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Staff gather outside Rome's Lazzaro Spallanzani National Institute for Infectious Diseases on Aug. 24, the first day of human trials for a made-in-Italy coronavirus vaccine.

Yara Nardi/Reuters

Italy treated its entry into the race to develop a COVID-19 vaccine as a national event, as if it were unveiling the country’s Olympic squad.

“Today, the Italian vaccine has begun human trials,” Health Minister Roberto Speranza wrote on his popular Facebook page on Aug. 24. “Our country’s brainpower and research are at the service of the global challenge to defeat COVID.”

He was referring to the launch of the first clinical trials of a vaccine candidate developed by Italian biotech company ReiThera. The trials will be managed by Rome’s Lazzaro Spallanzani National Institute for Infectious Diseases, a prominent front-line warrior in Italy’s six-month battle against the pandemic, and will see 90 healthy volunteers monitored for 24 weeks to determine the vaccine’s safety and ability to trigger an immune response.

Story continues below advertisement

If all goes well – if the volunteers do not get horribly ill – the wider Phase 2 and Phase 3 trials will start late this year in a virus-rich country such as Mexico, where the pandemic is still running rampant. The ReiThera vaccine is based on a cold virus from a gorilla, and biotech observers think it has a fair chance of emerging from the trials in flag-waving form.

While Italy, the original European epicentre of the pandemic, is proud that it is finally in the vaccine game in a serious way, it is entering an exceedingly crowded race. Every country, it seems, wants a piece of the vaccine action, and the political forces propelling the launch of vaccine candidates are powerful – and potentially dangerous.

At last count, on Aug. 28, the World Health Organization had recorded 33 vaccine candidates in clinical evaluation trials (Phases 1, 2 or 3) and 143 in preclinical trials – in total, almost 180 research efforts to find a safe and effective way to build mass immunity to a highly contagious disease that has killed more than 864,000 people around the world since January (other estimates put the vaccine candidate count higher). The three front-runners come from Oxford University and Britain’s AstraZeneca; China’s Sinovac Biotech; and U.S. drug inventor Moderna in partnership with that country’s National Institute of Allergy and Infectious Diseases.

race for a vaccine

A study by McKinsey & Co. has noted more than

250 COVID-19-vaccine candidates in development

globally, using a wide range of technologies

Vaccine candidates by technology platform

and development phase

Repurposed

Preclinical

4

Preclinical

(animal studies)

Inactivated

12

Phase I

Phase I/II

Live attenuated virus

10

Phase II

Phase II/III

Virus-like protein

16

Phase III

DNA

20

RNA

26

Undisclosed

33

Viral vector

44

Protein-subunit vector

88

Phase I: first-human studies for safety, side effects, dosing

and immune response. Tested on small groups.

Phase II: further safety and effectivenessesting on larger

groups up to several hundred people.

Phase III: randomized and double blind study that includes

vaccine being tested against a placebo on very large groups.

JOHN SOPINSKI/THE GLOBE AND MAIL, SOURCE:

mckinsey & co. (via BioCentury; ClinicalTrials.

gov; Milken Institute COVID-19 Treatment and

Vaccine Tracker; press search); philadelphia

college of physicians

race for a vaccine

A study by McKinsey & Co. has noted more than 250

COVID-19-vaccine candidates in development globally,

using a wide range of technologies

Vaccine candidates by technology platform

and development phase

Repurposed

Preclinical

4

Preclinical (animal studies)

Inactivated

Phase I

12

Phase I/II

Live attenuated virus

Phase II

10

Phase II/III

Virus-like protein

Phase III

16

DNA

20

RNA

26

Undisclosed

33

Viral vector

44

Protein-subunit vector

88

Phase I: first-human studies for safety, side effects, dosing and immune

response. Tested on small groups.

Phase II: further safety and effectivenessesting on larger groups up

to several hundred people.

Phase III: randomized and double blind study that includes vaccine being

tested against a placebo on very large groups.

JOHN SOPINSKI/THE GLOBE AND MAIL, SOURCE: mckinsey

& co. (via BioCentury; ClinicalTrials.gov; Milken

Institute COVID-19 Treatment and Vaccine Tracker;

press search); philadelphia college of physicians

race for a vaccine

A study by McKinsey & Co. has noted more than 250 COVID-19-vaccine

candidates in development globally, using a wide range of technologies

Vaccine candidates by technology platform and development phase

Repurposed

Preclinical

4

Preclinical (animal studies)

Inactivated

Phase I

12

Phase I/II

Live attenuated virus

Phase II

10

Phase II/III

Virus-like protein

Phase III

16

Phase I: first-human studies for safety,

side effects, dosing and immune

response. Tested on small groups.

DNA

20

Phase II: further safety and effectiveness

testing on larger groups up to several

hundred people.

RNA

26

Undisclosed

Phase III: randomized and double blind

study that includes vaccine being tested

against a placebo on very large groups.

