Wednesday, February 03, 2021



AstraZeneca Covid-19 vaccine will not be recommended for over-65s in France or Sweden as countries follow Germany’s lead

The Oxford AstraZeneca vaccine will not be recommended for over-65s in France or Sweden, the countries' health ministries announced today.

It comes after Germany advised against administering the jab to those over 65 and Emmanuel Macron claimed it was 'almost ineffective' for the age bracket.

Continental objections to the jab last week came amid a furious row between the Bloc and AstraZeneca over lagging supply, which has seen newly-unshackled Brexit Britain storm ahead in its immunisation roll-out.

Stockholm and Paris today agreed with Berlin that there was not enough data to show how the vaccine affects elderly patients.

Boris Johnson and UK health chiefs have insisted that the jab, made by Swedish-British pharmaceutical giant AstraZeneca, is effective for all age groups.

But pouring fuel on the row again today, European Commission President Ursula von der Leyen accused Britain of compromising on safety by giving swift approval to the jab.

Brussels last week descended into bitter attacks on Britain and AstraZeneca, which it accused of reneging on it contractual obligations to deliver the jab, with suspicions raised that the company had supplied the UK with the EU's doses.

The Commission is also in exploratory talks with Novavax (US, recombinant spike protein, efficacy unknown) for up to 200 million doses and with Valneva (French, inactivated virus vaccine, efficacy unknown) for up to 60 million doses.

Mr Johnson said on Friday that the vaccine 'is very good and efficacious' after health officials in Berlin warned that there was 'insufficient data to assess the efficacy of the vaccine for persons aged 65 years and older.'

AstraZeneca has been open about their initial tests in which only 10 per cent of the participants were 65 or older. However, there are trials ongoing throughout the world to prove its efficacy further in the older age groups.

Amid EU rancour last Friday, the European Medicines Agency, the Bloc's regulator, granted approval to the AstraZeneca vaccine for all age groups. The British Medicines and Healthcare products Regulatory Agency (MHRA) approved the jab in December, well before its European counterparts.

As a result of the fast approval and Britain's investment in its vaccine programme, the UK - which finally quit the EU on January 1 - has taken the lead in the roll-out stakes. As of Sunday, Britain had dished out 14.42 jabs per 100 people, while Germany has only managed 2.95 and France 2.35.

The UK committed £1.67 billion to ordering doses, while the EU spent only £1.57 billion for its 27 member states. That works out to £25.00 per capita for Britain, compared to £3.51 for Europe.

Germany's medicines regulator, STIKO, did not reveal the specific data used to come to their conclusion about not recommending the jab for over-65s.

But last week as the jab war raged between London and Brussels, two prominent German media outlets claimed the efficacy for over-65s was below 10 per cent. The reports were firmly rejected by AstraZeneca as well as by the German health ministry. 'A false claim does not become true just because it is repeated,' a German health ministry spokesman said of the reports.

He noted that it is a known fact that the AstraZeneca trials involved fewer older people than other manufacturers'. But 'that the efficacy is only eight percent is incomprehensible and in our view, wrong,' he added.

STIKO said that apart from the 'limitation' in data on older people, the vaccine was 'considered appropriate' for 18 to 64-year-olds.

British regulators had said that 660 older people took part in the Oxford AstraZeneca trials, acknowledging that there were too few to derive an efficacy figure for that specific group.

The trials showed one out of 341 older vaccine recipients testing positive for Covid-19, compared to one out of 319 who received a dummy jab - making a senior-specific comparison almost pointless.

But the vaccine did generate antibodies in all the over-65s who received two doses of the jab, which AstraZeneca cited as evidence that they had 'strong immune responses to the vaccine'.

AstraZeneca CEO Pascal Soriot said that older people had not been vaccinated until later in the trial because 'very ethical' Oxford scientists wanted to confirm there would be no negative side-effects. 'They're very ethical, and very academic. So they didn't want to vaccinate older people until they had accumulated a lot of safety data in the 18 to 55 group,' he said. 'They said it was not ethical to vaccinate old people until they had enough safety data in younger people.

'Other companies took this risk, went ahead and vaccinated older people faster or earlier. If you start earlier, you have more data. Essentially, because Oxford started vaccinating older people later, we don't have a huge number of older people who have been vaccinated.'

The physical roll-out of the vaccine is headquartered from an NHS office in London, with doses sent to more than 1,400 vaccine sites across the country.

It is easily the biggest vaccination drive in the history of the health service and many believe it will become an annual programme.

Britain used emergency procedures to grant market approval to the AstraZeneca vaccine, developed with Oxford University, and signed a contract three months earlier than the EU, which used a slower approval process.

The EU and many of its 27 members have faced criticism over their sluggish rollout, with fewer than 10million people getting a dose so far across the entire bloc.

Three vaccines are so far authorised for use across the EU's 27 member countries: one by German outfit BioNTech with US giant Pfizer; one by US company Moderna; and most recently one by Anglo-Swedish group AstraZeneca.

And chemicals giant Bayer announced that from 2022 it would produce a coronavirus vaccine that fellow German pharmaceuticals company CureVac is developing.

CureVac CEO Franz-Werner Haas said his company would also produce several hundred million doses of its own vaccine by the end of 2021.

CureVac's mRNA vaccine has yet to receive the green light from regulators, but German health minister Jens Spahn said it was 'on its way to approval in the coming weeks'.

French pharma group Sanofi agreed last week to help produce 125 million doses of the Pfizer-BioNTech vaccine.

