Credit ACIP/CDC
#15,880
Less than 24 hours ago, NIAID (National Institute of Allergy & Disease) released a favorable statement - (see Investigational AstraZeneca Vaccine Prevents COVID-19) - on the results of a combined U.S and South American trial on the UK based AstraZeneca COVID vaccine which is awaiting approval from the FDA.It read, in part:
March 22, 2021
Results from a large clinical trial in the United States and South America indicate that AstraZeneca’s COVID-19 vaccine, AZD1222, is well-tolerated and protects against symptomatic COVID-19 disease, including severe disease or hospitalization. The independent Data and Safety Monitoring Board (DSMB) overseeing the trial identified no safety concerns related to the vaccine. The United Kingdom-based global biopharmaceutical company AstraZeneca developed the vaccine and led the trial as regulatory sponsor.
This statement was based on results AstraZeneca had reported:
79% vaccine efficacy at preventing symptomatic COVID-19
100% efficacy against severe or critical disease and hospitalisation
Comparable efficacy result across ethnicity and age,with 80% efficacy in participants aged 65 years and over
Favourable reactogenicity and overall safety profile
All of which makes the release of the following statement - after midnight last night - from NIAID, a bit unexpected.
March 23, 2021
Late Monday, the Data and Safety Monitoring Board (DSMB) notified NIAID, BARDA, and AstraZeneca that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial. The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.
We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.Authorization and guidelines for use of the vaccine in the United States will be determined by the Food and Drug Administration and Centers for Disease Control and Prevention after thorough review of the data by independent advisory committees.
It is far from clear what `outdated' information may have been included in their clinical trial data, its potential impact on the effectiveness or safety of the vaccine, or why - mere hours after NIAID's initial statement - the agency felt compelled to release this follow up statement.
But this latest development comes amid a backdrop of considerable vaccine hesitancy of the the United States and Europe, and less than a week after the AstraZeneca vaccine was placed under extra scrutiny following a small number of blot-clot related incidents in recipients of the the vaccine.
Danish Health Authority Statement On Temporary Suspension of AstraZeneca Vaccine
WHO Statement on AstraZeneca COVID-19 Vaccine Safety Signals
EMA Statement On AstraZeneca Vaccine
The consensus from the WHO and EMA was that their was no evidence that the AstraZeneca vaccine caused these rare blood clot events, and that the benefits of the vaccine far exceed any potentials risks.
Vaccines are not perfect, but they remain among the safest, and most effective medical countermeasures in our disease prevention armamentarium. Which is why I got my first COVID shot 3 weeks ago, and look forward to getting my 2nd dose next week.
Hopefully we'll get further clarification, and eventually an `all clear' on any issues surrounding this vaccine, sooner rather than later.
