COVID

Monkeypox - Applying Lessons Learned to Improve an Equitable Global Response

j.harris — Fri, 26 Aug 2022 18:57:16 +0000

Monkeypox - Applying Lessons Learned to Improve an Equitable Global Response j.harris Fri, 08/26/2022 - 18:57

Authors: Victoria Hsiung and Wenhui Mao

Since May 2022, there has been an ongoing outbreak of the disease in countries across the globe, leading the World Health Organization (WHO) to declare the outbreak a Public Health Emergency of International Concern (PHEIC). As of August 25, 2022, there have been 46,337 cases of monkeypox reported in 91 countries that have not historically reported monkeypox (CDC).

As the monkeypox outbreak continues to evolve, the situation presents an opportunity to apply key lessons from the COVID-19 pandemic to respond to this outbreak more efficiently, effectively, and equitably. The latest issue brief from the Launch and Scale Speedometer team, Monkeypox: Recent Developments in the Outbreak and Lessons from the COVID-19 Pandemic, reviews key facts and developments in the outbreak so far, highlights challenges in controlling the outbreak in global and US contexts, and gives practical recommendations, drawing on lessons from the COVID-19 pandemic. The issue brief also focuses on analysis of the monkeypox vaccine marketplace, an urgent and pressing challenge as many countries face vaccine shortages amidst rising case numbers.

Read the full issue brief here.

Monkeypox Issue Brief

monkeypox

pandemic

COVID

The ongoing global outbreak of monkeypox is poised to test public health infrastructure across the globe. Monkeypox, a viral infection in the same family as smallpox, is usually uncommon in countries outside of West and Central Africa, where the disease is endemic.

Pills To Treat COVID-19 Are Here… Sort Of

elina.urli.hodges — Tue, 08 Feb 2022 21:55:59 +0000

Pills To Treat COVID-19 Are Here… Sort Of elina.urli.hodges Tue, 02/08/2022 - 21:55

Pills To Treat COVID-19 Are Here… Sort Of

Author: Andrea Taylor

We are excited to release data on purchases of therapeutics to treat COVID-19. The latest numbers are available from the Duke Global Health Innovation Center at the Launch and Scale Speedometer project here.

Oral therapeutics for COVID-19 have been heralded as a game changer, with the first two recently coming to market from Pfizer (Paxlovid) and Merck (molnupiravir). For the past year, vaccines and social distancing measures have been our only significant tools to combat COVID19. As we try to prepare for whatever comes after the omicron variant, which caused infection and hospitalization rates to surge globally, oral therapeutics provide one more line of defense, particularly for those at most risk of bad outcomes.

It is important to note that the two oral therapeutics on the market differ significantly. Among people at high risk of severe illness or death from COVID-19, Merck’s molnupiravir demonstrated 30% efficacy at preventing severe disease, while Pfizer’s Paxlovid was 89% effective. The risks (and recommended populations) are different. Both have received conditional approval in the US and many other countries worldwide, though some countries have expressed reservations about widespread use of Merck’s product.

It is going to be a long wait

As promising as they are, these drugs are not likely to change the game for most of the world in 2022 for three reasons. First, the supply for most of this year will be very limited and nowhere near enough to meet the need. Second, much like we saw with vaccines in 2021, the initial supply from Pfizer and Merck is already locked up by wealthy countries. And finally, effective use of these tablets depends on robust diagnostic capacity and a strong test-and-treat strategy, which is not yet in place for most of the world’s countries.

Source: Launch and Scale Speedometer, Duke Global Health Innovation Center. Updated February 4, 2022

There is good news

The makers of the oral therapeutics that have made it to market so far do appear to have learned from the disastrously inequitable distribution of vaccines in 2021. Both Pfizer and Merck have partnered with the Medicines Patent Pool (MPP) to allow generic manufacturing of their COVID-19 treatments. The MPP announced last month that 27 manufacturers in 11 countries have signed agreements to produce molnupiravir. A similar announcement for generic manufacturing of Paxlovid is expected in early March.

This will (eventually) support global access by allowing the pills to be manufactured in and distributed by low- and middle-income countries (LMICs). However, it looks like it will take between 9 and 12 months before the generic manufacturers licensed through MPP begin manufacturing at scale. While fast tracking generic manufacturing for LMIC distribution through the MPP is a welcome development, it is likely to pay dividends in 2023 rather than this year.

Counterfeit concerns

In the meantime, there are serious regulatory and quality concerns with generic versions of these products making it onto shelves in LMICs now. Ads on social media boast availability of generic molnupiravir and Paxlovid in many LMICs, including Thailand, Vietnam, and Myanmar, through private sellers and health clinics. And just a week after approving the oral therapeutics from Pfizer and Merck, the Mexican government warned of counterfeit versions for sale, manufactured by companies without regulatory or import approval.

With demand likely to outstrip supply for 2022, there is a high risk of black-market sales and fake drugs. For countries with low vaccination rates, the self-administered tablets may offer the only available protection against severe disease, increasing vulnerability to fakes.

We must prepare now

We now know that oral therapeutics can effectively treat COVID-19, providing another option to protect those most at risk of serious illness or death. We are not likely to see sufficient supply until 2023 but we can use the lead time strategically to ensure the world is ready when supply is available.

This must include a renewed focus on (and funding for) diagnostic manufacturing and distribution, as well as the development of test and treat strategies that can be rolled out at the country level. The oral therapeutics are most effective if taken within a few days of infection, meaning that people at risk of severe illness need to know they are infected and have almost immediate access to the drug after a positive test.

In addition, we must develop regulatory and distribution pathways that ensure high quality products will be available everywhere. Given the unpredictable nature of this virus, we should plan for global stockpiles that can address surges when and where they occur.

We will continue to track purchases, manufacturing, and the pipeline of COVID-19 therapeutics over the coming months. Through our work in the COVID GAP initiative, we are also looking closely at the potential role of COVID-19 therapeutics and recommendations for a global roll out, and we expect to publish a report on this topic by the end of February.

As always, please email us at info@launchandscalefaster.org if you have any additional data points or corrections for our COVID-19 therapeutics or vaccine data. We would love to hear about how you are using the data and are grateful for your support in making our data as complete and accurate as possible.

