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Scaling up Africa’s vaccine manufacturing easier said than done

The people and politics driving global health.
Jul 21, 2022 View in browser
 
Global Pulse

By Carmen Paun and Daniel Payne

THE BIG IDEA

HARARE, ZIMBABWE - DECEMBER 01: A nurse draws out the Sinopharm vaccine from its tube before vaccinating a patient at Parirenyatwa group of hospitals on December 01, 2021 in Harare, Zimbabwe. Zimbabwe is among the southern African countries facing travel bans after the Omicron Covid-19 variant was first reported in neighboring South Africa. Its president Emmerson Mnangagwa said all returning residents to undergo PCR testing and quarantine at their own cost even with negative PCR   test whilst the vice president urged people not to panic, and said the country's vaccination program - which has the goal of inoculating 60% of Zimbabweans by year's end - would prepare it for another wave of infections. Zimbabwe has fully inoculated around 2.8 million people since February, about 20% of its population. (Photo by Tafadzwa Ufumeli/Getty Images)

Africa faces significant challenges in building up its vaccine manufacturing infrastructure. | Tafadzwa Ufumeli/Getty Images

AFRICA'S VACCINE-MANUFACTURING CHALLENGE — Increasing vaccine manufacturing capacity in Africa is a no-brainer given the continent's limited access to Covid-19 shots during the pandemic.

Africa aims to produce 1.5 billion vaccine doses by 2040 to meet 60 percent of its needs, compared to the less than 1 percent it meets today. The Africa Centres for Disease Control and Prevention estimates that the 20-year plan will cost $30 billion.

But for that to be successful, the continent has many hills to climb.

Here are major obstacles to scaling up vaccine manufacturing in Africa, according to experts and pharma industry representatives Carmen spoke to:

Finding the right market. If they want to produce cheap, existing vaccines, African manufacturers will have to compete with Indian producers, which already manufacture in high volumes and for lower prices. African producers start at a disadvantage, with higher production prices than Indian manufacturers.

The key is to manufacture newly authorized shots, or some that are not produced elsewhere. Gavi, the vaccine alliance, said it needs more manufacturers for shots against measles; measles and rubella combined; cholera and malaria.

African producers would also have a bigger market if they produce vaccines for adults instead of only for children, said Thomas Cueni, the director general of the International Federation of Pharmaceutical Manufacturers and Associations.

For more on the quest for buyers of future African-made vaccines, read Carmen's deep dive .

Having strong regulators. This "is huge," said Nicole Lurie, executive director of preparedness and response at the Coalition for Epidemic Preparedness and Innovations, which works in vaccine research and development against emerging infectious diseases. Regulators evaluate clinical trials, assess vaccine efficacy, safety and purity, and the manufacturer's ability to produce it at the same quality level consistently, she said.

Only four of Africa's 54 countries — Egypt, Ghana, Nigeria and Tanzania — have drug regulators deemed as stable and well-functioning by the World Health Organization.

The effort to establish an African-wide regulator is ongoing , but it will take a long time for it to be able to evaluate vaccines. And it's unclear whether all African countries will automatically adopt the evaluations of the African Medicines Agency.

Getting tech transferred . That seems promising, with at least 20 initiatives to expand manufacturing in Africa, including plans by BioNTech and Moderna to build facilities in Kenya, Rwanda, and Senegal.

Indian manufacturers are also looking to expand to Africa, starting with the Serum Institute of India , the world's largest vaccine manufacturer.

Training people locally . In Rwanda, for example, the European Union is building skills locally.

WELCOME TO GLOBAL PULSE

WELCOME BACK TO GLOBAL PULSE. Send your vacation plans — and tips — to cpaun@politico.com and dpayne@politico.com . 

Global Pulse is a team effort. Thanks to editors Eli Reyes and Barbara Van Tine . Follow us on Twitter: @_daniel_payne and @carmenpaun .

IN THE SPOTLIGHT

Doctors Without Borders teams visit residents of Bentiu IDP camp to vaccinate them against hepatitis E.

Starting in March 2022, MSF and South Sudan's Ministry of Health have jointly carried out a hepatitis E vaccination campaign in Bentiu in South Sudan's Unity State. This is the first time anywhere in the world that the only available hepatitis E vaccine (Hecolin) is being used in a mass vaccination campaign and in response to an active outbreak of hepatitis E. | Peter Caton/MSF. April 26, 2022.

FIGHTING HEP E IN CAMPS — A vaccination campaign against hepatitis E in a camp in South Sudan offers hope that there's a way to fight the disease, which can kill one in four pregnant people who get it.

For the first time, Doctors Without Borders used the only vaccine against hepatitis E to fight an outbreak of the disease in the Bentiu camp for internally displaced people in northern South Sudan.

The vaccine, Hecolin, manufactured by Innovax, was approved in 2012 in China, but has not been used to fight an outbreak before, Doctors Without Borders wrote in a Lancet Infectious Diseases letter published Wednesday.

It still doesn't have a WHO endorsement, hampering efforts to use it in fighting the disease.

"A totally neglected disease": Hepatitis E, which is transmitted through contamination of food or water with feces, causes some 20 million infections and 44,000 deaths yearly, according to Doctors Without Borders. It usually happens in places where water and sanitation are inadequate, such as displacement camps.

There's no treatment for it.

Children and pregnant people are at higher risk of severe disease or death if they contract hepatitis E.

"It's a totally neglected disease," said Iza Ciglenecki, operational research coordinator at Doctors Without Borders.

"We often actually realize that there is an outbreak just because you have a cluster of pregnant women that are dying at the same time," she said.

