Pfizer, BioNTech say vaccine is 95% effective, EUA submission 'within days'
Pfizer and BioNTech have done the final efficacy analysis for their Phase III Covid-19 trial, and the results confirm the headline-grabbing release from last week: Their vaccine is 95% effective at preventing Covid-19.
They also said the vaccine was 94.5% effective in older adults, mitigating concerns that the first Covid-19 vaccines might not work as well in one of the populations most susceptible to severe disease.
The two companies said they have also crossed the FDA’s key safety threshold of two-months follow-up and will submit for an emergency use authorization “within days.” Although the agency will convene an advisory committee before making a decision, the announcement likely sets up the Big Pharma and their biotech partner to obtain the first FDA OK for a Covid-19 vaccine.
Pfizer CEO Albert Bourla said at different conferences yesterday afternoon that they had passed the safety threshold and would soon submit to regulators. The companies announced last week that their vaccine was “over 90% effective” in an interim analysis.
Moderna, which announced Monday that their vaccine was 94.5% effective at an interim analysis, is also expected to release final efficacy data and head to regulators soon. CEO Stéphane Bancel predicted the first advisory committee hearings for any vaccine to come Dec. 7th or Dec. 14th. The two vaccines both use mRNA and are highly similar.
Today’s efficacy data came from an analysis of 170 Covid-19 cases in their 44,000-person trial — 162 cases in the placebo group and 8 cases in the vaccine group. It also included Pfizer’s first safety results; the most severe side effects were fatigue, which occurred in 3.8% of recipients, and headache, which occurred in 2% of recipients.
Pfizer said they saw 9 cases of severe disease in the placebo group and 1 in the vaccine group, indicating the vaccine can help prevent hospitalization and death. Moderna’s first analysis had shown 11 severe cases on placebo and 0 in the vaccine group.
Key questions, however, still remain on how durable the vaccine will be.
Although other questions remain about how effectively Pfizer will be able to distribute its vaccine, which requires storage at -70 degrees Celsius (-94 Fahrenheit), Bourla expressed confidence yesterday that rollout would go far more smoothly than outside experts have feared.
The company has invested in freezer boxes to ship and store their vaccines on dry ice. State health officials have raised concerns about how well these will work for getting the vaccine to rural areas. Moderna has less stringent cold-chain requirements.
For a look at all Endpoints News coronavirus stories, check out our special news channel.