COPENHAGEN/LONDON: Bavarian Nordic – maker of the only licensed monkeypox vaccine – may use technically expired doses to help widen gap between supply and demand due to current outbreak He said he was looking for
In an interview with Reuters, CEO Paul Chaplin said the current global demand for vaccines “is outstripping supply capacity.”
Since early May, more than 40,000 confirmed cases of monkeypox have been reported in more than 80 countries where the virus is not endemic. This includes a small number of fatalities. About one-third of the current global cases are in the United States.
The World Health Organization has called the outbreak a global health emergency, but vaccine supplies are in short supply, prompting several countries to take steps to maximize their existing stocks. Motivated to scale up doses with mostly unknown results.
One way to address this issue is to assess whether the millions of technically expired doses that have arrived in the US over the past few years are still viable.
About 500,000 doses still have shelf life from tests conducted so far, Chaplin said, adding that the final decision on whether to use such doses rests with U.S. regulators. added.
Meanwhile, the United States, the European Union and the United Kingdom are changing how vaccines are administered to expand existing supplies.
This approach requires a small shot to be injected intradermally between layers of skin, increasing the dose available from a single vial by a factor of five.
Chaplin raises questions about the safety of this so-called split-dose approach, citing the limited data to support it and the local reactions when injected in this manner compared to the original method of injecting into the fat layer under the skin. provided evidence that may increase.
He also stresses that a small study that tested the feasibility of the new approach showed that about one-fifth of participants failed to receive a second injection with intradermal administration. Did.
At the moment, Bayern is not delivering vaccines at the pace demanded by countries, but the company plans to announce additional manufacturing partnerships in the coming weeks, Chaplin said.
“We are working to expand our manufacturing capacity to meet that demand as quickly as possible.”
A few days ago, the company said it signed a deal with Michigan-based Grand River Aseptic to expand its capacity to deliver finished doses, and on Wednesday said its Danish facility had reopened with expanded capacity. .
Overall, Bavaria hopes to deliver about 4 million doses of the vaccine to countries by the end of the year, using newly manufactured doses since May, Chaplin said.
According to a Reuters tally of government statements, there are 1.5 million vials of vaccine administered or currently available in the 10 worst-affected countries, accounting for almost 90% of all cases. The majority of doses are in the United States.
WHO estimates that 10 million doses will be needed globally to protect those at highest risk.
Bavaria, which has raised its outlook for 2022 six times since the outbreak began in May, said second-quarter sales of its monkeypox vaccine (called Jynneos, Imvanex and Imvamune depending on the region) were worth 117 million Danish. Crown ($15.65 million), it said.It also reiterated its full-year outlook Wednesday.