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Pfizer plans to share data on fourth dose of COVID-19 vaccine with FDA

By Brian Buntz | March 8, 2022

Pfizer BioNTech COVID-19 vaccineCOVID-19 vaccine heavyweight Pfizer (NYSE:PFE) will soon provide data related to the fourth dose of its COVID-19 vaccine, according to Bloomberg.

The company and its partner BioNTech (Nasdaq: BNTX) are also developing an omicron-specific version of the vaccine.

Pfizer CEO Dr. Albert Bourla said that the data to be shared with FDA involve the fourth dose of its original COVID-19 vaccine and a new formulation intended to protect against multiple SARS-CoV-2 variants.

“We’re going to submit to FDA significant packets of data about the need for a fourth dose and they need to make their own conclusions, of course,” Bourla said in a recent interview with CNBC‘s Squawk Box. “Clearly, there is a need in an environment of omicron to boost the immune response. I don’t think that would be a need in delta.”

Data related to the omicron-specific version are not yet available.

Bourla signaled to CNBC that the company had decided against making an omicron-specific vaccine. “We are making a vaccine that covers omicron and all the other variants and there are so much trials that are going right now and a lot of them will start reading by the end of the month and then much more next month,” he said. “We will have a lot of of data next month, but I am optimistic from the preclinical data that the clinical data will demonstrate that we can achieve the goal which is to cover both the old and the new variants, all variants, known so far.”

Pfizer also said that clinical trial data involving children under 5 who received three doses of its COVID-19 vaccine would be available in April.

A small Israeli study summarized in Nature last month indicated that a fourth vaccine dose provides a modest increase in antibodies.

This article was updated on March 11 to include quotes from Pfizer’s CEO. 


Filed Under: Infectious Disease
Tagged With: BioNTech, COVID-19 vaccine, Omicron, Pfizer, Pfizer-BioNTech
 

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