Regulatory

President Biden got his bivalent COVID-19 booster. What about the rest of the world?

j.harris — Fri, 28 Oct 2022 21:05:11 +0000

President Biden got his bivalent COVID-19 booster. What about the rest of the world? j.harris Fri, 10/28/2022 - 21:05

Authors: Katharine Olson and Wenhui Mao

Vaccines have played a large role in the global COVID-19 response and saved numerous lives. However, when highly transmissible variants such as Omicron (BA.1) appeared and quickly dominated the reported cases, the effectiveness of vaccinations was noticeably waning. The first U.S. case of BA.1 was reported December 1st, 2021, and by January 8th, 2022 it comprised 95% of new cases. In the last week of January 2022, confirmed new cases worldwide hit 23 million which is in stark contrast to previous highs of 5 million new cases a week. At the start of the BA.1 wave in late 2021, the primary vaccination series was only 44% effective at preventing infection and hospitalization. This prompted the push globally to administer booster vaccine doses as three doses were found to be 71.6% effective against BA.1. Waning effectiveness led vaccine manufacturers to create bivalent vaccines that could target two COVID-19 strains and provide better protection.

In this blog, we describe the features of the available bivalent COVID-19 vaccines, track the regulatory approval and the procurement of bivalent COVID-19 vaccines, new vaccine technologies in clinical development, and implications of introducing these medical countermeasures.

Mechanism and efficacy of the bivalent COVID-19 vaccines

Bivalent vaccines are one of the newest tools to protect against COVID-19 infection and severe outcomes. Bivalent COVID-19 vaccines contain a portion of the spike protein from the original wild-type strain as well as a portion of the omicron spike protein. Both Moderna (Spikevax) and Pfizer (Comirnaty) have updated their existing monovalent mRNA vaccines to include an omicron component, whether that be a portion of the original BA.1 or subvariant BA.4/5 spike protein.

Early clinical trials indicated that administration of a bivalent booster dose increased the average titer of neutralizing antibodies to BA.1 by 1.6 times that of a monovalent booster in those with no prior COVID-19 infection. In addition, administration of a bivalent booster dose increased neutralizing antibodies to BA.4/5 by 1.5 times that of a monovalent booster. While statistically significant differences in antibody titers have been found, there is concern that this might not translate to clinical significance.

Bivalent vaccines are meant to be administered as booster doses after the completion of the primary vaccination series and are recommended to be prioritized for high-risk populations. Similar to how the influenza vaccines work, the idea is that as the circulating COVID-19 strain changes, the boosters can be updated to provide targeted protection. These bivalent COVID-19 vaccines come in advance of a predicted surge in cases this fall and winter in the northern hemisphere, providing an extra line of defense for those who need it most.

Regulatory approval and procurement of bivalent COVID-19 vaccines

Currently, the bivalent vaccines from Pfizer and Moderna have received provisional approval in only a handful of high-income countries (HICs) or regions: European Commission, Italy, USA, UK, Israel, Canada, Australia, Taiwan, South Korea, and Japan. While the BA.4/5 subvariant has replaced BA.1 as the widely circulating strain, several countries have opted to prioritize purchasing vaccines that contain the BA.1 protein. Only the United States and Israel have purchased BA.4/5 bivalent vaccines. The discontinuity in approval of these vaccines globally coupled with the lack of clear clinical efficacy may create “two tiers” of vaccines, making it harder to achieve high levels of booster coverage and fueling vaccine hesitancy.

Purchases of these bivalent COVID-19 vaccines have come from COVAX and high-income entities which have achieved high levels of primary vaccination coverage, and are now focused on getting booster shots to vulnerable populations. There is significant vaccine supply available and wealthy countries have purchased far more doses than needed to vaccinate priority populations. Australia has purchased 15 million bivalent doses, enough to vaccinate the age 65+ population 3.5 times and the healthcare worker population 8.4 times. The United States has purchased nearly 171 million doses of bivalent vaccines which is over 3 times as many doses needed to vaccinate its 65+ and healthcare worker populations. In contrast to WHO recommendations that booster doses should be prioritized amongst high-risk populations, the United States is encouraging all age groups to take the bivalent vaccine, which may in part explain the disparity in doses purchased. Canada has purchased 12 million doses, which could vaccinate the 65+ population 1.7 times and the healthcare worker population 4.6 times.