And the EU was again shown to be lagging when the Novavax trial results were published last week showing 89.3 per cent efficacy.

While Britain has 60million doses ordered, the EU has only conducted 'exploratory talks' with the manufacturer, which were completed in December.

Even then, the 200million doses envisaged in an 'exploratory contract' are a smaller stockpile when adjusted for population size than Britain has ordered.

Each EU member state is responsible for its own rollout. Most are giving priority to the elderly and frontline health workers.

Almost all the vaccines require two jabs for a full vaccination. (Johnson & Johnson is aiming for a single-shot regimen, subject to trials and EMA approval.)

While the price of each vaccine has been kept secret in the European Commission's contracts, a Belgian minister's tweet in December - deleted afterwards - gave a breakdown.

The Moderna vaccine was listed as most expensive, with Brussels paying 14.70 euros a dose. The BioNTech/Pfizer one 12 euros. The AstraZeneca vaccine came in at 1.78 euros a dose.

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British legislator calls for widespread vitamin D rollout following 82% reduction in COVID-19 deaths in Spain

British Member of Parliament David Davis is urging the British government to strengthen its vitamin D supplementation program for people at-risk of COVID-19 following an impressive precedent set by Andalusia in Spain.

Speaking before the House of Commons on Thursday, Davis said that Britain should follow the lead of Andalusia, which distributed calcifediol, a vitamin D supplement, to care home residents last November. Since then, the Spanish region’s COVID-19 deaths dropped by 82 percent.

Because of this, Davis is imploring the British government to increase its dosage recommendations and implement a widespread vitamin D rollout.

The state already provides free vitamin D supplies to care home residents under the Public Health England‘s advice that they get 10 micrograms (mcg) daily for protection. However, Davis said this amount is too small to have a significant effect and the program should be for all at-risk populations.

But health officials said that there’s not enough evidence just yet for them to authorize or recommend taking vitamin D for treatment. This was despite a mountain of studies showing vitamin D deficiency can predispose people to severe COVID-19.

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Fauci Concedes 'There’s No Data That Indicates' Double-Masking Is Effective

Last week, Dr. Anthony claimed on NBC’s “Today” that wearing two masks “just makes common sense.”

“I mean, this is a physical covering to prevent droplets and virus to get in. So if you have a physical covering with one layer, and you put another layer on, it just makes common sense that it likely would be more effective,” Fauci said.

A week earlier, the New York Times had called the practice of double-masking a new “fashion trend” and a “sensible” and “easy way” to reduce your risk of catching COVID-19, but Fauci’s remarks really set off an intense public debate over whether Americans should start double-masking, after being told for nearly year that wearing a single mask and social distancing was adequate, which also came after Fauci told the American people in March 2020, “There’s no reason to be walking around with a mask.”

If you’re getting confused, you’re not alone, because a mere five days after saying that double-masking was “common sense,” Fauci seemed to walk back that statement.

“There are many people who feel, you know if you really wanna have an extra little bit of protection ‘maybe I should put two masks on.’ There’s nothing wrong with that, but there’s no data that indicates that that is going to make a difference. and that’s the reason why the CDC has not changed their recommendations.”

How does he go from saying double-masking is “common sense” to “there’s no data that indicates that that is going to make a difference” in five days? Shouldn’t we expect more from the highest-paid employee of the federal government? If Fauci admits there’s no data to support that double-masking will actually make a difference, why make the public believe they should be doing it in the first place? It was bad enough when the New York Times was quite literally fawning over the practice, but how many people bought into the practice because Dr. Fauci said it was common sense, despite the lack of data proving it?

Of course, Fauci is the same guy who praised Governor Cuomo and his COVID-19 response, so, as far as I’m concerned, Fauci lost all credibility last summer.

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NIH Revises Treatment Guidelines for Ivermectin for the Treatment of COVID-19 Ivermectin is Now a Therapeutic Option for Doctors & Prescribers

One week after Dr. Paul Marik and Dr. Pierre Kory—founding members of the Front Line Covid-19 Critical Care Alliance (FLCCC)— along with Dr. Andrew Hill, researcher and consultant to the World Health Organization (WHO), presented their data before the NIH Treatment Guidelines Panel, the NIH has upgraded their recommendation on ivermectin, making it an option for use in COVID-19.

This new designation upgraded the status of ivermectin from “against” to “neither for nor against”, which is the same recommendation given to monoclonal antibodies and convalescent plasma, both widely used across the nation. By no longer recommending against ivermectin use, doctors should feel more open in prescribing ivermectin as another therapeutic option for the treatment of COVID-19. This may clear its path towards FDA emergency use approval.

"Ivermectin is one of the world’s safest, cheapest and most widely available drugs,” noted Dr. Kory, President of the FLCCC Alliance. “The studies we presented to the NIH revealed high levels of statistical significance showing large magnitude benefit in transmission rates, need for hospitalization, and death. What’s more, the totality of trials data supporting ivermectin is without precedent.”

In its ivermectin recommendations update, the NIH also indicated they will continue to review additional trials as they are released.

“We are encouraged that the NIH has moved off of its August 27 recommendation against the use of ivermectin for COVID-19,” continued Kory. “That recommendation was made just as the numerous compelling studies for ivermectin were starting to roll in. New studies are still coming in, and as they are received and reviewed, it is our hope that the NIH’s recommendation for the use of ivermectin will be the strongest recommendation for its use as possible.”

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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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