Mexico

Will chicken eggs change the Covid-19 vaccine landscape?

j.harris — Fri, 09 Apr 2021 20:42:07 +0000

Will chicken eggs change the Covid-19 vaccine landscape? j.harris Fri, 04/09/2021 - 20:42

WEEKLY INSIGHTS

Will chicken eggs change the Covid-19 vaccine landscape?

Author: Andrea Taylor

A promising new vaccine candidate is getting a flurry of attention this week, even in a very crowded landscape that includes 11 vaccines on the market and 50+ more in Phase 2 or 3 trials. The newcomer NDV-HXP-S vaccine, developed through collaborations between researchers at University of Texas at Austin, PATH, and Mount Sinai, among others, is a mouthful to say but the name captures the two reasons people are excited about it.

NDV refers to the Newcastle Disease Virus, a disease that effects birds but does not harm people. Using NDV as a viral vector for vaccines means the vaccine can be developed in chicken eggs, as is commonly done for the flu vaccine. NDV has also been used as a vector for vaccines against SARS 1, RSV, and Ebola.

HXP stands for HexaPro, a spike protein developed by researchers in the US that is stronger than the protein used by the vaccines currently on the market. This means it can work well in difficult climates. Several of our current Covid-19 vaccines (we’re looking at you, mRNA) are divas – extremely difficult to manufacture and difficult to transport. The HexaPro protein was designed to be rugged and easy to make without falling apart, intentionally created with lower-income markets in mind.

The NDV-HXP-S vaccine candidate is being eyed as a potential gamechanger for several reasons:

Manufacturing: Many low- and middle-income countries (LMICs) already have expertise in making flu vaccines using chicken eggs and could apply this to making Covid-19 vaccine. And manufacturers in 80 LMICs can use HexaPro without paying royalties, thanks to a licensing agreement with University of Texas. This means countries such as Brazil and Thailand could own the manufacturing of this vaccine from start to finish.
Cost: Experts estimate that it could be produced for as little as $0.50 to $1 per dose, which would make it the cheapest Covid-19 vaccine by far.
Scale: Production can be scaled up very quickly, using existing infrastructure. The vaccine is so potent, that each egg can provide enough for 5 to 10 doses (typically flu vaccine gets 1 to 2 doses per egg).

This is not going to be a quick fix, however. The vaccine candidate is just beginning Phase 1/2 clinical trials in Brazil, Thailand, Vietnam, and Mexico (all of which also have the capacity to make it). If all goes well, it could potentially enter Phase 3 trials by late summer and, if effective and safe, start production by end of 2021 at earliest.

But most of the world will still be waiting for vaccines at the end of this year so this may still come in time to supply LMICs. It could also put us a much better position for global equity if boosters are needed.

To serve LMICs, a vaccine needs to be effective, affordable, available, and easy to transport. This vaccine looks like it can tick three of those boxes so far. We will have to wait on clinical trial results to see if it can tick all four.

INTERESTING TRENDS

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

We’ve posted a new visualization on our procurement webpage this week that shows how many doses per person have been purchased by each country, differentiated by country income category. (Note that to allow an apples-to-apples comparison, we doubled the single-dose vaccines Janssen and CanSino for this visualization.)

Indian manufacturer Panacea Biotech has signed up to manufacture the Sputnik V vaccine for global supply, with capacity to make 100 million doses per year.

The University of Oxford has launched a Phase 1 trial to test the Oxford-AstraZeneca vaccine delivered as a nasal spray, rather than injection.

The European Medicines Agency (EMA) is investigating reports of blood clots stemming from the Janssen (J&J) vaccine.

Pfizer and BioNTech filed for EUA expansion to include adolescents (12-15 years old) in the US. The companies plan to request expansion approvals across the world in the near future.

Many countries are restricting use of the Oxford-AstraZeneca vaccine in younger people, as a potential connection with rare blood clots (and now a bleeding disorder) are further investigated. In Europe, Italy, Spain, Belgium, Germany, the Netherlands, France, Finland, Sweden and the UK have required or recommended that the shot be used only for older age groups. Canada, Australia, and the Philippines have followed suit.