COVID Research Update

Therapeutics

COVID

The G7 underwhelms, with numbers that don’t add up

elina.urli.hodges — Fri, 18 Jun 2021 19:45:07 +0000

The G7 underwhelms, with numbers that don’t add up elina.urli.hodges Fri, 06/18/2021 - 19:45

INSIGHTS

The G7 underwhelms, with numbers that don’t add up

Author: Andrea Taylor

The G7 began their much-anticipated summit last week with a target to reach 1 billion doses of Covid-19 vaccine in pledged donations for low- and middle-income countries (LMICs). The result could be described as underwhelming (as well as unclear).

To be fair, the US set a high bar early in the week, with a plan to donate 500 million Pfizer-BioNTech doses (working “with,” but not necessarily through, COVAX). It was going to be hard for any other G7 member to make a splash in the wake of that announcement. But despite starting already halfway to the 1 billion dose target, the G7 essentially stalled out without leveraging the momentum from the US:Pfizer agreement.

According to the post-summit communique, the G7 pulled together commitments for 870 million donated doses. They then added in donation pledges made earlier in the year to push the total over the 1 billion dose target. Of the 870 million doses, G7 leaders “aim to deliver” half of those in 2021.

The dose donation pledges from the G7 summit, however, were not straightforward. Details are scarce and several of the commitments appear to be recycled, rather than representing additional supply. For example, France and Germany each announced donations of 30 million doses coming out of the G20 summit in May but these totals appear to be included in the G7’s 870 million.

Our search for clear indications of new commitments turned up only a total of 648 million doses (US 500M, UK 100M, Canada 13M, France 5M, Japan 30M). It is unclear if France, Germany, and Italy made pledges in addition to the commitment they have already made through the EU bloc (for a combined total of 100 million doses in 2021), aside from 5 million mentioned by the French president. Or perhaps the 870 million includes “dose equivalents” in funding for COVAX. Without transparency, it is difficult to parse how the G7 leaders arrived at the 870 million figure and, perhaps more importantly, impossible to hold them to account.

The post-summit communique also notes, with a self-congratulatory tone, that G7 countries will export 700 million (presumably purchased) vaccine doses in 2021, with “almost half” going to non-G7 countries. So it appears that the rest of the world, still waiting for delivery of the vaccine they’ve ordered, can expect the wealthiest countries to ship out 350 million doses in 2021. Is this the best we can do?

What the world needs now

It looks likely that LMICS will reach 20% coverage by the end of 2021 and that there will be sufficient doses produced to meet global demand by the end of 2022. But due to distribution, delivery, and demand challenges, we project that it will be well into 2023 before all countries have received and distributed vaccines to more than 60% of their populations.

The gaps in vaccine access have been widening, rather than shrinking, over the past few months. This is in part due to the export restrictions from India, which devastated COVAX 2021 supply. But it is also due to the rapid rates of vaccination in high-income countries, as several are extending vaccination to adolescents and teenagers, while countries across Africa are still waiting for doses to cover their healthcare workers.

As the US, EU, and UK begin to meet domestic demand over the next few months, we expect to see significant increases in exports and vaccine donations from these countries. This will help to make up for some of the COVAX supply shortfall and will help LMICs make a dent in vaccinating their priority populations.

But a vague promise of 870 million doses is not enough and this lackluster response will allow space and time for new variants to emerge. Immediate delivery of vaccine doses is needed to curb a crisis in countries in Latin America, Africa, and many parts of Asia. This must include donations but also expedited delivery of the purchases these countries have made.

Note: As donations will become an increasingly important part of reaching vaccine equity, we are building out new data and visualizations on vaccine donations, which we hope to launch next week.

INTERESTING TRENDS

Significant updates, news, and trends we saw last week:

We removed a deal in our vaccine procurement data this week for Taiwan of Pfizer-BioNTech vaccine, which fell through earlier this year. Thanks to the user of our website who alerted us to this change. Please do help us keep this data accurate and up-to-date and get in touch to let us know how you are using the data.

It was a great week for Novavax, which released positive findings from the Phase 3 trial of their Covid-19 protein subunit vaccine, with 90.4% efficacy overall.

Curevac had a worse week, reporting disappointing interim results from the Phase 2/3 trial of their Covid-19 mRNA vaccine, with 47% efficacy.

Hundreds of healthcare workers in Indonesia, vaccinated with Sinovac, have contracted Covid-19, and dozens of them have been hospitalized, raising concerns about the vaccine’s efficacy as the country reported its highest rate of infections in five months.

Wealthy countries, with plenty of vaccine and not enough takers, are getting creative with incentives for getting vaccinated. Washington State (in the US) is offering marijuana joints, while the Netherlands is offering herring.

The US FDA this week approved a batch of approximately 14 million doses of Janssen (J&J) vaccine produced at the Emergent plant in Baltimore after approving 10 million doses last week. However, another 60 million doses must be thrown away (in addition to the 15 million doses that were discarded earlier this year). The FDA is still assessing millions more doses of both Oxford-AstraZeneca and J&J produced at Emergent.

For more information on our research on Covid-19 vaccine supply, please see https://launchandscalefaster.org/COVID-19.

Weekly COVID Vaccine Research Update

COVID

High-income country confirmed dose total:	6 billion
Upper-middle-income country total:	2.2 billion
Lower-middle-income country total:	1.8 billion
Low-income country total:	271 million
COVAX total:	2.4 billion
Total worldwide confirmed purchases of Covid-19 vaccines:	12.7 billion doses

COVID-19 vaccines are flowing into the private sector. What does this mean for equity?

j.harris — Tue, 09 Mar 2021 04:46:06 +0000

COVID-19 vaccines are flowing into the private sector. What does this mean for equity? j.harris Tue, 03/09/2021 - 04:46

Weekly Insights and Interesting Trends

COVID-19 vaccines are flowing into the private sector. What does this mean for equity?

While the vast majority of Covid-19 purchases have been through the public sector, we have also seen some private sector deals. This appears to be increasing recently, as governments are partnering with private sector health providers to widen the reach of their vaccine rollouts.

Back in 2020, the Russian Direct Investment Fund (RDIF) was selling Sputnik V to private companies and setting up private distributers in countries including Egypt, India, and Mexico. At the time, there was very little private sector involvement with any other vaccine and most developers pledged that they would work only with governments during the pandemic.

