A Westchester Medical Center staff member prepares a monkeypox vaccine at a monkeypox vaccination point 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 a plan to administer Bavarian Nordic’s ( BAVA.CO ) monkeypox vaccine intradermally after the company raised doubts about the safety of the method, citing the lack of data.
The company said Tuesday that there was evidence that an injection of Jynneos between the layers of the skin could cause an increase in reactions compared to the approved method of injecting it under the skin.
FDA chief Robert Califf supported the method, saying that while intradermal administration caused some mild to moderate side effects, it produced an immune response similar to injecting the vaccine under the skin.
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“By authorizing the 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)
US health regulators had authorized emergency use of the vaccine on Monday by recommending an alternative method of use, which would result in dividing a single 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 potency of doses previously purchased by the government and stored in the Strategic National Stockpile to see if they can be used to combat the current outbreak.
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Reporting by Mrinalika Roy in Bangalore; Editing by Arun Koyyur
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