Pfizer’s new crown oral drug has progressed, but clinical trials of vaccines have exposed “scandals”
2021-11-07 09:02:59Source: Xinhuanet
Xinhua News Agency, Washington, November 5th. Pfizer announced on the 5th that an oral antiviral drug it has developed has shown a good treatment effect for the new crown in clinical trials. However, the company’s new crown vaccine clinical trial cooperation agency has recently been exposed to many irregular operations in the trial process, which has raised questions about the credibility of its drugs and vaccines.
A recent report in the British Medical Journal stated that Pfizer’s new crown vaccine clinical trial cooperation agency may have problems such as unreliable trial data and irregular trial operations.
According to the report, an institution called “Ventavia Research Group” acted as a contractor to assist Pfizer in carrying out some clinical trials of the new crown vaccine. The article said that former employees of the group revealed that there were many problems in the institution’s participation in the trial, such as poor laboratory management, the failure of patients participating in the trial to obtain timely follow-up and monitoring of possible vaccine side effects, violation of operating regulations, and Failure to report in time, test vaccines not stored at the appropriate temperature, confusion of test sample labels, doubts about the reliability of test data, etc.
The “British Medical Journal” article also said that in September last year, employees of the “Ventavia Research Group” reported to the U.S. Food and Drug Administration that the group had the above-mentioned problems, but Pfizer continued to let this institution use the research contractor’s Participate in other clinical trial projects of the new crown vaccine.
Some readers commented on the “British Medical Journal” website with real names, “How can we trust the safety data provided by Pfizer?”
In this context, Pfizer announced on the 5th new developments in oral drugs for the new crown. The company’s statement said that the results of the interim analysis of phase II/III clinical trials showed that patients with new crowns who took the company’s new antiviral drug PAXLOVID can reduce the risk of hospitalization and death by 89% compared with the placebo control group.
This randomized double-blind controlled trial involved thousands of adult patients with new coronary disease, who are at higher risk of developing severe illness. In the trial, some people took PAXLOVID every 12 hours for 5 days; the control group took a placebo. At the same time, this oral drug can be used in combination with another common antiviral drug, ritonavir, to enhance its efficacy.
Pfizer CEO Albert Bula said in a statement that trial data shows that if this candidate oral antiviral drug can be recognized by regulatory agencies, it will help reduce the severity of the disease in patients with new crowns and greatly reduce its development. The risk of hospitalization.