CDC launches pilot program to improve vaccine equity among monkeypox patients, Covid-19 vaccination temporarily lengthens patients' menstrual cycles, and more in this week's roundup of monkeypox and Covid-19 news.

Just how effective are monkeypox vaccines? Here's what we know—and don't.

Monkeypox:

• People who are vaccinated against monkeypox are at a significantly lower risk of infection than those who are unvaccinated, according to new data from CDC. Based on preliminary vaccine data from 32 states collected between July 31 and Sept. 3, researchers found that unvaccinated individuals were roughly 14 times more likely to be infected by the monkeypox virus than those who were vaccinated. Although the data is limited, CDC Director Rochelle Walensky said the results "provide us with a level of cautious optimism that the vaccine is working as intended." According to Walensky, data suggests that individuals vaccinated against monkeypox see protection as soon as two weeks after their first dose, but health officials still recommend people to get two doses to ensure maximum protection. CDC also announced that it is expanding eligibility of the monkeypox vaccine and moving towards a pre-exposure prophylaxis strategy to reduce transmission. Anyone who is at risk of monkeypox, including men who have sex with men or transgender/gender diverse individuals who have had more than one sex partner in the last six months, are now eligible for vaccination. "We're looking to ensure those at the highest risk for monkeypox receive the vaccine before exposure and that vaccines continue to be made available equitably to those who need them," Walensky said. (Firth, MedPage Today, 9/28; Weixel, The Hill, 9/28; Kimball, CNBC, 9/28; Branswell, STAT, 9/28; Weiland, New York Times, 9/28)

• According to CDC data, new cases of monkeypox in the United States have declined steadily over the past month, going from a daily average of more than 500 cases in early August to 163 cases on Sept. 27. Because of this, federal health officials are optimistic that the monkeypox outbreak is waning in the country and will be more manageable going forward. "I think it's going to look a little bit more like more episodic cases, smaller clusters," said Demetre Daskalakis, the deputy coordinator of the White House's monkeypox response team. However, some health experts caution that there still needs to be a significant effort to improve vaccine equity in underserved populations, including Black and Hispanic men, before the outbreak can truly be stopped. "Our progress is incredibly uneven," said David Harvey, executive director of the National Coalition of STD Directors. "The outbreak is far from finished." (Mandavilli, New York Times, 9/26; Stolberg, New York Times, 9/22)

• CDC earlier this month launched a pilot program to improve access to the monkeypox vaccine for groups who have been disproportionately affected by the virus but have faced barriers to the shots. For example, Black and Hispanic men currently make up the majority of confirmed monkeypox cases in the United States, but white men have received more than twice as many vaccine doses. Under the program, 50,000 doses of the Jynneos monkeypox vaccine will be set aside. State, local, and tribal health departments can then apply for these doses to administer pop-up clinics or other events in non-clinical settings. "We're now entering the harder phase of the vaccination campaign, while we work to get first doses into arms and use hyper-local strategies," said Demetre Daskalakis, deputy White House monkeypox response coordinator. (Dreher, Axios, 9/16)

Covid-19:

• Covid-19 vaccination may lead to a temporary increase in the length of menstrual cycles, according to a new study published in BMJ Medicine. In a previous study, researchers found that Covid-19 vaccines temporarily lengthened participants' menstrual cycles by 0.71 days after the first dose and 0.56 days after the second dose. In this new study, researchers from the same team analyzed data from almost 20,000 people worldwide. Among the participants, 14,936 were vaccinated and 4,686 were not. Overall, the researchers found that Covid-19 vaccination was associated with a roughly 1-day delay in participants' menstrual cycles. For people who received both vaccine doses in one menstrual cycle, their cycles increased by 3.91 days. A subset of 1,300 participants saw their cycles increase by eight days or more. "These findings provide additional information for counseling women on what to expect after vaccination," said Diana Bianchi, director of NIH's Eunice Kennedy Shriver National Institute of Child Health and Human Development. "Changes following vaccination appear to be small, within the normal range of variation, and temporary." (Hou, "Changing America," The Hill, 9/27; Sheikh, New York Times, 9/27)

• Multiple barriers, including a high number of low-quality applications, hindered FDA's ability to quickly authorize a Covid-19 test for emergency use in the early days of the pandemic, according to a new report from HHS's Office of Inspector General (OIG). For the report, OIG analyzed 237 developers who applied for emergency use authorization for Covid-19 test products between Jan. 1, 2002, and May 31, 2020. According to OIG, FDA saw "a record number of submissions—often low-quality and from developers lacking experience with FDA's process." Because the agency had to both review several submissions for unusable products and chose to waive clinical requirements for certain companies, some "problematic" Covid-19 tests were allowed on the market. "Furthermore, due in part to its limited engagement with the public health labs that were using CDC's test, FDA was slow to realize that testing by public health labs was far more limited than it initially expected," OIG wrote. (Twenter, Becker's Hospital Review, 9/22)

• Long Covid patients are more likely to have markers of autoimmune disease in their blood, according to a study published in the European Respiratory Journal—suggesting autoimmune responses may play a role in long-term Covid-19 symptoms. For the study, researchers collected blood samples from 106 Covid-19 patients at three, six, and 12 months after diagnosis and compared them to controls. Overall, 41% of the Covid-19 patients had autoantibodies in their blood, and around 20% to 30% had inflammation markers and two types of autoantibodies associated with autoimmune diseases in their blood. Many of the patients in the latter group had long-term symptoms, including lingering fatigue and shortness of breath. According to Manali Mukherjee, an assistant professor of medicine at McMaster University in Canada and the study's senior author, she and her team plan to follow up with the patients in the current study for up to two years post-infection to see if their symptoms eventually resolve or if they develop diagnosable autoimmune disorders. "There will be a subset of patients who will end up with a diagnosis for life," she said. (Gleeson, Becker's Hospital Review, 9/28; Bendix, NBC News, 9/27)