The US Food and Drug Administration reported that the coronavirus vaccine developed by the pharmaceutical company Johnson and Johnson is “safe and effective” and has 66% protection against the virus. The scientists claimed that the data presented in the panel on the J&J vaccine was “insufficient” but validated.
J&J submitted vaccine analysis data to the U.S. Food and Drug Administration 10 days before the Vaccines and Related Biologicals Advisory Committee meeting. Responding to criticism from scientists, officials admitted that they had not yet confirmed all the data submitted by J&J.
threatens public health
Committee member Dr. Michael Nelson said he acknowledged the J&J data were insufficient, but thought the presented safety and efficacy data were sufficient to support emergency use in the United States. Director of the FDA’s Center for Biological Research, Dr. Peter Marks reported that data on the J&J vaccine will take months to complete, and his investigations will continue throughout the process.
According to these results, the booster showed less side effects than the first dose, Dr. Timothy Brennan also said that the vaccine studies were insufficient. He emphasized that it is not possible to draw a valid conclusion on the grounds that there were only 17 participants between the ages of 18-55 in the study. Committee Chairman Dr. Arnold Monto stated that J&J’s rapid review studies led to poor performance compared to Pfizer and Moderna vaccines. He stated that the J&J vaccines, which have a lower effect than other vaccines, pose a threat to public health and that something needs to be fixed in a hurry.
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