coronavirus medley

UK put speed before public confidence in vaccine, says EU agency
Daniel Boffey, Groan, Dec 2 2020

The European Medicines Agency has suggested British regulators prioritised speed over winning public confidence to enable the UK to become the first western country to license a coronavirus vaccine. After it was announced that the Pfizer/BioNTech vaccine had been authorised for emergency use by the UK’s Medicines and Healthcare products Regulatory Authority (MHRA), the EU agency issued a statement backing its own “robust” approach. In a series of media appearances on Wednesday morning, the UK health secretary, Matt Hancock, erroneously claimed that speedy authorisation had been possible “because of Brexit,” contrasting the UK approach with the “pace of the Europeans, who are moving a little bit more slowly.” The EMA said the bloc’s member states had the option of taking the emergency authorisation route but that its own process was the “appropriate regulatory mechanism for use in the current pandemic emergency, to grant all EU citizens’ access to a vaccine and to underpin mass vaccination campaigns.” Germany’s health minister, Jens Spahn, said:

The idea is not that we’re the first, but the idea is to have safe and effective vaccines in the pandemic and that we can create confidence, and nothing is more important than confidence with respect to vaccines. We have member states, including Germany, who could have issued such an emergency authorisation if we’d wanted to, but we decided against this and what we opted for was a common European approach to move forward together.

The EMA’s statement said its conditional market authorisation, involving extra checks and evidence gathering, included “essential elements to ensure a high level of protection to citizens during the course of a mass vaccination campaign.” The agency said its assessment would be concluded by Dec 29, at the latest and that the differences in timings between the UK and EU authorisation “are not expected to affect significantly vaccines’ availability,” The emergency authorisation approach is limited to specific batches of vaccine, limiting the supply. Alok Sharma, the UK business secretary, claimed the authorisation was a British success story. The comments drew an angry response from Germany’s ambassador to the UK, Andreas Michaelis, who tweeted

Speaking after a meeting of EU health ministers, Spahn said:

We may have read some comments on Brexit: BioNTech is a European development funded by the EU, and it shows that a product from the EU is so good that it is authorised so quickly in the UK, that in this crisis what is best is European and international cooperation.

The EMA started its rolling review of preliminary data from Pfizer/BioNTech trials on Oct 6. The UK regulator launched a similar process on Oct 30, but came to a swifter conclusion by analysing less data. The former head EMA Guido Rasi told Reuters:

If you evaluate only the partial data as they are doing, they also take a minimum of risk. Personally I would have expected a robust review of all available data, which the British government has not done to be able to say that without Europe you come first.

June Raine, the head of the MHRA, defended its decision, saying:

The way in which the MHRA has worked is equivalent to all international standards.

UK becomes first country to approve Pfizer-BioNTech vaccine against Covid-19
RT.com, Dec 2 2020

Britain has become the first nation in the world to approve the Pfizer-BioNTech vaccine against the coronavirus for widespread use. The drug is expected to be rolled out as early as next week. A statement by the UK authorities read:

The Government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer-BioNTech’s Covid-19 vaccine for use.

With Britain so far registering more than 1.6m coronavirus cases and over 59k deaths, MHRA has moved at record speed to grant emergency authorisation to the vaccine in just a week’s time. The agency only received the final data from Pfizer-BioNTech on Nov 23. The vaccine, which, according to the developers, offers 95% protection from the virus, but has to be stored at -70 degrees Celsius (sic – RB), will also see a swift introduction in the UK. Health Secretary Matt Hancock said:

This is very good news. Vaccination in the country will begin next week.

Vulnerable groups, including residents of care homes, which have been hit the hardest during the pandemic, are expected to get the shots first. The UK has ordered 40m doses of the drug, jointly developed by the US and German biotech firms. It’ll be enough to vaccinate 20m people, as two injections are required. Pfizer CEO Albert Bourla said:

This is a historic moment in the fight against Covid-19. Further authorizations and approvals are expected in the EU and elsewhere.

