COVAX

How can India address a potential third wave of SARS-CV-2 infections?

j.harris — Fri, 11 Jun 2021 21:33:11 +0000

How can India address a potential third wave of SARS-CV-2 infections? j.harris Fri, 06/11/2021 - 21:33

INSIGHTS

How can India address a potential third wave of SARS-CoV-2 infections?

Author: Nikki Prattipati

Starting mid-March 2021, India has become the epicenter of COVID-19 as a second wave of infections devastated the country. India reported 50 percent of global cases and 30 percent of global COVID-19 deaths, and an alarming rate of over 400,000 daily new cases at the height of the wave in early May 2021. While official projections estimate 29 million total infections and 360,000 deaths, low testing rates and the lack of available data lead some to place the actual COVID-19 tallies at five to ten times the official numbers.

The new, more contagious B.1617 Delta variant is partially to blame for the intensity of the second wave. However, the premature lifting of initial population-level prevention measures, the paucity in medical supplies including hospital beds and oxygen, and a high proportion of unvaccinated population contributed to the wildfire-like spread of the virus, inflicting untold human suffering across the country.

With the number of cases declining, the second wave is waning, but many experts predict that a third wave is inevitable. India cannot squander this opportunity to prepare itself; the country must take proper precautionary measures to minimize the impacts of a third wave.

India needs to continue urging proper population level prevention measures, including mask wearing and physical distancing.

A study completed during the height of the second wave of COVID-19 revealed only half the population wearing a mask and only fifteen percent of the population wearing a mask properly. With the majority of its population still unvaccinated, India needs to increase proper mask wearing among its constituents.

Moreover, after a strict nationwide lockdown in early 2020 curbed infection transmissions, India prematurely congratulated itself on controlling the pandemic and recklessly allowed large gatherings, such as cricket games attended by more than 130,000 unmasked fans, hosted large election rallies, and permitted gatherings for religious festivals, allowing the virus to spread. In the absence of a national lockdown to address the second wave of infections, many Indian states implemented strict regional lockdowns in May. Unfortunately, these draconian lockdowns disproportionately hurt the poorest and most vulnerable, and cannot be implemented for an extended period of time. However, the country should continue enforcing restrictions against large gatherings until higher proportions of the population are vaccinated.

India needs to enhance its COVID-19 surveillance system, and its collection and use of granular data to better inform their policy response.

India’s low infection testing rates, far below the global average, make it difficult to precisely establish the situation and respond with targeted actions to prevent the spread of COVID-19 in the country. In rural India, for example, where two-thirds of Indians live, the lack of widespread testing makes it impossible to understand the COVID-19 burden in the area. Increasing COVID-19 testing and contact tracing across the country will provide India with more accurate data to control the spread of the virus.

In addition, the government is withholding official granular data on COVID-19 to those outside the government and to many within the government. Good data is at the heart of good policy planning, and allowing public health experts and epidemiologists access to the data will allow them to use their expertise in making recommendations for best allocating scarce resources in combatting this pandemic.

India needs to increase the speed of COVID-19 vaccine rollout, especially to their most vulnerable populations.

After first prioritizing healthcare workers and those over age 65, then those over age 45, the country has opened eligibility to all those over the age of 18. As of early June, only 12.6 percent of India’s population has been administered at least one shot of COVID-19 vaccine, but the country reported slowed vaccine rollout in the midst of the second wave.

Prime Minister Modi’s announcement that vaccines will be free for all adults over the age of 18 should greatly improve the cost barrier in accessing vaccinations, but India can take further steps to improve its vaccine rollout. With huge shortages in vaccines, India needs to prioritize groups not only based on age, but also with other comorbidities and those at risk for acquiring and spreading the virus—those who are unable to properly social distance, practice good preventative hygiene measures, or access information on COVID-19 should be specifically targeted with the limited available doses.

India needs to address some of the shortages highlighted in the second wave.

As the second wave overwhelmed the Indian healthcare system, patients resorted to social media to find medical care and some even tried to make oxygen at home. India has ordered additional oxygen concentrators, but the country is still woefully under oxygen sufficiency levels. In addition, a major problem in India is the distribution of supplies from the central level to individual hospitals, and these additional oxygen concentrators and other medical supplies need to be efficiently distributed to individual facilities to be useful.

