communities agree to subsidize large cities? Sooner or later, these citizens will say “Enough is enough, we want out!” They will want the urban centers to form their own “United Cities of America” with their own laws and lifestyles.
Simultaneously, Americans living in non-urban areas will want to forge closer bonds of their own as similarities are recognized even more.
The secession of 1860 will not happen again, but a different kind is already taking place.
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Parler fires CEO John Matze with social media platform largely offline following US Capitol riots
Parler, a social media platform favoured by US conservatives, has dismissed chief executive John Matze. Mr Matze confirmed the move to Reuters, after it was originally reported by Fox News, and said that he had not been given a settlement.
"On January 29, 2021, the Parler board controlled by Rebekah Mercer decided to immediately terminate my position as CEO of Parler. I did not participate in this decision," Mr Matze said in a memo sent to Parler staff, originally reported by Fox News.
He told Reuters that Parler now has an "executive committee" consisting of Matthew Richardson and Mark Meckler.
Ms Mercer, Mr Richardson, Mr Meckler and Parler did not immediately respond to requests for comment.
Parler remains largely offline after being dropped by Seattle-based Amazon's cloud-hosting division and the app stores of Apple and Alphabet's Google following the January 6 siege of the US Capitol.
The companies cited Parler's record of policing violent content, after far-right groups spread violent rhetoric on the platform ahead of the unrest in Washington.
Founded in 2018, Parler — which claims it has over 12 million users — has styled itself as a "free speech-driven" space.
The app has largely attracted US conservatives who disagree with rules around content on social media sites like Facebook and Twitter.
Mr Matze told Reuters on January 13 that Parler may be offline for good, but later pledged it would return stronger.
https://www.abc.net.au/news/2021-02-04/parler-sacks-ceo-john-matze/13120442
************************************Also see my other blogs. Main ones below:
http://snorphty.blogspot.com (TONGUE-TIED)
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com/ (AUSTRALIAN POLITICS)
http://awesternheart.blogspot.com.au/ (THE PSYCHOLOGIST)
https://heofen.blogspot.com/ (MY OTHER BLOGS)
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