Europe’s drug regulator on Friday recommended an alternative monkeypox vaccine dosing regimen aimed at stretching the limited global supply of doses, similar to the United States’ approach.
According to a
clinical trial of around 500 adults, a smaller dose given just beneath the skin produced similar levels of antibodies as a normal subcutaneous injection that requires five times as much vaccine.
Following advice from the European regulator’s emergency task force (ETF), the European Medicines Agency (EMA) said in a
statement that national authorities “may decide as a temporary measure” to use a lower dose of Imvanex injected intradermally.
Despite some unknowns remaining, the smaller dose was recommended to protect at-risk individuals, namely men who have sex with men, during the current monkeypox outbreak “while supply of the vaccine remains limited.”
EU Health Commissioner Stella Kyriakides
said on Twitter that EMA’s recommendation will allow the vaccination of five times as many people with the EU’s current supply.
“This ensures greater access to vaccination for citizens at risk and health care workers,” she said in a further
statement obtained by VOA news.
The alternative dosing approach was announced by the U.S. Food and Drug Administration a few weeks ago in a bid to stretch the limited supply of Bavarian Nordic’s Jynneos vaccine (known as Imvanex in Europe).
Questions Remain Over Efficacy for Some
It is thought the intradermal approach may stimulate a better immune response in healthy adults, according to EMA.However, the ETF noted in a statement (
pdf) that questions remain about the efficacy of the intradermal approach for the immunocompromised or people with HIV as the trial was conducted with only “healthy adults.”
Intradermal injections require only a 0.1 mL dose, which is one-fifth the dose needed for subcutaneous injection. The ETF also emphasized that only experienced health care professionals should administer the vaccine intradermally.
“Taking into account all these considerations, national authorities may decide as a temporary measure to use Imvanex as an intradermal injection at a lower dose to protect at-risk individuals during the current monkeypox outbreak while supply of the vaccine remains limited,” EMA said in a
statement.
Imvanex was authorized in Europe under exceptional circumstances in 2013 against smallpox and was extended on July 22 for use in protecting against monkeypox.
Outbreak
The World Health Organization in July declared the monkeypox outbreak a public health emergency. Since it emerged in May in Europe, there are now almost 40,000 cases worldwide, and over 13,000 cases in the United States.More than three-quarters, approximately 76.5 percent, of global monkeypox cases are among men 18 to 44 years old who have sex with men.
There is growing scientific evidence suggesting that monkeypox is transmitted specifically via sexual intercourse between men, as opposed to skin-to-skin contact as stated by public health officials.
According to a report by
NBC News, a string of scientific studies and reports from health authorities across the globe in recent weeks indicate that the advice of public health officials to date may be “precisely backward.”
“A growing body of evidence supports that sexual transmission, particularly through seminal fluids, is occurring with the current MPX outbreak,” Dr. Aniruddha Hazra, medical director of the University of Chicago Sexual Wellness Clinic, told NBC News.
The White House on Thursday
announced a plan to ramp up its monkeypox vaccine distribution program ahead of upcoming LGBT pride events as U.S. cases climbed closer to 14,000.
According to the WHO, monkeypox can be severe and very painful in some cases, but is usually a self-limited disease with the symptoms lasting from a few weeks. The current outbreak has a case fatality ratio of around three to six percent.
