There are a dozen Phase 3 COVID-19 vaccine candidates with more than 50 in either Phase 1 or Phase 2 trials. But the fact that Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) have vaccine candidates with efficacy greater than 90% could ultimately narrow the playing field.
“Efficacy matters, but I don’t think [Pfizer’s and Moderna’s efficacy rate of] greater than 90% shuts others down in the near term,” said Navin Jacob, a senior equity research analyst specializing in biotech and pharmaceuticals at UBS.
Still, the Pfizer and Moderna vaccines’ performance is far greater than the FDA’s COVID-19 vaccine requirement to prevent infections or decrease its severity in at least 50% of people.
The solid performance of vaccine candidates from Pfizer and Moderna could be bad news for vaccines that fail to offer similar performance. The prospects of less-effective vaccines will likely diminish, “possibly leading the field to be winnowed sooner than later,” according to Michael Breen, director of infectious diseases and ophthalmology at GlobalData.
The considerable demand for vaccines will ensure that COVID-19 vaccines are not a winner-take-all market, Jacob said. There is “not enough capacity to feed world demand,” he said.
The durability of vaccines is another wildcard. “Most companies and experts are saying one to two years of durability, which means we will need to boost again in a couple of years, which means even more demand,” Jacob added.
Another factor that could drive a heterogeneous vaccine market is regulatory agencies’ desire to have an arsenal of vaccines and medications available to battle the epidemic. “No regulatory agency wants to put the entire country’s health on the back of one or maybe even two companies/vaccines,” Jacob said. “They want to be able to spread the risk in case something happens to any one company or vaccine.”
Differences in safety profiles between vaccines could lead to certain vaccines being a better fit for a given patient population. Currently, however, there is a lack of long-term safety data regarding any COVID-19 vaccine.
Ultimately, the strong results from Pfizer and Moderna are potentially bad news for vaccine candidates that are close to FDA’s 50% efficacy requirement. “I don’t think you can get away with 60% efficacy either,” Jacob said. “Perhaps 75–80% is good enough if you have something differentiated.”
Other than efficacy, different potential ways vaccines could differentiate themselves include ease of storage requirements. A room-temperature stable vaccine would have a considerable advantage over one that must be stored at –70° C, such as Pfizer’s.
An oral delivery mechanism would be another advantage. Harvard University researchers, for instance, have developed a potential technique to deliver vaccines through oral administration.
While Jacob sees room for differentiation, “I don’t think you can have a vaccine that has much difference in severe COVID case reduction,” he said. “That has to be much more similar to whatever MRNA and PFE/BNTX show when we see final data.”
Filed Under: clinical trials, Drug Discovery, Drug Discovery and Development, Infectious Disease