Top Doctors 2022

Launching An Effective Bird Flu Vaccine Quickly Could Be Tough, Scientists Warn

The bird flu that's now spreading among cows doesn't yet appear to pose an imminent threat to most people. Scientists say the virus would need to mutate significantly to be able to transmit easily from human to human.

But federal health officials say they've started trying to develop a vaccine to protect people just in case a pandemic erupts.

"We've got some preparedness pieces in place that will give us a head start should we need a large-scale vaccination campaign in a pandemic situation," Dawn O'Connell, the assistant secretary for preparedness and response at the Health and Human Services Department, told NPR in an interview this week.

That includes two vaccines made from older, but similar strains of the virus that early testing indicates could protect people, O'Connell said. The government also has stocks of adjuvant, a substance that is used to increase a vaccine's effectiveness, O'Connell said.

"We actually have manufactured small lots of both of the candidates. So we have some to the tune of hundreds of thousands in prefilled syringes and in vials that could be deployed fairly quickly," she said.

The government also has the raw material to make 10 million additional doses within weeks, plus another 125 million doses within about four months, she said.

"You could imagine getting that first 100 million doses is going to be really important and is going to give us a good head start and then we would lean into the manufacturing from there to continue to ramp up," she said.

JIM WATSON

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AFP via Getty Images

Assistant Health and Human Services Secretary for Preparedness and Response Dawn O'Connell.

No one knows how much of a risk the bird flu poses of causing a human epidemic, and so a vaccine may not become necessary.

Some outside experts agree the U.S. Is well prepared to produce a vaccine. But some infectious disease specialists are skeptical about the nation's preparedness for this potential threat.

"The first thing we have to do is eliminate the happy talk," said Michael Osterholm, who runs the Center for Infectious Disease Research and Policy and the University of Minnesota.

"I think estimates of stockpiles that currently exist and the potential to use them should this emerge into a human pathogen where it's transmitted by humans to humans, have unfortunately been overstated," Osterholm said.

For example, not enough testing has been done yet to know how well the two candidate vaccines would really work, especially since the virus would have likely changed if it becomes a real threat to people, Osterholm said.

"I don't have a lot of faith that those vaccines will offer a great deal of protection," he said.

And even if an effective vaccine was available, most flu vaccines are still produced with old-fashioned technology that relies on growing virus in eggs — this can take months to make enough and can be unpredictable. The country would need more than 600 million doses because everyone would need two shots.

"Given those limitations, I think it's really critical for the federal government to take a much more aggressive posture," said Luciana Borio, a senior fellow for global health at the Council on Foreign Relations. "We can't afford to falsely reassure ourselves. We need to be more humble."

Borio and others argued the federal government's overly optimistic assessments are sending the wrong message to the public and to Congress, which would have to provide funding to really ramp up vaccine production.

"I do not think we are ready with our vaccine enterprise to be able to respond fast enough," said Rick Bright, who until 2020 worked at the Biomedical Advanced Research and Development Authority, or BARDA, a federal agency involved in pandemic research.

"There's a lot of gaps in our preparedness response. We don't have prioritization strategy on who to vaccinate first. We don't have distribution plan in place if we need to distribute vaccines," he said. "So there's a lot of work that needs to be done."

Bright thinks the government should develop a vaccine based on the strain of the virus that recently ratcheted up alarm when it infected a dairy worker in Texas.

"When we're starting with candidate vaccines that are from viruses in 2020 we're already perhaps four years behind the evolution of the virus," Bright said. "I would update those candidate vaccine viruses while we have the time."

The government should also start funding mRNA vaccine development directly, Bright said.

Bright, Osterholm, Borio and others worry that the response illustrates how little the country has learned from previous pandemics like COVID.

"It does feel like Ground Hog Day," said Jennifer Nuzzo, who heads Brown University's Pandemic Center. "We still seem to be stuck in reactive mode. We shouldn't be waiting for evidence that the virus is devastating us. We should be trying to act now to prevent the virus from devastating us."

In the interview with NPR, O'Connell of HHS acknowledged that the country could face problems developing and distributing a vaccine. But she stressed that beyond additional testing of one of the vaccine candidates, drug companies are also developing mRNA vaccines. The federal government is in talks to help with that too, she said.

"While we have a head start and we're not starting flat-footed as we did with COVID, that doesn't mean this is going to be simple and this is going to be easy," she said. "But I am pleased we have some tools to leverage."

