(Reuters) – Pfizer Inc. is betting that its coronavirus vaccine candidate will show clear evidence of effectiveness at the start of its clinical trial, according to internal documents reviewed by the company and Reuters, which describe how the hearing is being conducted.
In recent weeks, Pfizer said it should know by the end of October whether the vaccine developed in conjunction with Germany’s Biotech SE is safe and effective. If the vaccine shows up to work by then, Pfizer said it will seek regulatory approval quickly. It did not say what data it would use.
President Donald Trump, who is seeking re-election, has said the vaccine to fight the coronavirus epidemic is possible ahead of the November 3 U.S. vote, which could raise concerns about political interference. Scientists have questioned whether drug manufacturers will have enough evidence to achieve success by that time.
Pfizer’s clinical trial protocol company, scientists, scientists and regulators can show the drug manufacturer how its vaccine is available in the US. Meets efficacy and safety standards set by the Food and Drug Administration.
A company’s protocol is submitted to the FDA for review and is overseen by an independent panel of experts called the Data and Safety Monitoring Board.
Participants in this trial are asked to first evaluate the performance of the vaccine by a monitoring board after they have been infected with the novel coronavirus. The trial, which began in July, has so far registered more than 29,000 people, some receiving the vaccine and others receiving placebo.
The FDA has said the coronavirus vaccine should be at least 50 percent more effective than placebo in large-scale hearings for consideration for approval. However, a small sample of infection in a clinical trial, according to the researchers, changes the calculation of how the standard is obtained.
According to its protocol, the Pfizer vaccine must be at least 76.9% effective to show that it works based on 32 infections. This means that no more than six of those vaccinated became coronavirus cases, the documents show.
If the drug manufacturer’s vaccine does not meet the 76.9% efficacy target in this first intermediate analysis, it will face a statistically significant threshold during subsequent intermediate assessments, said biostatists reviewing the protocol.
“If our vaccine meets the strict standards set by the FDA, its interim analysis is designed to show evidence as quickly as possible between catastrophic epidemics,” Pfizer said. Pfizer will not say whether it will use interim analysis as a basis for obtaining approval.
The FDA declined to comment on whether such data would be considered sufficient for approval.
Enough evidence?
Interim analysis is usually used by the Data and Safety Monitoring Board to determine whether an experimental drug seems safe and effective enough to continue the trial or whether it should be prevented if a safety problem arises.
Thomas Lumley, chairman of Biostatistics, said that if a vaccine meets the FDA benchmark in an interim analysis without serious safety concerns, it could be used as an authoritative basis for controlling an epidemic that has killed some 440,000,000 people worldwide. Said Thomas Lumley, chairman of Biostatistics. Uck Cland University in New Zealand.
Another runner-up in the vaccine race, Moderna Inc., told Reuters that if his vaccine was at least 70 percent effective from his interim evaluation, he would seek emergency FDA approval to use his vaccine in high-risk groups.
Announcing its protocol on Thursday, Moderna said its first interim analysis of 53 infections is expected in November.
Some vaccine experts have said that drug manufacturers should wait for the final analysis of more than 150 cases before seeking FDA approval. They note the pace at which vaccines are being developed for Covid-19, narrowing down what could be a decade-long process.
Relying on a more limited interim analysis may increase the effectiveness of the vaccine because not enough participants in the trial were sick, they said. Proceeding faster in the trial process also means that a drugmaker may lose potential side effects that may occur if the trial is given more time.
“This is a shining sign of a short cut in the interim analysis,” said Eric Topol, director of the Scripps Research Translational Institute in La Jolla, California. “You’ll lose safety issues and you can exaggerate the benefits pretty well.”
In addition to Pfizer and Moderna, Reuters reviewed the clinical trial protocols for AstraZeneca plc and vaccine candidates developed by Johnson & Johnson.
AstraZeneca set its first interim analysis when about 40 coronavirus infections were reported in participants. A patient is currently in the U.S. after falling ill.
According to the protocol of their large-scale trial starting September 21, the first analysis of J&J will begin with 20 infections.
AstraZeneca and J&J declined to comment.
Reported by Marissa Taylor in Washington and Dan Levine in San Francisco; Edited by Michelle Gerschberg and Will Dunham
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