Purchases of bivalent COVID-19 vaccines by country and population of healthcare workers, Data collected by the Duke Global Health Innovation Center Launch and Scale Speedometer research team; healthcare worker and 65+ population data from WHO CRD and World Bank

Purchases of bivalent COVID-19 vaccines by country and population over the age of 65, Data collected by the Duke Global Health Innovation Center Launch and Scale Speedometer research team; healthcare worker and 65+ population data from WHO CRD and World Bank

Upcoming COVID-19 products in the clinical development pipeline

The bivalent vaccines are one of many potential new tools in the COVID-19 response. Several new vaccine candidates are in clinical development or have recently been approved. Intradermal “patch” vaccines are shown to be stable without refrigeration and could be self-administered, potentially solving cold chain and health workforce vaccination training barriers. Additionally, inhaled COVID-19 vaccines have been approved such as CanSino Biologics’ vaccine in China and Bharat Biotech’s vaccine in India. These are just two of sixteen oral and nasal vaccine candidates that have reached clinical trials in humans. Oral and nasal vaccines are thought to provide an advantage over conventional vaccines because they target the immune cells in the nose and mouth which are the first line of defense against COVID-19 infection. The hope is that this will prevent mild cases by stopping the virus at its point of entry while potentially blocking transmission to other people. Vaccines that can block transmission of COVID-19 would help protect those who cannot be vaccinated and limit the development of new variants that drive the ongoing pandemic.

Route of vaccine administration	Number in Clinical Development	% (of 172 total)
Injectable	156	91%
SC Sub cutaneous	5	3%
ID Intra dermal	9	5%
IM Intra muscular	142	83%
IN Intra nasal	13	8%
AE Aerosol	1	1%
IH Inhaled	2	1%
TBD/No Data (ND)	11	6%

Breakdown of the 172 COVID-19 vaccine candidates in clinical development by route of administration, Source: WHO COVID-19 Vaccine Tracker

Moving forward

Even though the regulatory approval and procurement of bivalent vaccines has only happened among HICs, there are some positive developments. The United Kingdom has already donated doses of the Moderna bivalent vaccine, and Gavi has signed an agreement with Moderna to provide access to up to 100 million bivalent vaccine doses via the COVAX platform.

However, there are many hurdles before the bivalent COVID-19 vaccines can truly contribute to the pandemic control globally. Bivalent vaccines have only been approved for use as boosters not for the primary vaccination series. Primary vaccination coverage is 19.5% of the total population in low-income countries, and booster coverage is even lower. Countries and manufacturers alike have had to destroy expired monovalent vaccines because supply far outweighs demand. Without proper coordination and sufficient clinical evidence, pushing to use these new tools may result in vaccine wastage in countries whose priorities remain on increasing primary COVID-19 vaccination.

There are hesitations around whether bivalent vaccines are effectively any better at preventing infection than current vaccines on the market, and whether BA.4/5 will be the primary strain circulating in the fall. The hope for bivalent vaccines is that they will pave the way for development of multivalent or pan-coronavirus vaccines that would provide broader protection than existing vaccines. Additionally in the United States alone, demand for bivalent boosters is modest with roughly 30% of adults saying they plan to get the booster as soon as possible. Considering the quantity of doses purchased by the U.S., low demand for vaccinations could lead to wastage.

As bivalent vaccines saturate HIC markets and new vaccine technologies are approved, it is imperative that regulatory and distribution pathways are created and maintained to ensure that these products are available everywhere. This is especially important as major funding mechanisms, such as ACT-A, are transitioning from emergency response to long-term disease control. Now more than ever, there must be renewed effort to enhance low and middle-income countries’ vaccination strategies and ensure equitable access to new vaccine technologies.

