This Site took a (small) degree of flak after I raised questions about the Oxford/AstraZeneca vaccine that Boris Johnson had touted as 90 per cent effective.

It turned out that the extra effectiveness only worked when a lower dose was administered first (of the two that were provided to test subjects).

It was enough for me to flag up concern – and that was enough for some people to complain. “Why the negative spin?”

Perhaps because there’s more to it, as the New York Times has revealed:

The regimen that appeared to be 90 percent effective was based on participants receiving a half dose of the vaccine followed a month later by a full dose; the less effective version involved a pair of full doses. AstraZeneca disclosed in its initial announcement that fewer than 2,800 participants received the smaller dosing regimen, compared with nearly 8,900 participants who received two full doses.

The biggest questions were, why was there such a large variation in the effectiveness of the vaccine at different doses, and why did a smaller dose appear to produce much better results? AstraZeneca and Oxford researchers said they did not know.

Crucial information was also missing. The company said that the early analysis was based on 131 symptomatic Covid-19 cases that had turned up in study participants. But it did not break down how many cases were found in each group of participants — those who received the half-strength initial dose, the regular-strength initial dose and the placebo.

Adding to the confusion, AstraZeneca pooled the results from two differently designed clinical trials in Britain and Brazil, a break from standard practice in reporting the results of drug and vaccine trials.

The company had not intended for any participants to receive the half dose. British researchers running the trial there had meant to give the full dose initially to volunteers, but a miscalculation meant they were mistakenly given only a half dose.

To many outside experts, that undercut the credibility of the results because the closely calibrated clinical trials had not been designed to test how well a half-strength initial dose worked.

The company’s initial announcement didn’t mention the accidental nature of the discovery.

Then… Moncef Slaoui, the head of Operation Warp Speed, the U.S. initiative to fast-track coronavirus vaccines, noted another limitation in AstraZeneca’s data. On a call with reporters, he suggested that the participants who received the half-strength initial dose had been 55 years old or younger.

Mr. Pangalos confirmed that on Wednesday, saying the participants received the half-strength dose over a matter of weeks before the error was discovered.

The fact that the initial half-strength dose wasn’t tested in older participants, who are especially vulnerable to Covid-19, could undermine AstraZeneca’s case to regulators that the vaccine should be authorized for emergency use.

So the vaccine’s 90 per cent effectiveness only works on people aged 55 or younger. For older people, it was 62 per cent effective – a significant drop, and enough to jeopardise the vaccine’s bid to be fast-tracked into use.

Johnson would have had it pressed into service straight away, if he could.

And how would that have affected older people who would then be encouraged to take it, based on a false belief?

Source: AstraZeneca Faces Difficult Questions About Its Vaccine After Admitting Mistake – The New York Times

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