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Coronavirus Vaccines Are Being Fast-Tracked And Calming Fears Over Safety Is Vital

It’s been likened to the Cold War-era space race: countries across the globe, all vying to lay claim to the first coronavirus vaccine.

With more than 23 million cases recorded worldwide and in excess of 800,000 deaths, the stakes have never been higher.

But while a new vaccine can take in excess of 10 years to develop, the sheer scale of the crisis has created overwhelming pressure to fast-track this process.

With more than 150 COVID-19 vaccines currently in development, there are hopes a prospective candidate could be available as early as this year.

And with that come inevitable questions around safety and what can be done to allay community concerns.

‘It is going to be produced more quickly’

With global economies thrust into a “crisis like no other”, the pandemic has fostered an undoubtable sense of urgency.

In the United States, authorities have vowed to slash “red tape to develop vaccines and therapies as fast as it can possibly be done”, while the so-called Oxford vaccine could be available by early next year, should further trials succeed.

Closer to home, one of Australia’s leading vaccine candidates — being developed by the University of Queensland — has yielded positive pre-clinical trial results, with preliminary results from human trials expected by the end of September.

“Everything is being accelerated, everyone is working with data in real-time and nobody is waiting for the next milestone before they proactively start the other things that need to happen, in particular relating to manufacturing and planning for clinical trials,” says Trent Munro, the University of Queensland’s vaccine roll-out project director.

A normal vaccine timeline is “around 10 to 15 years”, echoes Margie Danchin, a vaccine researcher at the Murdoch Childrens Research Institute.

“And now we’re looking at a timeline anywhere between nine to 18 months.

Indeed, Australian health authorities have vowed that if and when any vaccine becomes available, “it will go through all the necessary checks and balances”.

But this level of rigour has not been extended everywhere.

Just two months after human trials began, Russia announced approval for its own vaccine (dubbed Sputnik V), despite skipping the all-important phase 3 of clinical trials — a move labelled “reckless” by some within the medical community.

“Most Western scientists and medical professionals are concerned about that,” says Paul Komesaroff, a practising physician, ethicist and professor of medicine at Monash University.

“But it seems clear in that setting they’ve made a judgement that the urgency is such that they’re prepared to at least take some kind of risk.”

‘There has to be a judgement’

This sense of urgency has become a sticking point for those with concerns over a prospective vaccine — something Associate Professor Danchin fears will lead to an increase of “vaccine hesitancy”.

It is a sentiment echoed by Professor Komesaroff, who points to the potential repercussions of bypassing large-scale clinical trials, as is the case in Russia.

“It’s easy to understand why there’s a safety issue here and what the consequences may be,” he says.

“One needs to allow sufficient time to be able to identify whether an adverse effect has occurred [in clinical trials], because it may not be apparent in the first instance.”

While vaccines more broadly are “exceedingly safe” and often come under “undue criticism”, Professor Komesaroff adds, “the possibility of an adverse effect is always there”.

He points to the Cutter Incident in 1955, where over 250 cases of polio were attributed to some batches of a vaccine containing the live polio virus, produced by one company — a defining moment in the history of vaccine manufacturing and oversight that led to significant reform.

“Now that’s obviously a terrible disaster and tragedy, but it’s possible and it has happened, even if it’s exceedingly rare,” Professor Komesaroff says.

A ‘perfect storm’ for anti-vaxxers, but what about the fence-sitters?

Amid suggestions vaccine coverage may need to be as high as 80 per cent to ensure herd immunity, experts say it is imperative community concerns are appropriately acknowledged and addressed.

The coronavirus pandemic has created a “perfect storm” for anti-vaccination activity, says Associate Professor Danchin, “because people are already so uncertain and so concerned by what’s going on”.

But she also points to another group — those who are vaccine hesitant or “sitting on the fence”.

“So it’s absolutely vital now that we are trying to understand very clearly what those concerns are and that we are addressing them.”

In the current climate, this will require authorities to clearly articulate the process of testing for new vaccines and “the safety checks that go into that”, adds Katie Attwell, a senior lecturer in the School of Social Sciences at the University of Western Australia.

“And then explain how it is we’ve been able to do it more quickly this time,” she says.

“[Explaining] the fact that we’ve gone through the same procedures, for example, but going through larger groups of people at once means the trials can be concluded more quickly.”

Researchers also point to the increased collaboration among domestic and international organisations working to develop a prospective vaccine, which has allowed them to fast-track the process.

Professor Munro says the organisation implemented “robust” safety checks prior to moving to clinical testing, to ensure “we were making the right decisions and not cutting corners”.

As the vaccine moves into phase 2 and 3 trials, he adds, “there will be an absolute focus on ensuring, whether it’s safety signals or whether they enrol the right type of people, that all of that happens as safely as possible”.

The need for transparency

For Professor Danchin, bolstering the national uptake of any prospective vaccine will hinge on one key factor: trust.

And that also means being transparent about any potential side-effects, which are “expected and normal”.

During phase 1/2 trials of the Oxford vaccine, for example, 17 per cent of participants reported developing a fever, while more than six-in-10 had a headache.

Similarly, more than half of the 45 healthy volunteers who took part in Moderna’s phase 1 trial into a coronavirus vaccine experienced mild or moderate reactions such as fatigue, headache, chills and muscle aches.

“So it looks like these coronavirus vaccines are going to be more reactogenic, and what that means is create more local reactions or side effects like redness and swelling or systemic reactions like fever or body aches.

“So if we’re communicating clearly and transparently with people to expect these reactions then people don’t feel like they’ve been lied to… and that’s what I mean about creating trust.”

Attitudes towards a prospective vaccine will be “embedded in people’s trust of government”, adds Dr Attwell, who has cautioned against positioning it as mandatory before it’s even available.

“If we do end up in a scenario where the communications are not well managed, that could really put the rollout of the vaccine at risk and then mean that governments have to look to more coercive policies which are going to be unpopular,” she says.

“And they’re going to be more unpopular if more people are not on board with the vaccine, so it could be a very vicious cycle there and one we should try and avoid as much as possible.”


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