We are seeing an uptick of private sector involvement now, often at the invitation of governments, as countries struggle to ensure both supply and distribution. This makes sense particularly in countries where a large proportion of health care is provided in the private sector. Private sector involvement is a wide tent, however, and there are at least three key variables:

Who purchases the vaccine – private company or government?
Who pays for the vaccine – purchaser or end user? and
Who decides the priority groups and schedule for recipients?

The third variable holds the most risk of inequity at the country level.

For example, private companies could deliver government-purchased vaccine following the government’s priority schedule. This is a pragmatic move, leveraging all available health care providers and locations and is happening in many countries, both rich and poor, as vaccines are rolled out through local pharmacies and private care providers.

Or private companies could purchase their own vaccine and provide it to end users willing to pay. Where vaccines are sold directly to the public through private sector pharmacy chains or provided by employers, it can reduce the cost burden for governments that have not been able yet to purchase enough vaccine for their population. This may be on balance a positive trend in countries such as India, that have wide income disparity, where a large wealthy population can (and will) pay for a vaccine, ensuring that limited government funds support those in most need.

As in the case of India and Indonesia, private employers could purchase the vaccine and provide it to their employees free of charge. (In Indonesia, these doses must be acquired through the government and also be separate from the doses intended for the public sector campaign.) In the Philippines, more than 30 companies came together to purchase vaccine doses and promised to donate half to the government, while using half to cover their employees.

All of these options can relieve pressure on overburdened public health systems. But if people willing to pay are able to get vaccinated ahead of the priority schedule set by the government, countries risk creating a two-track vaccine rollout. Rich people will be vaccinated before poor people and may have access to different vaccines. It may also drive up prices for vaccines as a commercial product, tempt manufacturers to prioritize higher-paying private sector purchasers, and lead to an increase in fraud and black market activity.

While there is a critical and positive role for the private sector in the equitable distribution of vaccines at the national level in many countries, the key risk is when these companies work outside of the government priority schedule. Vulnerable populations around the world need to receive the vaccine on the same timescale to ensure the best results for everyone; the same is true at the country level. Public health priorities should continue to guide vaccine rollout, regardless of which sector administers the doses.

Interesting Trends

Significant updates, news, and trends we saw last week:

COVAX has delivered more than 12 million doses to 21 countries over the past two weeks: Ghana, Ivory Coast, South Korea, Nigeria, Angola, Cambodia, Democratic Republic of the Congo, the Gambia, Rwanda, Kenya, Senegal, Lesotho, Sudan, the Philippines, Indonesia, Fiji, Moldova, Uganda, Mali, Malawi, and Afghanistan. COVAX also this week published projected allocations by country through May.

Bharat Biotech released interim Phase 3 results, demonstrating 81% efficacy.

Sinovac’s vaccine (Coronavac) demonstrated 83% efficacy in phase 3 trials in Turkey. This data release follows phase 3 data announcements from Sinopharm (Wuhan) and CanSino last week.

Good news in real world data from the UK suggesting that the first dose of the Pfizer-BioNTech and Oxford-AstraZeneca vaccines prevents symptomatic cases among the elderly.

The European Medicines Agency has begun a rolling review of the Sputnik V vaccine. The vaccine has racked up a slate of approvals recently, including in Democratic Republic of the Congo, Iraq, and Sri Lanka.

Novartis will manufacture drug substance for CureVac’s mRNA vaccine in their Austrian facility. Novartis is also helping to produce the Pfizer-BioNTech vaccine in their Switzerland facility.

Merck will partner with J&J to produce the Janssen vaccine in the US.

Canada approved the Janssen (J&J) vaccine but may not receive its ordered doses before September.

The US government projects it will have enough doses in hand by May to cover the adult population.

France and Germany have only distributed a fraction of their Oxford-AstraZeneca doses. Meanwhile, the EU is offering an additional 100,000 vaccine doses each to Austria, Czech Republic, and Slovakia to combat rising Covid-19 cases. Italy and Germany are following in France and Spain’s footsteps, hoping to conserve vaccine by giving only a single dose to people confirmed to have already had Covid-19.

Italy invoked the EU export controls to block shipment of 250,000 doses of the Oxford-AstraZeneca vaccine to Australia, highlighting the vulnerability of global supply contracts. Australia is domestically manufacturing the vast majority of its Oxford-AstraZeneca order, however, so the export block is more of a diplomatic than supply issue.

On the topic of export controls, the CEO of the Serum Institute of India said this week that US export controls on raw materials such as bags and filters are a limiting factor for global manufacture of Covid-19 vaccines.

Pfizer’s opaque distribution strategy is motivated by order size, timing of deal, relationship between country and company leaders, data sharing agreements, and profit opportunity according to in-depth article in Bloomberg this week.

Chile donated 20,000 doses to Ecuador in one of the first donations we’ve seen among Latin American countries.

For more information on our research on Covid-19 vaccine supply, please see https://launchandscalefaster.org/COVID-19.

Weekly COVID Vaccine Research Update

Data Updates

High-income country confirmed dose total:	4.6 billion
Upper-middle-income country total:	1.3 billion
Lower-middle-income country total:	608 million
Low-income country total:	670 million
COVAX total:	1.12 billion
Total worldwide confirmed purchases of Covid-19 vaccines:	8.3 billion doses*

*Change from March 9, 2021 reported total of 14.7 billion, which included potential dose purchases

Today, we celebrate: This week's good news for global equity

j.harris — Tue, 02 Mar 2021 00:35:58 +0000

Today, we celebrate: This week's good news for global equity j.harris Tue, 03/02/2021 - 00:35

Weekly Insights and Interesting Trends

Today, we celebrate: This week’s good news for global equity

There were two significant developments this week that are great news for Covid-19 vaccine equity. To be clear, the picture is still bleak: rich countries hold more than half of the vaccine purchased and don’t want to share until they’ve had their fill. More than 100 countries have not administered their first vaccinations, even while coverage passed 90% in Israel, 60% in the UAE, and 30% in the UK. But there are also things worth celebrating.

