The cold realities of the malaria vaccine – Politico

ROLLING OUT THE ‘HISTORIC’ MALARIA VACCINE — The first malaria vaccine will likely not reach children at risk of dying from the disease in the next year.

Euphoria over having a vaccine that would prevent kids under age 2 from ending up in hospitals with severe symptoms — even if that’s only in 30 percent of cases — is giving way to the cold realities of rolling out shots to scores of mostly poor countries in sub-Saharan Africa.

Covid-19 vaccines were in people’s arms days after endorsement from regulators in rich countries, but the RTS,S four-dose shot against malaria faces a much longer, winding road ahead.

It could take up to a year for a country to be ready to introduce a new vaccine because of issues ranging from regulatory approvals and guidance for use to rollout creation and implementation. The response to the pandemic can make that timeline longer, said Deepali Patel, senior program manager for policy at Gavi.

The shot is aimed at the most deadly type of malaria. Work will continue on immunization and treatments for other variants, said Carlos Espinal, director of the Global Health Consortium at Florida International University’s public health school. Still, the vaccine “is a great achievement,” he told Joanne Kenen, Global Pulse contributor and Commonwealth writer-in-residence at Johns Hopkins School of Public Health. One challenge will be to integrate malaria shots into the routine childhood immunization schedule.

The 40 or so countries in sub-Saharan Africa with the highest burden of the deadliest malaria must first decide whether they want to invest in the vaccine, based on their own case numbers and financial resources.

Gavi, which works to ensure access to vaccines, is building an investment case for the malaria shot. It plans to present it in December to its board, which will decide whether it should procure the vaccine for the world’s poorest countries. As it does for other pediatric vaccines, Gavi would pay part of the cost and countries would cover a share based on their gross national income.

It’s not yet clear how much RTS,S will cost, but the models for cost-effectiveness put it at $2 to $10 per dose, Patel said.

“Initial introduction is always quite expensive, and part of our role here is to shape the market in the future, where there might be others who come into this space,” said Marta Tufet Bayona, Gavi’s head of policy.

And supply will be tight at the beginning.

GlaxoSmithKline has committed to producing up to 15 million doses a year, which will probably take a few years to be used, according to Patel. Scaling up production might happen in 2029 when Indian drugmaker Bharat Biotech will start producing the antigen for the vaccine, based on a deal with GSK.

But organizations like Gavi, donor countries and nations with endemic malaria must invest in production and ensure the shots are accessible in terms of costs and delivery, said Abdourahmane Diallo, CEO of the RBM Partnership to End Malaria. Other tools to fight malaria, such as insecticide-treated nets and drugs, will still be necessary, but they aren’t available everywhere they’re needed, he said.

“Prior to the [vaccine] announcement, from the 2019 data, we know there is about a $2.6 billion gap a year” for malaria-prevention tools, he said. “The potential of having the same problem will persist with the vaccine.”

WELCOME BACK TO GLOBAL PULSE, which turns one tomorrow. The pandemic upended the global health order, which remains unsettled a year after our “A world without America” inaugural edition. A new administration brought the U.S. back to the World Health Organization, and America now donates the highest number of vaccine doses to poorer nations. But mistrust lurks as many African officials point to continued export restrictions that hamper vaccine supply flows and booster rollouts in the U.S. while many people go unvaccinated — particularly in Africa.

Our second year promises to be at least as interesting as the first. WHO Director-General Tedros Adhanom Ghebreyesus is seeking a second, five-year term amid the geopolitical standoff between China and the U.S. A promising treatment for Covid-19 is on the horizon, but some are concerned it will be snapped up by rich countries just like vaccines were. And tuberculosis deaths are rising amid pandemic-related disruptions.

At Global Pulse, we’re thankful to our readers. And I would like to hear more from you: What are the biggest stories you’d like to see covered? What would you like to see more, or less, of in Global Pulse? Drop me an email at [email protected], and we’ll share some of your answers in future editions.

Global Pulse is a team effort. Thanks to my colleagues Joanne Kenen and Ashleigh Furlong and my editors Eli Reyes and Barbara Van Tine. Follow me on Twitter: @carmenpaun.

AFGHANISTAN TO RESTART POLIO VACCINATION — Much of Afghanistan’s beleaguered health care system is now crumbling as international money dried up after the Taliban takeover. But there’s also some good news: A new polio vaccination campaign to reach 10 million children across the country will start next month. The effort includes more than 3 million children in areas the Taliban ruled before it took control of the country and where door-to-door vaccination wasn’t allowed over security concerns.