India needs to provide centralized, credible information to increase transparency and improve trust in their COVID-19 response.

In the midst of severe medical shortages and absence of a central, trusted authority on COVID-19 information, misinformation on miracle cures such as lemon juice or cow urine led individuals to reject proper prevention measures for one of these spurious hopes. Credible and transparent information on the proper COVID-19 prevention measures is essential to ensure that everyone is taking the appropriate measures to protect themselves and their families.

After its first lockdown curbed COVID-19 cases in India, the country failed to take continued pandemic prevention measures leading to the second wave of infections across the country. But there are key steps that India can take now to prevent the same devastation in the next wave.

INTERESTING TRENDS

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

US President Biden announces a 500 million-dose Pfizer vaccine donation at $1.5 billion to lower income countries through COVAX, the coalition working to provide equitable access to COVID-19 vaccines globally, with delivery starting in August 2021.

UK Prime Minister Johnson announces a donation of 100 million surplus vaccine doses, 30 million by the end of 2021. About 20 million of the doses will be donated bilaterally and the rest through COVAX.

Preliminary research finds evidence for a stronger immune response when mix-and-matching doses for two dose COVID-19 vaccine regiments, leading Canada’s public health agency to permit the mixing of COVID-19 vaccines.

US FDA rejects emergency authorization of Bharat Biotech’s Covaxin vaccine, but will welcome an application for full authorization when complete results from the Phase 3 trial are available.

China approves emergency use of Sinovac for children over the age of 3.

US is investing $500 million in establishing a new Center for Epidemic Forecasting and Outbreak Analytics at the US Centers for Disease Control and Prevention, which will help lead a new global pandemic early warning network.

Mastercard Foundation will provide $1.3 billion to Africa CDC over the next three years to support the acquisition and delivery of COVID-19 vaccines.

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

Weekly COVID Vaccine Research Update

Vaccines

India

variant

COVAX

High-income country confirmed dose total:	6 billion
Upper-middle-income country total:	2.2 billion
Lower-middle-income country total:	1.4 billion
Low-income country total:	271 million
COVAX total:	2.4 billion
Total worldwide confirmed purchases of Covid-19 vaccines:	12.2 billion doses

What have we learned in one year of COVAX?

j.harris — Fri, 23 Apr 2021 21:56:33 +0000

What have we learned in one year of COVAX? j.harris Fri, 04/23/2021 - 21:56

INSIGHTS

What have we learned in one year of COVAX?

Author: Andrea Taylor

Launched as a global cross-organization collaboration only one month after the pandemic was declared, COVAX was built to facilitate global equity in the pandemic response. As COVAX passes the one-year mark this month, there are some early lessons and insights that can inform its further development and help us prepare for future crises.

In terms of numbers, COVAX is short of the mark. Photo ops of government officials on the tarmac to meet planes full of doses and declarations of the numbers of countries reached can paint an optimistic picture. But the truth is that COVAX has delivered 43 million doses to 119 countries. This is only 2% of the way towards the 2 billion dose goal for 2021 and about 70 COVAX-participating countries have not yet received any doses (though some of these countries have waived their doses).

As Dr. Tedros wrote in the New York Times this week, we are nowhere near the 20% mark, and with significant supply constraints set to continue through the second quarter of 2021, this is not likely to change soon. COVAX is also However, it is not all bad news. COVAX has supported manufacturing deals and bulk purchases that would not have been feasible without its pooled procurement approach. And while distribution of vaccines is coming in more of a trickle than a wave, it is still getting doses to some of the most remote and poorest regions of the world. One year in, we can look back and begin to see what has worked and what needs rethinking.

Iterating in the midst of a crisis is difficult

COVAX was pulled together by a group of people who foresaw the dangers of inequitable access to vaccines in a pandemic, part of the ACT Accelerator that also focused on access to diagnostics and therapeutics. But at the time it was launched, the shape and timeline of the pandemic were unknown, the symptoms and impact of Covid-19 were still not well understood, and no one yet knew if or which vaccine would work. There was not the luxury of time to wait for these answers before designing and market testing an equity solution.