In the short term, Nuzzo thinks the country should start vaccinating dairy workers as soon as possible.

"We need to protect farm workers and those exposed to raw milk," said Nuzzo.

That would protect workers' health and possibly help reduce the chances the virus would evolve to spread more easily among people, Nuzzo said.

During a briefing for reporters Wednesday, Vivien Dugan, director of the influenza division at the Centers for Disease Control and Prevention, said dairy worker vaccination might begin if any worrisome new changes are detected about the virus, such as changes in its genetic code.

Nuzzo and others said they are alarmed by the dearth of information being released by the federal government about the status of vaccine development and other important issues related to the virus.

"I wish there would be more transparency about what's going on because ultimately if we're ever going to ask people to use vaccines they need to understand the process by which they were generated so they can have confidence in that process. And we cannot do that at the last minute," Nuzzo said. "We saw the challenges of doing that in COVID and I do not want to see us do that again."

During Wednesday's briefing, David Boucher, who directs infectious disease preparedness for the federal Administration for Strategic Preparedness and Response, said two vaccine companies are already doing further testing of one of the two candidate vaccines.

Copyright 2024 NPR. To see more, visit https://www.Npr.Org.

Quiz: Can You Pass Our 9 Question Test On The Latest Theories Of COVID-19 Transmission

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Don't just sneeze without a tissue! That's the message of this early pandemic era graffiti in Dakar, Senegal. The World Health Organization has just issued an updated report on the way SARS-CoV-2 spreads. Take our quiz to see if you're up on your COVID terminology. Seyllou/AFP via Getty Images hide caption

toggle caption Seyllou/AFP via Getty Images

Don't just sneeze without a tissue! That's the message of this early pandemic era graffiti in Dakar, Senegal. The World Health Organization has just issued an updated report on the way SARS-CoV-2 spreads. Take our quiz to see if you're up on your COVID terminology.

Seyllou/AFP via Getty Images

The arrival of SARS-CoV-2, the virus responsible for COVID-19, brought a batch of vocabulary into the public eye, from "fomite" to "social distancing." See our guide from 2020.

And now there's a new report from the World Health Organization that proposes a set of new terms and definitions — along with a revised way of thinking about pathogens that transmit through the air.

Jeremy Farrar, chief scientist of WHO, considers the document to be a kind of base camp. With a shared vocabulary and approach, he and his colleagues are trying to get public health professionals on the same page to reduce confusion and streamline the containment of infections in the future.

This is needed because transmission is complicated. "It depends on my immunity. It depends on your immunity," says Farrar. "It depends on the humidity. It depends on the size of the room. It depends on the airflow. It depends whether I've been vaccinated or whether I'm immune. Depends on my age. Depends on whether I've got diabetes or I've got other conditions. It's complicated."

NPR has prepared a quiz to test your knowledge of this new thinking — and how WHO is hoping it will be used.

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DRC Is Seeing Its Worst Mpox Outbreak — But Has No Vaccines Or Treatments Yet. Why?

In the Democratic Republic of Congo, the fight against mpox – previously known as monkeypox – is entering a new phase.

While many are anxious to contain the outbreak – the largest mpox outbreak ever recorded in the DRC with more than 4,500 cases so far this year – experts say that's not yet possible: There are no vaccines or treatments in the country right now, and even the testing capacity is severely limited. Instead, this new phase of the mpox fight involves simply getting a better understanding of what exactly is going on.

"We've been doing a lot of groundwork and building support and trying to strengthen things. And now, I hope, we're at a pivot point," says Dr. Jennifer McQuiston of the U.S. Centers for Disease Control and Prevention. "Over the next three weeks, we expect to learn a lot about what's happening on the ground."

The CDC has worked with the DRC for 15 years but has increased their efforts in response to the current mpox outbreak, as has the World Health Organization. They've helped the DRC expand its testing capacity by opening labs in some of the most affected, remote areas. The CDC has also helped fund local epidemiological teams that can provide a more granular understanding of mpox cases.

A changing virus

The DRC's mpox outbreak is noteworthy not only for its size but for the changing nature of the virus.

According to Africa CDC, 11 African countries have reported mpox cases but the DRC is the clear epicenter, with a caseload three times what it was this time last year. The virus, which usually jumps from a small animal to a human and then spreads between people, causes painful lesions and sometimes fever, malaise and even death.

