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The clamor for greater transparency from top pandemic vaccine contenders has grown louder, especially after the AstraZeneca trial was briefly stopped in the UK (and is still on hold in the US). .
These growing demands for transparency have prompted Moderna (PDF), quickly followed by Pfizer / BioNTech (and a commitment from AstraZeneca), to publish its protocols this week, all of which are in the late stages of testing and are likely to see data, and perhaps emergency approvals, in the coming months.
The way Pfizer is running its phase 3, together with BioNTech, is focused on speed; It did not share a schedule for the competition, although CEO Albert Bourla has repeatedly said they should have data by the end of October.
The normally secret protocol says that Big Pharma will have an interim test after only 32 people test positive, that is, if six are positive in the vaccine group and 26 are positive in the placebo. For the final analysis, out of 164 cases, it will need to be 50% effective for the FDA to consider it a success.
Moderna said the data should be submitted by the end of the year or early next year, and AstraZeneca has previously given a similar schedule.
Moderna’s protocol also added color, saying its first analysis of data from early tests might not take place until late December, although company officials now say they expect initial analysis in November.
In terms of how you measure efficacy, a total of 151 COVID-19 cases “will provide 90% power to detect a 60% reduction in risk rate (60% vaccine efficacy [VE]), rejecting the null hypothesis ”, he said in his protocol.
“This is a case-based study,” said Moderna’s protocol. “If the pre-specified criteria for early efficacy are met at the time of interim analysis or overall efficacy in the primary analysis, a final study report describing the efficacy and safety of mRNA-1273 will be prepared based on the data available at that time. moment.
“In the event that the success criteria are met at the time of the interim analyzes or when the total number of cases has been accumulated towards the primary endpoint, participants will continue to be followed up blindly for up to one month 25, to allow the evaluation of – term of safety and durability of VE. If the study is concluded early, all participants will be asked to provide a final blood sample at the time of study conclusion. “
Your first interim analysis (IA) will occur when about 35% of the total cases have been observed and the second at 70%, and the primary analysis will be “performed when approximately 151 cases have been observed in the study”.
“There is no intention to stop the study early if efficacy has been demonstrated in any of the impact evaluations,” Moderna added. “If efficacy is demonstrated in an AI, the subsequent AI or primary analysis will be considered supportive in nature.”
So far, 25,000 patients have been enrolled in Moderna’s trial, and 10,000 have received their second injection.
US President Donald Trump is pouring a lot of political capital into these vaccines that arrive before the election, or shortly after, with mounting pressure for drug makers, many of whom get money from the government. Get a vaccine as soon as possible.
Earlier this month, AstraZeneca, which also promised to launch its vaccine protocol (but did not at the time of this writing), and its partner, the University of Oxford, had to stop their phase 3 after a problem arose. serious safety in a patient.
The trial was briefly halted in the UK before resuming (although it is still on hold in the US), officials raised concerns about the event and many on bio-Twitter wondered why AstraZeneca is shy about the exact details of what happened.
Media reports, including CNN, suggested that a rare nerve disease had affected a patient, but AstraZeneca has come out to deny this outright. The diagnosis was “based on preliminary findings” and is inaccurate, he said in response to the articles. If you publish your protocol, this information will not be part of it.
The publication of the protocols has generated praise from some members of the scientific community. “I want to say thank you for a good turn,” said Peter Doshi, faculty member of the University of Maryland School of Pharmacy in Baltimore and editor of The BMJ. speaking to The New York Times.
“They have opened up, for the first time, the ability of researchers who did not participate in the trial to form their own independent judgment about the design of this study.”