Pfizer/BioNTech Covid vaccine approved for use in UK to be rolled out next week
Sarah Boseley, Josh Halliday, Groan, Dec 2 2020

The UK has become the first western country to license a vaccine against Covid, opening the way for mass immunisation with the Pfizer/BioNTech vaccine to begin in those most at risk next week. The vaccine has been authorised for emergency use by the Medicines and Healthcare Products Regulatory Authority (MHRA), ahead of decisions by the US and Europe. The MHRA was given power to approve the vaccine by the government under special regulations before Jan 1, when it will become fully responsible for medicines authorisation in the UK after Brexit. The first doses of the vaccine will arrive in the coming days, said the company. The UK has bought 40m doses of the vaccine, which has been shown to have 95% efficacy in its final trials. A Department of Health and Social Care spokesman said:

The government has today accepted the recommendation from the MHRA to approve Pfizer/BioNTech’s Covid-19 vaccine for use. This follows months of rigorous clinical trials and a thorough analysis of the data by experts at the MHRA who have concluded that the vaccine has met its strict standards of safety, quality and effectiveness. The joint committee on vaccination and immunisation will shortly also publish its latest advice for the priority groups to receive the vaccine, including care home residents, health and care staff, the elderly and the clinically extremely vulnerable. The vaccine will be made available across the UK from next week.

Matt Hancock, the health secretary, said the first doses would be issued to the most vulnerable people. The UK will have 800k doses available next week, he said. he told Sky News:

This is fantastic news. The MHRA, the fiercely independent regulator, has clinically authorised the vaccine for rollout. The NHS stands ready to make that happen. From early next week we will start the programme of vaccinating people against Covid-19 here in this country. The MHRA have approved it as clinically safe and we have a vaccine, so it’s very good news. Rolling out the vaccine across the UK will be challenging, because it needs to be kept at -70C (sic – RB). A network of 50 hospitals was ready to deliver the first jabs, and specialist vaccination centres are being built. The vaccine will also be available from some GPs and pharmacists if they have cold storage facilities.

Hancock told BBC News each person would need two jabs and the “bulk” of the 40m order was expected to be available in the new year. Hancock said:

Older people and those in care homes, including staff, will be first in line for immunisation, and then it essentially comes down the age range, NHS staff are also high on that priority list and also the clinically extremely vulnerable. The goal will be to vaccinate through the NHS right across the UK as rapidly as the company can manufacture. It will help save lives. Once we’ve protected the most vulnerable it will help us all get back to normal and back to some of the things that we love. From Easter next year, the country will return to some normality, and no restrictions will be needed by summer. So many families have suffered, including my own. I’m just so, so pleased! 2020 has been just awful and 2021 is going to be better. Help is on its way with this vaccine, and we can now say that with certainty rather than with all the caveats that normally have to put around that. I’m confident now with the news today that from spring, from Easter onwards, things are going to be better. We’re going to have a summer next year that everybody can enjoy. Between now and then we’ve got to hold our resolve.

The JCVI is expected to set out later on Wednesday morning which groups of people will be eligible from next week. Albert Bourla, the chairman and chief executive officer of Pfizer added:

Today’s emergency use authorisation in the UK marks a historic moment in the fight against Covid-19. This authorisation is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the UK.

Although the vaccine has to be kept at -70C, the companies say it can be stored for up to five days in a fridge, at 2-8°C (false – RB). The first priority groups for vaccination are care home residents, who may not be able to come to a vaccination centre, together with the staff who look after them. At fridge temperatures, it may be possible for the vaccine to be brought to them. Next in line will be the over-80s and NHS staff. The trial data showed the vaccine had equal efficacy among younger volunteers and those over 65 who are most at risk from Covid. Gender, race and ethnicity also made no difference. Pfizer and BioNTech say their combined manufacturing network has the potential to supply globally up to 50m vaccine doses in 2020 and up to 1.3bn doses by the end of 2021. The delivery of the UK’s 40m doses will start immediately. Delivery will continue throughout 2020 and 2021 in stages “to ensure an equitable allocation of vaccines across the geographies with executed contracts,” say the companies. The US, which has ordered 100m doses, and Europe, which has bought 200m, are expected to approve the vaccine within weeks. The MHRA has moved with unprecedented speed to grant emergency use authorisation within just a week, having received the final data from the companies on Nov 23. It has been carrying out a rolling approval process, scrutinising data from early trials as they came in. Ugur Sahin, the CEO and co-founder of BioNTech, said:
The emergency use authorisation in the UK will mark the first time citizens outside of the trials will have the opportunity to be immunised against Covid-19. We believe that the rollout of the vaccination programme in the UK will reduce the number of people in the high-risk population being hospitalised. Our aim is to bring a safe and effective vaccine upon approval to the people who need it. The data submitted to regulatory agencies around the world are the result of a scientifically rigorous and highly ethical research and development programme.

