Novavax is part of the FDA’s COVID-19 booster debate, but its vaccine still hasn’t been authorized

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The COVID-19 vaccine candidate played a central role during this week’s debate on how best to upgrade COVID-19 enhancers to better protect against omicrons.

The capture? The company’s main feature series is still being reviewed by U.S. regulators.

Novavax’s COVID-19 recombinant protein candidate vaccine has been seen as a possible alternative for people hesitant to be immunized with the new mRNA technology used in Modern MRNA and BioNTech BNTX / injections. Pfizer PFE.

It’s been three weeks since the Food and Drug Administration’s advisory committee recommended the authorization, which is the last step before the FDA makes its decision. While JPMorgan analysts predict that the FDA’s decision on the Novavax vaccine will arrive in mid-July, the delay between the committee’s recommendation and the FDA’s final decision is a deviation from the speed with which the regulator goes previously grant authorizations for other vaccines against COVID-19.

“We haven’t given an emergency permit yet,” Dr. Peter Marks, director of the FDA’s Center for Biological Assessment and Research, said Tuesday, “but I think we need to understand when [Novavax] The vaccine could be available if the company is willing to discuss it, if an emergency use permit would be granted. “

Marks is part of a group of federal health officials and independent vaccine experts who met Tuesday to discuss whether and how to upgrade COVID-19 reinforcements for the fall to better combat omicron or other potential variants.

The executives of Moderna and Pfizer presented, in addition to Dr. Gregory Glenn, Novavax’s R&D president, told the committee that the company’s primary features still under investigation appear to maintain its protection durability at six months and withstand omicron’s annoying and more transmissible subvariants.

“Boosting with the Novavax prototype vaccine may be an option, as it provides high levels of antibodies that recognize variants and lasting immune responses,” he said.

In response to Marks’ question, Glenn added that the company plans to have doses for its primary series of vaccines ready for distribution in July, and Novavax could update its vaccine during the last three months of the year to focus on BA.4, which was behind 15% of new cases in the US last week. (This compares with only 6% of cases in the first week of June).

With Novavax’s permission still up in the air, two temporary voting members of the Vaccine and Related Biological Products Advisory Committee raised questions about the status of Novavax’s application for the primary series of shootings in a discussion intended to focus on a new generation of COVID- 19 reinforcers.

“The most compelling thing I’ve seen today is the Novavax data, which shows that your protein vaccine can cause neutralizing antibodies to the prototype strain, at BA.1, BA.2, and BA.5,” said Dr. James. Hildreth, president and CEO of Meharry Medical College. “Their data seems more impressive to me than the data presented by Pfizer or Moderna. I just wonder if it would be appropriate or not for the agency to quickly review the data and make a decision to approve the Novavax vaccine.”

Dr. Wayne Marasco, a professor of cancer immunology and virology at the Dana-Farber Cancer Institute, asked a similar question to regulators.

“We have heard from Novavax about the potential coverage of their vaccine, but they have not been granted a US,” he said. “Will this also be in the fall formula? Will this vaccine be available? Or is this beyond what the commission should discuss?

Shares of Novavax have fallen from their all-time high of $ 319.93 on February 8, 2021. They have fallen 63.7% so far this year, while the broader S&P 500 SPX,
down 19.8%.

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