FDA到底还是把Novavax的批文拖入下半年了

https://www.healthline.com/health-news/fda-approval-of-the-novavax-covid-19-vaccine-delayed-by-manufacturing-changes

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• Even though the FDA vaccine advisory committee voted to recommend emergency use authorization (EUA), the FDA will need additional time to review manufacturing changes.
• There is no confirmed release date for the Novavax COVID-19 vaccine.

 

After an all-day meeting on June 7, the FDA’s independent panel of vaccine experts voted 20 to 0, with one abstention, to recommend that the vaccine receive an emergency use authorization (EUA).

The FDA normally follows the committee’s recommendation, but it is under no obligation to do so.

As a result of the manufacturing changes, the agency may take longer to authorize Novavax’s vaccine than it did with the Pfizer-BioNTech, Moderna, and Johnson & Johnson vaccines, all of which received approval shortly after getting the thumbs up from the advisory committee.

In a statement to CNBC, the FDA said that Novavax notified it of changes to its manufacturing process several days before the advisory committee was set to discuss data on the vaccine’s safety and efficacy.

The FDA did not provide a timeline for when it would complete its review of the vaccine.

 

 

Fuz注：套用传统中国俗语：这个Novavax, 就是TMD贱妾养的。想在美国当家作主翻身，没门，拖死你。

从去年春天说申请正式批文，拖到现在，居然连个EUA都不给。FDA高官说：七月中旬再讨论。谁知道届时又会出啥妖蛾子。要知道，FDA近期的重点在秋天推出新疫苗，这种仍然针对原始株的疫苗不在重点考虑之中。

想等这个疫苗的，去别的国家打吧。

 

前几天（June 25, 2022）P公司刚刚宣布新疫苗对欧密有效 https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-omicron-adapted-covid-19

FDA马上开会（June 30, 2022）强推。

https://www.nbcnews.com/health/health-news/fda-recommends-omicron-subvariants-ba4-ba5-fall-covid-boosters-rcna36125

正房出的，待遇就是不一样。可TMD还是mRNA疫苗啊！

 

 

 

PS

花街分析：

https://www.marketwatch.com/story/novavax-is-part-of-the-fdas-covid-19-booster-debate-but-its-vaccine-still-hasnt-been-authorized-11656528348

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Novavax’s recombinant protein COVID-19 vaccine candidate has been viewed as a possible alternative （请注意：只是替代品的待遇）for people who are hesitant to be immunized with the newer mRNA technology used in the Moderna MRNA and BioNTech BNTX/Pfizer PFE shots. 

It’s been three weeks since the Food and Drug Administration’s advisory committee recommended authorization, which is the last step before the FDA makes its decision. Although JPMorgan analysts predict the FDA’s decision on Novavax’s vaccine will land in mid-July, the lag between the committee’s recommendation and the FDA’s final decision is a departure from how quickly the regulator previously granted authorizations to other COVID-19 vaccines. 

“We have not given an emergency authorization yet,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said Tuesday, “but I think it behooves us to understand when the [Novavax] vaccine might be available if the company is willing to discuss that ?（请注意：在为进一步拖延找借口）— were an emergency use authorization to be granted.”

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