It is a difficult thing to build the car while you are driving it. The designers of COVAX and the partners who have steered its implementation have had to iterate as they go along, adding this, removing that. They have navigated the same dynamic landscape as national leaders, responding to changes in disease patterns, infection rates, vaccine trial results, manufacturing supply. But they’ve had to do all of this while keeping the world’s leaders engaged, maintaining a vision and strategy that would hold both wealthy and poor countries and everyone in between. It is worth keeping in mind the sheer difficulty of this task. To large degree, COVAX was down to grit and persistence.

Nationalism will win, so let’s plan for it

COVAX was premised on an all-for-one-and-one-for-all approach to defeating the pandemic. It was a way to invest together in a portfolio of vaccines and therapeutics and then ensure that the successful ones were shared out equally, regardless of country wealth or geopolitics. We know from economic and epidemiolocal modeling that this would have led to the best outcomes for everyone and was our best hope for ending the pandemic quickly. But we also know from experience that the world doesn’t really work this way. And COVAX used a traditional donor-aid model to drive an all-in-this-together program, leading to, as the Lancet put it this week, “a funding shortfall and a system not based on solidarity but rather one that reinforces inequities.”

Vaccine purchase decisions are made (for the most part) by national leaders, whose primary responsibility is to protect their own population. If leaders have the opportunity to control the purchase (and production) of vaccines for their country, they will. If they have the opportunity to prioritize their population over others, they will. This is their job.

For future iterations of COVAX, nationalism must be baked into the design from the beginning. COVAX needs to assume that government leaders will prioritize their own, and work with that. Perhaps vaccine makers could commit that 20% of every batch produced goes to supply COVAX, while 80% can go to the wealthy countries first in line. The important thing is to bake it in from the beginning so that it not a choice of “giving up” doses that leaders have to explain to their voting population.

Messaging matters

COVAX can be described in many ways but transparent is not one of them. The risk-averse partnership has consistently kept its cards close to its chest, providing information only in broad strokes and only when absolutely necessary. While we can understand why, we also think this may be a strategic error.

When COVAX does share information, the tone tends to be defensive and protective and the data shared is difficult to parse. The risks and dangers inherent in the COVAX design are not lost on the watching world and simply choosing not to talk about them doesn’t make them disappear. Rather, clear messaging about the benefits of vaccine equity (which are well documented by others), what is needed to get there, and the potential pitfalls on the way could allow COVAX to drive and shape the story. Unfortunately, opaque supply updates built on data that cannot be externally validated undermine, rather than build, confidence.

COVAX is the largest purchaser in the Covid-19 vaccine market and could use its platform and purchasing power to push for more transparency and accountability in Covid-19 vaccine purchases and manufacturing. Making its supply deals public, including prices and delivery schedules, and clearly communicating about the gaps, could drive urgency and more transparency across the board.

Equitable distribution must begin with equitable manufacturing

The location of manufacturing matters and countries with domestic manufacturing of Covid-19 vaccines are better able to ensure supply. While COVAX was quick to secure manufacturing capacity, this is less relevant in the context of export controls. COVAX does not have a country or government and is unable to use policy levers to commandeer manufacturing when the going gets tough.

Ensuring equitable access to vaccines globally means that manufacturing must be global. There are a very limited number of manufacturing partners who could provide the scale of vaccine needed for COVAX and this led to an overreliance on Serum Institute of India (SII). When a second wave of Covid-19 infections hit India and sent it into crisis, export controls cut short the COVAX supply. There was no Plan B and no clear options for making up the shortage in production for countries counting on COVAX.

The world needs more regional manufacturing hubs that can produce vaccine independently and do not require drug substance to be imported from other regions. There is a particularly acute need in Latin America, the African continent, South East Asia, and the Pacific. With more equitably distributed manufacturing, COVAX or a similar future effort could draw on a broad network of manufacturing partners to supply the world and lower-income regions could control their own supply.

