United States reports six volunteers died during Pfizer/BioNTech vaccine clinical trial

Editado por Ed Newman
2020-12-09 18:00:28

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United States reports six volunteers died during Pfizer/BioNTech vaccine clinical trial

Washington, December 9 (RHC)-- The Food and Drug Administration of the United States (FDA) confirmed, in informative documents published before the next meeting of the advisory committee of vaccines and biological products, that six people died during the trial of the coronavirus vaccine developed by Pfizer and BioNTech.

Similarly, the federal agency stressed that four of the deaths were recorded in the placebo group and two in the vaccine group, both of which died over 55 years of age.  Despite this contingency, the FDA insisted that none of the deaths are related to the antidote, which is shown to be safe and effective.

They also highlighted that one of the two deceased vaccinees experienced a cardiac arrest 62 days after receiving the second dose of the vaccine and died three days later, while the other died from arteriosclerosis three days after receiving the first dose of the vaccine.

The information was released ahead of a meeting scheduled for Thursday to discuss emergency use of the vaccine, and concluded that the antidote "met the prescribed success criteria" in its clinical trial.

In addition, the United Kingdom recommended Wednesday that those with a history of severe allergies not receive the Pfizer/BioNTech vaccine after two people had an allergic reaction after the first dose.

Other vaccines, such as Sputnik V from Russia, in phase of massive and voluntary application to medical personnel and teachers, did not report unexpected adverse events, the same as to proceed with CoronaVac from China, in third phase of trials, and the Cuban candidates Soberana 01 and 02, first developed in Latin America.



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