Posts Tagged ‘vaccines’

EU vaccine shambles “an advertisement for Brexit”

January 28, 2021

There is little doubt that the EU member states would each have done much better if they had taken care of their own and not relied on the EU negotiating for them or believing in EU solidarity. It is not just incompetence that the EU was late in placing vaccine orders. It became gross incompetence when the orders they placed were “junk orders” with pledges for “best efforts” and with no commitments. The EU contract with AstraZeneca has a “best efforts” clause and no specific time-table.

The EU did not allow member countries to negotiate for themselves but, instead, insisted on negotiating for the block – late and apparently without much display of competence. Ursula von der Leyen is catching the blame but it is the cowardly, risk-averse and cover-your-ass attitude of the EU bureaucracy which is the main culprit. That is the EU sickness.

La Grande Guerra:

German media savages EU for vaccine shambles which it calls ‘an advert for Brexit’

German media has rounded on the EU over Europe’s vaccine debacle today – calling it ‘the best advert for Brexit’ while blaming chief Ursula von der Leyen for the delays. The EU is acting ‘slowly, bureaucratically and protectionist… and if something goes wrong, it’s everyone else’s fault’ fumed a front-page editorial in Die Zeit, one of Germany’s best-respected broadsheets. Meanwhile Bild tore apart Von Der Leyen’s explanation of the vaccine delays and threat to stop supplies heading to the UK line by line, accusing her of placing ‘junk’ orders for vaccines three months behind Britain. ‘She says: “We know that there is no time to lose in a pandemic,” but what she means is: “We may have wasted time. But we will NEVER admit that”,’ the newspaper wrote. ……..

Bild added: ‘[Von Der Leyen] is responsible for EU junk orders. ‘Also for the fact that the EU only reached an agreement with AstraZeneca in August, not in June – as [German health minister] Jens Spahn wanted but was not allowed to. Valuable preparation time passed. Von der Leyen cannot do anything for the current audacity of AstraZeneca. The criticism is justified. But it must also be self-criticism.’

‘In the UK,’ Die Zeit adds, ‘the government’s independent and swift vaccination policy is seen as evidence that the EU is too bureaucratic and slow – and is now left behind.’ 

The criticism came as the CEO of AstraZeneca – the company which sparked the row by cutting EU vaccine supplies by 60 per cent – spoke out to defend himself, while also pointing the finger at delays in Brussels. Asked why supplies were being cut to the EU but not the recently-departed UK, Pascal Soriot said it had nothing to do with national favourtism and everything to do with the fact that the EU placed its vaccine order late. ‘We had problems in the UK too,’ he told a trio of European newspapers including Italy’s Repubblica. ‘But the contract with the British government was signed three months before the one with the EU, therefore we had time to prepare and resolve similar issues. The UK and the EU have two different production chains and at the moment the British ones are more efficient because they started earlier.’

Britain signed a contract for 300million doses of vaccine in mid-May, he revealed, but it took the EU until August to put pen to paper on the same deal. Embarrassingly for the bloc, it appears that Germany, the Netherlands, France and Italy had originally been looking to do a deal with AstraZeneca in May – but were blocked by the EU, which insisted it take over negotiations. ………

Meanwhile Bild newspaper accused Von Der Leyen of shirking blame and wasting time, while adding that ‘Brexit Brits’ have escaped the crisis. According to ITV’s Robert Peston: ‘The extra talks with the European Commission led to no material changes to the contract, but wasted time on making arrangements to make the vaccine with partner sites.’ The delays in producing the vaccine are now thought to be due to under-production at one of those sites, located in Belgium. Face with growing public anger over the failings, Italy threatened to sue to get its vaccine doses, while Von Der Leyen has ordered AstraZeneca  to ‘meet your obligations.’ But, according to Soriot, the company is meeting its obligations because it only signed a ‘best effort’ deal with the EU – promising to try and achieve 300million vaccines, but acknowledging that the complex process might be hit by delays. ‘We are two months behind schedule,’ Soriot admitted. ‘But we are working to solve these problems.’


Vaccine philanthropy is only possible if you first have vaccine nationalism

January 23, 2021

There have been a number of sanctimonious platitudes about the dangers of vaccine nationalism from the usual suspects (UN Sec Gen, WHO Dir Gen, …). This has been virtue signalling at its worst. Any national government which did not first secure its own citizens would be failing in its primary task. It is again a case of people forgetting that international is not possible without first securing the national. Philanthropy between countries cannot happen unless there is first nationalism.

And so it is between India and Brazil.

Covishield is the brand name of the AstraZeneca/Oxford vaccine manufactured by the Serum Institute of India. So far India has despatched over 3 million doses of Covishield to Bangladesh, Nepal, Bhutan, Myanmar, Seychelles, Mauritius and Brazil. Brazil receives 2 million doses today. President Bolsanaro has invoked images from the Ramayana in his message of thanks. Sri Lanka and Afghanistan are to also receive vaccines in the next despatch. This vaccine can be transported and stored at between +2 and +8 degrees Celsius and has a shelf-life of 6 months. This vaccine philanthropy by India is only possible because sufficient stocks, greater than the rate of vaccination, are available for its own citizens.

The EU has not yet approved this vaccine but this approval is expected on 29th January. Neither has the US approved. I have my own theory that the EU delay in approval is not unconnected with protecting some market for the other, more expensive, more difficult to transport vaccines. Not quite a conspiracy theory but at least some unconscious collusion.



