Vaccine maker says the different administration method lasks data.
Food and Drug Administration Commissioner Robert Califf backed an alternative way to administer monkeypox vaccines last week. The vaccine is typically administered under the skin layers, but the FDA commissioner believes that injecting it between the skin layers is also effective.
Bavarian Nordic, the manufacturer of the vaccine, had written a letter to the FDA last week, encouraging the FDA to not back this alternative administration method due to a risk of increased reactions and a lack of data.
However, Commissioner Califf said the FDA has found the immune response to be similar whether the vaccine is administered below the skin layers or between skin layers. “In authorizing an unapproved use of an already approved product, the FDA is ensuring the vaccine meets high standards for safety, immune response, and manufacturing quality,” Dr. Califf stated.
As the Lord Leads, Pray with Us…
- For Commissioner Califf as he leads the Food and Drug Administration.
- For FDA officials as they review and research medications and treatments.
- For federal health leaders to seek God’s wisdom as they issue recommendations.
Sources: The Hill, Reuters
