AZ Plans Emergency Use Filing Within Weeks Based on Positive U.S. Trial Data
AstraZeneca’s (AZ) COVID-19 vaccine clocked in at 79 percent efficacy in preventing symptomatic infection and fully shielded against severe disease and hospitalization in the company’s phase 3 U.S. trial, opening the door for an Emergency Use Authorization (EUA) filing with the FDA in a matter of weeks.
The drugmaker Monday unveiled the results of its late-stage U.S. trial’s interim analysis, which showed the two-dose vaccine held a respectable 79 percent efficacy overall at preventing symptomatic COVID-19 when doses were given four weeks apart, well above the FDA’s 50 percent threshold for EUAs.
Significantly, the inoculation was found to grant complete protection against severe disease and hospitalization and was found to be effective across all age groups, including showing 80 percent efficacy in participants age 65 years and older.
With the strong interim results finally arriving after significant delays to its U.S. trial last year (DID, Sept. 9, 2020), the drugmaker now expects to file for emergency authorization in the first half of April, according to Ruud Dobber, executive vice president of AZ’s biopharmaceuticals business unit. Should the shot receive emergency clearance and become the country’s fourth authorized COVID-19 vaccine, AZ plans to immediately deliver 30 million doses to the U.S, Dobber said. Last May, the U.S. secured 300 million shots of the AZ vaccine in a $1.2 billion deal (DID, May 22, 2020).
The vaccine, which has been in the spotlight in Europe after more than a dozen countries temporarily halted its use as cases of blood clots were investigated, was shown to be safe and well-tolerated in the 32,449-participant U.S. trial, with no safety concerns identified. Out of that large number of enrollees, only 141 symptomatic cases of COVID-19 were seen.
Among the 21,583 participants that were given at least a single dose, the trial’s independent data safety monitoring board found no increased risk of blood clots, providing reassurance that the AZ vaccine was likely not the culprit behind the European incidents.
“It was very pleasing to see that even with a magnifying glass, the data safety monitoring board didn’t see any imbalance between the vaccinated group and the placebo group, so that gives us a lot of confidence,” Dobber said.
He said the company is currently analyzing its vaccine against coronavirus mutations and will include data on its efficacy against the variant strains in AZ’s submission to the FDA.
An FDA emergency authorization would be a much-needed boost for AZ, which has experienced a series of setbacks and has been unable to make good on its supply commitments in Europe and has seen diminishing public confidence in its vaccine there. The European Commission reportedly plans to send a letter to the drugmaker in the hopes of informally resolving the delivery disputes, though legal action is not off the table if informal talks fail to bring a resolution (DID, March 19).
The AZ vaccine can be shipped and handled at normal refrigerator temperatures (36 to 46 degrees Fahrenheit) and stored in that temperature range for up to six months. It also requires no preparation in healthcare settings prior to administration, making it an easier shot to distribute and use. — James Miessler