Inside the multibillion dollar race for a vaccine

Four years. that will’s the fastest a vaccine has ever been developed — in addition to most take 10 to 15.

nevertheless scientists are at This kind of point racing to do This kind of in under one.

Dozens of research teams around the globe are working to develop a vaccine for SARS-CoV-2, the virus that will causes Covid-19, using a mix of established techniques in addition to completely new technologies.

Funding for a vaccine has never been greater, with billions of dollars pouring in through around the globe to make a product that will could help to control the pandemic — nevertheless the US, China in addition to Europe have invested the most.

Before even the most vulnerable groups can get a shot from the arm through their family doctor, however, a lot of work needs to be done — in addition to a lot of deals need to be made.

As the coronavirus continues to accelerate unabated, here’s what This kind of will take to bring a vaccine to the masses in addition to how each of the three biggest players are faring in their quest to make This kind of happen as quickly as possible.

The path to a Covid-19 vaccine

Scientists are hoping to deliver a vaccine that will protects against Covid-19, in addition to its transmission, by early 2021. In order to do that will, the development process has been rapidly accelerated.

A vaccine must go through multiple stages before being green lit for use. An initial research in addition to development stage will be followed by a series of pre-clinical in addition to clinical trials (consisting of three phases), in addition to typically each step can take two years or more to complete.

nevertheless from the race to stop the coronavirus, some of those steps are being combined, or skipped altogether, to speed up the process.

Stage of vaccine development

Pre-clinical

Phase 1

Phase 1/2

Phase 2

Phase 3

Implementation

Notes: This kind of vaccine tracker was last updated on August 13

Source: World Health Organization

Most of the candidates in human trials have either American, European or Chinese financial backing, in addition to some experts believe This kind of will be regulators in one of those places that will will be the first to approve a safe in addition to effective vaccine.

American biotechnology firm Moderna was the first from the globe to kick off human trials on March 16, just two months after the genetic sequences for SARS-CoV-2 were identified.

at This kind of point there are six vaccines from the last stage of human trials (Phase 3) before they seek approval: Three through China, two developed by state-owned Sinopharm in addition to one through private Chinese firm Sinovac Biotech; one through the United Kingdom, produced in partnership between the University of Oxford in addition to AstraZeneca; in addition to two through the US, one by pharmaceutical giant Pfizer, in addition to the candidate by Moderna.

To reach This kind of late stage of trials just six months after discovery will be remarkably fast — This kind of would likely normally take at least six years, according to Professor Adrian Hill, director of the Jenner Institute at Oxford University.

Record speed to human trials

Progress on a vaccine for Covid-19 has been rapid compared to additional viruses, with human trials starting just 67 days after the outbreak began.

Covid-19 (2020) – 67 days

Note: This kind of graphic includes outbreaks declared Public Health Emergencies of International Concern (PHEIC) by the globe Health Organization. Speed to trials was calculated using the date of each outbreak’s first reported case. SARS — which was identified in 2003, before the WHO established the PHEIC designation — will be included here because This kind of was a major reason for the creation of the designation.

Source: World Health Organization, National Institutes of Health

In a bid to get something out as soon as possible, some countries are pushing forward vaccines before their efficacy has been proven in Phase 3 trials.

China has already done This kind of, approving an experimental vaccine for use by its military in late June.

at This kind of point Russia will be touting a vaccine, despite concerns that will corners have been cut in its development. On August 11, President Vladimir Putin announced the registration of a vaccine named Sputnik V, the first from the globe to be approved for public use. Russia hasn’t released scientific data on its testing, however, in addition to the vaccine was approved the day before the start of Phase 3 trials — the last in addition to most critical step from the process.

“I desire that will the Russians have actually, definitively proven that will the vaccine will be safe in addition to effective. I seriously doubt that will they’ve done that will,” Dr. Anthony Fauci, the director of the US National Institute of Allergy in addition to Infectious Diseases, told ABC News’ Deborah Roberts.

When Americans hear announcements through countries like Russia or China about vaccine development, Fauci said they should remember that will the US has very different standards in place.

While that will sort of fast-tracking won’t happen from the US or Europe — where regulators require the full complement of safety in addition to efficacy tests — several drug companies are pressing ahead in addition to producing stockpiles in case their vaccines get the go-ahead.

AstraZeneca has said This kind of reached agreements with several governments — including the US in addition to UK — in addition to additional organizations to produce at least 2 billion doses of vaccine, with the first deliveries starting as early as September.