The first COVAX delivery landed in Accra, Ghana this past week, with 600,000 doses of the Oxford-AstraZeneca vaccine from the Serum Institute of India. This was quickly followed by a COVAX delivery of 500,000 doses in Abidjan, Ivory Coast. Together, these deliveries can cover 550,000 people. Outside of Morocco (which launched an enviable immunization campaign this past month), only 260,000 people across the entire continent of Africa have received a vaccine (this is roughly 6 in 100,000 people). (According to Our World in Data, which is tracking vaccination rates around the world, updated daily.) In this context, delivery of 1.1 million doses is a significant event, and worthy of taking a moment to cheer.

COVAX has notably gotten off to a slow start, taking longer to secure deals than many of the countries that funded it. The COVAX collaboration prioritized value, while countries like the US and UK prioritized speed. COVAX’s slow and steady approach to building supply chains (through investment in R&D and manufacturing contracts) and closing purchase deals may start to pay off now as they begin shipping millions of doses around the world. We are still not confident in their supply projections for 2021 (which depend on exercising 900 million optioned doses from Serum Institute), but the arrival of the first shipment is cause for celebration and helps build momentum in a positive direction. COVAX expects to deliver another 11 million doses this coming week.

In other good news, the Janssen (J&J) vaccine received emergency use authorization in the US this weekend and will be rolled out immediately, with 20 million doses being delivered to the US this month. The vaccine is under rolling review in several more countries and, importantly, the company has filed for emergency use listing (EUL) with the WHO, required for COVAX distribution. Janssen has committed (through a memorandum of understanding) 200 million doses to COVAX in 2021, with 300 million more to follow in 2022.

As the first single-shot Covid-19 vaccine to hit the market, Janssen’s vaccine is a game changer for vaccine implementation. Like Oxford-AstraZeneca, the Janssen vaccine can be stored for up to three months at standard refrigeration temperatures but, at one dose per person, only needs half the hours from providers to administer. This will be welcome news in countries with care provider shortages (much of the world) and with large rural and remote populations. Halving the number of injections needed to reach last-mile populations is no small thing.

If there were one vaccine we wanted to prioritize for manufacturing and distribution to LMICs, this is the one. At least until the heat-stable nasal spray vaccines make it to market and change the game again.

Interesting Trends
Significant updates, news, and trends we saw last week:

The first COVAX deliveries landed in Ghana and Ivory Coast this week. Both countries launched their vaccination campaigns today (March 1).

The Janssen/J&J single-dose vaccine received emergency use approval in the US on Saturday. Janssen has also filed for emergency use authorization with the EU and emergency use listing with the WHO and is under rolling review in other countries.

Vaccine purchases (across all income categories) have slowed down over the past few weeks. The rate of purchases may continue to slow, with numbers holding relatively steady, while countries wait for deliveries so that they can being to administer doses they have ordered.

Vaccine campaigns launched last week in Afghanistan, Australia, Bolivia, Gaza, Hong Kong Malaysia, Mongolia, San Marino, Senegal, South Korea, and Ukraine.

The African Export-Import Bank approved $2 billion in funds to help African countries secure vaccines.

Vaccine scandals continue to unfold in Latin America. Following resignations of government officials in Peru and Argentina last month, Ecuador’s Health Minister has resigned after admitting that he helped his mother and others jump the queue. Nurses in Brazil have been accused of injecting people with empty syringes and embezzling the vaccine.

Sinopharm released Phase 3 data for their Wuhan-developed vaccine, reporting 72.5% efficacy, and have applied for authorization for general use in China (their Beijing-developed vaccine is already approved and being administered in China and other countries).

CanSino also released early analysis of Phase 3 data, reporting 65% efficacy, and applied for general use authorization in China (CanSino’s vaccine is already approved for use in the Chinese military and has received emergency use in several other countries). The vaccine is a single-shot vaccine that can be stored at standard refrigeration temperatures, though CanSino is also testing a double dose regime.

The FDA has approved Pfizer’s request for a change to the storage requirements for the Pfizer-BioNTech vaccine, stating that it can be kept in standard freezer up to two weeks.

For more information on our research on Covid-19 vaccine supply, please see https://launchandscalefaster.org/COVID-19.

Weekly COVID Vaccine Research Update

Data Updates

High-income country confirmed dose total:	4.6 billion
Upper-middle-income country total:	1.3 billion
Lower-middle-income country total:	597 million
Low-income country total:	670 million
COVAX total:	1.12 billion
Total worldwide confirmed purchases of Covid-19 vaccines:	8.2 billion doses

Rhetoric first, action later: the G7 approach to global equity

j.harris — Mon, 22 Feb 2021 22:46:17 +0000

Rhetoric first, action later: the G7 approach to global equity j.harris Mon, 02/22/2021 - 22:46

Weekly Insights and Interesting Trends

Rhetoric first, action later: the G7 approach to global equity

The G7 countries met (virtually) on Friday, February 19, to share variants of “no one is safe until everyone is safe” and discuss the importance of global equity of Covid-19 vaccines and the need for international cooperation. (Sound familiar? That’s because we heard the same things from the G20 in November.)

The countries together pledged another $7.5 billion in funding for COVAX (including the $4 billion that the US Congress set aside for COVAX in December’s Covid relief bill). Funding, while important, is unlikely to improve the immediate picture for global equity as manufacturers churn out millions of doses heading for the same wealthy countries.

Low- and middle-income countries need doses now. As even wealthy countries are learning, purchases on paper are not the same as doses in hand. (Canada, which purchased more doses per capita than any other country, has received very little and is behind most other rich nations in its vaccine roll-out.)

And COVAX, while important, does not solve for equity at 20% coverage. Even with COVAX, poor countries still need to purchase supply for 40% to 50% of their population in order to reach herd immunity levels. But low- and middle-income countries making purchases now will have to wait in the queue to receive delivery, while manufacturing slots for much of 2021 are already reserved.

French President Emmanuel Macron joined Norway in calling for rich countries, which have purchased far more than they need (see table below), to donate doses now, as they are still vaccinating their priority populations. Asking countries to pledge 5% of their supply immediately, Macron made the point that it is speed that counts. Seeming to miss this entirely, UK leadership suggested they would likely donate a much more generous amount but that it was “difficult to say” when. The US and Canada, as well as EU leadership, have similarly committed to donations in principle but hedged on timing.

