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THE END OF the year is fast-approaching and pharmaceutical companies and scientists have been working flat-out all through 2020 to develop a safe and effective vaccine for the virus that causes Covid-19.
Health officials have said the roll-out of a vaccine is the only thing that can ensure a full return to the normality people knew before this pandemic. Although the research is by no means complete, there is a strong sense of optimism in the medical and scientific community about the prospect of a vaccine in 2021.
Dr Fidelma Fitzpatrick, consultant and senior lecturer in microbiology at the Royal College of Surgeons (RCSI) has said the speed of pace in this race for a vaccine has been “amazing”.
“It normally takes between five to 10 years to bring a vaccine to market,” she told TheJournal.ie. “Usually one of the biggest hurdles can be funding, which doesn’t seem to be an issue now. Other issues can be manufacturing, logistics and scaling up. But it all starts in the lab with scientists in the pre-clinical stages.
“There is a huge amount of pre-clinical work before it gets to clinical trials – cell culture and animal testing before moving to tests on human. Most vaccine candidates stop at this point.”
After the pre-clinical stage and before a vaccine can be manufactured, it goes through three phases of clinical trials.
Phase One involves between 20 and 100 volunteers and the intention is to establish whether the vaccine is safe, whether it seems to work and whether there are any serious side effects. This phase will also look at how the size of the dose may be related to side effects.
Phase Two will involve several hundred people and aims to establish the most common short-term side effects and how the immune systems of those who have been given the vaccine respond.
Phase Three is the most crucial and the most thorough. It involves hundreds of thousands of people, some of whom will be given a placebo.
This phase examines how people who get the vaccine compared with those who get the placebo, whether it is safe and/or effective and it also aims to catch less common side effects as it involves a larger – and ideally more diverse – pool of people.
The results of the the trials go straight to regulators for examination after Phase Three and if the vaccine is approved based on the results, it can begin to be manufactured and administered.
The World Health Organisation has said 44 candidate vaccines are in clinical evaluation with 10 of those at the Phase Three clinical stage. These are:
Some methods for making a vaccine are tried-and-true, while others remain experimental.
Inactivated ‘classic’ vaccines use a virus germ that has been killed or a weakened or “attenuated” strain that is virulent enough to provoke antibodies but not to cause disease. Other inactivated vaccines include polio, hepatitis A and rabies.
Viral vector varieties use other forms of live virus to deliver DNA into human cells, triggering an immune response. A measles virus modified with a coronavirus protein, for example, could be deployed against Covid-19.
The Johnson & Johnson vaccine uses a dose of a cold-causing adenovirus, modified so that it can no longer replicate. This is combined with a part of the new virus, SARS-CoV-2, called the spike protein that it uses to invade human cells.
‘Sub-unit’ vaccines, such as the Novacvax one, contain a fragment of the pathogen that it is derived from to produce an appropriate immune response. Other examples include the HPV and hepatitis B vaccines.
There are also experimental gene-based vaccines using DNA or RNA fragments.
How the trials are progressing
Results from many of these initial phases are encouraging, but until Phase Three data from these vaccines is published, it is too early to tell which ones could be used en masse.
Preliminary results from Sinpharm‘s trials, published in The Lancet journal, show it provoked an immune response. The company has said it anticipates antibodies from its jab to last between one and three years.
Recently the Sinovac vaccine, even though it hasn’t been approved for mass market distribution, was made available to some residents in an eastern Chinese city. Officials said the vaccine would be given to people aged between 18-59 with “urgent needs”. The vaccine requires two doses, given up to 28 days apart. The company has also already completed construction of a vaccine factory able to produce 300 million doses a year.
In September, trials on the coronavirus vaccine developed by AstraZeneca and Oxford University were paused after a UK volunteer developed an unexplained illness. The vaccine is one of the most advanced Western projects, having already been tested on tens of thousands of volunteers worldwide. British regulators and an independent review concluded the illness was not a side effect of the vaccine.
Trials resumed earlier this month in Japan but not the United States, where AstraZeneca is working with regulators. This week it was confirmed that a volunteer participating in clinical trials of the vaccine developed by Oxford University had died, but the man had received a placebo, rather than the active vaccine. The Phase Three trial is continuing.