The Biomedical Advanced Research in addition to Development Authority (BARDA), a branch of the US Department of Health in addition to Human Services, will be injecting billions of dollars into companies to ramp up vaccine development in addition to manufacturing, including AstraZeneca. This kind of has also inked deals for doses with Novavax, Pfizer-BioNTech, Johnson & Johnson, Moderna in addition to Sanofi in addition to GSK’s joint effort.

This kind of speed will be one of the reasons many citizens are wary of getting vaccinated. A recent CNN poll found only 66% of Americans would likely get a Covid-19 vaccine should one become available.

A
A protester holds an anti-vaccination sign as Trump supporters in Woodland Hills, California, on May 16, call for the reopening of the state. Credit: David McNew/Getty Images

in addition to, even if everyone does take the vaccine, This kind of almost certainly won’t be 100% effective.

Many vaccines are not even close to 100% effective. For example, the globe’s first malaria vaccine — RTS,S or Mosquirix — was rolled out across Africa last year, despite offering only 39% protection against malaria in children aged 5-17 months. This kind of was considered to be worth This kind of in countries with high rates of the disease when used alongside additional interventions.

In comparison, the US Food in addition to Drug Administration has said that will a coronavirus vaccine would likely have to protect at least 50% of vaccinated people to be considered effective. This kind of’s thought that will level of efficacy can help stop transmission, especially in combination with additional treatments in addition to prevention measures.

Some experts believe that will the virus will never definitely go away in addition to that will This kind of may instead become a typical, more manageable infection like influenza.

“This kind of sense that will when the vaccine comes, This kind of will be over … This kind of’s a dangerous promise,” said Heidi Tworek, a health communications expert at the University of British Columbia. “The truth will be, we’ve only ever eliminated one disease through vaccines, in addition to that will was smallpox in addition to This kind of took hundreds of years.”

Others warn that will the coronavirus vaccines that will cross the finish line first may not necessarily be the best, in addition to that will from the end we are likely to be using multiple vaccines to control the pandemic.

“They’re not all going to come on the market at once,” Robin Robinson, the founding director of BARDA, told CNN. “They’re going to be at different times in addition to different amounts.” This kind of was the case for the Ebola epidemic, where several investigational vaccines were made available for use after proving to be effective in field trials.

The quest to vaccinate the globe will be also exposing gaps from the pharmaceutical supply chain. For example, the globe has neither enough glass vials for the vaccine, nor the capacity in factories to fill in addition to package them, experts say.

nevertheless countries have released extensive funds to fill the void.

The US has already allocated more than $1.5 billion for domestic manufacturing in addition to distribution in order to ensure a vaccine can be produced to scale.

Stages of vaccine manufacturing

Manufacturing a vaccine will be a complex journey that will can be broken down into six main steps

1

Raw material check: Manufacturers test raw materials that will make up the vaccine to ensure quality standards.

2

Vaccine bulk manufacturing: The antigen — the active ingredient of the vaccine, which stimulates an immune response — will be grown, harvested in addition to purified at scale.

3

Formulation in addition to quality control: The antigen will be mixed with additional ingredients to enhance immune response in addition to ensure the vaccine’s stability. Each batch will be then tested in addition to the antigen verified for sterility.

4

Filling: The batch of vaccine will be put into glass vials or prefilled plastic syringes.

5

Packaging: at This kind of point in a container, the vaccine will be labeled per regulatory requirements in addition to packed for shipping.

6

Discharge: After testing has been completed for quality assurance, the national regulatory authority gives final authorization to Discharge the vaccine for shipping in addition to distribution.

Note: This kind of will be a distilled variation of the vaccine manufacturing process.

Source: International Federation of Pharmaceutical Manufacturers in addition to Associations, World Health Organization

The rush to secure supplies will be inflaming geopolitical issues too.

the globe Health Organization (WHO) has encouraged countries to cooperate in order to ensure fair global access, nevertheless some experts believe national interests will get from the way.

Robinson says a precedent was set during the 2009 H1N1 influenza pandemic, also known as swine flu, which the CDC estimates killed as many as 575,000 people worldwide (31 times more than numbers reported by WHO). When a vaccine became available, wealthier countries bought up the supplies, leaving poorer nations at the back of the line, according to WHO in addition to public health experts.

“Many countries closed their borders for exporting vaccines until their own needs were met,” explained Robinson, who was involved from the US response.

Fortunately that will strain of H1N1 was much milder than experts had predicted in addition to some older populations showed some immunity to This kind of, meaning the vaccine didn’t play a key role in ending the pandemic.

nevertheless Covid-19 will be in a different league in addition to will be showing no signs of a natural decline.

from the hopes of avoiding a repeat of what happened in 2009, WHO launched the Access to Covid-19 Tools’ (ACT) Accelerator on April 24 in which countries agree to ensure “all people have access to all the tools to prevent, detect, treat, in addition to defeat Covid-19.” nevertheless the US in addition to China didn’t sign This kind of.