33

Viral vector

44

Protein-subunit vector

88

JOHN SOPINSKI/THE GLOBE AND MAIL, SOURCE: mckinsey & co. (via

BioCentury; ClinicalTrials.gov; Milken Institute COVID-19 Treatment

and Vaccine Tracker; press search); philadelphia college of physicians

Trials of a Chinese-sponsored vaccine get under way in Manama, capital of Bahrain.

MAZEN MAHDI/AFP via Getty Images

To be sure, jingoism is part of the motivation to invent a life-saving vaccine, but only a small part.

Governments fear vaccine nationalism will ensure that the countries that develop a vaccine will naturally exhaust the production run on their own citizens, leaving little or nothing for outsiders. The best insurance policy against nationalism is, of course, nationalism. If ReiThera’s vaccine works, Italy, with ample pharmaceutical manufacturing capacity, should be able to pump out torrents of it to keep its own people above ground.

“Countries may say that they support equitable access, but hoarding is already happening,” said Els Torreele, the Belgian biomedical researcher and former director of the Médecins Sans Frontières Access Campaign, the charity’s effort to ensure the poor can receive affordable medicines and medical treatment. “You may think as a government that you are expected to protect your own population first, but it undermines global solidarity.”

While politicians are working hard to ensure their countries get ample supplies of vaccines, the political pressure could backfire, Dr. Torreele said, if regulatory corners are cut to rush vaccines to market. Quickie approvals might deliver vaccines that are weak or, worse, dangerous. “What I fear is that we will end up with vaccines that are far less effective than they should be,” she said.

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Andrea Crisanti of the University of Padua worries that getting a vaccine too quickly could make it 'dangerous or inefficient.'

John Sopinski/The Globe and Mail

That’s also the view of Andrea Crisanti, the Italian microbiologist and professor at the University of Padua who was an early proponent of mass testing to detect asymptomatic cases. His research in the town of Vo, in northeastern Italy, early in the pandemic determined that 40 per cent of COVID-19 cases were asymptomatic. In an interview in July, he said vaccines are “complex” beasts that normally require many years of research and trials on human guinea pigs to get right.

He added that the record vaccine jaunt from start to finish was 3½ years, for the Ebola vaccine, rVSV-ZEBOV, which was created in Canada and approved in 2019. Despite decades of effort, there are no vaccines for other ugly and often fatal viral or parasitic infections, including malaria, HIV and hepatitis C.

“The turnaround for a vaccine is usually five to 10 years, and you need a huge population to get the testing right,” Dr. Crisanti said. “If we have a [COVID-19] vaccine by the end of the year, it could be dangerous or inefficient.”

The WHO has said that a vaccine should be at least 50 per cent effective, meaning half the injected population would be protected from the disease. But the WHO guidelines are just that – guidelines. The agency has no legal authority to ensure that vaccines are, say, 90 per cent effective, and some former drug regulators have suggested that less than 50 per cent for a first-generation vaccine should be acceptable, even welcome, given that the pandemic is in full swing in the United States, Latin America, India and other parts of the world. Their argument is that saving a few lives is better than saving none and that the second-generation vaccines will up their game.

Still, the WHO is warning that truly lousy vaccines could emerge soon.

“There is a danger that political and economic pressures for rapid introduction of a COVID-19 vaccine could lead to widespread deployment of a vaccine that is in reality only weakly effective, perhaps because of a misleadingly promising result from an underpowered trial,” the WHO’s Solidarity Vaccines Trial Expert Group said in an Aug. 27 article in the Lancet medical journal. “Deployment of a weakly effective vaccine could actually worsen the COVID-19 pandemic if authorities wrongly assume it causes a substantial reduction in risk, or if vaccinated individuals wrongly believe they are immune.”

Vials of a Russian vaccine candidate are shown at the Nikolai Gamaleya National Center of Epidemiology and Microbiology in Moscow.

Alexander Zemlianichenko Jr/ Russian Direct Investment Fund via AP

Political pressure for a vaccine or treatment is intensifying as the body counts rise. U.S. President Donald Trump is leading the charge, with enthusiastic support from Russian President Vladimir Putin and British Prime Minister Boris Johnson.

Last month, Mr. Putin’s government was the first to approve a COVID-19 vaccine, known as Sputnik V, even though it had undergone no large-scale testing, with no published results from the small Phase 1 trial. Later in the same month, Mr. Trump announced the approval of a convalescent plasma therapy for COVID-19, which he claimed was a “historic breakthrough” that could result in 35 per cent fewer deaths. His information came from a study that was wildly misinterpreted by U.S. Food and Drug Administration commissioner Stephen Hahn. He later admitted his mistake; the plasma success rate is nowhere near as high.

Pierre Morgon, a Swiss-based biotech consultant and vaccine specialist, does not agree that fast-tracking approvals will automatically result in the delivery of potentially faulty or ineffective vaccines. He pointed out that the first novel coronavirus genome sequence was published in early January, giving biotech companies a head start in vaccine development, and that the trial results will be published by the vaccine developers, ensuring transparency. It’s not in any drug company’s best interests to rush the delivery of a vaccine that saves few lives. Still, he thinks it’s unlikely that an effective vaccine will achieve widespread distribution before this time next year, citing manufacturing and supply-chain constraints. “We’ll start to get some clarity by the end of this year about timing,” he said.