During the summer, China’s military approved the CanSino vaccine for use within its ranks. Pakistan regulators also approved Phase Three testing for this vaccine in the country’s first ever clinical trial of this kind. However this vaccine uses a weakened human cold virus, adenovirus 5, and the Phase Two trial found high pre-existing immunity to this cold virus in participants reduced the immune response.
The Russian vaccine, developed by Gamaleya Research Institute, has already been used to vaccine high-profile Russians, including President Vladamir Putin’s daughter. Patients in early trials involving 76 people all developed antibodies, according to research published in The Lancet medical journal last week, while experts said the trials were too small to prove safety and effectiveness.
The Johnson & Johnson trial was paused recently over safety concerns after one patient became sick. Its Phase Three had started recruiting participants in September with a goal of enrolling up to 60,000 people. Pre-clinical testing on rhesus macaque monkeys that were published in the journal Nature showed it provided complete or near-complete protection against virus infection in the lungs and nose.
The US firm Novavax, which uses insect cells to grow synthesised pieces of the spike protein of the SARs-CoV-2 virus. Its early trials found the vaccine was well-tolerated and elicited robust antibody responses. The company has said it proved the efficacy of a flu vaccine using this same technology.
Initial results from Moderna‘s trials indicate those who receive the vaccine produce antibody reactions from T-cells (a type of white blood cell). The company recently said it had successfully recruited ethnic minorities, older people and those with underlying conditions for its Phase 3 trial as it works to “develop a vaccine for everyone, including communities that have historically been under-represented”. It is aiming to file for authorisations soon after 25 November.
The Pfizer vaccine’s first two phases showed it produces antibodies and T-cell responses specific to the coronavirus protein. It has said it will apply for emergency authorisation in the US in late November if safety data pans out.
Optimistic
Dr Fitzpatrick said the pace at which these vaccines have been developed has been “remarkable” and she is optimistic about the development of a safe vaccine.
“It can take nearly 10 years to complete a vaccine and we have 10 of them at Phase Three already so that has to be cause for optimism.
“It’s so unprecedented, in October to have this number of candidates, anything can happen. Once we get to one or more being approved, the big question is where do you start? And how do you compare different trials? The WHO is now looking at trying to harmonise the methodology for vaccine makers to better facilitate that. We need to be able to compare like with like.
“Once we get that sorted we’re looking at the global distribution issues. Who do we prioritise, which areas of the world, which groups of people? How do we ensure we don’t overwhelm the cold chain? Because they have to be transported in fridges.”
She said it is likely that the first people to receive the vaccine will be healthcare workers and those in high-risk groups. However she said people should bear in mind that they will likely have to keep going with infection control measures for some time.
“The whole world isn’t going to get it at once,” she said. “This isn’t the be all and end all.”
“We will still have unknowns, like how long does it last and what we do in terms of people who just don’t respond to the vaccine, but there are other options such as giving monoclonal antibodies that might be open approach down the road.”
Fitzpatrick said she acknowledges some people may be wary of getting a new vaccine – and one that has been developed so quickly.
Knowledge is power here. I always say to people to go and read the facts for themselves, go to reliable sources to inform yourself when you’re making a decision.
“There has never been a time when the entire world has been so focused on one type of vaccination programme so there will be huge scrutiny of the safety of these vaccines. The whole point of the Phase Three trials is to find any rare side effects that wouldn’t come through in the Phase One and Two trials.
“This isn’t going to get a free pass, there’s too much to lose, the entire world is looking at it so the regulators aren’t just going to push things through.”
- With reporting from AFP.
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Everybody should ban/boycott the rag! Hillsborough was enough of a reason on its own
@Soccer T’s: Some people still believe in freedom of the press believe it or not.
@Soccer T’s: some of us still believe in the freedom of the press believe it or not.
@Charlie Hebdo:
the sun is not freedom of press it is rupert murdoch and the belief system. There is a huge difference between cutting edge analysis and insulting, lazy and vindictive journalism.
@Charlie Hebdo: and some of us believe in the truth
@ktsiwot: I am no fan of the Sun but I believe in freedom of the press for all news outlets, not just the ones I like or agree with.
@Charlie Hebdo: freedom of the press to insult and incite a whole community through disgusting narrow minded racist and elitist articles? Absolutely.
And in turn we should all exercise our right to boycott this sensationalist braindead rag of pure tripe.
Agreed?