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

vaccine

bivalent

Regulatory

The global picture of Covid-19 vaccine approvals

j.harris — Fri, 16 Apr 2021 19:17:57 +0000

The global picture of Covid-19 vaccine approvals j.harris Fri, 04/16/2021 - 19:17

INSIGHTS

The global picture of Covid-19 vaccine approvals

Author: Blen Biru

COVID-19 vaccines across the world have been produced and authorized for use with record speed. So far, 13 vaccines have received either limited or full regulatory approval. It’s important to note that the safety of the vaccines is continuously monitored even after limited and full regulatory approvals are granted. The recent post-approval regulatory revisions and suspensions of Oxford-AstraZeneca and J&J demonstrate the continuous monitoring efforts by regulatory bodies. To highlight the importance of regulatory oversight for global vaccine access and confidence, we’re launching a visualization tracking country-level and vaccine-level regulatory authorizations today and providing insights in this blog.

The regulatory approval process and timeline differ from country to country, with the first approval announced by Russia for their Sputnik V vaccine manufactured by Gamaleya Research Institute on August 11th 2020. The approval of the vaccine with no reliable phase-III clinical trial data was widely criticized globally, though some countries followed Russia’s lead and gave Sputnik V limited approval. Six months later, data demonstrating Sputnik’s high efficacy of 91.6% in phase-III clinical trials was later published in The Lancet, leading to approvals in more countries, now totaling 61. However, some countries are still wary of approving Sputnik V without further investigation, leading to a split between countries in the EU. Russia has also given emergency use approval (in a similar manner, without late stage clinical trial results) for domestic candidates EpiVacCorona and CoviVac manufactured by the Vector Institute and Chumakov Centre respectively.

China also gave emergency use approval to their locally developed vaccines Sinopharm (Bejing) and Sinovac ahead of phase-III clinical trial findings in summer 2020. Data from the phase-III clinical trials later showed 50-79% efficacy rate, which led to approval for general public use in December 2020 and February 2021. Two more Chinese vaccines Cansino and Sinopharm (Wuhan) were approved for general public use in China in Feb 2021. A fifth Chinese vaccine, produced by Anhui Zhifei Longcom Biopharmaceutical Co. Ltd. and the Chinese Academy of Sciences, received emergency use approval in March 2021 making China the country with the most home-grown vaccine approvals.

Of note, both China and Russia have only approved domestically developed vaccines so far (though Hong Kong has purchased Pfizer-BioNTech and Oxford-AstraZeneca doses, in addition to Sinovac).

The UK was the first stringent regulatory authority (SRA) to approve a Covid-19 vaccine, granting emergency use authorization to the Pfizer-BioNtech vaccine in early December 2020, followed quickly with emergency authorizations for Oxford-AstraZeneca (December 2020 ) and Moderna (January 2021). The EU followed a few weeks behind, authorizing Pfizer-BioNTech in December 2020 and Oxford-AstraZeneca and Moderna in January 2021.

The US has given emergency use approval to three vaccines: Pfizer and Moderna in Dec 2020, followed by Janssen (Johnson & Johnson) in Feb 2021. As SRAs, the approval process in the UK, EU, and US can be considered more rigorous, compared to China and Russia, requiring results from late-stage clinical trials and longer vetting process.

In Latin America, AstraZeneca was first approved for emergency use on Dec 30 2020 by Argentina and El-Salvador (the same date as in the UK). Latin American countries have now widely approved Pfizer-BioNTech and Oxford-AstraZeneca, with a few also providing limited approval for Sputnik V. Most Latin American countries have also provided limited approval for either Sinopharm (Beijing) or Sinovac, with a near-even split. Brazil is the only country in Latin America that has given full regulatory approval to any vaccine, granting this status to Pfizer-BioNTech in February 2021 and the Oxford-AstraZeneca vaccine in March 2021.

Other vaccines that received limited regulatory approval include the domestically developed COVAXIN by Bharat Biotech in India before phase-III data was available (like China and Russia) in January 2021. Outside India, COVAXIN is being used in Iran. India has also given emergency use authorization for the domestically manufactured AstraZeneca vaccine (Covishield) by Serum Institute in January 2021.