FDA panel recommends approval of Pfizer vaccine, 17 to 4. But why did 4 oppose?

December 11, 2020

As expected, the FDA’s independent vaccine advisory committee recommended approval of the Pfizer vaccine yesterday, “17 to 4 in favor of recommending the drug for emergency use for people aged 16 years and older, with one of the members withholding”.

CBS News

A federal advisory panel on Thursday recommended the emergency use of Pfizer’s COVID-19 vaccine. The Food and Drug Administration is expected to approve the drug, kicking off a massive nationwide operation to get nearly 3 million doses of the vaccine to hospitals and drug stores across the country. The experts voted 17 to 4 in favor of recommending the drug for emergency use for people aged 16 years and older, with one of the members withholding. Health care workers and nursing home residents will be among the first to get the vaccine.  …….. Clinical trials showed the Pfizer vaccine was nearly 95% effective for adults 18 to 64 and was just as effective for people of all ethnicities. However, some groups — people with weak immune systems, individuals with severe allergic reactions, and pregnant women — could be restricted from getting the shot. However, British health officials on Wednesday warned that people with a history of “significant” allergic reactions to vaccines, medicine, or food should not be given Pfizer’s vaccine. Hahn said the FDA is working closely with its partners in the U.K. to understand what happened with the allergic reactions. “We study the data very carefully to say who should not receive the vaccine and these are the things the FDA does to ensure the safety and effectiveness” of the drug, Hahn said Thursday.

The advisory committee’s recommendation will probably lead to FDA approval by the weekend. The consensus is that the vaccine is safe and 95% effective. The Covid-19 pandemic is clearly out of control and there is a fear – quite justified – that without widespread acceptance of the vaccines the pandemic may continue unchecked. The Spanish flu pandemic (1918 – 21) lasted almost 3 years without any vaccine. Even with widespread and effective vaccination against Covid-19, this pandemic is set to last for at least two years until Spring 2022. Currently there is a widespread, global “information campaign” in favour of vaccination. Sometimes the simplistic and unnuanced messages are, I think, counter-productive. The WHO and UN information programs, in particular, talk down to the “great unwashed” and come close to being brainwashing attempts.

It can be expected that all members of an expert panel on vaccines will generally be in favour of vaccines. A key question then is why 4 of the expert panel did not recommend approval. In the current climate the dissenting expert views are of special importance. Unfortunately there is not much reporting of their views (with some exceptions).

The WSJ has some details:

Archana Chatterjee, dean of the Chicago Medical School at Rosalind Franklin University of Science and Medicine, said she dissented from the recommendation vote because there isn’t enough data justifying including 16 and 17 year olds in an emergency authorization. …. Oveta Fuller, a virologist at the University of Michigan Medical School, also dissented, saying in an interview that she would like to see at least two more months of data on trial participants that could help determine whether the vaccine reduces transmission.

The issue of using placebos in double-blinded trials for some patients and denying such patients vaccines came up (of effectively using humans as guinea-pigs). This is not really an ethical question at all, though the medical profession assuages its conscience by presenting it as such.

……. Doran Fink, deputy clinical director of the FDA’s division of vaccines, said further evaluation of the vaccine after its release will be necessary to see if its benefits continue to outweigh its risk, and whether any labeling changes will be required. Dr. Fink also addressed one major topic that has been in question—whether patients in the Pfizer trial who were randomly assigned to placebo should automatically be switched over and get the vaccine. FDA staffers told the committee they shouldn’t.

Steven Goodman, a Stanford University School of Medicine dean and epidemiologist, described that choice in testimony before the panel as an “ethical dilemma” in which both answers—getting vaccines to placebo patients and developing long-term safety and effectiveness—are right, and neither is unethical. ….. Marion Gruber, director of the FDA’s office of vaccines (and no relation to Bill Gruber), said she is concerned that if there is an unblinding of patients, that might limit the ability of the study to gather enough data about the vaccine’s safety.

Of course, there is no ethical dilemma. It is a simple case of the one being over-ruled by the many. Those patients involved in trials who get placebos instead of the vaccines are effectively human guinea-pigs whose health (and lives) are being adventured, without their knowledge, “for the common good”. Guinea-pigs (human or not) are not required to be told, or to understand, their fate. Their role is only to be counted in the appropriate column.

Throughout human history “the few” have always been sacrificed for “the many”. That, after all, is the essence of democracy. The reality is that the health of those receiving placebos in a vaccine trial is always subordinated to the results of the trial.


Vaccine races

December 4, 2020

Long-term effects can only show up in the long-term. The UK has won the Pfizer race but Russia and China already won their own races. The EU and the US are just slow (but claim credit for a prudence that is not possible). They are both so heavily invested that they cannot not approve. In fact, the world needs the vaccination initiatives to proceed with all speed, no matter the immunization conferred. Deployment of their own vaccines has started in Russia and China and the Pfizer vaccine will start being deployed in the UK next week. Other countries will follow – have no choice but to follow. The low cost vaccine is the Astrazeneca / Oxford vaccine which is probably 2 months away. Some few countries will deploy the Chinese and Russian vaccines. 2021 is vaccination year. It remains to be seen if this succeeds in preventing another Covid-19 spike in spring 2021.

Long-term effects are unknown but unlikely. The period of conferred immunization is unknown and will come out in the wash.



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