Oxford University scientists published a study today showing their coronavirus vaccine was safe and 70 percent effective in clinical trials.
And the UK regulator now faces a "dilemma" over whether to approve a 1.5-dose regimen that appeared to increase it to 90 percent after researchers accidentally discovered the improvement.
The MHRA has been considering approving the vaccine since November 27 and is expected to make a decision before the end of the year.
AstraZeneca, the drug company that makes the vaccine, said its 62 percent effectiveness in people who received two full doses of the jab was good enough to meet regulatory standards around the world.
However, it was found that a small group of volunteers who were mistakenly given only half a dose first followed by a full dose received far better 90 percent protection from Covid-19.
The project's researchers said the discovery was "fascinating" and "unplanned", but they had no idea whether the MHRA would approve it that way.
Dr. Andrew Pollard, Chairman of the Oxford Vaccine Group, said today, “Most of the data was generated to support the two full doses. I think that will be the focus of the regulatory review.
“However, it is entirely up to regulators to decide exactly what they want the label to say in the end.
"It makes it more complicated – we didn't start with the expectation that there would be differences between groups."
Scientists from Oxford University and the UK pharmaceutical company AstraZeneca have developed a coronavirus vaccine, a study shows that on average it is 70 percent effective at preventing Covid-19
An expert said it was a "dilemma" for regulators deciding how to dispense the vaccine, with a dosage regimen only being tested on a small number of people who appear to be more effective (Picture: A volunteer receives the Oxford Shock in a study in England)
Dr. Simon Clarke, a microbiologist at the University of Reading who was not involved in the development of the vaccine, said: “The Oxford / AstraZeneca vaccine trial report poses a dilemma for regulators.
“The data are most compelling for the cohort that received half a dose of the vaccine in their first burst.
“Not only does this appear to offer better protection against disease, but there is also a reduction in asymptomatic transmission of the virus in this group, which is essential for gaining herd immunity for broader protection of the population.
“Unfortunately, this cohort was relatively small, which affected the reliability of the results. In addition, it did not include older participants (55 years and older) and it is still possible that most regulators allowed the vaccine to be used in this way at risk group may not be protected. & # 39;
The study published today confirms the results the scientists announced in late November.
That was that in a group of 5,807 people given the vaccine, only 30 tested positive for coronavirus, compared to 101 out of 5,829 people given a counterfeit vaccine.
Overall, the vaccine prevented 70.4 percent of coronavirus cases in people who had it, the study says.
More detailed data showed that three out of 1,367 people who received half a dose followed by a full dose got the disease, which is 90 percent prevention, compared to 71 out of 4,455 people who received the normal two full doses ( 62 percent). .
The 90 percent protection would of course be preferable for regulators, but there's far less data to show that it works, meaning the results may have been a fluke and it hasn't been tested on anyone over the age of 55.
The half-dose program was done because of the wrong dose measurement, and the researchers only discovered that the people had already had the bumps.
When the results were originally released, scientists raised concerns about the 90 percent figure, but the Oxford team said today that they had already notified drug regulators of the bug and agreed to make it long before it was discovered for reasons Including transparency in their test results will be more effective.
Dr. Pollard said, “I think it's fair to say that more research is needed.
& # 39; The low dose use was unplanned, but we discussed the dosage with regulators before the Phase 3 trial began …
"They agreed that it was appropriate to continue half the dose."
Margaret Keenan, a 90-year-old woman from Coventry, became the first member of the public to be vaccinated against Covid-19 today as the UK became the first country in the world to start poking citizens
(tagsToTranslate) Dailymail (t) Nachrichten (t) AstraZeneca (t) Coronavirus