The world is better off with COVAX than without it. But one year in, we can see how far we are from the goal and the factors that have prevented success. One of the strengths of COVAX is its ability to iterate and it will continue to do so in a continually changing environment. And importantly, we now have something on which to build and improve for future global crises.

INTERESTING TRENDS

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

India’s health systems are collapsing from the pressure of a near-vertical rise in infections. With more than 330,000 new cases on Friday, India set a world record for the second day in a row.

In response, India is opening up vaccine eligibility to all adults aged 18 and older, starting May 1. The country is facing a significant vaccine shortage, however, and has declared that domestic manufacturers must sell 50% of their doses to the government but can sell the other 50% on the private market within India. Prices for the private market can be different than the government rate but must be transparent and set in advance.

The European Medicines Agency (EMA) found a possible link between a very rare blood clotting disorder and the Janssen (J&J) vaccine, similar to that identified with the Oxford-AstraZeneca vaccine, but stressed that “the vaccine’s benefits in preventing Covid-19 outweigh the risks of these very rare side effects.”

Dr Tedros offered a scathing indictment of the choices wealthy countries have made in the pandemic in a NYT opinion article, and called on rich countries to support COVAX financially, to donate vaccine doses, and to share manufacturing expertise to allow production to scale up globally.

Japan will host the next fundraising summit for COVAX in June, bringing together leaders from the US, Japan, and European countries.

New Zealand, France, and Spain announced plans this week to donate excess vaccine doses through the COVAX Facility.

The ACT Accelerator released a report in honor of its first anniversary: ACT Now, ACT Together: 2021 Impact Report.

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

Weekly COVID Vaccine Research Update

High-income country confirmed dose total:	4.7 billion
Upper-middle-income country total:	1.5 billion
Lower-middle-income country total:	732 million
Low-income country total:	770 million
COVAX total:	1.12 billion
Total worldwide confirmed purchases of Covid-19 vaccines:	8.9 billion doses

Will India’s export controls doom supply for low- and middle-income countries?

j.harris — Fri, 26 Mar 2021 21:34:53 +0000

Will India’s export controls doom supply for low- and middle-income countries? j.harris Fri, 03/26/2021 - 21:34

Weekly Insights and Interesting Trends

Will India’s export controls doom supply for low- and middle-income countries?

Author: Andrea Taylor

India’s announcement this week that it would halt exports of domestically produced Covid-19 vaccines in the short term seemed to take the world by surprise. It probably shouldn’t have.

For months, India’s Covid-19 cases appeared to plateau. As wealthier countries dithered about donations and paused exports, India led the way on donations and was lauded for their significant part in supplying COVAX and lower-income countries. The Serum Institute of India (SII) is frequently seen as the key to vaccine equity and is expected to produce the bulk of COVAX 2021 supply, as well as making bilateral deals with low- and middle-income countries.

But cases in India began to spike this month and a new “double mutant variant” was identified in the country. (Health officials say that the variant has not been linked to the rise in cases.) Facing a daily caseload that has more than tripled in three weeks, India is following the path paved by the US, EU, and others. As domestic need rises, governments prioritize their citizens over neighbors.

India’s export controls are bad news for COVAX and global equity. COVAX allocated 110,328,000 doses of SII’s version of the Oxford-AstraZeneca vaccine to ship out to 60 countries by May. Indian government reports that 17.9 million doses have been exported to COVAX so far.

The remaining doses will now be delayed and shipments expected beyond May are in question. COVAX is negotiating additional supply deals, which may help to fill the gap later this year. But it is unlikely that any manufacturer will be able to provide a significant number of doses to COVAX in the next quarter.

The news from India highlights the risks of the complex supply chains and uneven distribution of manufacturing capacity around the world. Countries manufacturing vaccine can commandeer doses when domestic need requires it. Countries without the means to produce vaccine (which is most countries) are left to wait through their own crisis until the crisis elsewhere subsides.

Even before the export controls were announced, SII was facing manufacturing shortfalls. They linked shortfalls to a lack of materials (cell cultures, filters, pumps, chemicals) needed from countries like the US, a complaint that has been echoed by other vaccine makers. The US government, meanwhile, is using the Defense Production Act to keep key components within the country and speed up domestic manufacturing.

