Posts on Jan 1970

Opinion: A Call to Boost African Manufacturing for COVID-19 and Other Vaccines

As governments begin to issue the first emergency use authorizations to deploy a COVID-19 vaccine, the world is facing the stark reality that the need for these vaccines far outstrips global production capacity.

An estimated 14 billion doses of vaccine would be needed to stop the pandemic. Governments of high- and middle-income countries have already made deals with the leading vaccine manufacturers to reserve at least 6.8 billion doses, leading to a situation where lower-income countries may be waiting until 2023 or 2024 before gaining widespread access to COVID-19 vaccines.

Funding to purchase COVID-19 vaccines in low- and middle-income countries is beginning to amass through the COVAX Facility and other mechanisms. More will be needed. However, even if the money materializes, there are insufficient vaccine doses available for purchase and significant infrastructure and logistical challenges.

To compound matters, without a stable supply, opportunities for substandard and falsified vaccines to enter the supply-chain may increase, diminishing trust in vaccines and health systems.

In the face of this global shortfall, calls to scale up vaccine production capacity in Africa are growing louder. While not a panacea for filling the COVID-19 vaccine production gap in the immediate term, bolstering capacity in Africa to conduct key aspects of the manufacturing process, namely, formulation, filling, and packaging for COVID-19 vaccines will help facilitate access.

Developing the fledgling industry will also help countries prepare for greater self-sufficiency in meeting their growing vaccine needs and prevent future vaccine access crises when the next pandemic hits.

The role of regional manufacturing in Africa

In recent years, a concerted effort to build up local pharmaceutical manufacturing capacity in Africa has begun to pay dividends, paving the way for the nascent vaccine industry. Manufacturers in Nigeria, Ethiopia, South Africa, Egypt, and elsewhere are becoming major producers of priority medicines for their countries and regions.

A concerted, decades-long effort by USP, the United States Agency for International Development, and others to bolster the quality assurance systems of pharmaceutical manufacturers in LMICs toward achieving international quality standards has made many products more competitive.

Although 70%-90% of pharmaceuticals used in Africa are still imported, local manufacturing sectors are poised with latent capacity, and bolstering local production is being urgently prioritized in the face of COVID-19 related shortages.

On the other hand, vaccine production in Africa has largely failed to launch. African vaccine manufacturers currently produce less than 1% of the vaccines that are used across the continent. Many manufacturers ceased production over the last 25 years due to inability to compete with imported vaccines.

As of 2017, there were eight vaccine manufacturers in Africa, only two of which were performing all aspects of the vaccine manufacturing process from active ingredient production through packaging.

COVID-19 as a stimulus for expansion

The COVID-19 pandemic has the potential to tip the scales in favor of accelerating local vaccine production in Africa. Major barriers — including a fragmented vaccine market, high cost and complexity of manufacturing, and absence of political will to invest — are no longer insurmountable with the pooled procurement mechanisms, capital investments, and urgent political mandate brought on by the pandemic.

Building on current vaccine production capacity for the last steps of vaccine manufacturing — including fill and finish in countries like Senegal, Egypt, Tunisia, Ethiopia, and South Africa — may provide an opportunity for stepwise integration of vaccine production capacity on the continent.

Recent technology transfers by major vaccine developers are providing a stepping stone to address current and future threats like COVID-19. For example, Biovac of South Africa has begun producing the six-in-one vaccine Hexaxim — given to children to prevent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type b — for the South African market and will begin production of Pneumovax — which prevents pneumococcal disease — as soon as next year.

One major COVID-19 vaccine developer has already struck the first deal with South Africa’s Aspen Pharmacare to perform the final steps of COVID-19 vaccine manufacturing on the continent.

In addition, the Africa Centres for Disease Control has identified and is working with eight companies in Africa that may be able to help manufacture COVID-19 vaccines, particularly if booster shots are needed on an ongoing basis. These companies could serve as sites for future vaccine production across Africa.

Ingredients for success

Beyond the complexity of the vaccine manufacturing process itself, the prerequisite supplies, equipment, facilities, and highly specialized scientific expertise needed to make quality-assured vaccines is beyond the purview of any one company. For example, sourcing inactive ingredients, vials, and stoppers can be limiting factors.

Simultaneously, like any other business, vaccine manufacturers in Africa must be able to make a return on investment while competing with established manufacturers in countries like India, China, Indonesia, and Pakistan. Important factors include sufficient demand in the country or region, government investment policies and incentives, cost of labor and capital, availability of raw materials, and physical infrastructure.

Each of these individual barriers can be overcome, but taken as a whole, expanding vaccine manufacturing capacity in Africa requires cohesive national and regional strategies that align with national pharmaceutical and industrial policies while addressing areas of weakness and laying out incentives to attract investment.

For instance, a regional strategy for manufacturing active pharmaceutical ingredients could help support this nascent industry while avoiding fragmentation and redundancies. In addition, international procurement agencies could support sustainable access to vaccines and other health products in Africa by carving out a portion of global procurements for African manufacturers producing quality-assured health commodities.