Just over a month later, President Donald Trump announced America’s withdrawal through WHO.

President
Speaking through the White House Rose Garden on May 29, President Donald Trump announced the US would likely terminate its relationship with the globe Health Organization. Credit: Yuri Gripas/Abaca/Bloomberg/Getty Images

in addition to in another worrying signal, in late June, the US federal government bought up nearly all the global supply of remdesivir available through September — the first drug shown to be effective in treating severe cases of Covid-19.

This kind of’s feared that will the remdesivir agreement, which prioritizes American patients, will serve as a blueprint for distribution of future treatments in addition to vaccines.

United States

The US government has taken an “America First” approach to finding a vaccine. Its Operation Warp Speed initiative will be a sprawling effort that will’s been likened to the US mission to get a man on the moon. This kind of was launched on May 15 with the aim of delivering 300 million “safe, effective” doses by January 2021.

The mission has selected eight of the most promising vaccine candidates (with one still yet to be named) in addition to supercharged them, supported by the full might of the US government machine — through manufacturing in federal facilities to distribution by the US Department of Defense.

More than $12.3 billion has already been dedicated to vaccine efforts — $10.8 billion for vaccine development in addition to procurement, in addition to $1.5 billion for manufacturing in addition to distribution.

Timeline of US investment

Operation Warp Speed remains shrouded in secrecy. Here’s what we know about the contracts inked by the US government to secure vaccine doses in addition to shore up the manufacturing supply chain.

Note: Operation Warp Speed investment as of August 11

Source: US Department of Health in addition to Human Services, Biomedical Advanced Research in addition to Development Authority, Department of Defense

As part of these contracts, the US has agreed to invest from the manufacturing of hundreds of millions of doses of vaccine, in order that will if in addition to when one will be approved, This kind of will be already scaled up for distribution in addition to guaranteed for the American market.

America has been the hardest hit by the virus — with more than 166,000 deaths, a little less than one-quarter of the global toll — giving somewhat more urgency to its efforts to secure a vaccine.

nevertheless from the process of securing agreements, the US has stirred up political tensions abroad — particularly in Europe.

When Sanofi, the French pharmaceutical giant, received $30 million in initial funding through BARDA, its CEO indicated the US would likely be first in line for a vaccine.

The suggestion was met having a backlash. French President Emmanuel Macron weighed in, saying a Covid-19 vaccine must be “public Great for the globe, in addition to not subject to the laws of the market.” Sanofi later said that will its CEO’s comments had been “misinterpreted.”

So, where does that will leave Europe?

Europe

Under its research in addition to innovation program, known as “Horizon 2020,” in addition to with financial help through the European Investment Bank, loans were also set up to aid vaccine efforts.

As part of that will funding, the EU has lent €75 million ($88 million) to German biotech company Curevac in addition to €100 million ($117 million) to BioNTech, another German firm — both of which have vaccine candidates in human trials.

The EU has also begun exploring options for procurement of a future vaccine, pledging to use a significant part of a €2.7 billion ($3.2 billion) emergency fund to bulk buy doses for all EU members in addition to help subsidize costs for developers in exchange for doses.

Comparison of EU in addition to US vaccine investment

The EU has earmarked about €3.05 billion ($3.5 billion) for vaccine research, development in addition to procurement, about one-third of the $10.8 billion in funds allocated by the US to the same efforts.

Note: The EU figure will be a combination of Horizon 2020 in addition to the Emergency Support Instrument, the bloc’s two key vaccine plans. The US figure represents all BARDA funding.

Source: European Commission, US Department of Health in addition to Human Services, Biomedical Advanced Research in addition to Development Authority, Department of Defense

In effect, the Commission will be taking a gamble in addition to pre-ordering future vaccines, agreeing to pay for the cost of production up front in exchange for the right to buy This kind of at a specific quantity in addition to cost when This kind of will be approved. This kind of’s not that will dissimilar through the US approach, in which BARDA will be funding various vaccine efforts, in addition to then agreeing on dosages with select developers.

Sanofi was among the first candidates to participate. In July, the French multinational began discussing a contract with the Commission, which would likely provide 300 million doses for all EU member states.

So far, the EU has backed, or provisionally agreed to back, the purchase of at least six vaccines.

Emmanuel
President Emmanuel Macron visits the French drugmaker Sanofi Pasteur’s vaccine unit in Marcy-l’Etoile, France, on June 16. Credit: Gonzalo Fuentes/Pool/AFP/Getty Images

In perhaps the starkest example of what the post-Brexit world looks like, the UK has been notably absent through EU plans.