@Charlie Hebdo: Did I say they should be closed down or anything like that? No I said that people/individuals should make the choice to boycott the rag. The more that boycott them the less viable their business model.
“Everybody should ban/boycott the rag! ”
Ban ≠ Boycott.
Reading comments here it appears “everyone” already boycotts it and have done for years.
@Charlie Hebdo: You’re looking for drama where there is none. If I had said that the paper should be shut down, you would have a valid point but I’m afraid you will have to find your drama elsewhere today. People/ organisations being encouraged to ban/boycott is not censorship!!
@Charlie Hebdo: I don’t think “everyone” comments on the journal but I may be wrong.
@Charlie Hebdo: Using “Freedom of the Press” as a means of defending The Sun is an insult to real journalists who risk their lives or livelihoods to report the truth. This guy was a glorified troll looking to insult and degrade people for the sake of it.
If you can’t see the difference you are an utter fool.
@Soccer T’s: You probably are wrong as you’ve been wrong in all your other commentary, there’s a pattern emerging.
@Charlie Hebdo: Aha maybe the trend is your lack of understanding/education. Nice try!
@Ricky Spanish: should the right of freedom of the press only apply to outlets you like or agree with?
“insult to real journalists who risk their lives or livelihoods to report the truth”
FYI very few journalists risk their lives anymore, case in point thejournal.ie
“insult to real journalists who risk their lives or livelihoods to report the truth”
Any journalist working for the Sun would meet your criteria just by being in Liverpool, Ricky.
@Charlie Hebdo: And Charlie was responsible for the deaths of so many innocents including his own workers and I am sure in the KKK.English Defence League HQ MacKenzie is a true patriot.
@Charlie Hebdo: they can print what they want. I also have the freedom to not buy or read the rag. Well done everton.
@Charlie Hebdo: I think you’re wilfully missing the point in order to soap-box. No one’s calling for The Sun to be banned. Simply Everton FC are availing of their own right to reply and offering a rebuttal. That they, a private company, are choosing not to engage with another private company whose practices they fundamentally disagree with, is hardly tantamount to shutting down the press.
@Charlie Hebdo: Some of the most thought provoking and enlightening journalism comes from points of view I disagree with. This article was neither of those things. What exactly has this guy added to the public discourse with this article? It’s trash and people have every right to voice their criticism without being accused of harming the freedom of the Press.
@Fergal O’ Reilly: ” No one’s calling for The Sun to be banned” . . . The OP called for it to be banned and that is what my original comment was responding to. also Everton have banned the newspaper.
@Charlie Hebdo: Believe it or not, some people don’t want gutter journalism.
@Charlie Hebdo: Maybe you struggle with basic language but if you would like to re-read my original comment you will find that I did not call for the Sun to be banned. I said that people and organisations should make that decision. If I had said that “the sun should be closed down or banned” you would have a very valid point but it’s obvious that you are just grandstanding for the sake of it.
@Charlie Hebdo:
Wow charlie, you really are going all out to defend the sun. How on Earth did you find yourself in such an unenviable position. The sun paper is in no way being censored or discouraged from printing its tripe, EFC have simply decided that they don’t want the suns product on their private property. Like a children’s food store might choose not to sell rat poison on their shelves. But all of this has already been explained to you, but you seem unwilling or unable to process sensible explanations or arguments. You seem dogged in your defence of one of the most disgusting papers ever to go to print. Are you proud of yourself? Is anyone proud of you?
@Peedur Dante: To be fair to him he’s defending freedom of the press rather than the Sun specifically
@Soccer T’s:
And I’m pointing out to him that the freedom of the press is not being attacked here. This is a different matter all together. He is confusedly arguing that EFC’s actions towards the sun constitutes an attack on the free press. This is not the case, and if he felt so passionately about the freedom of press why not comment on an article about vladimir putin rather then defend the sun so vigorously.
@Soccer T’s: Labour Party and Tory party should be treated like sc€m for this and the other covers ups.
Don’t have anything against British people but their government are consistently awful.
How you can trust a government to do good abroad when they even have such disdain for their own people.
The double standards in the press here w.r.t British parties is galling.
@Soccer T’s: best selling paper in England and the sun is printed in Knowsley in Liverpool so as to boycotting it not all Liverpool is so you all wasting your time just get over yourself and move on , great paper buy it everyday.
