Updated Covid-19 booster shots could be available in September

 By Naomi Thomas, CNN

Updated 1951 GMT (0351 HKT) July 29, 2022

https://edition.cnn.com/2022/07/29/health/updated-covid-boosters-fall/index.html

(CNN)Moderna and Pfizer booster shots updated to target Omicron coronavirus subvariants could be available in early fall, pending signoff by federal health agencies, the US Department of Health and Human Services said Friday.

The US Food and Drug Administration advised vaccine makers in June to update the boosters to add an Omicron BA.4/5 component and create a bivalent booster.

Why the Omicron offshoot BA.5 is a big deal

"Pfizer and Moderna have indicated that they anticipate the modified vaccines being available as early as September," an FDA spokesperson said.

HHS announced Friday an agreement to purchase 66 million doses of Moderna's bivalent booster shot for potential use in fall and winter. That's in addition to 105 million bivalent boosters the US government has purchased from Pfizer.

The FDA spokesperson said that agency "has been working closely with vaccine manufacturers over the past several months to ensure that modified COVID-19 vaccines are available this fall to meet evolving public health needs, following FDA's review for safety and effectiveness. The agency will work expeditiously to review submissions to make COVID-19 vaccines available."

Updated shots would need to be authorized by the FDA and recommended by the US Centers for Disease Control and Prevention. Pfizer and Moderna have not responded to requests for comment.

Currently, people 5 and older are eligible for a first booster shot, but only those 50 and older and some immunocompromised people are eligible for second boosters.

Should you get your booster now or wait until the fall? An expert weighs in

Adults 50 and older who have not received a second booster dose with current Covid-19 vaccines "should consider doing so now," the FDA spokesperson said. "You can still benefit from existing booster options and leave time to receive an updated booster in the fall."

At this time, the FDA is not considering authorizing a second booster for otherwise healthy adults under 50 with the original formulation of the Covid-19 vaccines.

"Once boosters containing a BA.4/5 component become available, individuals may consider getting one following an appropriate interval following their prior dose," the spokesperson said.

In late June, vaccine makers said boosters updated to target Omicron showed a stronger immune response than the current vaccines.

Combined, the US government's agreements with Moderna and Pfizer would make about 171 million bivalent vaccine booster doses available for the fall and winter, should they be authorized and recommended.

But the Biden administration added in its announcement Friday that that would not be enough for every US resident. Although both agreements include options to purchase a total of 600 million doses -- 300 million from each company -- those options "can only be exercised with additional funding from Congress," the announcement said.

"We look forward to receiving these new variant-specific vaccines and working with state and local healthcare partners to make the vaccines available for free in communities around the country this fall," said HHS Assistant Secretary Dawn O'Connell, who leads the Administration for Strategic Preparedness and Response, in the HHS news release.

CNN's Jacqueline Howard, Katherine Dillinger and Jamie Gumbrecht contributed to this report.

https://edition.cnn.com/2022/07/29/health/updated-covid-boosters-fall/index.html

Monkeypox: WHO chief advises men who have sex with men to reduce partners to limit exposure to monkeypox

 By John Bonifield, CNN

Updated 0901 GMT (1701 HKT) July 28, 2022

https://edition.cnn.com/2022/07/27/health/who-monkeypox-msm-sex-partners/index.html

(CNN)The vast majority of cases in the growing monkeypox outbreak are among men who have sex with men, according to the World Health Organization. WHO Director-General Tedros Adhanom Ghebreyesus advised members of this community Wednesday to limit their exposure to the virus by reducing their number of sex partners and reconsidering sex with new partners.

"This is an outbreak that can be stopped if countries, communities and individuals inform themselves, take the risk seriously and take the steps needed to stop transmission and protect vulnerable groups. The best way to do that is to reduce the risk of exposure. That means making safe choices for yourself and others.

"For men who have sex with men, this includes, for the moment, reducing your number of sexual partners, reconsidering sex with new partners and exchanging contact details with any new partners to enable followup, if needed," Tedros said at a briefing.

WHO declares monkeypox a public health emergency of international concern

While Tedros said the focus for all countries must be on engaging and empowering communities of men who have sex with men to reduce the risk of infection and transmission, he also cautioned nations to safeguard human rights.

"The stigma and discrimination can be as dangerous as any virus," he said.

Monkeypox isn't considered a sexually transmitted disease, but most people who have gotten it in the US recently report some level of sexual activity, Dr. Demetre Daskalakis, a US Centers for Disease Control and Prevention official working on the monkeypox response, told CNN this month. That can include penetrative encounters as well as oral sex.

The virus spreads primarily though skin-on-skin physical contact, but it can also be transmitted by touching objects like sheets or towels that may have been used by somebody with monkeypox, as well as through close face-to-face interactions like kissing.

