US to expand supply of monkeypox vaccines with lower doses

As cases of monkeypox continue to rise among people at high risk, federal authorities announced on Tuesday that they would stretch limited vaccine supplies by giving only one-fifth of the current dose.

The move would quintuple the existing supply of monkeypox vaccine doses, a priority in hard-hit communities such as Los Angeles County and San Francisco, where the virus has risen rapidly in communities where men have sex. sex with men and where vaccines remain rare.

The U.S. Food and Drug Administration has issued emergency use authorization allowing healthcare providers to use the new vaccination technique for high-risk adults.

“Over the past few weeks, the monkeypox virus has continued to spread at a rate that clearly shows that our current vaccine supply will not meet current demand,” said FDA Commissioner Dr. Robert Califf, in a statement. “The FDA quickly explored other scientifically appropriate options to facilitate access to the vaccine for all affected individuals. By increasing the number of doses available, more people wishing to be vaccinated against monkeypox will now be able to do so.

Los Angeles County health officials said they are awaiting direction from federal authorities and hope to implement the strategy once clinicians are trained.

“With this new alternative regimen that we just learned about, we will now have five times the doses,” said Dr. Rita Singhal, chief medical officer for the LA County Department of Public Health.

As the number of reported cases of monkeypox continued to rise, officials scrambled to administer as many vaccines as possible and stretch the limited supply of doses.

Governor Gavin Newsom declared a state of emergency amid the spread of the virus earlier this month to “support the state’s vaccination efforts.” And the White House has declared the disease a public health emergency.

Health experts say one of the only ways to bring the growing epidemic under control is to drastically increase vaccinations, adding that the higher the cases climb, the harder the spread will be to contain. Doctors fear that further spread could make the virus endemic in the wildlife population, meaning it would be virtually impossible to eliminate it as a new disease of concern in the United States.

In an interview earlier this week, UC San Francisco infectious disease expert Dr. Peter Chin-Hong said expanding the availability of the monkeypox vaccine would be key to meeting the ‘epidemic. Currently, the vaccine is administered subcutaneously, or under the skin. The new technique would be to administer an injection intradermally or inject it in a shallower way.

Federal officials were expected not to act until more data became available later this year on the effectiveness of the shallower injection method. But some scientists have noted that the intradermal technique has been used in other vaccines, such as for yellow fever, when doses are scarce, according to Chin-Hong.

The FDA based its decision on data from a 2015 clinical study that found that people who received the vaccine intradermally — between layers of the skin — had a similar immune response to those who received the vaccine. vaccine under the skin.

“Intradermal administration resulted in more redness, firmness, itching, and swelling at the injection site, but less pain, and these side effects were manageable,” the FDA said in a statement.

The FDA action on Tuesday also allows people under the age of 18 at high risk of infection to get vaccinated against monkeypox. But they will need a full dose given subcutaneously, rather than the smaller intradermal dose.

At a public meeting with colleagues last week, Chin-Hong expressed concern about the rate at which monkeypox is spreading.

“When you look at the rates of increase, you can see that they’re really close to an exponential curve. And unfortunately it will become increasingly difficult to control the increase in these numbers,” he said.

Anyone can get monkeypox. However, it has spread rapidly in LGBTQ communities in part because contagious lesions may appear first in the rectum, urethra, and mouth before appearing on the skin, and because early symptoms may appear as harmless as a pimple. This allows the virus to be transmitted to other people during intimate sex without the infected people knowing that they are contagious.

Cases are rising sharply among men who have sex with men and transgender people who have sex with men, Chin-Hong said. About 98% to 99% of cases involve people from these groups.

The spread of monkeypox cases has also been amplified by Pride events, particularly at gay saunas and at pool parties where there is intimate skin-to-skin contact, Chin-Hong said. The virus is not transmitted through swimming pool water and generally not through surfaces. It can, however, be transmitted through infected linens.

The Jynneos vaccine is a two-dose series with injections given four weeks apart. It can also be used preventively and within two weeks of exposure.

However, supplies are limited, prompting health officials to recommend prioritizing first doses rather than stockpiling second shot supplies in many cases.

“While supplies remain scarce, vaccinators in California can offer first doses of Jynneos to other at-risk individuals rather than maintaining inventory as second doses for immunocompetent individuals, even if second doses are by therefore administered at an interval greater than 28 days”, states the California Department of Public Health.

The same is true in Los Angeles County, where the local Department of Public Health “is asking all providers to prioritize the first doses of Jynneos vaccine to eligible immunocompetent individuals in order to protect as many people at risk as possible”.

Singhal said Tuesday that LA County continues to prioritize first doses, but noted that the move by federal regulators could allow administrators to provide second shots sooner.

Immunocompromised people should receive their second dose within the 28-day window whenever possible, officials said.

“There are no data available to indicate that one dose of Jynneos will provide long-lasting protection, which will be needed to control the current outbreak of monkeypox,” the FDA said in a statement.

Asked about the FDA’s potential action last week, Los Angeles County Public Health Director Barbara Ferrer said that “we fully support any effort that can be made to safely increase the number of people who will be able to be vaccinated with the hand doses.”

“We would work absolutely hard to make sure we could do it very quickly here in LA County,” she said in a recent briefing, noting that administrators would need to be trained in the new technique.

Singhal said 683 cases of monkeypox have been identified in Los Angeles County, including Pasadena and Long Beach, which have separate health departments – “double the number of cases we had 10 days ago” .

As of Thursday, the most recent date for available data, 1,310 cases of monkeypox had been reported statewide, most in LA County and San Francisco.

Of the 885 cases for which data is available, state officials said the vast majority — about 97% — did not require hospitalization. No deaths from the disease have been reported.

However, the number of cases is increasing rapidly.

“Our rate of new cases has increased over the past few days and so that’s certainly concerning,” Orange County Deputy Chief Health Officer Dr. Matthew Zahn said in a Thursday briefing. “If you compare us to surrounding counties, certainly LA County, our numbers aren’t as high. But we’re definitely seeing our numbers go up in Orange County.

On Monday, Orange County health officials were reporting 37 confirmed and probable cases of monkeypox.

Los Angeles Times

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