Investing now in strengthening vaccine production capacity on the continent will set countries up for success as they prepare to graduate from receiving foreign assistance.

Quality is paramount

Access to poor-quality vaccines is worse than no access. The goal of local manufacturing must be to ensure quality, protect patients, and foster trust in vaccine safety.

Therefore, quality assurance is an essential ingredient to make vaccine production sustainable. Very few national regulatory authorities in Africa have achieved the level of maturity required to enable the production of quality-assured vaccines in their countries. However, there are feasible steps regulators can take to expedite access to COVID-19 vaccines.

Additionally, efforts to pool expertise and streamline regulatory oversight of vaccines on the continent are moving forward through the African Vaccine Regulatory Forum. For their part, local vaccine manufacturers should work with partners — like Africa CDC, the Developing Countries Vaccine Manufacturers Network, the African Vaccine Manufacturing Initiative, the Federation of African Pharmaceutical Manufacturers Associations, and USP — to strengthen their quality management systems toward attaining international standards.

Boosting pandemic preparedness

Gavi CEO Seth Berkley projected that COVID-19 vaccines “will be the single largest and most rapid global vaccine deployment we have ever seen.”

By harnessing the strong political will and investment behind COVID-19 vaccines to advance regional vaccine manufacturing in Africa, we have the opportunity to facilitate greater access in the immediate term and prepare for future vaccine needs for both routine immunization programs and unexpected health emergencies.

About the authors

Perrer Tosso
Dr. Perrer Tosso is a scientist and thought leader with over a decade of experience in drug discovery and drug development. He is currently the senior manager of advanced manufacturing technologies at USP. Tosso has worked with governments and public health organizations to enable manufacturing in low- and middle-income countries to increase access to affordable, safe, quality-assured, life-saving medical products. He holds a Ph.D. in medicinal chemistry from Georgetown University.

Skhumbuzo Ngozwana
Dr. Skhumbuzo Ngozwana is CEO of Kiara Health and chairman of the board of Biovac, a South African vaccine manufacturer and a board member of the Federation of African Pharmaceutical Manufacturers Association. A tireless advocate for local biopharmaceutical manufacturing in Africa, he has worked with several global public health organizations. He has consulted for the World Health Organization, the United Nations Industrial Development Organization, and USP.

While First COVID-19 Vaccines Arrive, Much of the World Will Have to Wait

While the first shots against COVID-19 are rolling out in the United States, Britain and Canada, nearly a quarter of the world’s population likely will not have access to a vaccine until at least 2022, according to a new study.

Even in a best-case scenario, the world does not have the manufacturing capacity to cover the entire global population.

Wealthier countries made deals to buy the bulk of vaccine doses before the shots have even finished testing or received regulatory approval.

Meanwhile, a partnership aimed at securing vaccines for low- and middle-income countries has so far reserved only a fraction of the doses it has promised to deliver.

“Many governments in the poorest parts of the world are very, very concerned about the significant lag of when these vaccines are hitting these wealthy countries … and when they’ll actually be in developing countries,” said Kate Elder, senior vaccines policy adviser at the nonprofit Doctors Without Borders, who was not part of the study.

First arrivals

Last week, pharmaceutical and biotech partners Pfizer and BioNTech began delivering their COVID-19 vaccine in Britain. The first patients in the United States and Canada received their shots on Monday.

A second vaccine from biotech firm Moderna is expected to receive U.S. Food and Drug Administration authorization this week.

The World Health Organization is reviewing these vaccines, along with a third from pharmaceutical company AstraZeneca and Oxford University.

While these and other vaccines were still in clinical trials, countries committed billions of dollars to secure hundreds of millions of doses for their residents.

According to the new study, 13 manufacturers have signed preorder deals for nearly 7.5 million vaccine doses. Just over half of those preorders are from high-income countries, though they account for less than 14% of the world’s population.

Canada has secured enough vaccines to immunize its population nearly five times over, while the United States has reserved just over one vaccine course per person. Brazil and Indonesia have not ordered enough to fully immunize even half their populations.

Uncertainty

According to the study, the leading vaccine manufacturers have said they will have the combined capacity to produce enough vaccines to immunize 6 billion people by the end of 2021.

That means in a best-case scenario, in which every vaccine candidate works and there are no financing shortfalls or manufacturing glitches, supplies would be more than 1.6 billion courses short.

While most of the world’s manufacturing capacity will be tied up with preorders next year, up to 40% may still be available for low- and middle-income countries that have not reserved doses, the study says.

However, some of the countries that preordered vaccines have the option to buy more. Because the details of the deals are not public, it is not clear whether those countries would get priority.

“What these agreements between vaccine manufacturers and countries really entail is the uncertainty factor that makes many (other) countries wonder whether or not they will be at the front of the line or the back of the line,” said study co-author Anthony So, director of the Johns Hopkins University Innovation+Design Enabling Access (IDEA) Initiative.

With low- and middle-income countries at risk of being left out, WHO helped put together a system, called COVAX, to ensure more equitable COVID-19 vaccine access.