Supply of the Janssen (J&J) vaccine in the US is expected to drop by 80% this week, though the reasons are unclear. The company says it is still on target to deliver 100 million doses to the US by midyear.

The Biden administration in the US has appointed Gayle Smith to a new State Department role leading the US response to Covid-19 globally. Ms. Smith is the CEO of the ONE campaign and previously served as USAID administrator; she has advocated for vaccine donations and a more coordinated international response to support lower-income countries.

However, an article this week in Vanity Fair explores how and why the US may be contractually restricted from sharing surplus doses with other countries.

Last week, we noted that the Emergent BioSolutions facility in Baltimore accidentally mixed ingredients for the Oxford-AstraZeneca and Janssen (J&J) vaccines, invalidating a batch of Janssen vaccine. Emergent’s facility will now only manufacture Janssen and the manufacture of Oxford-AstraZeneca will be relocated.

Serum Institute of India (SII) asked the government of India for $400 million to help increase production to relieve its “very stressed” capacity. SII is the primary supplier of doses for COVAX and many LMIC markets but India’s recent export controls have delayed shipments out of the country.

Despite the stress on SII’s production capacity and resulting delays to COVAX and LMIC supply, the EU asked if they could possibly get 10 million doses of Oxford-AstraZenca vaccine from SII to make up for the shortfall from European manufacturers. The UK made a similar request earlier this year and received half of their order from SII.

African Union and Africa CDC are hosting a two-day conference on “Expanding Africa’s Vaccine Manufacturing,” April 12 and 13.

The US will host a (virtual) event on April 15 bringing together private- and public-sector leaders to make the case for additional investment in the COVAX AMC to support access to Covid-19 vaccines for lower-income countries.

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

Weekly COVID Vaccine Research Update

Vaccines

Manufacturing

scale

Brazil

High-income country confirmed dose total:	4.6 billion
Upper-middle-income country total:	1.5 billion
Lower-middle-income country total:	721 million
Low-income country total:	770 million
COVAX total:	1.12 billion
Total worldwide confirmed purchases of Covid-19 vaccines:	8.8 billion doses

The curious case of upper-middle income countries

j.harris — Fri, 02 Apr 2021 20:57:15 +0000

The curious case of upper-middle income countries j.harris Fri, 04/02/2021 - 20:57

Weekly Insights and Interesting Trends

The curious case of upper-middle income countries

Author: Andrea Taylor

The global imbalance in Covid-19 vaccines is often framed in terms of wealthy versus poor countries. While it can be summed that way (wealthy countries do have the majority of doses, while low-income countries have almost none), this overlooks the experience of upper-middle income countries (UMICs), such as Brazil, Indonesia, and China.

The challenges faced by UMICs are different than those faced by lower-middle and low-income countries. They do not lack public funding to make vaccine purchases; countries like Mexico and Brazil can finance large purchases. But UMICs were less willing to make these purchases at risk, when there was no indication that any of the vaccines would work. While high-income countries (HICs) purchased from multiple vaccine makers in the summer of 2020, before any efficacy data were released, UMICs tended to wait until there was some indication of efficacy before negotiating a deal.

This put them behind the large orders from HICs for vaccines like Pfizer-BioNTech, Moderna, and Oxford-AstraZeneca and meant their delivery dates were generally later. This issue is compounded by the location of manufacturing capacity for vaccines that have come to market. Most of the doses that have received authorization from stringent regulatory authorities are currently manufactured in HICs, many of which leveraged early investment in manufacturing (and sometimes export controls) to guarantee priority delivery.

So while UMICs have purchased a combined 1.5 billion doses so far, few of these vaccines have been delivered. This translates into low vaccination rates. About a third of UMICs have covered less than 1% of their population with a first dose. Another third have covered between 1% and 5% of their populations, and one-third have covered more than 5% of their population with first doses (according to data on vaccine administration as of March 31, 2021 from Our World in Data).