@Brian OConnor:
If you buy the sun everyday and consider it a great paper, all I can do is pity you.
Good news. Horrible publication and an even more horrible man.
Everton fans don’t buy that rag, as it insulted their family members. The Mail, Express any rag of a paper owned by Rubert Murdoch.
@Ossi Fritsche: the family that use to own the mail owned Everton for many many years.
How anyone still buys that rag defies belief..
@SteveW: Low IQ, so low in fact that they can’t even use a smartphone.
28 years late is better than never. They should have shown solidarity with Liverpool over their articles on Hillsborough
@Alan Lawlor: Huh? What you talking about? Everton have never shown anything but solidarity with Liverpool.
@Alan Lawlor: ya… because everton hasn’t shown enough support over the years. .. wind your neck in lad
@Alan Lawlor: Alan Liverpool only banned the Sun 2 months ago so Everton should get no criticism here.
@Alan Lawlor: still going on about that.
@Alan Lawlor: A bit of an ill informed comment. Everton football club and supporters have ALWAYS shown solidarity with LFC in the fight for justice for the 96 fans that died at Hillsborough.
https://youtu.be/Nmzu29eRhMU
@Alan Lawlor: and stupidest comment of the week goes to…..You.
@Alan Lawlor: Troll.
Haven’t read that rag in years. The article was published to upset Liverpudlians on the eve of the anniversary of the Hillsborough tragedy and does not surprise me one little bit. The editor should be fired for publishing it and the author should be shot for….just being himself.
The Sun is only one of two publications that I’ve actually wiped my ar$e with.
@Muiris O’Daltuin: My sympathies to your butthole. It’ll never be the same again.
@Muiris O’Daltuin: better not download the app then.
@J.D. Finnerty: It was no Andrex quilts, thats for sure. Cheap paper for cheap words.
I thought the sun was a great news paper. Both it and the Daily mail are often only a euro. Which is a quarter the price of smoke pellets for testing newly installed stoves. I honestly used to buy them for that until I realised I was supporting them by buying it, so now I pay more for another news paper just to burn.
@Bilbo Baggins: you are a modern day Joan of Arc.
Great news rag of a ‘paper’
What I don’t understand is why The Sun is still going, when everybody claims to not buy it.
The Sun like all of Rupert Murdoch’s publications and TV outlets are pure dirt.
Says a lot about the eNglish, when this is their most popular paper.
300k a year for a colume! I’m in the wrong line of business. No wonder he’s on holiday
I automatically assume that anyone who gathers their information from outlets like the sun, daily mail, etc. are buffoons whose opinion should be ignored at all costs.
Their 99% rags most of them but that sc$m is on another level
This sets a very dangerous precedent and creates a chilling effect for all sports journalists. Restricting the free press is dangerous.
@Charlie Hebdo: demanding the press reports the truth seems reasonable
@Charlie Hebdo: what he wrote was nothing got to do with sports journalism. Allowing these views are more dangerous. We have a right to free press alright but not the opinion and ramblings of a spiteful hateful person.
@Joe Travers: in other words Joe you just disagree/dislike his views and want them suppressed, freedom of the press should apply to all news outlets not just the ones you like or agree with.
@Charlie Hebdo: dangerous precedent my ar$e. You’re still living in the 70s are ya when journalists actually reported News rather than deliberately incite hatred, persecute and vilify persons of their own choosing and sensationalise tragic stories.
In fact small gestures like this might actually prompt editors to be more responsible in their reporting.
Unlikely though.
@Charlie Hebdo: Err just to educate you, Kelvin Mc Kenzie the author of the offending article, is not a sports journalist.It must be dizzy up on your high horse.
It may be a loathsome publication but I think a complete ban on it or its employees sets a dangerous precedent. Sanitised news/reporting only results in dumbed down information.
Everton ban the sun from its stadium…it’s going to a dull aul place without any sun!!
Jesus what a stupid pc world we live in,so what the sun said something bad about someone what’s new, ppl these days need to grow up and grow a pair
The paper is a rag, it must be said, and that phrase, “Any publicity is good publicity.”, makes me think they won’t care one bit about all this, and might actually be secretly delighted their paper is in the news.
A comic of a newspaper….actually that’s not fair on comics…a pure gutter rag…
have your say