Researchers are investigating whether the virus can be spread by someone who has no symptoms or through semen, vaginal fluids and fecal matter, according to the CDC.

An additional 786,000 monkeypox vaccine doses will soon be available in the United States

The CDC says that wearing a condom may help, but alone, it probably will not protect against the spread of monkeypox. However, the agency still emphasizes that condoms can prevent other sexually transmitted infections.

Tedros' comments about reducing sex partners are among the strongest yet on the matter. Other WHO communications haven't been characterized so sharply.

"Reducing your number of sexual partners may reduce your risk," one WHO flyer reads.

"How can I protect myself?" another says. "To catch monkeypox, you need skin-to-skin contact, including during sex, with someone infectious or their contaminated belongings. To reduce the risk of contracting monkeypox: practice safer sex, keep your hands clean."

"Remember that close physical contact, including sex, may increase your risk of exposure. Having multiple and frequent sexual contacts, including with anonymous partners, may put you more at risk of infection of monkeypox. To protect yourself practice safer sex," a third WHO flyer advises.

Health officials in the US have also advised reducing sex partners but used softer language.

What is monkeypox, and how can you stay safe as it spreads?

"Avoid skin-to-skin contact, including intimate contact, with people who have a rash that looks like monkeypox. Other harm reduction actions include minimizing sexual activity with multiple or anonymous sexual partners," CDC Director Dr. Rochelle Walensky said in mid-July.

Daskalakis advised last week, "In line with our harm reduction guidance, thinking about reducing your number of partners, potentially trying to avoid anonymous contacts ends up being smart from the perspective of decreasing the risk of exposure."

The CDC also says people might want to reduce skin contact as much as possible by having sex with clothes on or after covering areas where the rash is present. If they choose to have sex with someone who has monkeypox or who might have been exposed to it, they should talk about the virus ahead of time.

Another thing people can do to protect themselves is avoid close face-to-face contact like kissing with those who are clearly infected.

Scientists are still studying how monkeypox is spreading in this outbreak, but they say people don't seem to be getting sick after, say, walking past someone or giving them a hug and brushing over a lesion on their skin.

Get CNN Health's weekly newsletter

Sign up here to get The Results Are In with Dr. Sanjay Gupta every Tuesday from the CNN Health team.

"If it's a hug that doesn't necessarily include a shirt, there's a theoretical risk of transmission there, but that's not what we're hearing in terms of what's happening with our cases, so it's lower risk. I can't say zero risk," Daskalakis said.

Rather, it's longer contact that seems to be responsible for most cases now. "If you were to ask me how long 'long' is, I can't answer that question, but it seems as if it's possible that this is not being transmitted by a light brush," Daskalaskis said. "Realistically speaking, skin-on-skin contact of any variety theoretically can transmit monkeypox, but what we're seeing is, you kind of have to work at it a bit."

CNN's Jen Christensen contributed to this report.

https://edition.cnn.com/2022/07/27/health/who-monkeypox-msm-sex-partners/index.html

Scientist at forefront of China's early investigations into Covid-19 steps down

 By Simone McCarthy

Updated 0940 GMT (1740 HKT) July 27, 2022

George Gao, now former head of the Chinese Center for Disease Control and Prevention, attending a forum in Beijing last year.

A version of this story appeared in CNN's Meanwhile in China newsletter, a three-times-a-week update exploring what you need to know about the country's rise and how it impacts the world. Sign up here.

https://edition.cnn.com/2022/07/27/china/china-cdc-director-george-gao-fu-covid-intl-hnk-mic/index.html

(CNN)George Gao, head of the Chinese Center for Disease Control and Prevention, has stepped down after five years at the helm of the health body, ending a tenure that placed him at the fore of early investigations into the first outbreak of Covid-19 in central China and the country's rapid development of Covid-19 vaccines.

The leadership change, announced by the agency on Tuesday, comes amid a restructuring that has seen the China CDC moved from its position directly under the monolithic centrally controlled National Health Commission and placed within a new nominally streamlined bureau, borne of pandemic-era calls for reform.

China's Wuhan shuts down district of 1 million people over 4 asymptomatic Covid cases

It also comes as China continues to grapple with fresh outbreaks of Covid-19 across the country, despite a stringent zero-Covid policy that has seen it maintain tight border controls and implement frequent mass testing and lockdowns.

Oxford University-educated and internationally connected Gao, 60, known also by his Chinese name Gao Fu, would no longer serve as director "due to his age," according to the China CDC readout of a meeting announcing the changes. Sixty is a standard retirement age for male civil servants, though many do not adhere to this.