The concern is heightened because the type of mpox circulating, called Clade I, is 10 times deadlier than the type of mpox that caused a worldwide outbreak in 2022. About 10% of Clade I cases are fatal; DRC has confirmed 311 mpox deaths this year. In addition,early evidence suggests there is a new strain of the mpox virus in the eastern part of the DRC that's circulating among sex workers and seems to be sexually transmitted. Clade I has never been known to transmit sexually.

Other countries and international organizations have been working to balance their desire for quick action against the DRC's right to address its own health plans and priorities. The nation is juggling a number of pressing health challenges, including measles, cholera and plague.

"We have work to do," says Dr. Mandy Cohen, the director of the CDC. "[We] have to work with a sovereign country. And they have a lot of health threats... And so helping them work through not just mpox but their overall response is really what we're trying to do."

Earlier this month, the Africa Centres for Disease Control and Prevention – the public health agency of the African Union – helped convene a high-level emergency meeting on mpox in Kinshasa, DRC. The meeting brought together hundreds of experts.

No vaccines in DRC yet

By the end of the meeting, the DRC had announced its intent to use vaccines against mpox – although it still needs to approve the vaccines and draw up a strategy for delivery. In addition, the DRC said it would work quickly to approve a treatment option.

Vaccines have been used to combat mpox outbreaks in other places, including the U.S., Europe and Japan. So far, they have not been approved for use in most African nations.

One challenge is that there is very limited data on how the vaccines work in children – who represent the majority of mpox cases in the DRC – and also minimal data on its use in populations that deal with other health issues, like malnutrition. In March, the WHO's vaccine advisory committee recommended the off-label use of the mpox vaccine in children but urged further study.

There are also major logistical challenges to rolling out an mpox vaccination effort, given that most of the cases are in remote areas and parts of the country face violent unrest. Now that the DRC has declared its intent to use two types of mpox vaccines, its National Regulatory Authority is meeting for a vaccine assessment. While mpox vaccines are likely months away, these steps are being heralded as progress – as is the country's acknowledgement of the scale of the concern.

Should an emergency be declared?

"This situation constitutes a public health emergency," said Samuel-Roger Kamba, the Minister of Health in the DRC, speaking in French at the Africa CDC meeting's closing ceremony. "The Democratic Republic of Congo remains very concerned by the scale and severity of the mpox epidemic which is raging in 23 of the country's 26 provinces."

Nicaise Ndembi, a virologist and senior adviser to the director-general of the Africa CDC, says that, so far, that speech has not been followed by an official declaration of a health emergency. "Meetings are meetings, right? Except if we really take action," he tells NPR.

Ndembi says there are a lot of considerations that come into play before an official declaration can be issued. Many countries vividly – and bitterly – remember how travelers from numerous African countries were banned after Botswana and South Africa shared news about the discovery of Omicron, which was then a new strain of COVID. These bans cost the countries economically and drew criticism since simultaneous cases in Europe did not receive the same response. "So, it's very sensitive," he says.

Nonetheless, Ndembi says his instinct is that the scientific evidence merits a health emergency, particularly because the DRC borders nine countries and the virus could spread through travelers as it did in 2022.

"I would say: Declare! Because, by declaring, you have access to the drugs, you have access to the vaccines. We don't need to go through all the approval processes. And that will open the door for international support to mobilize resources," he says.

But in the interim, there are steps that can be taken, including disease surveillance, emergency response communication, infection prevention control and improved clinical care, even without mpox treatments in the country, says Dr. Rosamund Lewis, the WHO's technical lead and emergency manager for mpox.

"Small children [with mpox] can become dehydrated very quickly. When you have enlarged lymph nodes in the neck and sores in the mouth, children can't eat or drink. So without access to rehydration methods, nasogastric tubes, intravenous [fluids] if needed – without basic medical care that you would take for granted anywhere else – the children have a very high risk of severe disease and death, which we're seeing in the data," explains Lewis.

"Our responsibility, as a global community, is to support and accompany the DRC in their actions," she says.

"I will remind everyone that in two and a half, three years of mpox response, there hasn't been a single penny of donor money invested at a global level for controlling mpox," adds Dr. Michael Ryan, executive director of the WHO's Health Emergencies Programme. "So while the concerns of the world are very well known, I don't see the concerns of the world reflected in the investment of resources needed to actually contain this virus."

Copyright 2024 NPR. To see more, visit https://www.Npr.Org.

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