In addition to country-level approvals, WHO also has a process in place to register vaccines under Emergency Use Listing (EUL). The Pfizer-BioNTech vaccine was the first vaccine to receive WHO’s EUL on December 31, 2020 followed by AstraZeneca on Jan 29, 2021. Several other vaccines have applied for WHO EUL and the review status can be found here. Vaccines distributed through COVAX need to have WHO EUL.

Some countries such as India are considering approvals granted by other regulatory bodies such as EUL, USFDA and EMA, in lieu of waiting for their own local regulatory approvals (for vaccines developed in other countries) to fast-track vaccine administration.

Vaccines expected to be approved soon include Novavax (under review in several countries now and expected to be approved in the US and UK soon) and CureVac (under review and expected to be approved by the EU in June 2021). Additional approvals (following rigorous and robust review) are welcomed as they ensure increased access to vaccines worldwide. More on regulatory approvals and our perspective forthcoming in the next few days.

INTERESTING TRENDS

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

COVAX and the US government launched an investment opportunity event to support Gavi COVAX Advance Market Commitment and pool resources.

Health and development organizations urged the Biden administration to set up a global vaccine manufacturing program to tackle the pandemic.

UNICEF fund facilitates to raise 2.5B USD to provide health supplies for low-and middle-income countries and promote equitable access to COVID-19 tests, treatments, and vaccines.

COVAX created COVID-19 vaccine introduction toolkit to equip countries with the necessary guidelines and items needed for safe delivery of vaccines.

The World Bank and GAVI encouraged countries to give away their excess doses in order to have the pandemic under control.

Cuba is developing two vaccines that are in late-stage trials: Soberana 2 and Abdala which will make the country the smallest country to make COVD-19 vaccines as well as the first Latin America country to develop a COVID-19 vaccine.

EU is discussing with Pfizer about the possibility of purchasing up to 1.8B vaccines to be delivered in 2022 and 2023.

Conference held by the African CDC and African Union outlined manufacturing expansion plan on the African continent. CEPI signed a memorandum of understanding to support African Union’s plan of expanding manufacturing capacity.

Kenya suspends the private sector involvement in COVID-19 vaccine procurement and distribution due to counterfeit vaccines.

The South Korea based company SK Bioscience will produce NOVAVAX’s shots in June 2021 with a planned delivery of 20M by end of fall.

Novavax reported experiencing lack of raw materials such as plastic bags that are hindering COVID-19 manufacturing.

A report by GreenLight Biosciences highlights the health and economic damage of COVID-19 and provides a blueprint to promoting vaccinations across the world.

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:	731 million
Low-income country total:	770 million
COVAX total:	1.12 billion
Total worldwide confirmed purchases of Covid-19 vaccines:	8.9 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

Tracking COVID vaccine regulatory approvals around the world

rwatkins — Fri, 18 Dec 2020 13:00:00 +0000

Tracking COVID vaccine regulatory approvals around the world rwatkins Fri, 12/18/2020 - 13:00

Weekly Insights and Interesting Trends

Tracking regulatory approvals around the world

We have seen a lot of movement in regulatory approval of Covid-19 vaccines over the past two weeks, as vaccination campaigns begin to roll out. When tracking the Covid-19 vaccine landscape, it is important to keep in mind the difference between emergency use authorization and full authorization. Most Covid-19 vaccine approvals received thus far have been limited to emergency use. This may be granted to address a health emergency, on the basis of early clinical trial data (generally results from Phase III trials), is temporary, and may place restrictions on the eligible population (e.g. age) and method of distribution. Vaccines receiving emergency use authorization are expected to apply for full regulatory approval (or licensure) after additional safety data is collected.

Regulatory approval for vaccines is complex in the best of times; there are at least 51 paths to various levels of authorization across 24 countries. While many countries do share information and coordinate in the process of regulatory approval, there is no global vaccine regulatory body, which means that vaccine developers need to seek authorization for every market in which they intend to sell.

Two mechanisms coordinated by the World Health Organization (WHO) help to streamline this process. The Emergency Use Listing process, recently launched by the WHO for public health crises, essentially provides a stamp of approval for unlicensed vaccines, therapeutics, and diagnostics in low- and middle-income countries. The WHO has not yet granted EUL status to any Covid-19 vaccine candidates, though several including Russia’s Sputnik V and Moderna have reportedly applied and are under review.

