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It’s bad science to give out incomplete covid-19 vaccine study results by press release, consumer group says

CoronavirusPfizer and BioNTech announced Monday that the initial interim analysis of data from the phase 3 study of the companies’ experimental covid-19 vaccine shows that it’s more than 90 percent effective.

The release of preliminary and incomplete clinical trial data by press release to the public is bad science, said Michael Carome, director of Public Citizen’s Health Research Group. Public Citizen is a consumer advocacy group.

“Until the trial results are independently reviewed and scrutinized by staff at the U.S. Food and Drug Administration and the independent experts on the agency’s Vaccines and Related Biological Products Advisory Committee, enthusiasm for the apparently promising interim results announced by Pfizer and BioNTech must be tempered,” Carome said.

He said crucial information is absent from the companies’ announcement; any evidence that the vaccine prevents serious covid-19 cases or reduces hospitalizations and deaths due to the disease.

“More importantly, critical safety data from the phase 3 trial of the Pfizer and BioNTech vaccine is not yet available,” Carome said.

In order to ensure public confidence in this vaccine or any other covid-19 vaccine being tested, the FDA must wait for sufficient long-term safety monitoring of subjects to be completed before approving such vaccines, he said.


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