A Westchester Medical Center staff member prepares monkeypox vaccine at a monkeypox vaccination station at Westchester Medical Center in Valhalla, New York, U.S., July 28, 2022. REUTERS/Eduardo Munoz
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Aug 11 (Reuters) – The head of the U.S. Food and Drug Administration on Thursday defended Bavarian Nordic’s ( BAVA.CO ) plan to inject a monkeypox vaccine intradermally after the company raised doubts about the method’s safety, citing a lack of data.
On Tuesday, the company said there is some evidence that injecting Jynneos between the layers of the skin may lead to increased reactions compared to the approved method of injecting under the skin.
However, FDA chief Robert Califf supported the method, saying that while intradermal administration causes some mild to moderate side effects, it elicits a similar immune response to injecting the vaccine under the skin.
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“By authorizing unapproved use of an already approved product, the FDA is ensuring that the vaccine meets high standards of safety, immune response, and manufacturing quality,” Califf tweeted. (https://bit.ly/3SEedCt)
On Monday, US health regulators authorized the emergency use of the injection, recommending an alternative method of use that would have split one vial of Jynneos into five doses.
“This may have a negative impact on vaccine uptake and coverage,” the company said in a letter to the FDA on Tuesday.
The company is also testing the efficacy of doses that the government has previously purchased and is keeping in the strategic national stockpile to see if they can be used to fight the current outbreak.
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Reporting by Mrinalika Roy in Bengaluru; Editing by Arun Koyyur
Our standards: The Thomson Reuters Trust Principles.
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