UK likely to be first western country to license a Covid vaccine
Sarah Boseley, Jessica Elgot, Denis Campbell, Groan, Dec 1 2020

Britain is expected to become the first western country to authorise a coronavirus vaccine, raising the prospect of immunisations beginning weeks ahead of the rest of Europe. The UK medicines regulator is set to license the Pfizer/BioNTech vaccine for emergency use within days, and possibly as soon as Wednesday. Britain has ordered 40m doses, of which 10m are expected to be available this year. Meanwhile the European regulator suggested on Tuesday that it might not reach a decision until the end of December, which would make the start of vaccination programmes across Europe unlikely before 2021. Such an outcome would be viewed as a political triumph for Boris Johnson.

The UK could begin immunisations before any other country in the west thanks to a globally well-regarded body, the Medicines and Healthcare products Regulatory Authority (MHRA). With less than a month until the end of the Brexit transition period, its supporters are also likely to seize on the MHRA’s ability to act at speed and alone for the first time, without waiting for the rest of Europe. Until Jan 1 2021, licensing decisions on medicines and vaccines would have been taken by the European Medicines Agency (EMA), which was based in London until Brexit. But the UK government passed regulations to allow the MHRA to give emergency authorisation to Covid vaccines if manufacturers had sufficient data to apply before the end of the year. A Whitehall source said:

The MHRA’s approval of the Pfizer vaccine, when it comes, will be a big moment not just for the UK but for the world. From our perspective, us making provision to be able to authorise a vaccine ahead of the EMA was definitely the right call. It means we will have a three-week head start on every other country in Europe in terms of deploying this vaccine. Germany might have a better diagnostics industry than we do but when it comes to deploying vaccines we are #1.

The MHRA has been conducting a rolling review of several vaccines over recent months, including that of Pfizer/BioNTech, which submitted its final data on Nov 23. A government source said there was an expectation the regulator would approve the Pfizer/BioNTech vaccine within days, even as early as Wednesday. The MHRA is an independent body, however. Speaking in the Commons on Tuesday before a vote on new stricter tiered restrictions, Johnson sounded a note of caution about the likely speed of approval. The prime minister said:

We have to be realistic and we have to accept that this vaccine is not here yet, no vaccine is here yet. And whilst all the signs are promising, and almost every scientist I have talked to agrees that the breakthrough will surely come, we do not yet have one that has gained regulatory approval. We can’t be completely sure when the moment will arrive. And until then, we cannot afford to relax, especially during the cold months of winter.

Europe has only just begun to consider data from the final trials of the Pfizer vaccine. On Tuesday the EMA announced it had received final data from Pfizer and Moderna, the US company making a similar vaccine. Both have reported 95% efficacy in phase 3 trials. The EMA said the assessments would be accelerated thanks to its own rolling review of the data from earlier trials and other information, with an opinion on authorisation coming potentially within weeks. But the regulator suggested it might not be able to make a decision until the end of December. It said in a statement:

The agency and its scientific committees will continue working on the assessment over the Christmas period. If the data submitted are robust enough to conclude on the quality, safety and effectiveness of the vaccine, EMA’s scientific committee for human medicines will conclude its assessment during an extraordinary meeting scheduled for Dec 29 at the latest.

If the EMA gives the green light, the European commission will consider within days whether to grant conditional marketing authorisation, which would mean the vaccine is approved for use in all member states. In the US, the FDA is examining all the Pfizer/BioNTech data. It has said it will meet to make a decision on Dec 10. UK plans for mass immunisation are well advanced. They will be logistically complex, however, because of the need to keep the vaccine in freezers at -70C. Once removed, it can be stored in a fridge at 2C – 8C for five days (wrong – RB). Once transported from Belgium, where it is produced, the MHRA and Public Health England will conduct “quality assurance tests” to check transportation conditions have been followed. It will then be sent to locations including hospitals, where NHS leaders expect frontline health workers to begin receiving it. Sources estimate it will be four to six days between the vaccine’s arrival and the first doses being administered. The UK regulator is also looking at the data from trials of the Oxford University/AstraZeneca vaccine, which has reported 62% efficacy in a large trial but 90% efficacy in a subset of volunteers under the age of 55. The UK has ordered 100m doses of the vaccine, which does not need to be kept in freezers and is intended to be the mainstay of the immunisation programme.

