Pharmaceutical company AstraZeneca has released its full data from the US phase III clinical trial of its COVID-19 vaccine and there’s much to be hopeful for. The vaccine is 100 percent effective against the most severe version of the disease and death and it has an overall efficacy of 76 percent against any symptomatic form of COVID-19.
The analysis is expected to be submitted for peer review in the coming weeks as well as being submitted to the US Food and Drug Administration so that the vaccine can be reviewed and approved for use in the US. The clinical trial saw 32,499 participants randomized in a two-to-one ratio between those that got the vaccine and those that received a placebo.
Of the over 20,000 people that received two doses of the vaccine four weeks apart, only 190 caught COVID-19 with identifiable symptoms. For adults older than 65, one of the most vulnerable groups, the efficacy was around 85 percent, similar to what was seen in general population studies of people who had received the vaccine in the UK.
Interim results were released on Monday showing slightly better overall efficacy of 79 percent and slightly worse efficacy for over 65 for data up to mid-February. However, it is perfectly normal for data to change slightly between interim and final results.
“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,” Mene Pangalos, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca, said in a statement.
The release of the interim results caused a bit of a media storm this week, as it appeared AstraZeneca had jumped the gun announcing its results, perhaps to mitigate the recent concerns surrounding blood clots and the vaccine – which EU regulators ultimately found was not linked. The press statement released announced that the US Data and Safety Monitoring Board (DSMB) had not identified any safety concerns related to the vaccine. However, the DSMB put out a stern statement saying that the company’s statement didn’t include the most up-to-date information, something they wanted to be addressed as soon as possible, which has been with the release of these final results.
Opinions vary a lot regarding what is ultimately a PR disaster. Some think that the unprecedented DSMB statement was too harsh, stoking vaccine hesitancy when it comes to the AstraZeneca vaccine. Others consider AstraZeneca publishing interim results just days before the full results, a transparent PR move for good publicity, which may now cause distrust in pharmaceutical companies and also increase vaccine hesitancy.
Despite this parenthesis of avoidable drama, the results show that the jab is safe with no particular concerns related to the vaccine being identified.