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Will know by November-end if Covid-19 vaccine works, says Moderna

In order for the vaccine to be considered for authorisation by the US Food and Drug Administration (FDA), at least 53 study participants needed to become ill with Covid-19.

Coronavirus, vaccine, covid, drugs, clinical trials
The preliminary data on Moderna’s study is being prepared for submission to the monitoring board

Moderna has finished accumulating data for a first analysis of its Covid-19 vaccine and expects to have an announcement on the vaccine’s efficacy by the end of the month, the company said in a statement on Wednesday.

The American biotechnology firm is conducting a clinical trial of about 30,000 participants, with half of the participants receiving the vaccine and the other half receiving a place­bo, which is a shot of saline that does not seem to have any effect, media reports said.

In order for the vaccine to be considered for authorisation by the US Food and Drug Administration (FDA), at least 53 study participants needed to become ill with Covid-19.

The trial hit that 53 mark on Wednesday, but Moderna doesn't know if the participants who became ill received the vaccine or the placebo. The company is now preparing data to send to the trial's Data and Safety Monitoring Board, an independent panel of experts.

That board will look to see how many of the participants who became ill received the vaccine and how many received the placebo. If a statistically significant number received the placebo, that means the vaccine is effective against the virus.

“Moderna has seen a significant increase in the rate of case identification across sites in the last week,” the company said in a statement. “As a result, the company expects the first interim analysis will include substantially more than 53 cases, the targeted trigger point for the analysis.”
The preliminary data on Moderna’s study is being prepared for submission to the monitoring board, Moderna said. The board will say whether the vaccine is effective, doesn’t work, or that the trial should continue because the results are inconclusive.

The bet among top experts in the field is that Moderna’s therapy, which uses a similar mRNA technology to Pfizer’s, will likely prove to be highly effective, perhaps mirroring Pfizer’s announcement earlier this week that its shot appears to be more than 90 per cent effective.

“Overall I would expect similar results” in Moderna’s trial, said Drew Weissman, an immunologist and mRNA expert at the University of Pennsylvania who helped develop key modifications used in mRNA vaccines.

“It is hard to imagine how it would be much different,” according to Weissman, whose lab receives research funding from BioNTech SE, the company partnering with Pfizer on its vaccine.

In vaccine trials, a certain number of volunteers -- a percentage of which get a placebo -- have to get infected in order to determine if the vaccine works. That’s easier to accomplish with the pandemic in the US hitting record infections on a daily basis. Pfizer got a burst of results in recent weeks that pushed that trial over the line to take a first look. Now Moderna’s interim analysis could come within days.

Whatever happens in the trial — and there are no guarantees until it is done — the results are certain to have a big impact on Moderna shares, which have more than quadrupled this year in a wild roller-coaster ride. The stock closed up 8.4 per cent in New York trading at $82.44 Wednesday. On Thursday, the shares rose another 5 per cent in pre-market trading.