This appears to run counter to leaders’ oft repeated belief that “no one is safe until everyone is safe.” Because of manufacturing limitations, the fastest way to ensure that countries are able to move together to vaccinate their priority populations is for rich countries to send a portion of doses as they receive them.

The G7 countries (including the EU) have already purchased enough vaccine to cover more than 2 billion people. Even after vaccinating 100% of their populations, they would still have enough vaccine left to cover a combined 1.2 billion people.

Rich countries have tied up the bulk of the supply for this year. If these countries wait to share until after their adult populations have been covered and until after they know whether or not boosters will be needed, as the UK has suggested it will do, global inequities will grow. Meanwhile, while rich countries dither, China and India have moved quickly to donate millions of doses to poor countries even while both countries face shortages for domestic supply.

Vaccine purchases by G7 countries (including EU)

Country	People covered by vaccine purchased	% population covered	Surplus (in people covered)
Canada	190,000,000	505%	152,410,738
EU	1,017,500,000	227%	569,987,959
Japan	157,000,000	124%	30,735,069
UK	243,500,000	364%	176,665,595
USA	655,000,000	200%	326,760,477
TOTAL			1,256,559,838

Note: Data accurate as of February 19, 2021. Purchase data includes only finalized purchases and does not include optioned doses.

Interesting Trends
Significant updates, news, and trends we saw last week:

The G7 countries increased their financial support to COVAX, while remaining non-committal on the timing for donations of actual doses (our take below).

Novavax and SII have signed an MOU with Gavi to supply 1.1 billion doses of the Novavax vaccine to COVAX, though delivery schedule is not provided.

Vaccine scandals in Argentina and Peru prompted the resignation of government officials, who were found to have jumped the queue for vaccinations, in some cases receiving shots before national immunization programs had even begun.

Gavi announced a global no-fault compensation program for the 92 COVAX-funded countries, offering lump sum compensation in the case of vaccine injury. Russia has offered 300 million doses of Sputnik V to the African Union, which if taken up by African countries, would bring the AU total to 970 million purchased doses.

South Africa will share its now-unwanted SII Oxford-AstraZeneca doses with the African Union, though it is unclear if this will be a donation, trade, or other arrangement.

CEO of the Serum Institute of India noted in a tweet that SII has been directed to prioritize India’s domestic supply needs with manufacture of the Oxford-AstraZeneca vaccine.

Bharat Biotech has filed for approval of their Covid-19 vaccine in more than 40 countries. The vaccine has been widely rolled out in India, though Phase III clinical data is not expected until March at the earliest.

Russia approved its third Covid-19 vaccine, CoviVac, this week before large-scale trials have even begun.

New data submitted for FDA review suggest that the Pfizer-BioNTech vaccine may remain stable when stored at standard freezer temperatures. • Oxford University is testing the Oxford-AstraZeneca vaccine in children aged 6 to 17.

Pfizer-BioNTech announced that it is working on a booster to address new variants, following similar announcements from Moderna and Oxford-AstraZeneca.

For more information on our research on Covid-19 vaccine supply, please see https://launchandscalefaster.org/COVID-19.

Weekly COVID Vaccine Research Update

COVID

Vaccines

Procurement

Data Updates

High-income country confirmed dose total:	4.6 billion
Upper-middle-income country total:	1.3 billion
Lower-middle-income country total:	631 million
Low-income country total:	671 million
COVAX total:	1.12 billion
Total worldwide confirmed purchases of Covid-19 vaccines:	8.25 billion doses

Vaccine hesitancy will soon become the primary obstacle to global immunity

rwatkins — Tue, 16 Feb 2021 01:00:00 +0000

Vaccine hesitancy will soon become the primary obstacle to global immunity rwatkins Tue, 02/16/2021 - 01:00

Weekly Insights and Interesting Trends

Vaccine hesitancy will soon become the primary obstacle to global immunity

Global manufacturing capacity has been the primary rate limiter for Covid-19 vaccinations. Our vaccine manufacturing infrastructure was not designed to produce enough doses to cover 70% of the world’s population within a year (in addition to regular and routine vaccines) and, as expected, demand is outstripping supply. There has been good news on the manufacturing front, however, with several large pharma companies recently joining with rivals to ramp up production.

At the same time, data on vaccine hesitancy suggest that it may soon overtake manufacturing capacity as the primary obstacle to global coverage and reaching herd immunity. If this is the case, we will soon find that producing enough vaccines does not translate to enough vaccinations.

Covid-19 vaccine hesitancy is growing around the world. A survey of 15 countries found that willingness to get a Covid-19 vaccine dropped in nearly all of the countries between October and December 2020. France and Russia had the lowest rates of vaccine intent in the survey, below 50%. Another survey of 32 countries found that fewer than half of the population in Lebanon, France, Croatia, and Serbia intend to get vaccinated.

In Peru, vaccine hesitancy grew by 26 percentage points (from 22% to 48%) between August and December and the population is now evenly split between those willing and those not willing to receive the vaccine. Other data indicate some countries fall much lower: in the Philippines, fewer than a third are willing to have a Covid-19 vaccine.

Even in China, a country with historically high rates of vaccine take-up, intent to get a Covid-19 vaccine dropped in late 2020 (though at 80% China was still at the top of the chart). Negative coverage of western-developed vaccines in Chinese state media appears to be fueling mistrust of even Chinese-developed Covid-19 vaccines and slowing vaccination rates.

In both the US and UK, recent studies found that hesitancy rates are highest among younger adults, racial minorities, and people with lower education and income. A similar trend was noted this week in Israel, where vaccine take-up has slowed and is particularly low among minority communities and younger populations.

There was improvement in vaccine intent among Black and LatinX populations in the US between December and January; however, these groups are still most likely to say that they will “wait and see” rather than get the vaccine as soon as possible. Experts suggest that supply may outstrip demand in the US as early as April.

Public health leaders in countries around the world have pulled every lever they can to secure vaccine doses to protect their populations. Each dose is the result of unprecedented scientific and industry cooperation, complex negotiations, and a flat-out global effort. But the race to develop, manufacture, and distribute vaccines must result in vaccinations. We need to get ahead of vaccine hesitancy now, with strong outreach campaigns, before it becomes the rate limiter.

