U.S. Health Officials Question AstraZeneca Vaccine Trial Results

U.S. Health Officials Question AstraZeneca Vaccine Trial Results

U.S. Health Officials Question AstraZeneca Vaccine Trial Results

U.S. Health Officials Question AstraZeneca Vaccine Trial Results

The company had not disclosed until Tuesday how up-to-date those data were. That information is important, because sometimes a more current look at clinical trial results can present a different effectiveness and safety.

If the analysis was conducted on data from a month or two ago, it is possible that a more current look would present a different picture of the vaccine’s effectiveness and safety. The company has said it will provide the F.D.A. with a more comprehensive, recent set of data than what it disclosed on Monday. Although no clinical trial is large enough to rule out extremely rare side effects, AstraZeneca reported that its study turned up no serious safety issues.

The fresh data may have arrived too late to make much difference in the United States, where the vaccine is not yet authorized and is unlikely to become available before May. By then, federal officials predict, there will be enough vaccine doses for all of the nation’s adults from the three vaccines that have already been authorized: Pfizer-BioNTech, Moderna and Johnson & Johnson.

Even so, the better-than-expected results were seen as a heartening turn for AstraZeneca’s shot, whose low cost and simple storage requirements have made it a vital piece of the drive to vaccinate the world.

The results were also thought to ease concerns about the AstraZeneca vaccine in Europe. Regulators there said last week that the shot was “safe and effective,” having conducted a review after a small number of people who had recently been inoculated developed blood clots and abnormal bleeding. The U.S. trial did not turn up any sign of such problems, although some safety issues can only be detected in the real world, once a drug or vaccine has been widely used.

Many millions of people have received the AstraZeneca shot worldwide, including more than 17 million in Britain and the European Union, almost all without serious side effects. In an effort to increase public confidence, many European political leaders have gotten the injections in recent days. The AstraZeneca vaccine has also been administered in the past week to leaders in South Korea, Taiwan and Thailand.

AstraZeneca said on Monday that it would continue to analyze the new data and prepare to apply in the coming weeks for emergency authorization in the United States. The vaccine has already been approved in more than 70 countries, but clearance from American regulators would bolster its global reputation.


Source link

Check Also

Texas Froze and California Burned. To Insurers, They Look Similar.

Texas Froze and California Burned. To Insurers, They Look Similar.

Texas Froze and California Burned. To Insurers, They Look Similar. Texas Froze and California Burned. …