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No Coronavirus Vaccine Is Fully FDA-Approved

Right now, no coronavirus vaccine is fully approved by the FDA. You have a right to know why.

HEALTHLINE – There are several COVID-19 vaccines out right now, including one from AstraZeneca.

Although it has been approved for use in other countries, it has not yet been approved by the Food and Drug Administration (FDA).

Knowing more about the AstraZeneca vaccine can help you make informed decisions about which vaccine to get if it does get approved for use in the United States.

Important information about the AstraZeneca COVID-19 vaccine

“The vaccines in use have been granted emergency use authorization. This means that the known and potential benefits of the vaccine outweigh the known and potential risks.”

The AstraZeneca COVID-19 vaccine, now called Vaxzevria, is a viral vector vaccine, just like the vaccine from Johnson & Johnson.

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The vaccine uses a chimpanzee adenovirus to carry spike proteins from the coronavirus into your body to create an immune response. It can be produced on a large scale and inexpensively, which is crucial during a pandemic. It can also be kept in a regular refrigerator, unlike the vaccines from Pfizer and Moderna.

Despite initial pauses about its safety with blood clots, it has been deemed safe by the European Medicines Agency (EMA) and is still recommended by the World Health Organization (WHO).

Why is the AstraZeneca COVID-19 vaccine not yet approved in the United States?
Right now, no coronavirus vaccine is fully approved by the FDA. The vaccines in use have been granted emergency use authorization. This means that the known and potential benefits of the vaccine outweigh the known and potential risks.

The AstraZeneca COVID-19 vaccine is not yet approved in the United States because the FDA has asked AstraZeneca to show results from a large-scale trial.

The FDA found that in initial trials, some participants mistakenly got half doses of the vaccine. They also found that the trial did not include enough people over age 65. They asked the company to do a larger trial so they could get clearer data.

Warning signs for complications from a COVID-19 vaccine

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As with any vaccine, there are risks of complications and adverse effects … Click here to read more. 

 

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