For more on this topic, register for the Duke Global Health Institute’s (virtual) conversation with experts addressing vaccine hesitancy later this month.

Interesting Trends

Significant updates, changes, and trends we are seeing this week:

Analysis published in The Lancet provides a data-driven perspective on challenges and policy recommendations to achieve global vaccine equity. This research includes findings from a 32-country study on vaccine hesitancy (see Insights section below for more on vaccine hesitancy).

The WHO gave emergency use listing (EUL) to two versions of the Oxford-AstraZeneca vaccine, produced by SK Bioscience (South Korea) and the Serum Institute of India. This clears the way for doses to be shipped out by COVAX to countries all over the world.

WHO also launched a call to action to ensure that vaccinations of health workers and the elderly are underway in all countries around the world within the first 100 days of 2021.

Despite agreeing to support equitable access, Moderna has sold nearly all of its doses to wealthy countries and has not yet confirmed an agreement with COVAX.

Concerns about domestic supply (as well as vaccine hesitancy) are slowing vaccine rollout in China.

China and India continue to send donations of vaccines to other countries, even while in the beginning stages of their own domestic immunization campaigns.

Meanwhile, the US is on track to have extra doses by this year but says it is still too soon to discuss when and how they will share excess vaccines globally.

Thailand defends decision not to join COVAX, even as it faces internal criticism for being too slow to procure vaccines and launch a mass immunization program.

Peru government officials are resigning their posts after admitting they were vaccinated with donated Sinopharm doses before the national immunization campaign launched.

Hungary became the first EU country to approve and administer Russia’s Sputnik V vaccine and also expects to be the first EU country to administer Sinopharm, starting this week.

Israel’s Covid-19 infection data mirrors Phase III efficacy data from Pfizer-BioNTech, showing 94% drop in infections among 600,000 people who received both doses of the vaccine compared with a group of the same size and medical histories that were not vaccinated.

For more information on our research on Covid-19 vaccine supply, please see https://launchandscalefaster.org/COVID-19.

Source: bma.org.uk

Weekly COVID Vaccine Research Update

COVID

Vaccines

Data Updates

High-income country confirmed dose total:	4.6 billion
Upper-middle-income country total:	1.2 billion
Lower-middle-income country total:	599 million
Low-income country total:	670 million
COVAX total:	1.12 billion
Total worldwide confirmed purchases of Covid-19 vaccines:	8.2 billion doses

COVAX released draft allocations for the first half of 2021

rwatkins — Mon, 08 Feb 2021 13:00:00 +0000

COVAX released draft allocations for the first half of 2021 rwatkins Mon, 02/08/2021 - 13:00

Weekly Insights and Interesting Trends

COVAX released draft allocations for the first half of 2021

The COVAX partnership released last week its first estimates of dose allocations for participating countries, covering planned deliveries from February through June. These are labeled as “indicative,” meaning the estimates are non-binding and subject to a list of caveats provided in both the distribution forecast and the supply update released in January. In fact, the language surrounding both documents seems on balance to contain more hedging than forecasting.

This is largely because allocations and delivery timelines will depend on factors out of COVAX’s control, including manufacturing partners successfully meeting their targets and WHO EUL status for the vaccines. (Only the Pfizer-BioNTech vaccine so far has received EUL listing by the WHO.) The Oxford- AstraZeneca vaccine produced by the Serum Institute of India will undergo regulatory review separately from the vaccine produced by AstraZeneca. Both of these vaccines are currently under EUL review, with decisions expected in February.

Canada, New Zealand, and Singapore were the only wealthy countries to request allocations in this first COVAX delivery: Canada is estimated to receive 1.9 million doses of the Oxford-AstraZeneca vaccine, New Zealand will receive nearly 250,000, while Singapore is set to receive 288,000. As Canada and New Zealand have both made bilateral deals sufficient to cover than their populations multiple times, their COVAX requests were noted with some surprise (and criticism).

However, it is important to remember that doses on paper are not the same as doses in hand. New Zealand has purchased more than 20 million doses for its population of just under 5 million people but has yet to receive any. Canada purchased the most per capita of any country (enough to vaccinate its population 5 times) but these have been only trickling in and less than 3 percent of Canadians have been vaccinated so far. (See this Washington Post article for more of our take on this.)

For many of the recipient countries, the shipments coming through COVAX in the next few months will be their first shipment of vaccines. Even with all of the hedging and uncertainty, this is a hopefulmoment in the race for global equity. Many countries will be able to begin vaccinating their most vulnerable people with these doses.

COVAX is a critical part of the solution but we must remember that it is not the whole solution. Even if COVAX delivers 20 to 30% coverage in the next year, many countries will still not have access to enough vaccines to reach herd immunity. As immediate next steps, wealthy countries should commit to donating doses in parallel with their own vaccination campaigns, so that vulnerable populations are covered at the same time the world over. To improve local supply and distribution channels globally, rich countries and multilateral donors need to invest to increase manufacturing capacity in low- and middle-income countries.

Interesting Trends

Significant updates, changes, and trends we saw last week:

We are posting a new interactive map on our website this week that shows the percentage of population coverage by country by month, starting with the first deals in May 2020.

The Lancet published Sputnik V data from a large-scale Phase III trial in Russia demonstrating 91.6% efficacy. The vaccine recently received approval in Armenia, and emergency-use authorization in Tunisia, Mexico, Nicaragua, and Lebanon.

COVAX released initial allocations expected to be delivered in the first half of 2021, with shipments to begin in late February or March (our take on this below).

Bayer and Rentschler will help to produce CureVac’s vaccine, expected to ramp up in 2022.

Vaccine fraud is emerging all over the globe. Last week, 80 people were arrested in China, suspected of creating more than 3,000 doses of fake Covid-19 vaccine.

Pfizer-BioNTech withdrew their application for emergency authorization in India, after it seemed unlikely to be approved without locally generated data on safety and efficacy.

A pre-print study indicates that the first dose of the Oxford-AstraZeneca vaccine provides 76% efficacy and 100% protection against severe disease for 90 days.