High uptake: The Bentiu vaccination campaign targeted some 27,000 people between the ages of 16 and 40. A majority were vaccinated in two rounds in March and April. The final dose of the three-shot vaccine will be administered in October.

"We were really amazed about the acceptance," Ciglenecki said. "People really knew the disease" because in this part of South Sudan there have been other hepatitis E outbreaks, she said.

What's next: Doctors Without Borders hopes the vaccine could be used more often to fight outbreaks.

 

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THE STATE OF THE PANDEMIC

PANDEMIC 'TREATY' TO BE LEGALLY BINDING — The International Negotiating Body this week opened its second meeting to work toward an international agreement for pandemic preparedness, prevention and response — and countries have agreed it should be legally binding, POLITICO's Ashleigh Furlong reports.

Interested parties have been — and will continue through the end of the week — giving input on the current outline of goals for the agreement, trying to shape the details of the agreement.

The current outline of the agreement, first reported by POLITICO, included a focus on vaccine and treatment equity, bolstered health systems around the world and improved coordination in responding to outbreaks. That draft will be reviewed this week to set the stage for a more detailed draft.

But we're probably still a long way from an agreement. Public hearings have been rescheduled for late September, and a more concrete draft won't be ready until late in the year, officials said at the meeting Tuesday.

Until then, expect more debate about how intellectual property rights and vaccine sharing are handled and how the agreement will interact with other international pandemic tools, such as the World Bank's Financial Intermediary Fund.

A man adjusts his mask after getting his routine coronavirus test at a testing facility in Beijing, Wednesday, July 20, 2022. (AP Photo/Andy Wong)

Covid-19 cases have continued rising around the world, fueled by more transmissible variants. | AP Photo/Andy Wong

COVID CASES NEARLY DOUBLE IN SIX WEEKS — The number of reported Covid-19 cases has nearly doubled globally over the past six weeks, the WHO said Wednesday.

"More cases means we can expect to see more hospitalizations and deaths in the coming weeks," WHO Director General Tedros Adhanom Ghebreyesus told reporters.

He warned that the surge has been fueled by more contagious variants that could continue changing into "something completely new."

Even so, many countries — like the United States — have not dramatically altered their approach to the virus.

PHARMA PROMISES RESERVES FOR POORER COUNTRIES — The pharmaceutical industry proposed an agreement that would reserve some vaccines, treatments and tests for poorer countries — as long as IP rights, open trade and international procurement mechanisms are protected, POLITICO's Ashleigh Furlong writes.

The proposal to G-7 and G-20 leaders is an industry answer to calls for systemic change in the wake of vaccine inequity throughout the pandemic. It comes as some advocates have argued for the waiver of some IP protections to speed manufacturing and sharing of treatments and vaccines in a health emergency.

Some important players, such as Gavi and Indonesia, have backed the proposal, acknowledging challenges it may face. But civil society groups, such as the People's Vaccine Alliance, challenged the proposal, saying the larger system of IP protections and trade rules needed to change.

It comes amid larger debates — from the World Trade Organization to the international pandemic agreement negotiations — about how to prevent inequity in the future.

 

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GLOBAL PULSE NUMBER

$1.3 BILLION

The amount of money USAID is committing to fight hunger in the Horn of Africa amid historic food shortages.

BEYOND THE PANDEMIC

IS MONKEYPOX AN INTERNATIONAL HEALTH EMERGENCY? — The International Health Regulations Emergency Committee will meet today to discuss whether the virus qualifies as a Public Health Emergency of International Concern.

The committee met just under a month ago, concluding that the virus was not, at that point, a PHEIC. Some in the committee did not agree with that decision, and the WHO decided to reconsider it as the outbreak progressed.

Since the last meeting, the virus has continued spreading to new countries and the global number of cases has risen, though the WHO said Wednesday that some countries were seeing a decline in national cases.

Even if a PHEIC is declared, experts say the concrete effects from the decision would be questionable .

Either way, countries are stocking up on vaccines and therapeutics for growing outbreaks. The growing number of cases being reported around the world is fueling new orders for the vaccine and therapeutic to treat and prevent the spread of the virus.

The U.K. is set to get 100,000 more doses of the vaccine later this month, POLITICO's Helen Collis reported. The EU announced this week that it signed a contract for more than 50,000 more doses. And another European country inked a deal for 1.5 million doses to be delivered next year, the manufacturer announced Tuesday.

Bavarian Nordic, the maker of the vaccine, also said in a statement this week that multiple contracts with countries have been signed for more vaccines.

That's in addition to the 2.5 million doses the U.S. ordered on top of its earlier contracts — as well as the $28 million in new orders from other countries for Tecovirimat, an antiviral believed to be helpful in treating the disease.

GAVI PREPARES MALARIA VACCINE LAUNCH — Ghana, Kenya and Malawi could be among the first countries involved in the initial mass-vaccination campaign for malaria, as Gavi, the vaccine alliance, opens applications for the rollout.

Those nations have been part of the vaccine's pilot program and now can apply for the formal rollout. Other countries with moderate-to-high malaria risk can express interest in the vaccine ahead of the next application window later this year.

The rollout comes after the WHO recommended the vaccine for widespread use last year and Gavi decided to invest $155 million for the first three years of the campaign.

But the lack of financial support from the Bill and Melinda Gates Foundation for the rollout and the vaccine's limited supply and low efficacy rate could hamper a wider uptake.

WHAT WE'RE CLICKING

The Guardian : 'A bright life ahead': Botswana on path to seeing no babies born with HIV.

STAT : With monkeypox spreading globally, many experts believe the virus can't be contained.

NPR : Global health meetings can be out of reach for attendees from the global south.

 

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