Biotech
Wednesday, August 10th, 2022 8:09 am EDT
Dive Brief:
- U.S. regulators took steps to make Bavarian Nordic’s monkeypox vaccine, Jynneos, more widely available to Americans as they rush to stretch limited supplies amid a public health emergency.
- The Food and Drug Administration said adults at high risk of the disease can now receive the vaccine intradermally, or between the top layers of skin, instead of the usual shot that goes straight into a person’s arm and into the fat below. That method requires only one-fifth of the usual dose but is just as effective, the FDA said Tuesday.
- At the same time, the FDA will allow providers to offer the vaccine to people who are younger than 18 if they are deemed to be at high risk for infection. In those younger individuals, the normal method of administration – known as subcutaneous — will be used.
Dive Insight:
U.S. health officials are trying to contain the monkeypox outbreak before it becomes a larger epidemic. In less than three months, the virus has spread to nearly all parts of the country, with almost 9,500 cases confirmed as of Tuesday.
Unlike the novel coronavirus that sparked the COVID-19 pandemic, monkeypox is a known quantity with an effective vaccine that’s been approved since 2019. The problem is the shot is in short supply.
The FDA in July finally signed off on a plant used to manufacture the vaccine, which freed up more doses. But it’s clear that the current supply won’t meet demand without other steps, FDA Commissioner Robert Califf said in the agency’s statement.
After distributing more than 670,000 vials to local jurisdictions, the U.S. now has 400,000 in reserve, said Robert Fenton, the White House monkeypox response team coordinator. By allowing providers to administer the shot intradermally, those 400,000 vials could be stretched to provide 2 million doses.
The action is a “game changer,” Fenton told reporters Tuesday. “It’s safe, it’s effective and it will significantly scale the volume of vaccine doses available for communities across the country.” European health officials are considering following the U.S. lead to stretch their own supplies, Reuters reported.
People who receive the vaccine need a booster shot after four weeks, and that won’t change with the new method of administration. The Centers for Disease Control and Prevention will work with providers to educate them about the intradermal method, which is already used for some vaccines and skin tests for tuberculosis, CDC Director Rochelle Walensky said.
Monkeypox is most often transmitted through physical contact, including during sex and via skin lesions that are characteristic of the disease. Outside of getting vaccinated, people can limit their chance of contracting monkeypox by taking steps such as avoiding close, skin-to-skin contact with others and washing their hands often, the CDC says.
“Every American should take monkeypox seriously and every American must do their part to help us beat back monkeypox,” Health and Human Services Secretary Xavier Becerra told reporters.
This post has been syndicated from a third-party source. View the original article here.