The UK is now recruiting for a trial that will test a combination of the Pfizer-BioNTech and Oxford-AstraZeneca vaccines, potentially adding Novavax and Janssen to the mix if they are approved. AstraZeneca and RDIF are also recruiting in multiple countries for a trial testing one shot each of the Oxford-AstraZeneca and Sputnik V vaccines.

South Africa has postponed the launch of their immunization campaign, set to begin this week with the Oxford-AstraZeneca vaccine, after a trial found that it may be less effective against the South African variant. Oxford University is developing a version that targets the variant but it likely will not be available until third quarter 2021.

Sinovac released data from Phase III trials in Brazil and Turkey, which indicate 51% efficacy, with 84% protection against cases needing treatment, and 100% protection against severe disease. China has granted the vaccine conditional approval for use in the general public and Indonesia approved it for use in the elderly.

For more information on this research and our findings, please go to https://launchandscalefaster.org/COVID-19.

Weekly COVID Vaccine Research Update

COVAX

COVID

Vaccines

Data Updates

High-income country confirmed dose total:	4.2 billion
Upper-middle-income country total:	1.2 billion
Lower-middle-income country total:	582 million
Low-income country total:	670 million
COVAX total:	1.11 billion
Total worldwide confirmed purchases of Covid-19 vaccines:	7.8 billion doses

What is at Stake in EU’s Move to Control Vaccine Exports

rwatkins — Mon, 01 Feb 2021 13:00:00 +0000

What is at Stake in EU’s Move to Control Vaccine Exports rwatkins Mon, 02/01/2021 - 13:00

Weekly Insights and Interesting Trends

What is at Stake in EU’s Move to Control Vaccine Exports

AstraZeneca recently alerted the EU that it would only be able to deliver 25% of the 80-100 million doses of Covid-19 vaccine expected this quarter, due to production problems in the European plants. The EU responded by suggesting, in the firmest of tones, that AstraZeneca divert doses from the (recently Brexited) UK manufacturing plants to fulfill the EU contract. AstraZeneca replied that would be impossible, as its UK contract stipulates that doses purchased by the UK must be delivered before their manufacturing capacity can be used for other orders. The EU, with a tone closer to furious, respectfully disagreed.

Amid this row, the EU approved the Oxford-AstraZeneca vaccine and then immediately followed this with export controls. Under the new controls, EU member states can block exports of Covid-19 vaccines if they believe that the vaccine producers are in danger of not meeting their supply contracts with the EU. (The EU appears to be targeting certain countries, including the UK, Canada, the US, and Australia, as it has exempted more than 90 other countries and COVAX from these controls.)

In essence, the EU is saying it will use its significant vaccine production capacity to serve itself first, the world second. And if vaccine producers don’t get in line, the EU will prevent them from fulfilling their global contracts.

Despite rhetoric from EU leaders over the past months about the need for “unprecedented global cooperation,” and calls to treat Covid-19 vaccines as “global public goods” rather than “bargaining chips,” we are now seeing what happens when their own supply is threatened.

To be clear, production of Covid-19 vaccines is incredibly complex, with many partners and pieces coming together. We’ve seen many vaccine developers walk back manufacturing projections over the past 4 months and we will see more production delays in the coming year.

The move by the EU reminds us that, amongst this dynamic landscape, the flow of imports and exports are subject to sovereign whims. As leaders in Australia and Japan noted this past week, the best way to secure vaccine supply is with local production. Countries and regions with limited capacity to develop or manufacture vaccines are most at risk, including most of Africa.

A new report commissioned by the International Chamber of Commerce paints the harshest picture yet of the consequences of unequal access to Covid-19 vaccines globally, modeling economic losses of US $1.5-9.2 trillion, at least half of that falling on wealthy countries. To prevent this, we need to take a global view of vaccine manufacturing, not just distribution.

As a global community, we need to invest now in manufacturing capacity on every continent and every region to ensure truly global response to future pandemics. Nationalism may be inevitable in a global crisis but we can soften the blow and prevent the worst.

More to come from us soon on the importance of manufacturing. Our team is working on new analysis of global vaccine manufacturing data, which we hope to release later this month.

Interesting Trends

Significant updates, changes, and trends we saw last week:

The EU granted emergency use approval to the Oxford-AstraZeneca vaccine for all adults. Germany, however, recommended that the vaccine only be used in adults under age 65, given the lack of data in older people.

The EU’s emergency use approval of Oxford-AstraZeneca’s vaccine was immediately followed by export controls on all Covid-19 vaccines, the latest move in their row with the vaccine developer over a manufacturing shortfall (our take on this below).

Janssen (J&J) released promising early Phase III results for their single-dose vaccine, expected to receive emergency use authorization in many countries later this month.

Australia issued full approval (not limited to emergency use) to the Pfizer-BioNTech vaccine and expects to begin vaccination in late February.

Hungary has issued emergency approval to Sputnik V, Oxford-AstraZeneca, and Sinopharm vaccines and ordered 2 million doses of Russia’s Sputnik V vaccine and 5 million doses of China’s Sinopharm. Hungary is the first EU country to order either Sputnik V or Sinopharm.

The US has exercised 100 million doses in options for both the Pfizer-BioNTech vaccine and the

Moderna vaccine, increasing its confirmed order to 300 million doses of each.

Pharmaceutical companies Sanofi and Novartis will use their own capacity to manufacture millions of doses of rival Pfizer and BioNTech’s Covid-19 vaccine to boost global supply in the short term.

Peru has granted “exceptional approval” to allow 1 million doses of Sinopharm’s vaccine to be administered in the country, as the country’s health system nears collapse.

Merk announced that it is discontinuing the development of both of its Covid-19 vaccines, after disappointing Phase I results.

Egypt and Bangladesh launched immunization campaigns this week, with Sinopharm in Egypt and SII’s Oxford-AstraZenca vaccine in Bangladesh.

South Africa has granted emergency authorization to SII’s Oxford-AstraZeneca’s vaccine as it prepares to launch a national vaccine roll out.

Israel secured expedited delivery of Pfizer-BioNTech vaccine by paying far above market value and agreeing to share patient data.

Pfizer-BioNTech have increased their manufacturing projections for 2021 but this is in part because they have decided the vials contain six doses, rather than five. They are urging countries to change the approved labeling to state that each vial is six doses and they are adjusting delivery quantity to reflect this, as the deals are based on number of doses, not number of vials. The catch is that a special type of syringe is needed to extract the six doses. Suddenly a hot commodity, the syringe is now in short supply.