He would be succeeded by former president of the Nanjing Medical University Shen Hongbing, currently vice-director of the National Administration of Disease Prevention and Control, the new bureau established in 2021.

The shift brings to an end the tenure of an internationally respected virologist who observers say grappled with the limitations of an agency with little sway over policy-making -- a key distinction between China's CDC and the US agency it was modeled after.

Legacy of an overseas-educated virologist

Gao also oversaw the agency at a time of increasing acrimony between China and the United States, made worse by questions over the origins of the coronavirus and accusations that China had suppressed its investigation.

Gao, who gave presentations at international scientific forums in English and had professional relationships with Western scientists, including top American epidemiologist Anthony Fauci, was widely respected among the international scientific community and seen as a rare point of contact with China.

"He will be remembered for being more open-minded and willing to reach out to his counterparts in Western countries," said Yanzhong Huang, a senior fellow for global health at the Council on Foreign Relations in New York.

'More work' to be done': Key takeaways from the WHO report on origins of the Covid-19 pandemic

"Under him the China CDC became a more prominent actor in China's response to the pandemic, especially in the early stages of the outbreak, and also an important window for the outside world to learn about China's Covid response," Huang said.

Prior to the pandemic, Gao was known for his work in Sierra Leone countering a 2014 Ebola outbreak, when he was still deputy director of the China CDC. He took up the director role in 2017.

Gao was among a group of top-level health officials who traveled to Wuhan, the epicenter of the first known outbreak of Covid-19, before the disease became a global crisis in January, 2020. China has been criticized for its actions during that period, due to the three-week lag between local officials' announcement of the outbreak and confirmation the virus could pass between people.

Gao played a key role in early scientific papers documenting the outbreak in Wuhan, and went on to develop one of the seven Covid-19 vaccines authorized for use in China.

He has also been involved in research into the origins of the virus, suggesting, contrary to recently published studies, that a Wuhan market linked to early cases was not where the new virus emerged, but rather a place where it was able to spread rapidly between people.

But he has sparked controversy within China and is considered by some in China's public health community as a "loose cannon," according to Huang.

In one instance last year, Gao appeared to suggest during a presentation that China's homegrown vaccines offered a low protection rate -- comments he later walked back in an interview with state media in which he called this a "misunderstanding" of his point.

He was also criticized after an interview last fall with the editor of Caijing magazine, in which he discussed the conditions under which China might relax its zero-Covid policy -- a sensitive subject in China, where the policy is viewed as the personal directive of leader Xi Jinping.

On Tuesday, Gao, who remains vice-president of China's grant-giving National Natural Science Foundation, said he supported the changes and that he would "continue contributing to developing disease control and public health."

Virus flare-ups

Gao's departure was announced as China continues to grapple with flare-ups of the virus, relying on frequent mass testing and snap lockdowns to handle outbreaks, while most of the rest of the world has moved into some mode of living with the virus.

As of Wednesday, China has identified 776 high-risk areas in 24 cities across the country, where residents are subject to partial or full lockdowns, according to information from the country's State Council.

Authorities in Wuhan, which was locked down for more than two months in early 2020, announced Wednesday they would be implementing control measures for three days in the main urban area of Jiangxia district, banning its roughly 1 million residents from leaving the area and shuttering a number of businesses and public transportation. Four cases had been identified in the district the previous day, according to official reports.

But as the head of China CDC, Gao himself had a limited role in forming policy to respond to and control the virus, observers say, as such matters are dictated by the cabinet-level National Health Commission, while the CDC has played a more technical, advisory role.

"Though restricted, (Gao) still tried his best to fulfill CDC's role as a public health and scientific adviser," said Xi Chen, an associate professor at the Yale School of Public Health.

"His scientific publications in the early stage of the pandemic helped inform the world about the virus. He also championed the publication of a scientific journal in English -- China CDC Weekly -- that aimed to make communications with the global public health arena more timely and transparent."

It remains unclear exactly what role the agency will play now that it is under the National Administration of Disease Prevention and Control. That body was set up following calls to strengthen China's disease prevention and control systems in the wake of the Covid-19 outbreak.

In Tuesday's meeting, Wang Hesheng, head of the National Administration of Disease Prevention and Control, praised Gao's contributions and laid out several goals regarding "reform" of the CDC and its operations under the new leadership. These included taking a "clear stand on politics" and to "faithfully implement General Secretary Xi Jinping's important directives and instructions."

And as a result of the new structure, it is possible that Gao's successor could be given more power, according to Chen. "Hopefully, the empowerment of China CDC under Shen may achieve something George Gao was unable to," he said.

CNN's Beijing bureau contributed to this report.

https://edition.cnn.com/2022/07/27/china/china-cdc-director-george-gao-fu-covid-intl-hnk-mic/index.html