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COVID-19: Vaccine and testing procedures Megathread Part 2 [Mod Warning - Post #1]
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In and out of lockdowns if we don't get the most vulnerable vaccinated first
There is concern in Brussels whether the AstraZeneca vaccine will also be approved for people over 55 years of age. If the approval does not come quickly, the Chancellor's patience will break, he says
Every week counts, emphasized Federal Chancellor Sebastian Kurz (ÖVP) after a video conference with the so-called "first mover" countries on Monday. That is why the approval of the vaccine from Astra Zeneca cannot go fast enough.
Together with Denmark and Greece, Austria wants to urge the EU for the European Medicines Agency (EMA) to approve the vaccine quickly and unbureaucratically. In an interview with Puls 4, Kurz became even clearer: If a quick approval does not succeed, "he would lose patience at some point," the broadcaster quoted the Chancellor in a broadcast. Kurz also admitted that, in retrospect, other countries were faster with their orders than Austria, which had joined the common EU vaccine strategy.
But there is concern in the background when it comes to the approval and availability of Covid vaccines. As DER STANDARD learned, it is currently questionable whether the long-awaited vaccine from Astra Zeneca can actually get full approval. Its effectiveness in older people should not be fully clarified even shortly before the EMA's decision.
Concern about Astra Zeneca approval
As for the vaccine from Astra Zeneca - the vaccine that the Chancellor wants to approve as quickly as possible - representatives from science and politics in Brussels as well as in Vienna are racking their brains about its effectiveness in older people. The British-Swedish company's application for approval for the vaccine against Covid-19 developed at Oxford University was received by the EMA last Tuesday. There are high hopes that the vaccine will bring the pandemic, which has been raging for almost a year, under control.
The vaccine with the designation AZD1222 is intended to be used by the general public and is well suited for this: The vaccines from Biontech / Pfizer and Moderna, which have been approved in the EU up to now, need deep freezing at temperatures as low as minus 70 degrees - AZD1222, on the other hand, can be kept for a long time at refrigerator temperatures. In addition, the Astra-Zeneca vaccine is much cheaper than the other two substances.
But that is currently pending. In Brussels there are concerns that there could be problems with the EU approval of the third Covid-19 vaccine planned for January 29th. The next EU summit of heads of state and government will take place on Thursday, which will exclusively deal with the situation of the corona pandemic via video conference. It is questionable whether the vaccine can get full approval.
The reason for this is an evidence problem. For some EMA experts, who have to make decisions independently of politics, the data from the series of tests in autumn are not sufficient for the time being. For those over 65 years of age, the effectiveness was not convincingly clarified, unlike the products from Biontech and Moderna, which were able to demonstrate over 90 percent effectiveness.
Good values in comparison
Overall, the Astra-Zeneca vaccine has an effectiveness of 70 percent, which is a very good value compared to flu vaccines. But the 90 percent effectiveness of Biontech has set new standards.
The STANDARD was confirmed by a high-ranking expert who is involved in the implementation of the European vaccination strategy that there is a "big headache everywhere" in this regard. Astra Zeneca has deficiencies in the "verifiable effectiveness" in people over 65. This does not have to be associated with a higher risk of vaccination, but the protection against corona infection may be lower.
Expert Nicolodi: Too little evidence
The independent Austrian vaccine expert Christina Nicolodi is not surprised by these problems. Evaluations of Astra Zeneca, which consider certain subgroups - for example based on age - are still pending. In the STANDARD conversation, Nicolodi specifies that the age limit of 55 years is generally relevant for vaccinations. From this age onwards, the immune system changes and reacts differently to immunizations than in younger people.
From the phase III tests of the vaccine, to the best of her knowledge, there is only data on "1,000 to 1,500" people in this age group out of a total of around 11,000 test subjects. That is not enough to really assess the effect on the elderly.
"Breakdown" during testing
It is also unclear what role older people played in the "breakdown" that led to a retesting of the vaccinated vaccine doses: after the Astra-Zeneca vaccine had shown an immunization level of around 70 percent after two equally large partial vaccinations After a dosage error, it turns out that a first vaccination of half a dose and a second vaccination of a whole dose provide 90 percent protection.
How the EMA's decision will turn out is open at the moment. A political problem would arise for the heads of government and the President of the Commission if they were only partially approved. For one, Astra Zeneca's vaccine plays a major role in the EU vaccination strategy. On August 27, 2020, the Commission already bought 400 million doses for all 27 member countries - the first sales contract for Covid 19 vaccines in the EU out of a total of seven.
Approved for everyone in the UK
To be on the safe side, consideration is being given to only approving the Astra-Zeneca vaccine in the age category up to 55 years if it is approved by the EMA. In the case of partial approval, however, it would be difficult to explain to the general public that there are vaccines of different quality, according to the STANDARD from government circles in Vienna.
This could also raise questions, because in the UK, for example, AZD1222 is used in all age groups as part of an emergency approval.
Rethink vaccination plans
Should it come to the restricted EMA approval, there would probably have to be a shift in the vaccination plans in the EU. Over 55-year-olds would then have to be vaccinated with the available doses from Biontech and Moderna. If there is no approval of the Astra-Zeneca vaccine for over 55-year-olds or for over 65-year-olds (a decision is pending), this could mean that the ordered vaccine will first be used in younger people, according to the council.
That would not change anything about the Austrian vaccination strategy, said Health Minister Rudolf Anschober (Greens) on Friday. The older groups would be vaccinated in the initial phase anyway. At the press conference, Anschober also made it clear that the decision as to which vaccine should be approved is not a political one.
On Monday, a spokesman from the Ministry of Health made this more concrete: Thanks to the doses from Pfizer and Moderna, you have a "buffer", but "if Astra Zeneca is approved, it will of course be faster". However, it is also pointed out that the ongoing vaccinations in Great Britain are gaining live experience, which could improve the data situation.
Admission can be postponed
It is also conceivable that the EMA will postpone the approval decision at the end of January until Astra Zeneca provides more data. The company has been asked to provide additional data - and has agreed to do so. A broad study is also underway in the USA.
In response to a STANDARD request, Astra Zeneca said that the company's Phase III registration study published in the "Lancet" journal included people of all ages over 18 years. "All currently available safety and efficacy data for the whole population have been submitted to the EMA," said Astra Zenecas Medical Director in Austria, Botond Ponner.
According to Astra Zeneca "robust immune responses"
In addition, the results of the phase II / III study with AZD1222 also published in "Lancet" had shown that the vaccine "elicited similarly robust immune responses to Sars-CoV-2 in all age groups, with older adults (56 to 70 years old) even there were fewer and fewer local and systemic reactions ".0 -
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IRISHSPORTSGUY wrote: »In and out of lockdowns if we don't get the most vulnerable vaccinated first
If its under 55s then that's fine realistically.
It's always been said that if one was to be used only for certain ages then other groups will get the other. Likewise if required they would swap the groups around and the young would get vaccinated first should a reduction in transmission be proven.
I.e under 55 to get AstraZeneca and most at risk Pfizer or Moderna. Wouldn't be a worry to be honest if that happened. Realistically its probably the way it'll go anyway0 -
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