FDA endorses Bavarian Nordic's monkeypox vaccine, marking world's first approval
In 2003, scientists traced the monkeypox virus to a patient’s pet prairie dog in Marshfield, Wisconsin. Altogether, forty-seven confirmed and probable cases of monkeypox were reported from six US states — marking the first instance that an outbreak was recorded outside of Africa, after a shipment of 800 small mammals from Ghana were imported to Texas. On Tuesday, the first vaccine for the disease — which can be fatal — was approved by the FDA.
Monkeypox is a rare virus transmitted to humans from animals such as rodents and primates, and is primarily native to Africa near tropical rainforests. It is similar to human smallpox — which was eradicated in 1980 — so most of the global population is now vulnerable, although older smallpox vaccines are shown to have a high degree of success of protecting humans from monkeypox. Meanwhile, an ongoing monkeypox outbreak in Nigeria — which has spread to the UK, Israel, and Singapore — has demonstrated a spike in human-to-human transmission, causing trepidation.
Bavarian Nordic’s vaccine, Jynneos, was endorsed by the US drug regulator to protect against both smallpox and monkeypox disease — and was developed in partnership with the US government. The subcutaneous injection is based on a live, attenuated vaccinia virus — which cannot be replicated but is strong enough to induce an immune response.
The vaccine was tested in 22 clinical trials — including two late-stage studies — encompassing 7871 individuals aged 18 through 80 years who received at least one dose (7109 smallpox vaccine-naïve and 762 smallpox vaccine-experienced individuals). In patients who had previously been given ACAM2000 (the other FDA-approved smallpox vaccine), Jynneos’ impact was comparable.
The approval for monkeypox was based on survival data derived from lethal monkeypox virus studies in non-human primates. Overall survival in various models ranged from 80% to 100% of Jynneos-vaccinated animals compared to 0-40% in control animals, the Denmark-based biotech said.
As part of its approval, the company has been given a Priority Review Voucher (PRV) — which it intends to sell. PRV’s are valuable as they give the owner-drugmaker the VIP treatment in the queue to get its products reviewed, and have them sold for hundreds of millions of dollars in recent years.
Bavarian Nordic has given the United States 28 million doses of the vaccine for emergency use, and it has a decade-long contract in place with BARDA to replenish and potentially expand the stockpile. The vaccine is also approved in Europe and Canada to protect against smallpox.
Although monkeypox is much milder than smallpox, it can be fatal — killing between 1% and 10%, of infected patients, with most deaths occurring in younger age groups, according to the WHO.
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