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Kristina Partsinevelos of FOX Business on the possibility of a coronavirus vaccine warrant in some states.
AstraZeneca is considering an additional global trial to further study the effectiveness of its COVID-19 vaccine, according to comments from company CEO Pascal Soriot on Thursday.
Soriot told Bloomberg in an interview that the company would potentially launch a new study to assess whether a lower dose of its vaccine would be more effective than a full dose.
“Now that we have found what appears to be better efficacy, we need to validate this, so we need to do further study,” he said.
A spokesperson for AstraZeneca told FOX Business in a statement that there is “great interest in continuing to further study the half-dose / full-dose regimen.”
“We are still evaluating the data and will work with regulators on the best approach for further assessment,” the spokesperson added. “This would add to the data from existing trials that are currently being prepared for regulatory submission.”
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The potential move follows recognition by AstraZeneca and the University of Oxford of a manufacturing error that raised questions about the vaccine’s preliminary results.
The University of Oxford said on Wednesday that some of the vials used in the trial did not have the correct concentration of vaccine, so some volunteers were given half a dose. The university added that it had discussed the issue with regulators and agreed to complete the late stage trial with two groups.
According to the university statement, the manufacturing problem has now been fixed.
The statement describing the error came days after the drug company and the university described the injections as “very effective.”
The group of volunteers who received the lower dose appeared to be much better protected than those who received the two full doses. In the low dose group, AstraZeneca said the vaccine appeared to be 90% effective. In the group that received two full doses, the vaccine appeared to be 62% effective. Together, the drugmakers said the vaccine appeared to be 70 percent effective.
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However, experts question how the results were achieved and communicated by companies.
They argue that the relatively small number of people in the low-dose group makes it difficult to know whether the efficacy seen in the group is valid or a statistical oddity. AstraZeneca said about 2,741 people received a half dose of the vaccine followed by a full dose, while a total of 8,895 people received both full doses.
In addition, none of the volunteers in the low dose group were over 55 years old. Younger people tend to develop a stronger immune response than older people, which might explain why the low dose group seems to be more effective, rather than the size of the dose itself.
David Salisbury, associate member of the Chatham House Think Tank Global Health Program, told The Associated Press that another point of confusion comes from a decision to pool the results of two groups of participants who received different dosage levels to reach an average of 70%. efficiency.
“You took two studies where different doses were used and you found a composite that didn’t represent any of the doses,” he said of the number. “I think a lot of people have problems with this.”
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The next step for AstraZeneca’s vaccine will be published in medical journals which will be provided to UK regulators so they can decide whether or not to allow the vaccine to be distributed.
The report will include a detailed breakdown that will include demographic and other information about who has fallen ill in each group, and will offer a more complete picture of the vaccine’s effectiveness.
Moncef Slaoui, who heads the U.S. government’s coronavirus vaccine program Operation Warp Speed, told reporters on a call Tuesday that U.S. officials are trying to determine what immune response the vaccine has produced and may decide to alter it. AstraZeneca study in the United States to include half a dose.
“But we want it to be based on data and science,” Slaoui added.
The partial results announced on Monday come from large studies underway in the UK and Brazil to determine the optimal dose of vaccine, as well as to examine safety and effectiveness. Multiple combinations and doses have been tried in volunteers. They were compared to others who received a meningitis vaccine or an injection of saline.
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AstraZeneca is not the only vaccine to have shown results on its effectiveness.
| Teleprinter | security | Latest | Change | % Change |
|---|---|---|---|---|
| AZN | API ASTRAZENECA | 52.60 | -0.97 | -1.81% |
| PFE | PFIZER INC. | 36.53 | -0.07 | -0.19% |
| BNTX | BIONTECH SE | 104.96 | +3.09 | + 3.03% |
| RNAm | MODERNA INC. | 109.18 | +10.62 | + 10.78% |
Pfizer’s latest trial data released earlier this month found their vaccine, developed in partnership with BioNTech, to be over 90 percent effective. Meanwhile, Moderna said its vaccine was 94.5% effective in preventing COVID-19.
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The Associated Press contributed to this report
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