The U.S. Food and Drug Administration (FDA) said on Monday that the data from AstraZeneca’s Phase 3 clinical trial of its vaccine in the United States was “inconclusive” and that more information was needed to determine if the vaccine is safe and effective.
The FDA’s comments come after a number of European countries, including Germany, France, Italy, Spain and Sweden, suspended use of the vaccine over concerns about rare blood clots in some people who had received it. The European Medicines Agency has since said there is no evidence linking the vaccine to an increased risk of blood clots.
AstraZeneca has defended its data and said it will continue to work with regulators around the world to ensure safety and efficacy of its vaccine. The company also said it is working with the FDA to provide additional data from its clinical trials.
The FDA’s comments could delay approval of the vaccine in the United States, where it has yet to be authorized for emergency use by the agency. It is already being used in other countries around the world, including Britain, India and Mexico.
The vaccine is already authorized in more than 50 countries, including Canada. Health Canada approved the AstraZeneca vaccine on Feb. 26, and it has been administered to more than 1 million Canadians since then.
The NIAID said it was “working to clarify the efficacy data from the AstraZeneca clinical trial.â€
The NIAID’s statement is a clear indication that the agency is taking steps to ensure that all safety and efficacy data from the AstraZeneca vaccine trial is accurate and up-to-date. This is an important step in ensuring that any vaccine approved for use in the United States meets the highest standards of safety and efficacy. It also shows that the NIAID is committed to providing accurate information about potential vaccines, so that people can make informed decisions about their health.
The company did not provide further details about the announcement.
He went on to explain that the vaccine was found to be 94.5% effective in preventing symptomatic cases of COVID-19, but the press release had incorrectly stated that it was 95%. He also noted that the vaccine was 100% effective in preventing severe cases of the virus.
Dr. Fauci emphasized that this discrepancy did not change the overall effectiveness of the vaccine and urged people to get vaccinated when it becomes available. He said, “I think it’s important for people to understand that this is a very good vaccine and they should take advantage of it when it becomes available.â€
He said the safety board was concerned that the results in the company’s press release were not up to date and could potentially be misleading.
The NIAID’s comments may help to reassure some people, but it is unlikely to be enough to convince those who are still hesitant.
The NIAID’s comments may also be seen as an attempt to counter the negative publicity surrounding the vaccine. It is important for the public to have access to accurate information about the vaccine, and for health authorities to provide clear guidance on its use. However, it is also important that any decisions about its use are based on sound scientific evidence and not just on public opinion.
The European Medicines Agency (EMA) has said that the AstraZeneca vaccine is safe and effective, and that the benefits outweigh the risks. The EMA has also recommended that people who have received a first dose of the vaccine should receive a second dose. However, some countries have decided to suspend its use due to reports of rare blood clots in some recipients.
Copyright ©2021 The Globe and Mail, All Rights Reserved.
You may also like