What is particularly curious about the experience of UMICs is that many of these countries have manufacturing capacity and contracts to produce Covid-19 vaccines, but this isn’t leading to national supply. Brazil, Indonesia, Mexico, and Thailand (among others) have manufacturing contracts in place for a variety of Covid-19 vaccines but actual production has been slow to get going. Russia, which funded the development, testing, and manufacture of domestically produced vaccines, is so limited by domestic bottlenecks in production that it is relying on manufacturing partners in other countries. China, another UMIC with domestically developed vaccines, has far more manufacturing capacity but is still struggling to meet projections for domestic and global production.

The production delays in UMICs have significant epidemiological consequences. In Brazil, for example, the health system is overwhelmed; shortages of hospital beds and oxygen mean acute cases go untreated. The country now accounts for a quarter of daily Covid-19 deaths globally and the death rate among even younger adults is rising rapidly. There are many factors contributing to the unchecked spread of Covid-19 in Brazil, including a chaotic response from the national government, contradictory public health messages, and rampant misinformation. But another crucial factor has been the slow rollout of vaccines.

Brazilian firms have technology transfer agreements in place to manufacture Oxford-AstraZeneca, Sputnik V, and Sinovac’s Coronavac, for domestic and regional distribution. But the doses are not materializing and only 2% of Brazil’s population have been fully vaccinated (9% have received a first dose). If we are going to address equitable access to vaccines, we need to better understand why production in Brazil and other UMICs is so far behind. Clarity on the causes of bottlenecks and delays for UMIC manufacturing will improve decisions about the manufacturing investments and policy changes needed to increase regional production.

Interesting Trends

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

WHO expects to have a decision on emergency use listing (EUL) for Sinopharm-Beijing and Sinovac’s Coronavac vaccines by end of April. Receiving EUL status would ease the path to regulatory approval in many countries around the world and make the vaccines eligible for use in COVAX.

Sinovac reported that, with a third plant up and running, their annual capacity is now 2 billion doses.

UAE tech company Group 42 announced plans to manufacture Sinopharm’s Beijing-based vaccine, with capacity to produce 200 million doses a year

However, Group 42, which currently distributes the Sinopharm-Beijing vaccine in the UAE, also reported that some people may need a third dose, due to low immune response.

CanSino’s single-dose vaccine may also need a booster, six months after the first shot, in order to maintain efficacy.

A new Covid-19 variation was discovered in Tanzania, with the most mutations yet seen. Tanzanian’s recently deceased president claimed that there was no Covid-19 in Tanzania, which has not officially reported any cases since the spring of 2020.

The US FDA said that, with the right syringes and needles, providers can extract 11 doses (instead of 10) from Moderna vials. They also gave approval for Moderna to fill vials with up to 15 doses, which may speed the pace of delivery.

New data show that efficacy of the Pfizer-BioNTech remains high six months after vaccination, with a small drop to 91.3% protection from symptomatic cases.

Pfizer-BioNTech also reported very positive results in their trial with children ages 12-15, demonstrating 100% efficacy.

BioNTech said that, together with Pfizer, they will increase 2021 manufacturing capacity to 2.5 billion doses globally.

In response to recent reports of possible increased risk of blood clots for women under 50 receiving the Oxford-AstraZeneca vaccine, Canada has said they will only use the vaccine in people over the age of 55 while Germany restricted it to people over age 60.

Manufacturing partner Emergent reported contamination of the drug substance for up to 15 million doses of Janssen (J&J) vaccine, due to human error.

Brazil health regulator Anvisa declined to approve the Covid-19 vaccine made by Bharat Biotech in India, saying that it did not meet manufacturing standards. The government of Brazil has ordered 20 million doses. Bharat plans to appeal the decision.

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:	691 million
Low-income country total:	670 million
COVAX total:	1.12 billion
Total worldwide confirmed purchases of Covid-19 vaccines:	8.6 billion doses