He thinks the vast majority of the vaccines under development will be stillborn. The high number of attempts, he says, is in good part the result of quick and easy financings to advance their sponsors’ technologies. “Governments and NGOs are throwing massive amounts of money at this effort, and biotech companies are taking what they can get,” he said.

But the biotech players who haven’t received their loot yet are running out of time, because governments and other vaccine funding bodies are shifting their focus from the labs to production and distribution deals. Canada is among them; it recently struck agreements with Novavax, Johnson & Johnson, Pfizer and Moderna to secure access to millions of vaccine doses. “The money is shifting from upstream to downstream,” Mr. Morgon said.

Just how many vaccines will make it to market, when they will do so, which countries they will come from and how effective they will be remain open questions. As thousands continue to die every day from COVID-19, political leaders who are facing re-election, such as Mr. Trump, will push ever harder for a vaccine – any vaccine. Politics and science never make good companions, and shoddy vaccines cannot be ruled out.

Story continues below advertisement


How do COVID-19 vaccines work?

There are several approaches to making a vaccine, some of which are being tried for the first time in humans against COVID-19. While different, all approaches seek to trigger an immune response by placing fragments of the coronavirus on the surface of antigen-presenting cells. They bring the proteins to other immune cells which are then activated to identify and fight anything that carries the same structure. Here are four strategies used by some of the leading global candidates as well as vaccines that are approved for or nearing clinical trials in Canada

1

PROTEIN-BASED VACCINES

Fragments of coronavirus spike proteins

Antigen-

presenting cell

Portions of coronavirus protein are displayed to trigger immune response

VIRUS-LIKE PARTICLE (VLP)

2

Mimics structure of coronavirus but lacks genetic material to reproduce

Antigen-

presenting cell

3

ADENOVIRUS VECTOR

Artificially altered virus includes DNA instructions to surround itself with coronavirus proteins

RNA VACCINE

4

RNA surrounded in a lipid envelope

Host cell uses RNA instructions to make coronavirus proteins

Coronavirus proteins produced within host cells are now free to be taken up and presented to immune system like a protein-based vaccine.

MURAT YÜKSELIR AND IVAN SEMENIUK /

THE GLOBE AND MAIL

There are several approaches to making a vaccine, some of which are being tried for the first time in humans against COVID-19. While different, all approaches seek to trigger an immune response by placing fragments of the coronavirus on the surface of antigen-presenting cells. They bring the proteins to other immune cells which are then activated to identify and fight anything that carries the same structure. Here are four strategies used by some of the leading global candidates as well as vaccines that are approved for or nearing clinical trials in Canada

1

PROTEIN-BASED VACCINES

Fragments of coronavirus spike proteins

Antigen-

presenting cell

Portions of coronavirus protein are displayed to trigger immune response

VIRUS-LIKE PARTICLE (VLP)

2

Mimics structure of coronavirus but lacks genetic material to reproduce

Antigen-

presenting cell

3

ADENOVIRUS VECTOR

Artificially altered virus includes DNA instructions to surround itself with coronavirus proteins

RNA VACCINE

4

RNA surrounded in a lipid envelope

Host cell uses RNA instructions to make coronavirus proteins

Coronavirus proteins produced within host cells are now free to be taken up and presented to immune system like a protein-based vaccine.

MURAT YÜKSELIR AND IVAN SEMENIUK / THE GLOBE AND MAIL

There are several approaches to making a vaccine, some of which are being tried for the first time in humans against COVID-19. While different, all approaches seek to trigger an immune response by placing fragments of the coronavirus on the surface of antigen-presenting cells. They bring the proteins to other immune cells which are then activated to identify and fight anything that carries the same structure. Here are four strategies used by some of the leading global candidates as well as vaccines that are approved for or nearing clinical trials in Canada

ANTIGEN-PRESENTING CELL

Portions of coronavirus protein are displayed to trigger immune response

1

PROTEIN-BASED VACCINES

Fragments of coronavirus spike proteins

VIRUS-LIKE PARTICLE (VLP)

2

ANTIGEN-PRESENTING CELL

Mimics structure of coronavirus but lacks genetic material to reproduce

3

ADENOVIRUS VECTOR

ANTIGEN-PRESENTING CELL

Artificially altered virus includes DNA instructions to surround itself with coronavirus proteins

RNA VACCINE

HOST CELL

4

Coronavirus proteins produced within host cells are now free to be taken up and presented to immune system like a protein-based vaccine.

RNA surrounded in a lipid envelope

Host cell uses RNA instructions to make coronavirus proteins

MURAT YÜKSELIR AND IVAN SEMENIUK / THE GLOBE AND MAIL

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