It’s not censorship, it’s ‘positive change’: Red Cross chief says social media should promote ‘the right information’ on vaccines
RT.com, Dec 2 2020

Protest in London, May 16, 2020 Photo: John Sibley/Reuters

With the Red Cross warning governments to clamp down on a “second pandemic” of misinformation, the organization’s health and care chief told RT that he’s not demanding censorship, but pushing for “positive change.” The first batches of Covid-19 vaccines are on the cusp of availability, but International Federation of the Red Cross President Francesco Rocca said that a “second pandemic” of “fake news” about vaccines might turn the public off getting the jab. He told the UN Correspondents Association on Monday:

We believe that the massive coordinated effort that will be needed to roll out the Covid vaccine in an equitable manner, needs to be paralleled by equally massive efforts to proactively build and protect trust.

Whether stemming from concerns about their long-term side effects, skepticism over their rapid development process, or online conspiracy theories, coronavirus vaccines have not inspired widespread confidence. In a quarter of countries his organization surveyed, vaccine acceptance was around 50%. Nearly half of US adults say they’ll definitely or probably not take a vaccine, while more than a third of people in the UK will refuse the shot. Emanuele Capobianco, head of health and care at the IFRC lamed the public’s lukewarm enthusiasm on “fake news” from the “anti-vaxx movement.” Speaking to RT on Tuesday, Capobianco said that governments and scientists need to work on “correcting misinformation” and convincing the public that vaccines are “effective and safe.”

Capobianco denied that he was suggesting that people be forced to take a vaccine, nor was he asking for a ban on vaccine-skeptic content online. Instead, he said that governments and social media companies should focus on “sharing the right information as widely as possible.” He singled out tech companies as having the potential to be “agents of positive change.” Yet these companies have explicitly banned vaccine-skeptic content. YouTube, Facebook and Twitter have all partnered up with governments to fight “the wave of false claims” surrounding the virus, with Facebook and YouTube both removing “misinformation” on the disease and vaccines. Of course, any effort to limit the spread of vaccine “misinformation” runs the risk of backfiring spectacularly. YouTube and Facebook learned this first-hand back in May when they pulled conspiracy documentary ‘Plandemic’ from their platforms. The ban only increased interest in the film, and a book by its subject shot straight into third place on the NYT’s bestsellers list.

UK wants to use literal army to fight ‘anti-vaccine propaganda’ online. Are we in a budding totalitarian state?
Lewis Olden, RT.com, Dec 2 2020

With the anti-lockdown narrative beginning to become more prominent throughout the UK following the arrest of 150 people over the past weekend, a clampdown on independent thought is looming. The arrests were made because of anti-lockdown protests in London, and the heavy-handed nature of dealing with these protests is extraordinarily alarming. Now the crackdown is moving online, where the gradual destruction of free speech is becoming ever more blatant and cynical. The Sunday Times reported that there is even a brazen operation to suppress people’s fundamental right to express their opinion. The UK authorities intend on literally using military intelligence brigades to manage the elimination of free speech. The primary target of this military operation is what the Times calls “anti-vax militants” and supposed propaganda content across the internet and social media.

The unit that will be leading this operation are the renowned 77th Brigade. The 77th Brigade has been mobilised to conduct information warfare and was initially conceived to assist in operations against the Taliban and Al-Qaeda. The covert unit often works in cohesion with psychological operations teams within the army. The 77th Brigade is a unit that combines the Army and Army Reserves for the purpose of non-lethal warfare and behavioural influence. The unit is currently based at Denison Barracks in Berkshire. It bills itself as “an agent of change” that uses “targeted information” activity and online outreach to assist with military objectives. The use of psychological operations to influence the narrative across social media platforms to ensure that the general conversation reflects the desired viewpoint is a powerful tool. Throughout 2020 the 77th Brigade has been coordinating with the Cabinet Office to counter ‘misinformation’ related to Covid-19.

It is interesting to note that the recently appointed Parliamentary Under-Sec State for Covid Vaccine Deployment, Nadhim Zahawi, is the co-founder of YouGov. Targeting online polls is a specific method of psychological impression, as when people see their view is not the common understanding of reality, they may begin to reassess their opinion on a specific topic. The interpretation of who is deemed to be an “anti-vaccine militant” is subjective, and there is certainly a wide scope for the abuse of such operations. Authorities have their own distorted idea of what constitutes ‘propaganda’ – and the damning label can potentially be slapped on anyone who dares to raise concerns about the imminent vaccines that have been developed within an unprecedented timeframe. Critiquing or even questioning any potential side effects or the motives behind the vaccine could result in the abolition of your name from the internet.

