Now is the time for Moderna Inc. to be in the spotlight.
The same US explosion of Covid-19 cases that helped Pfizer Inc. get results for its vaccine study earlier this week is helping to accelerate the Moderna study. Moderna said Wednesday that its study had accumulated more than 53 infections, so a preliminary analysis of the effectiveness of the shot could begin. The stocks jumped.
Moderna didn’t predict how long it could take an independent monitoring committee to analyze the data, but said the company could get the data to the committee in a matter of days. The company said it was still blind to the data.
“Moderna has seen a significant increase in the case identification rate in various locations over the past week,” the company said in a statement. “As a result, the company expects that the first interim analysis will include significantly more than 53 cases, the targeted trigger for the analysis.”
Laboratory equipment is on the shelves of Moderna Therapeutics Inc. in Cambridge, Massachusetts. (Bloomberg)
Preliminary data on Moderna’s study is being prepared for submission to the monitoring committee, Moderna said. The board will say whether the vaccine is effective, not working, or that the study should continue as the results are inconclusive.
The bet among top experts in the field is that Moderna’s therapy, which uses mRNA technology similar to Pfizer’s, is likely to prove highly effective, possibly reflecting Pfizer’s announcement earlier this week that the shot is appears to be more than 90% effective.
“Overall, I would expect similar results,” said Drew Weissman, an immunologist and mRNA expert at the University of Pennsylvania who helped develop key modifications for mRNA vaccines.
“It’s hard to imagine how it would be otherwise,” said Weissman, whose laboratory receives research funding from BioNTech SE, the company that works with Pfizer on its vaccine.
In vaccine trials, a certain number of volunteers – a percentage of whom will receive a placebo – must be infected to see if the vaccine works. This is easier to achieve when the pandemic is causing record infections in the US on a daily basis.
Pfizer has had a number of results in the past few weeks that have brought this attempt over the line for a first look. Moderna’s interim analysis could now be done within a few days.
Whatever happens in the study – and there are no guarantees until it’s done – the results are sure to have a huge impact on Moderna stocks, which have more than quadrupled in a wild roller coaster ride this year. The stock closed 8.4% in New York trading at $ 82.44 on Wednesday. On Thursday, the stock rose another 5% in pre-market trading.
Preliminary analysis in Moderna’s study would likely have been available if the shot had only been 60% effective, according to research firm Airfinity Ltd. However, if Moderna vaccine was found to be 90% effective, that length of time would be lengthened and Moderna would now get results, Airfinity said.
The more effective a vaccine, the longer it takes for the cases to add up, as half of the participants who received the vaccine have fewer infections than a placebo.
The strong resemblance to the successful Pfizer vaccine strengthens confidence in Moderna’s, which was developed in collaboration with the US National Institute of Allergy and Infectious Diseases.
The Pfizer result “validates the mRNA platform,” said Anthony Fauci, director of NIAID and the US government’s best infectious disease doctor, speaking to reporters on Monday. “Moderna is an mRNA candidate from which we would expect similar results.”
The final stage of Moderna began on the same day as the major Pfizer trial in late July. The company is slightly behind Pfizer mainly due to structural differences in the trials. The two doses of Moderna vaccine are given four weeks apart instead of the three-week break for Pfizer’s vaccine.
In addition, Moderna doesn’t start counting coronavirus cases until 14 days after the second dose of vaccine, as opposed to 7 days after the second dose in the Pfizer study. Pfizer’s study also had more participants.
Pfizer had originally planned to analyze its results after only 32 cases, but the plan to look at the results this early has been controversial among medical experts. The drug company agreed with the U.S. Food and Drug Administration to wait for 62 cases to appear in its study before beginning to analyze the results. However, at the time the data was processed, a total of 94 cases had been received.