African Union announced another purchase of 400 million doses of SII’s Oxford-AstraZeneca

For more information on this research and our findings, please go to https://launchandscalefaster.org/COVID-19.

Weekly COVID Vaccine Research Update

COVAX

COVID

Vaccines

Data Updates

High-income country confirmed dose total:	4.2 billion
Upper-middle-income country total:	1.2 billion
Lower-middle-income country total:	524 million
Low-income country total:	670 million
COVAX total:	1.11 billion
Total worldwide confirmed purchases of Covid-19 vaccines:	7.2 billion doses

The US formally joined COVAX. Will it Matter?

rwatkins — Mon, 25 Jan 2021 13:00:00 +0000

The US formally joined COVAX. Will it Matter? rwatkins Mon, 01/25/2021 - 13:00

Weekly Insights and Interesting Trends

The US formally joined COVAX. Will it Matter?

Dr. Anthony Fauci, newly named the US Chief Medical Advisor, warmly addressed the WHO executive board within the first 24 hours of the Biden administration. Dr. Fauci confirmed that under President Joe Biden, the US will rejoin the WHO and will also join COVAX, the global mechanism designed to ensure equitable allocation of vaccines across the world.

The value of this move may be largely symbolic at this point. The US has already ordered enough vaccine through bilateral deals to cover 200% of its population and is the largest single donor to the COVAX effort, with $4 billion allocated to Gavi last month. But the symbolism is still powerful. The US is joining a multilateral approach to a multilateral problem and putting its weight behind a cooperative effort.

Last week, Dr. Tedros, Director General of the WHO, warned that “the world is on the brink of catastrophic moral failure” as vaccine deliveries flow to high income countries while poor countries wait. Our data show that high income countries, with 16% of the world’s population, reserved 60% of the Covid-19 vaccine that has been purchased and many have ordered enough vaccine to cover their population several times over. Middle- and low-income countries, however, are clearly in trouble.

Significant gaps in vaccine access threaten everyone. Some middle-income countries have secured vaccine deals but not enough to cover their population. Many have not yet purchased any vaccine. We just saw the first purchase for low-income countries come through last week, with the African Union’s purchase of 270 million doses that will be allocated to countries across Africa.

Unequal distribution of the vaccines is dangerous for everyone. In addition to the ethical arguments, modeling of the health and economic impacts of vaccine access demonstrates that we are all much worse off if poor and rich countries do not receive the vaccine at the same time. It would cost about $25 billion USD to supply enough vaccines for lower-income countries. But it will cost high income countries about $120 billion a year in lost GDP if this is not done.

But wealthy countries face competing incentives, wanting both to ensure their populations are covered as quickly as possible and also to support global equity. Unfortunately, the first undermines the second.

In practical terms, there are two significant ways that the US and other high-income COVAX countries can help to close the gap that Dr. Tedros warns about. The first is funding. WHO needs $27 billion in 2021 to support Covid-19 tests, drugs, and vaccines. The US and other wealthy countries must continue to support global efforts to fight the pandemic.

The second is through donation of excess doses, on the same timescale as vaccination in wealthy countries. COVAX announced on Jan 22 that, in addition to 40 million doses from Pfizer-BioNTech, the multilateral partnerships will have another nearly 150 million doses of Oxford-AstraZeneca vaccine (some from SII and some directly from AZ) available to ship out this quarter. This means fewer than 200 million doses are expected to ship out across 190 COVAX countries by end of March.

To cover the gap, rich countries must donate doses to cover the most vulnerable in other countries before they have covered their general population. Norway has led on this front, stating that they will donate excess doses “in parallel” with vaccination of the Norwegian population. India and China, both middle-income countries, have also begun shipping donated doses to poor countries while still vaccinating their high-priority populations. Canada, the UK, and the EU have stated their commitment to sharing extra doses but have not said whether they will do so before finishing vaccination of their populations.

The high-income countries in COVAX, including the US, have already scooped many doses off the market, hampering efforts for efficient and equitable allocation. But these countries have an opportunity to support the COVAX goal of equitable access by redirecting extra doses to other countries now, so that all vulnerable populations can be vaccinated, preventing needless death.

Interesting Trends

Significant updates, changes, and trends we saw last week:

India and China began rolling out donations of domestically-produced vaccines, with India shipping doses of Serum Institute’s Oxford-AstraZeneca to Bhutan. They expect to follow this with donations to eight other neighboring countries. China is donating 500,000 doses of Sinopharm’s vaccine to Pakistan.

The EU proposed development of a mechanism to share excess doses with poorer countries, either through COVAX or directly. Meanwhile, Norway announced that it will donate doses in parallel with domestic vaccinations.

Brazil has requested additional data about the Sputnik V vaccine, as part of the review for emergency use approval, though the country is reportedly manufacturing doses of the vaccine in the meantime.

There was a fire in a Serum Institute factory, in which five people died. SII reports that it was a new facility, constructed to manufacture Rotavirus and BCG vaccine and will not impact the production of Covid-19 vaccine.

The US announced that it will join COVAX (our reflection on this below).

COVAX has signed an advance purchase agreement with Pfizer-BioNTech for 40 million doses and expects delivery to begin next month.

Last week saw the first vaccine purchase for Azerbaijan, which ordered 4 million doses of Sinovac’s Coronavac.

Relative vaccine newcomers Valneva and Bharat Biotech announced new deals. The EU concluded exploratory talks with Valneva, marking the second purchase for Valnelva (which has also made a deal with the UK). Bharat Biotech announced their first deals, with India and Brazil.

For more information on this research and our findings, please go to https://launchandscalefaster.org/COVID-19.

Source: Duke GHIC, Launch & Scale Speedometer

Weekly COVID Vaccine Research Update

COVAX

COVID

Vaccines

Data Updates

High-income country confirmed dose total:	4.2 billion
Upper-middle-income country total:	1.14 billion
Lower-middle-income country total:	444 million
Low-income country total:	270 million
COVAX total:	1.11 billion
Total worldwide confirmed purchases of Covid-19 vaccines:	7.2 billion doses