JYNNEOS Smallpox Vaccine Description
Bavarian Nordic JYNNEOS smallpox vaccine is based on a live, attenuated vaccinia virus (Modified Vaccinia Ankara, MVA-BN), incapable of replicating in the body, yet still capable of eliciting a potent immune response. And, is incapable of replicating in the body, yet still capable of eliciting a potent immune response.
JYNNEOS is indicated for the prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.
JYNNEOS is the only FDA-approved non-replicating smallpox vaccine and the only FDA-approved monkeypox vaccine.
The vaccine is marketed under the brand names IMVANEX® and IMVAMUNE® in the European Union and Canada for the treatment of smallpox.
The vaccine was developed in partnership with the U.S. Government to ensure all adult populations can be protected from smallpox, including people with weakened immune systems or who are at high risk of adverse reactions to traditional smallpox vaccines, which are based on replicating vaccinia virus strains.
The MVA is cultured in Chicken Embryo Fibroblast cells placed in a serum-free medium. It is purified and filtered from the cells using various methods, including benzonase digestion.
Typical severe adverse reactions known for replicating vaccinia virus strains, such as myocarditis, encephalitis, generalized vaccinia, or eczema vaccinatum, were not observed during the clinical development program of JYNNEOS.
Bavarian Nordic is a Denmark-based biotechnology company.
JYNNEOS Smallpox Vaccine Indication
JYNNEOS is indicated to protect people from smallpox, including people with weakened immune systems or who are at high risk of adverse reactions to traditional smallpox vaccines, which are based on replicating vaccinia virus strains.
The WHO states 'Vaccination against smallpox with first-generation vaccinia-virus-based smallpox vaccine was shown to be 85% effective in preventing monkeypox in the past. Family and community members, health workers, and laboratory personnel who were vaccinated against smallpox in childhood may have some remaining protection against monkeypox.'
JYNNEOS Smallpox Vaccine Dosage
For subcutaneous injection only. Administer 2-doses (0.5 mL each) 4-weeks apart.
JYNNEOS Smallpox Vaccine News
November 12, 2020 - Bavarian Nordic A/S announced that Health Canada has expanded the approval of the Company’s non-replicating smallpox vaccine, IMVAMUNE® to include additional indications – specifically, monkeypox and related orthopoxvirus infections and disease in adults 18 years of age and older determined to be at high risk for exposure.
October 1, 2020 - The WHO announced from 1 January through 13 September 2020, a total of 4,594 suspected cases of monkeypox, including 171 deaths (case fatality ratio 3.7%), have been reported in 127 health zones from 17 out of 26 provinces in the Democratic Republic of the Congo.
April 30, 2020 - Bavarian Nordic A/S announced that the U.S. Biomedical Advanced Research and Development Authority has placed a new order under the contract, awarded in 2017, for the manufacturing and supply of JYNNEOS® (Smallpox and Monkeypox Vaccine, Live, Non-replicating), at a total value of US $202 million. This new order is in addition to the existing option to manufacture approximately 13 million freeze-dried doses worth USD 299 million that the Company expects to start manufacturing in 2022 and revenue recognize following approval by the U.S. Food and Drug Administration (FDA) of this vaccine formulation.
September 24, 2019 - The U.S. Food and Drug Administration announced today the approval of Jynneos Smallpox and Monkeypox Vaccine, Live, Non-Replicating, for the prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. This is the only currently FDA-approved vaccine for the prevention of monkeypox disease.
JYNNEOS Smallpox Vaccine Clinical Trial
FDA approval of JYNNEOS for smallpox comes from a development program comprising 22 clinical trials, which included two phase III trials. The program enrolled a total of 7,871 individuals aged between 18 and 80 years who received at least one dose of the vaccine. Approval for monkeypox indication comes from survival data gathered from studies conducted in non-human primates. The survival rate ranged from 80%-100% in animals vaccinated with JYNNEOS, compared to 0%-40% in the control group.
ClinicalTrials.gov Identifier: NCT02977715 - The phase 3 study will evaluate the proportion of participants who after being vaccinated 1) develop suspected or confirmed monkeypox infection, and 2) experience exposure to monkeypox virus. The study will also evaluate the safety and immunogenicity of IMVAMUNE. Last Update Posted: September 23, 2020.