Cnn
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The Food and Drug Administration of the United States has delayed the granting of a complete approval of the COVVI-19 vaccine in Novavax, although it is on the right track to be authorized until Tuesday afternoon, said a person familiar with the situation at CNN.
The agency is looking for more data on the vaccine, said that the source, which refused to be appointed because it was not authorized to speak publicly about the situation. The Wall Street Journal first reported that the FDA had missed its date of decision.
This decision came while FDA, Dr. Scott Steele, acting director of the Center for Biologics Evaluation and Research, oversees the regulation of vaccines, a few days after the former director of Dr Peter Marks was forced. In his letter of resignation, Marks cited “the efforts put forward by some on the harmful effects of health vaccination” which he called “concerning”.
The American secretary for health and social services, Robert F. Kennedy Jr., a longtime anti-vaccine defender, falsely called the vaccines for COVID-19 “the deadliest vaccine ever made” and recently made misleading statements on the security of the measles vaccine in the middle of a deadly epidemic centered in western Texas.
The Novavax vaccine, which uses a more traditional protein-based technology than the new PFIZER / BionTech and Moderna mRNA vaccines has been the subject of an emergency authorization since 2022. But with the action of the FDA, it would be the third vaccine against COVVI-19 to receive complete approval from the FDA. Complete approval would make the vaccine available beyond an emergency declaration and could ensure additional insurance for people looking for the vaccine.
The company said on Wednesday that it had not received an official decision from the FDA, but that April 1 was the date on which the agency had been planned to make the decision.
“On Tuesday, April 1, we responded to all FDA information requests and we think that our (biology license application) is ready for approval,” said Novavax in a statement, noting that the demand “included robust data of the clinical trial of phase 3 which showed that our vaccine is sure and effective for the prevention of COVVI-19.”
“We are convinced that our well tolerated vaccine is an important alternative to COVVI-19 mRNA vaccines for the United States,” said Novavax.
The FDA press office was put on administrative leave on Tuesday as part of the HHS reduction in efforts. A spokesman for HHS told CNN: “The FDA independent examination process for the Novavax vaccine, like all vaccines, is based solely on safety and efficiency, not political considerations. All delays are the result of a scientific review. ”