Countries put money into COVAX to support development of several vaccines at once. Since some are likely to fail, backing more than one raises the odds that a country will have access to at least one successful vaccine.

COVAX members get access to enough vaccines for up to 20% of their populations. The organization aims to deliver 2 billion doses by the end of 2021.

At least 184 countries have joined COVAX, including 92 donor-funded, low- and middle- income countries.

Not included

The Pfizer and Moderna vaccines are not part of COVAX.

Some middle-income countries are signing bilateral agreements for these shots outside COVAX, “but this is all done through untransparent backdoor deals,” said Elder, of Doctors Without Borders.

As for when these vaccines might arrive in the rest of the world, she added, “I think a lot of us are scratching our heads.”

Of the 13 manufacturers that have signed preorder deals, COVAX has agreements with three. That includes 300 million doses from AstraZeneca and 200 million from Novavax, which has a product in late-stage clinical trials.

COVAX also committed to buy 200 million doses of a vaccine from drugmaker-collaborators Sanofi and GSK.

That vaccine suffered a setback Friday, when early data showed it fell short in older adults.

Sanofi and GSK said they are continuing their studies with a reformulated vaccine.

COVID-19 to Add as Many as 150 Million Extreme Poor by 2021 – World Bank Group

Eight out of 10 ‘new poor’ will be in middle-income countries

WASHINGTON, Oct. 7, 2020 — Global extreme poverty is expected to rise in 2020 for the first time in over 20 years as the disruption of the COVID-19 pandemic compounds the forces of conflict and climate change, which were already slowing poverty reduction progress, the World Bank said today.

The COVID-19 pandemic is estimated to push an additional 88 million to 115 million people into extreme poverty this year, with the total rising to as many as 150 million by 2021, depending on the severity of the economic contraction. Extreme poverty, defined as living on less than $1.90 a day, is likely to affect between 9.1% and 9.4% of the world’s population in 2020, according to the biennial Poverty and Shared Prosperity Report. This would represent a regression to the rate of 9.2% in 2017. Had the pandemic not convulsed the globe, the poverty rate was expected to drop to 7.9% in 2020.

“The pandemic and global recession may cause over 1.4% of the world’s population to fall into extreme poverty,” said World Bank Group President David Malpass. “In order to reverse this serious setback to development progress and poverty reduction, countries will need to prepare for a different economy post-COVID, by allowing capital, labor, skills, and innovation to move into new businesses and sectors. World Bank Group support—across IBRD, IDA, IFC and MIGA—will help developing countries resume growth and respond to the health, social, and economic impacts of COVID-19 as they work toward a sustainable and inclusive recovery.”

The report also finds that many of the new poor will be in countries that already have high poverty rates. A number of middle-income countries will see significant numbers of people slip below the extreme poverty line. About 82% of the total will be in middle-income countries, the report estimates.

The convergence of the COVID-19 pandemic with the pressures of conflict and climate change will put the goal of ending poverty by 2030 beyond reach without swift, significant and substantial policy action, the World Bank said. By 2030, the global poverty rate could be about 7%.

Increasing numbers of urban dwellers are expected to fall into extreme poverty, which has traditionally affected people in rural areas.

Progress was slowing even before the COVID-19 crisis. New global poverty data for 2017 show that 52 million people rose out of poverty between 2015 and 2017. Yet despite this progress, the rate of reduction slowed to less than half a percentage point per year between 2015 and 2017. Global poverty had dropped at the rate of around 1 percentage point per year between 1990 and 2015.

In addition to the $1.90-per-day international poverty line, the World Bank measures poverty lines of $3.20 and $5.50, reflecting national poverty lines in lower-middle-income and upper-middle-income countries. The report further measures poverty across a multidimensional spectrum that includes access to education and basic infrastructure.

While less than a tenth of the world’s population lives on less than $1.90 a day, close to a quarter of the world’s population lives below the $3.20 line and more than 40% of the world’s population – almost 3.3 billion people – live below the $5.50 line.

The COVID-19 crisis has also diminished shared prosperity – defined as the growth in the income of the poorest 40 percent of a country’s population. Average global shared prosperity is estimated to stagnate or even contract over 2019-2021 due to the reduced growth in average incomes. The deceleration in economic activity intensified by the pandemic is likely to hit the poorest people especially hard, and this could lead to even lower shared prosperity indicators in coming years.

The prospect of less inclusive growth is a clear reversal from previous trends. Shared prosperity increased in 74 of 91 economies for which data was available in the period 2012-2017, meaning that growth was inclusive and the incomes of the poorest 40 percent of the population grew. In 53 of those countries, growth benefited the poorest more than the entire population. Average global shared prosperity (growth in the incomes of the bottom 40 percent) was 2.3 percent for 2012-2017. This suggests that without policy actions, the COVID-19 crisis may trigger cycles of higher income inequality, lower social mobility among the vulnerable, and lower resilience to future shocks.

The report calls for collective action to ensure years of progress in poverty reduction are not erased, and that efforts to confront poverty caused by COVID-19 also face threats that disproportionally impact the world’s poor at the same time, particularly conflict and climate change.