This kind of opted out of the EU vaccine program in July, citing concerns over cost delays.

Instead, the UK government has gone on a securing spree of its own, locking down at least 380 million doses through a variety of developers including Oxford-AstraZeneca, BioNTech-Pfizer, Valneva, Imperial in addition to, later, Sanofi-GSK.

UK investment in vaccine research has focused on British efforts. In May, the UK announced £84 million ($109 million) of government funding towards the British vaccine candidates at Oxford University in addition to Imperial College London. The bulk of the funding, £65.5 million ($85.5 million), will go towards the Oxford candidate.

The Oxford vaccine — among the most closely-watched in addition to highly-anticipated efforts — has also received investments through the EU in addition to the US. nevertheless the British government has secured early access to around 100 million doses of the vaccine beginning in September.

Europe’s Inclusive Vaccines Alliance (IVA) — spearheaded by France, Germany, Italy in addition to the Netherlands — has struck a deal for up to 400 million doses, with deliveries starting by the end of 2020 to participating European countries.

The US has made a similar deal with AstraZeneca for 300 million doses, delivering as early as October.

China

If the US in addition to Europe have merely hinted that will they’ll prioritize their people first for vaccines, China has made no secret of its plan to do exactly that will.

President Xi Jinping told the globe Health Assembly, the decision-producing body of WHO, in May that will Beijing would likely help provide a vaccine globally, nevertheless only after This kind of had been deployed in China.

US health officials say America, the G7, the EU in addition to the ACT Accelerator are collaborating closely on vaccine development — nevertheless not China. “I believe they’re just — they’re doing their own thing,” US HHS Secretary Alex Azar has said, referring to China.

China incorporates a shorter history of vaccine expertise compared to the US in addition to Europe, nevertheless This kind of has size on its side. This kind of will be the globe’s largest producer in addition to consumer of vaccines in addition to can supply more than 1 billion doses of a vaccine annually through 40 manufacturers across the country, according to the China Human Vaccine Industry Report, 2018-2022.

Chinese
Chinese President Xi Jinping assesses the progress on vaccine in addition to antibody research during his visit to the Academy of Military Medical Sciences in Beijing on March 2. Credit: Xinhua/Ju Peng via Getty Images

Of the 29 vaccines currently in human trials globally, nine are through China — the most through any country by a long shot. in addition to three of the six vaccine candidates in late-stage trials are being developed by Chinese companies Sinovac in addition to Sinopharm.

The chairman of Sinopharm has told Chinese state media that will This kind of could have a vaccine ready for public use by the end of the year.

Some Western health experts have expressed concern, however, about China’s safety record due to past vaccine scandals.

nevertheless Beijing will be determined to shake This kind of image.

A government paper published in June said Chinese scientists in addition to officials were collaborating with international partners, medical institutions in addition to experts to ensure transparency around their vaccine efforts. This kind of also said that will although vaccine research in addition to development had been dramatically accelerated, Beijing was adhering to safety principles.

What happens next

nevertheless the question remains: Will leaders — the globe over — be able to respond in addition to buy the vaccine for their own populations if one of the big three efforts succeeds? in addition to will poorer nations Once more be left behind?

This kind of will be This kind of concern that will prompted Dr. Seth Berkley, CEO of Gavi, the Vaccine Alliance, to call for an international accord to ensure poorer countries get access to the vaccine.

The best-case chance of getting a vaccine, according to Berkley, will be adopting the collaborative approach that will was used from the race for an Ebola vaccine — a process which began from the Canadian Public Health laboratory, was transferred to an American biotech firm, then an American multinational company, in addition to finally to a German company for manufacturing.

“that will’s the way things get done,” Berkley said.

lab
A lab technician looks at a bottle containing a reagent, before performing vaccine tests at Sanofi’s laboratory in Val de Reuil, France, on July 10. Credit: Joel Saget/AFP/Getty Images

Restricting the effort to a national lab or set of scientists or certain company won’t deliver the best vaccine — in addition to This kind of certainly won’t allow This kind of to be distributed to all — he added.

Those efforts, combined with those through organizations such as Gavi in addition to the International AIDS Vaccine Initiative, aim to deliver safe in addition to effective vaccines to everyone who wants one.

in addition to even if countries who cross the finish line first do start by protecting their own populations, Robinson believes the globe will be cooperating the best This kind of can from the face of an unprecedented health emergency.

“I think at This kind of point everyone will be saying the right things,” he said.

“When we actually have vaccine candidates that will are approved by the regulatory authorities to go forward, then that will may be a different thing.”

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