Our analysis of the global manufacturing landscape identifies 100 manufacturing partners in more than 30 countries currently working to produce Covid-19 vaccine (add to this the hundreds of suppliers of parts and materials). This is amazing. But if materials get stopped at borders and cannot get to all of the manufacturers, then they cannot do their job and we are wasting desperately needed capacity.

There may be a negative feedback loop at work here: the perception of scarcity is driving nationalism, which is in fact driving further scarcity. This is inefficient, and we cannot afford inefficiency.

Vaccine makers are projecting they can make a total of about 12 billion doses of Covid-19 vaccine this year. We think that is a best-case scenario; recent history indicates these projections will likely be lowered as the production process encounters problems. But it is realistic to expect that manufacturing is going to ramp up exponentially in the second half of 2021. Whether or not these doses will be efficiently distributed may be decided by governments in a few countries that are home to much of the manufacturing capacity.

Interesting Trends

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

The WHO Director-General spoke on Monday about the disparities in access to Covid-19 vaccines, saying, “We have the means to avert this failure, but it’s shocking how little has been done to avert it. The gap between the number of vaccines administered in rich countries, and the number of vaccines administered through COVAX is growing every single day, and becoming more grotesque every day.”

India has covered 55 million people so far in their national vaccine drive, though recent export controls will impact doses going to low- and middle-income countries, both through COVAX and bilateral deals. Read our take on this above.

China accelerated its national vaccine campaign this week and has now administered nearly 75 million doses, according to a government spokesperson. (CanSino is a one-dose vaccine, while Sinovac and both Sinopharm vaccines are two doses, so it is not clear exactly how many people have been covered.) A government official reported that China’s production capacity can fully meet the nation’s needs.

South Africa worked with the African Union to sell its unused doses of Oxford-AstraZeneca vaccine to 14 other African countries. South Africa ordered the vaccine from Serum Institute but later decided not to roll it out because of reduced efficacy against the dominant variant in the country.

Two biotech companies in India, Virchow and Stelis, recently signed on to manufacture 200 million doses each of the Sputnik V vaccine, with production expected to begin in the summer.

This week also saw a number of new bilateral purchases for the Sputnik V vaccine.

Cuba announced the final phase of clinical trials for their homegrown vaccine Soberana 2. As part of the trial, Cuba will vaccinate 150,000 frontline workers. Cuba is also testing a second vaccine, Abdala, which is entering late-stage trials.

Catalent is partnering with J&J to produce “millions” of doses of the Janssen vaccine for the US market.

Norway donated 700,000 doses from its COVAX allocation to poorer countries, while still in the early stages of its national vaccine roll out.

New report in Nature breaks down the manufacturing landscape, why it is difficult to scale, and how we can do better.

After some confusion over the data originally submitted by AstraZeneca to US regulators, the company has resubmitted data with an adjusted efficacy of 76% (from 79%), though efficacy for over 65s in the US trial was 85%.

EU leaders met this week and agreed to maintain (or strengthen) export controls on vaccines, while stopping short of an outright export ban. They also agreed to increase production within the EU.

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

Weekly COVID Vaccine Research Update

High-income country confirmed dose total:	4.6 billion
Upper-middle-income country total:	1.5 billion
Lower-middle-income country total:	711 million
Low-income country total:	670 million
COVAX total:	1.12 billion
Total worldwide confirmed purchases of Covid-19 vaccines:	8.6 billion doses

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

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

Direct COVID vaccine deals by poorer countries are an important and encouraging development

rwatkins — Tue, 19 Jan 2021 13:00:00 +0000

Direct COVID vaccine deals by poorer countries are an important and encouraging development rwatkins Tue, 01/19/2021 - 13:00

Weekly Insights and Interesting Trends

Direct deals by poorer countries are an important and encouraging development

This past week, we saw the first direct vaccine purchases made for low-income countries with the African Union’s purchase of 270 million doses of Covid-19 vaccines from Pfizer-BioNTech, OxfordAstraZeneca, and Johnson & Johnson (J&J). A relatively modest purchase of 270 million doses, when 7 billion doses have already been bought, might be overlooked but it actually represents a significant shift in the global power dynamics of the Covid-19 response.

