[ad_1]
LAST UPDATE: 18.36
Most likely, AstraZeneca will proceed with a new clinical trial of the vaccine that it has jointly developed with the University of Oxford against Covid-19, according to statements by its CEO, Pascal Soriot, cited by Bloomberg.
The new clinical trial, according to the agency, will evaluate the effectiveness of the action of the lower dose of the vaccine, which appeared to have more positive results than the normal dose. The company’s recognition that the lower dose was administered due to a manufacturing error raised significant concerns about the approval process for the use of the vaccine.
Soriot also said that he did not expect the additional clinical trial to delay the approval of the vaccine by regulators in the UK and the European Union, as large numbers of volunteers would not be needed.
As for the US, FDA approval is likely to be delayed as it is difficult for the US agency to authorize a drug for which clinical trials have been conducted abroad, especially after the ones were announced. first results days ago.
As Capital.gr previously reported:
AstraZeneca Plc and the University of Oxford, among the leaders in the “race” for the development of a coronavirus vaccine, are facing increasing questions about the results of their clinical trial on the effectiveness of their vaccine. production process.
While AstraZeneca and the University of Oxford announced Monday that the results of their final vaccine study showed them to be 70% effective on average, the few details that have been released have raised concerns about whether regulators would be able to approve their release. according to Bloomberg.
A statement from the University of Oxford later said that a difference in the production process had led some participants to take half the dose rather than the full one.
AstraZeneca and the University of Oxford said their vaccine was 90% effective when given half a dose before the second full dose, adding that two full doses showed 62% effectiveness.
However, the head of the US vaccine program, known as Operation Warp Speed, said the next day that the dose showing the greatest efficacy was tested in younger populations, adding that half the dose was administered. some participants due to an error in the amount of vaccine. it contained some vials. None of the above was disclosed in AstraZeneca’s original statement.
The findings raised optimism that the end of the pandemic is in sight and that many vaccines to combat the coronavirus could be ready soon, following positive results also announced by Pfizer Inc. and Moderna Inc.
AstraZeneca and the University of Oxford are also close, although the way they handled their large clinical trial has shocked scientists and investors, increasing the risk of slowing down their efforts.
“Anytime there is confusion about testing, it is not good because it reduces credibility,” says Ketan Patel, fund manager at EdenTree Investment Management. “I think there will be much more careful scrutiny of the AstraZeneca product due to the problem in the production process.”
In a statement, the University of Oxford said that when it was discovered that a lower dose was being used, it was discussed with regulators and an agreement was reached to promote both regimens. “Concentration measurement methods are already in place and we can ensure that all vaccine batches are equivalent,” the university said.
An AstraZeneca spokesperson said the tests were carried out “to the highest standards” and that more tests were underway to determine the effectiveness of the vaccine.
Effectiveness “unknown”
“The most likely explanation for divergent efficacy in your mid-term analysis is either random or related to patient demographics,” wrote Sam Fazeli, an analyst at Bloomberg Intelligence. “In any case, approval based on current data means that people will be vaccinated with a vaccine whose true effectiveness is unknown.”
In any case, it is worth noting that the “battle” to deal with the coronavirus is at a critical moment, and encouraging findings were announced this month through clinical trials of two candidate vaccines: the Pfizer vaccine and the BioNTech SE vaccine and the Moderna Inc.’s vaccine was approximately 95% effective in preliminary analyzes of end-stage clinical trial data in thousands of volunteers.
