Governments Can Face “Tough Choices” Over Vaccines

The AstraZeneca / Oxford vaccine is currently being evaluated by the Medicines and Healthcare Products Regulatory Agency (MHRA) for use in the United Kingdom.

Data from the two arms of the Phase 3 trial published last week showed a total efficacy of 70%.

A subset of the data found that the half dose followed by the full dose was 90% effective in protecting against Covid-19, while 62% of people were given two full doses. did.

90% of the results were based on the dosing regimen given to 2,741 patients, but 8,895 patients were involved in the double-dose group of the study.

AstraZeneca has announced that it will conduct more global clinical trials to evaluate its 90% dosing regimen. We admit that this is the result of a misadministration.

Professor Salisbury said on a BBC Radio 4 today show that problems could arise if 90% of the findings weren’t scrutinized.

This was after some scientists, including the United States, questioned the validity of the data, including the fact that 90% of dosing regimens were only given to people under the age of 55.

“This should not have been selected and I think the number of patients employed so far may not be able to do it,” said Professor Salisbury.

“If this vaccine is really 90% successful, cheap and doesn’t require a much stricter cold chain than RNA vaccines (from Pfizer and Moderna), it’s great results.

“But if that’s achieved at 62% and the other vaccines achieved so far are 90%, I think we need to carefully consider what to do with 100 million unprotected doses of the product. As well as choices?

“I think there are difficult choices.”

When the World Health Organization (WHO) set the standard for effective vaccines at 50%, asked if MHRA could say that 62% is not enough, Astra Zeneca has a serious jab. He said he would protect him from illness. They (MHRA) judge it based on the criteria set and the information given to them. I have great confidence in their judgment and their ability to do it.

“When a highly effective vaccine becomes available, I think there will be handling issues with less effective vaccines.”

He suggested that the most effective vaccines may be preferred for older and more vulnerable people.

But he added: “The review process they (MHRA) do isn’t always that long. That’s an implication I think I have to sort out.

“And it would be great if this could be a 90% effective vaccine. If it really is 60%, it should be considered carefully.”

A government scientific adviser said it was too early to make a comparison between vaccine trials.

On Thursday, some British scientists sought to defend Oxford University and AstraZeneca on the results of clinical trials. This will be announced at Lancet shortly.

Data from an early phase II trial published at The Lancet show that the vaccine responded strongly to all age groups.

Helen Fletcher, a professor of immunology at the London School of Hygiene and Tropical Medicine (LSHTM), said: “Notably, Oxford University and AstraZeneca have increased from 1 million to 100 million in less than a year.

“It’s not surprising that manufacturing issues were still resolved when we started clinical trials, but all early-stage trials are about safety, and the safety data we see is very high. It’s robust. “

She said it was important to wait for the complete dataset to be published.

“I also think that lower initial vaccine doses can increase the effectiveness of the vaccine,” she said.

“When it comes to vaccines and immunotherapy, the more you have, the better.

“You need to stimulate the immune response, but if you push it too hard, you can run into a negative feedback loop where the immune system tries to control and weaken the response.

“A strong immune response to the first vaccine may effectively block the immune response to the second shot of the same vaccine, but we should be able to see evidence when the data are released. “

Stephen Evans, Professor of Pharmacology and Epidemiology at LSHTM, said: “The idea that the protocol has not been published (by Oxford and AstraZeneca) is simply not true.”

He added: “The way the data is put together is specified in the protocol and is very carefully scrutinized by regulators to ensure that there is no” cherry picking “in the results. “

Professor Andrew Polard, director of the Oxford Vaccine Group, told reporters at a UK-based press conference last week that the 90% efficacy finding already met “the necessary statistical evidence required by regulators.” He said he was.

He said more evidence would probably be available next month, which is “a very important result even in the numbers we have.”

In an interview with PA news agency last week, Tom Keith Roach, president of AstraZeneca, UK, said, “Regulators have been based on the results of very statistically significant efficacy in all subgroups. I think we will consider it. “

Oxford University said it would not comment prior to the data published in peer-reviewed publications.

Meanwhile, Downing Street said it had “no plans” to print the Union flag on the Oxford vaccine after reports that the number 10 “Union Unit” required the package to display the British flag.