COVAX, a partnership between Gavi, CEPI, and WHO, is the only mechanism we have to promote global equity to Covid-19 vaccines. With 190 countries participating, COVAX leverages its large market share to bulk buy vaccines and then allocates them equally among member countries, based on population. Lower-income countries will be provided vaccines to cover 20% of their population at no cost. The aim is to vaccinate high-priority and vulnerable populations worldwide on the same timescale, to protect healthcare systems and emergency services, and reduce mortality. We know that this approach to vaccination is better for everyone, both in terms of health and economic outcomes.

While COVAX is important and must succeed, we need to support additional, complementary mechanisms for low- and middle-income countries (LMICs) to get priority access to Covid-19 vaccines. Even with the 20% population coverage provided through Covax, LMICs will need another 40% to 50% population coverage to reach herd immunity levels. As our data show, however, most LMICs are nowhere near this goal. The African Union and Africa CDC have coordinated leadership across African countries to pool procurement and increase the purchasing power in the global vaccines market.

The timing of the African Union deal is at least as important as the quantity of doses: all 270 million doses are to be delivered in 2021, with 50 million doses delivered between April and June. African countries won’t have to wait at the back of the line to begin vaccination campaigns for their highest priority populations.

Also important is the selection of vaccines. Pfizer-BioNTech is the only Covid-19 vaccine that currently has WHO Emergency Use Listing (EUL) status, and the purchase by the African Union demonstrates that this isn’t just a vaccine for wealthy countries. As Dr. Ahmed Ogwell, Deputy Director of the Africa CDC stated, the capital cities will be able to store and administer Pfizer’s mRNA vaccine that requires ultracold storage. The Oxford-AstraZeneca vaccine has emergency approval in the UK (for the AstraZeneca- manufactured version) and is currently under review for WHO EUL status. The Serum Institute has committed to prioritize distribution to LMICs with the doses they manufacture. The J&J single-dose vaccine, with US emergency approval expected in February, will reduce both cost and burden of vaccination by eliminating the need for a second shot per person.

The purchase of 270 million vaccines as part of the whole-Africa approach represents an encouraging step towards global equity. Pooled procurement by LMIC leadership can increase leverage in the global market and should be encouraged and supported by global leaders and vaccine developers.

Interesting Trends

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

The first purchase by low-income countries was made through the African Union’s pooled procurement approach. A total of 270 million doses (50 million from Pfizer-BioNTech, 100 million from Oxford-AstraZeneca through Serum Institute, and 120 million from Johnson and Johnson) will be allocated to countries across Africa.

The Indian government made its first official purchase, with 11 million doses of the OxfordAstraZeneca vaccine through Serum Institute, which were quickly rolled out through a mass immunization campaign.

Switzerland and the EU granted emergency use approval for Moderna’s Covid-19 vaccine and the EU is currently reviewing an application by the Oxford-AstraZeneca vaccine, with a decision possible in late January.

BioNTech increased its manufacturing goal from 1.3 billion to 2 billion doses in 2021. The scaleup is expected to cause temporary disruption in supply but the company expects capacity to increase by mid-February.

Johnson and Johnson expects to submit final Phase III data to regulatory authorities within the next two weeks and plans to manufacture 1 billion doses in 2021.

Brazil granted emergency use authorization to Sinovac’s Coronavac (despite disappointing results from the Phase III trial) and the Oxford-AstraZeneca vaccine, launching vaccinations moments after approval was granted. Turkey also granted emergency use authorization to Sinovac this week.

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

Weekly COVID Vaccine Research Update

Data Updates

High-income country confirmed dose total:	4.2 billion
Upper-middle-income country total:	1.12 billion
Lower-middle-income country total:	411 million
Low-income country total:	270 million
COVAX total	1.07 billion
Total worldwide confirmed purchases of Covid-19 vaccines:	7.4 billion doses