Under fire, AstraZeneca hustles out a primary cut of the numbers for its Covid-19 vaccine supporting positive efficacy
After spending the last 48 hours in a pressure cooker of widespread criticism, AstraZeneca has updated its data on its controversial Covid-19 vaccine.
The pharma giant announced Wednesday evening that their vaccine was 76% effective in the primary analysis, a small slip on overall efficacy from its first cut of the data. There was 100% efficacy in preventing severe disease and hospitalization. The slight revision still bears up well in comparison with the 72% efficacy rate cited by J&J for its vaccine, leaving AstraZeneca in a solid position to win an emergency authorization from the FDA.
The data came from 190 overall cases of Covid-19, including 49 new cases since their previous data cut. There were 8 cases of severe diseases, all of them in the placebo group.
AstraZeneca R&D leader Mene Pangalos says the company is pushing straight ahead with its request for emergency authorization in the US.
The primary analysis is consistent with our previously released interim analysis, and confirms that our COVID-19 vaccine is highly effective in adults, including those aged 65 years and over. We look forward to filing our regulatory submission for Emergency Use Authorization in the US and preparing for the rollout of millions of doses across America.
AstraZeneca had earned kudos on Monday with a round of interim data that spotlighted a 79% rate in preventing symptomatic Covid-19 with a 100% elimination of severe disease. For the multinational operation, that score marked a dramatic turnaround from the roasting it was getting in Europe and around the world as experts and health officials questioned its effectiveness in combating variants or in people over the age of 65.
But that momentary turn of events evaporated late Monday, after the DSMB charged with overseeing the trial alerted officials at the NIH that the company had ignored its recommendation to tell the public that the data they were seeing in February and March indicated a rate of 69% to 74%.
It amounted to simple cherry picking of the data, they noted. In their letter, which The Washington Post obtained, the observers noted:
The point that is clear to the board is that the [vaccine efficacy number] . . . they chose to release was the most favorable for the study as opposed to the most recent and most complete. Decisions like this are what erode public trust in the scientific process.
That sort of embellishment was widely condemned, and Scripps’ Eric Topol added to the din of criticism, repeatedly asserting on Twitter that AstraZeneca could instantly clear the air.
NIAID chief Anthony Fauci, meanwhile, consistently asserted that while the data may have been wrong, the final numbers would bear out its overall value.
The new data help confirm that assertion, although the numbers are still not entirely settled: AstraZeneca said that there were 14 additional possible Covid-19 cases that had yet to be fully adjudicated.
14 endpoints still to be adjudicated so the data may fluctuate. But this is a far better presentation than their interim analysis missing 41 of the 190 endpoints
— Eric Topol (@EricTopol) March 25, 2021
At this stage of the game, after so much criticism in a storm of controversy, the vaccine is still likely to run into stiff resistance — particularly in the more affluent nations that have a choice. Poor countries, though, now may have little choice in the matter.
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