The irony of calling this an operation against “propaganda content” must not be lost on those who are executing it. Such an operation is an attempt to control free speech, it is an extraordinarily dangerous precedent to set and the death of debate is a very slippery slope. Sliding into a dictatorial state where people cannot oppose the authorities’ actions or plans leaves us all at risk of losing our fundamental human right to freedom of speech. An elite force, that from conception has been trained to control minds, is now being utilised against ‘state actors’ spreading ‘anti-vaccine propaganda.’ The Ministry of Defence claims the UK population will not be targeted, but we have all seen how easy it is for the government to ascribe any dissent to malign foreign influence, thus devaluing any legitimate concerns of its citizens.

This is a terrifying example of UK authorities manifesting the totalitarian power that they believe they possess. The silencing of those who legitimately are sceptical about the circumstances in which a vaccine has been produced are being denied the right to voice their fears. No matter how mad a conspiracy theory or how deluded an individual may be, they should always retain the right to speak their mind without fear of retribution, so long as they are not doing so in a threatening manner. The UK is purchasing over 350m doses of the Covid-19 vaccine from various pharmaceutical companies. The panic in which the vaccine was formulated and subsequently approved should lead to questions about its efficacy and safety. In any other situation, these would be seen to be perfectly reasonable concerns. In the world we live in, every decision you make is recorded and watched, and a calculation as to why you elected to make that decision is made. Many of your thoughts are predetermined and fabricated before you even think them, you do not even question whether they are your own. Advertising so imperceptible, you are often blissfully unaware of how easily and comprehensively your personality is understood.

Society is starting to truly appreciate the power that data can hold. It is widely accepted that large technology companies are abusing the control they have obtained and are diminishing their user’s right to privacy. We are seeing various technologies being maltreated by publicly listed corporations for profit, and the control they can have over your daily life grows with every second you engage with their technology. Now, just imagine the power a state-backed cyber warfare unit could have. The mission that the 77th Brigade is on and its methods are still only vaguely understood, but the state already possesses a wide range of methods for covert information warfare. GCHQ’s Joint Threat Research Intelligence Group (JTRIG), for example, boasts an arsenal of over 200 “info-weapons,” ranging from spoofed SMS messages to artificially increasing traffic to a specific website and manipulating online polls. With society’s growing reliance on technology to guide our collective consciousness, controlling this battlefield could be a means to conquer our minds and effectively police our thoughts. Thinking the wrong thing could become a crime, and we could find ourselves living in a state of perpetual anxiety where the defiance of compliance will never go unpunished.

The ever-darkening addiction to a glass screen that’s on your person 24 hours a day and knows who you are with more precision than you know yourself is not natural. Promoting products you didn’t realise you needed until they were thrust before your eyes. Reading various articles all presented at particular moments on specific platforms to ensure the commentary results in you attaining the preferred conclusion. The majority of many people’s lives are now spent interacting with screens and lockdown has only enhanced this phenomenon. It is therefore understandable why the UK authorities choose to focus their attention on controlling what is permitted to be shared online. By controlling these mediums of communication with subtle manipulation that is invisible, the illusion of control can be achieved by phantom force that remains intangible. Using technology to understand how modern society thinks and behaves enables state actors to accurately predict their population’s reaction to specific information and prepare for the outlawed conjecture. This, in combination with silencing the critics, allows a single narrative to form which is taken as gospel by a large proportion of society.

The power to infect people’s minds is unlike any political tool in history. Creating the realms of perception and concocting the premeditated response enables the infiltration of free thought. What news-related media impacts your impression of reality and the ability to impact what you believe to be your individual opinion cannot be underestimated. Your activity and behaviour online provides a more precise picture of who you really are than your ego would ever allow. Therefore, those with the access to your data can ascertain what truly motivates you and what your core beliefs are. If these do not correlate with their own ambitions, a campaign of misinformation and manipulation can be initiated to attempt to alter these points of view. Fear hangs heavy in the air and the greatest fear of all is, no one is sure what they are afraid of. The revelation about the conduct of the 77th Brigade sheds some light on the concise operation against free thought, yet the most horrifying elements of control remain disguised in broad daylight and inconspicuous in the shadows. Freedom is never free; you have to fight for it.

One Comment

  1. Paul
    Posted December 3, 2020 at 6:12 am | Permalink

    It’s really simple to restore confidence in vaccination: Let the Government’s Health advisers go first, televised, and have a group on hand to certify that the vaccine they get isn’t a saline placebo. If they are all so confidant in it, then they can lead by example.

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