With only one case of wild poliovirus reported in Afghanistan this year, “there’s a real opportunity right now to finally eradicate wild poliovirus, and it’s ours to lose,” said Hamid Jafari, the WHO director of polio eradication in the region. Here’s more from our conversation, which is edited for length and clarity:

How did you convince the Taliban to start this vaccination campaign?

The Taliban has never been opposed to polio vaccination.

The ban they have put in place in the areas they were controlling previously was purely from a security calculus, because they were concerned about a large number of people moving house to house.

There’s a new team now in the ministry of health, and we discussed with them the importance of polio vaccination. We don’t want to miss this opportunity and create another resurgence of polio. I think they understood the urgency.

Their main concern was the sustainability of their basic health service, which has been in crisis since the World Bank, USAID and the European Union suspended their funding.

The U.N. central emergency relief fund has been brought into play. That allows the basic health services to continue through January. So [the Taliban] have given full support for a nationwide house-to-house vaccination campaign.

How will this campaign work in practice, especially with women polio workers?

The program strategy is to engage as many women as possible because they have greater trust and more access inside households to women and babies.

We have to make an extra effort now to get to the 3.3 million children where we didn’t have access for household vaccination, and we have to re-engage the system, the front-line workers and mobilize and engage the communities, because they’re not used to seeing people coming house to house with vaccines for some time.

One of our major discussions with the Taliban authorities has been particularly in support in three areas.

First and foremost is the safety and security of all our workers.

Second is the mobilization of their new health leadership in provinces and political leadership … to support the campaign.

And the third: We asked the Taliban leadership to use their channels of communications … to assure the community and to encourage them to participate in this campaign.

The active vaccine delivery is about five days.

Are the polio workers paid?

They are paid. This is also a significant consideration when there is such an economic crisis in the country.

The money comes from the Global Polio Eradication Initiative.

LIABILITY SLOWING DOWN EU VACCINE DONATIONS — The European Union has shipped 56 million doses to poor countries, a quarter of what it promised to send by year’s end. Liability exposure to the vaccines donated by EU countries has slowed down delivery, people with knowledge of the negotiations told POLITICO’s Hans von der Burchard and Ashleigh Furlong. Before an EU country donates doses to the global vaccine equity effort COVAX, liability must be transferred to the recipient country.

But donating countries are still concerned about being on the hook, with a Finnish diplomat saying the legal and administrative agreements need to get a lot of attention “so that no surprises come up later.”

The solution, according to a German official: Increase pressure on pharma to be more flexible with donation and resale of the doses they sold to EU countries. “It is unacceptable that manufacturers dictate minimum sales prices, impose exaggerated compensation schemes on recipients, reject swap procedures or prohibit distribution to international organizations,” Thomas Steffen, state secretary at the German health ministry, wrote in a letter to the European Commission seen by POLITICO.

A $10 COVID PILL? — The global effort to provide poor countries equitable access to Covid-19 vaccines, drugs and treatments is expecting to pay $10 a course for new antivirals, such as Merck’s investigational pill molnupiravir, Reuters reported. That’s much less than the $700 a course the U.S. is paying. The price is meant to help poor countries access the promising treatment, which has instigated a global purchasing race.

Meanwhile, the Bill and Melinda Gates Foundation Wednesday pledged up to $120 million toward developing generic versions to make it affordable to poor countries.

But getting the pill to countries isn’t enough. People infected with the virus would need to take the drug within five days of symptoms to cut their risk of hospitalization and death. That requires quick and affordable testing, Joanne writes, which remains limited in many places. As a result, only one in seven infections are detected in Africa, the WHO said last week.

VACCINE PASSPORTS, BUT NOT FOR THE U.S. — The U.S. rules allowing fully vaccinated international travelers into the country as of Nov. 8 will leave many people out, including Argentina and France’s presidents.

Those who received shots not approved by the Food and Drug Administration or the WHO are not considered vaccinated. That’s the case for Argentina’s President Alberto Fernández, who got immunized with Sputnik V, not yet endorsed by the WHO.

The U.S. will also not consider as fully vaccinated people who only got one shot of a two-dose vaccine after recovering from Covid-19, as did French President Emmanuel Macron.

POLITICO: Novavax sought to reassure that its vaccine will be ready for global use this year after a POLITICO report on manufacturing problems that could jeopardize deliveries.

New York Times: Tuberculosis, like Covid, spreads by breathing, scientists report.

Health Policy Watch: WHO will spend $15 million to prevent sexual exploitation and abuse after the scandal of the Ebola response in the Democratic Republic of the Congo

The Washington Post: In Russia, experts are challenging official pandemic figures as too low. They refuse to be silenced.

Reuters: India’s vaccination campaign has slowed despite amassing record vaccine stockpiles as authorities maintain a wider-than-usual gap between doses.