FDA advisers meet on Covid Shots by Novavax

Speaking to the committee, Martha Dawson, president of the National Black Nurses Association, said some patients will feel more comfortab...


Speaking to the committee, Martha Dawson, president of the National Black Nurses Association, said some patients will feel more comfortable with protein-based vaccines, a technology that has been used for decades. “I encourage the FDA to give us another more traditional medical intervention in this fight,” she said.

In clinical trials, the Novavax vaccine has been shown to have a 90.4 percent efficiency prevent mild, moderate or severe infection with older variants of the virus. None of the volunteers who received the vaccine experienced moderate or severe infection, which translates to 100% efficacy.

The trial took place before the rise of the Delta and Omicron variants, which evaded some of the immunity of other vaccines.

In background papers released on Friday, FDA scientists identified six cases of myocarditis and pericarditis, forms of heart inflammation, in approximately 40,000 volunteers. FDA documents said that the cases raised concerns that the vaccine was the cause and that the rates of problems could prove to be higher than with mRNA vaccines.

Moderna and Pfizer-BioNTech found no cases of myocarditis or pericarditis in their early clinical trials. But after authorization, once the vaccines were given to millions of people, they were both found to create a small additional risk of myocarditis in boys and young men.

In their presentation on Tuesday, Novavax officials defended their vaccine against these concerns. Their analysis revealed that the cases of myocarditis and pericarditis were balanced between the group of volunteers who received the vaccine and the group who received a placebo. In the real world, there have been reports of one case of probable myocarditis and eight cases of probable pericarditis out of 744,000 doses administered in wealthy countries that have licensed the vaccine, the company said.

“We believe that the totality of clinical evidence here is not sufficient to establish an overall causal relationship to the vaccine,” said Dr. Denny Kim, Chief Safety Officer of Novavax.

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Newsrust - US Top News: FDA advisers meet on Covid Shots by Novavax
FDA advisers meet on Covid Shots by Novavax
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