The WHO also maintains a list of Stringent Regulatory Authorities (SRAs), trusted national regulatory bodies whose decisions can be used to guide other countries. SRAs use rigorous and transparent processes for the review and approval of vaccines and therapeutics. Other governments can use approval by an SRA as the basis for expedited approval in their own country.

China was the first country to grant emergency to any Covid-19 vaccine candidates, approving CanSino for use in the Chinese military, and then Sinovac’s Coronavac for use in high-risk populations, before results from Phase III trials were known. Russia followed with emergency authorization for Sputnik V, again without any data from Phase III trials.

The (Beijing-based) Sinopharm vaccine is the first to receive full authorization in any country, after the UAE and Bahrain registered it this week, even before Sinopharm has reported Phase III results. China has granted emergency authorization to both (Beijing- and Wuhan-based) Sinopharm vaccines and is currently seeking full approval for domestic use.

However, China, Russia, Bahrain, and the UAE are not recognized as SRAs. We do not yet know whether the vaccines developed in China and Russia will be reviewed and approved by an SRA. Approval by a non-SRA regulator body may not provide enough safety and efficacy evidence for other countries to follow suit without a full review.

There are significant differences in the review process even among SRAs. For example, the UK review process relies on analysis provided by the vaccine developer while in the US, regulators conduct their own analysis with the raw data.

The Pfizer-BioNTech vaccine has been first out of the gate to receive emergency use authorizations from SRAs, which was followed by multiple other countries this week. The Pfizer-BioNTech vaccine now has emergency approval in the UK, the US, Canada, Chile, Ecuador, Mexico, Panama, Costa Rica, and Singapore.

Moderna has applied for emergency authorization in the US (the advisory committee has recommended authorization, which is expected next week), the EU, Canada, Switzerland, UK, Israel, and Singapore. As noted above, Moderna has also reported plans to apply for EUL with the WHO.

Other leading contenders are rounding the regulatory bend as well, with the finish line in sight. The Oxford-AstraZeneca vaccine is under review in the UK, with a decision expected in December or early January. Johnson and Johnson’s single-dose vaccine is under rolling review in multiple markets, including the EU, Canada and South Africa, and expects to apply for emergency use authorization with the US in February.

Interesting Trends

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

COVAX partners Gavi, CEPI, and WHO announced today that they have secured access to nearly 2 billion doses of Covid-19 vaccines. (Most of these doses fall under options on existing deals and are thus shown as potential in our data. We are seeking clarification on the purchase details and will update our data accordingly.) Pending regulatory approval of the vaccines, they expect to begin shipment of doses to all participating countries by the first quarter of 2021, a very positive development for global equity.

China made its first bilateral purchase of a Covid-19 vaccine, buying 100 million doses of the Pfizer-BioNTech vaccine through Shanghai Fosun Pharmaceutical Group.

The Inter-American Development Bank (IDB) announced it will mobilize $1 billion to support the purchase and deployment of Covid-19 vaccines for Latin America and the Caribbean. The IDB will work closely with COVAX and the Pan-American Health Organization (PAHO) in this effort. This funding commitment follows the $9 billion announced by the Asian Development Bank last week and the $12 billion announced by the World Bank in October to support procurement and distribution of vaccines in low- and middle-income countries.

Mild to serious allergic reactions were reported for individuals who took the Pfizer vaccines in the UK and US. This has led to discussions of whether any populations (e.g. people with known allergies) should be excluded from receiving this vaccine.

GSK-Sanofi’s clinical trial results were not promising in achieving the expected immune response in the elderly population, warranting the launch of another study in February 2021. Results from the new trial are expected by the end of 2021, a major setback for global supply of the vaccine.

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 billion
Upper-middle-income country total:	1.1 billion
Lower-middle-income country total:	1.8 billion
Low-income country total:	0
COVAX total:	870 million
Total worldwide confirmed purchases of Covid-19 vaccines:	7.7 billion doses