AstraZeneca published an updated analysis Thursday confirming that a Phase 3 trial involving its COVID-19 vaccine was safe and effective, and was shown to be 76% effective against symptomatic COVID-19. The update came after the National Institute of Allergy and Infectious Diseases (NIAID) said the company may have provided an incomplete view of efficacy data after the Safety and Data Monitoring Board (DSMB) said it was concerned about the information included in the statement.
“The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” the NIAID said in a statement earlier this week. “We urge the company to work with the DSMB to review the effectiveness data and ensure that the most accurate and up-to-date effectiveness data is released as soon as possible.”
The above data reflects a 79% efficacy in preventing symptomatic infections and 100% efficacy in preventing serious illness and hospitalization. The new analysis also reported 100% efficacy “against serious or critical illness and hospitalization.”
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“High-level positive results from the primary analysis of the AZD1222 phase III trial in the US have confirmed the efficacy of the vaccine in line with the pre-specified interim analysis announced on Monday, March 22, 2021,” according to a statement release published by AstraZeneca early Thursday. “These results have been submitted to the independent Data Safety Monitoring Board. The primary analysis is pre-specified in the protocol and will be the basis for a regulatory submission for the Emergency Use Authorization to the US Food and Drug Administration. .
On Wednesday, when asked if sharing information on data submission may increase doubt about the vaccine in the U.S., Dr. Anthony Fauci praised the FDA’s transparent approval process to help build trust. in the public in case the vaccine is approved.
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“We are always concerned when there is an apparent ‘miscommunication’, if you want to use that word, which would add to the already existing levels of vaccinations, which is why we want to make sure that we are always completely transparent in everything related to messages and vaccines, “Fauci said during the COVID-19 briefing at the White House on Wednesday.
He said the process “will hopefully allay any doubts associated with this little bump in the road that we had most recently with AstraZeneca.” Questions about how the public would perceive the AstraZeneca vaccine were already circling after reports of blood clots in Europe saw several countries temporarily pause the launch. Since then, European regulators have found the vaccine to be safe and effective, and the rollout has continued.
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“At the end of the day, when you look at the data, this is going to turn out to be a good vaccine,” Fauci said.