FDA Considers Dividing Monkeypox Vaccine Doses
Under the Biden administration, the FDA considers dose sparing by dividing the monkeypox vaccine doses into fifths.
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- Monkeypox was declared a public health emergency by the WHO on Saturday, July 23, 2022. Since the rise of monkeypox rates, public health organizations have urged at-risk populations to seek vaccination. Due to the limitations of monkeypox vaccine doses, the FDA is considering dividing vaccine doses into fifths to provide a more significant portion of the population with vaccines.
According to a New England Journal of Medicine publication, monkeypox is a zoonotic virus transmitted “through large respiratory droplets, close or direct contact with skin lesions, and possibly through contaminated fomites. There is no clear evidence of sexual transmission through seminal or vaginal fluids. Vertical transmission and fetal deaths have been described.”
This disease can cause rash, fever, headache, muscle ache, swollen lymph nodes, chills, and fatigue, among other symptoms.
The CDC’s recommended prevention method for monkeypox is the JYNNEOS two-dose vaccine series given 14 days apart. In May this year, the CDC released over 1,000 stockpiled vaccine doses. Since then, vaccine doses have rapidly depleted. Because of this, the FDA is considering splitting the vaccine doses into fifths.
“We’re considering an approach for the current doses of JYNNEOS that would allow healthcare providers to use an existing one-dose vial of the vaccine to administer a total of up to five separate doses. This approach, which we’re referring to as dose-sparing, would change the method of administration for JYNNEOS, which is currently administered subcutaneously,” said FDA commissioner Robert Califf according to an article on The Hill.
Dividing the vaccine doses would mean implementing a different injection method and opting for intradermal injections. Additionally, the vaccine would remain a two-dose series but would be administered approximately 28 days apart.
Research from the National Institute of Allergy and Infectious Disease suggests that the immune response should not differ between the two distribution methods. Califf claims that this proposed solution should not alter the safety or efficacy of the product.
As this public health crisis progresses, the public is urged to discuss vaccination with their healthcare provider and adhere to the vaccination schedule to ensure the appropriate use of resources.
