THE speed that a Covid-19 vaccine has been produced and approved should not be a source of concern from the public about its safety, a Scottish scientist has said.

The Medicines and Healthcare Products Regulatory Agency (MHRA) has warned anti-vaccine rhetoric could derail the programme to introduce the new Pfizer/BioNTech vaccine, with some people likening it to thalidomide – the drug that resulted in thousands of children being born with birth defects in the 1960s.

Dr Lynda Chang, whose work involves scrutinising clinical trial data on behalf of doctors, said it was important for the public to understand the journey to approval.

She said the collective effort had “cut through the red tape” that can see medical research projects take years to get off the ground.

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The fact Covid-19 is very infectious meant trial results were observed very quickly, she said, while scientists who are generally in competition and “hide” data in order to be the first to publish it shared information freely to accelerate efforts to find a vaccine.

Ms Chang, who lives in Lanarkshire and is scientific director at a medical communications agency, said: “I think it’s about educating the public about what goes into making a drug. People do take it for granted that these 
drugs appear.

“What we have shown is that you can get rid of a lot of the red tape.

"Normally, if you are going to be doing a clinical trial first of all you have to find the money to have that clinical trial and then you need to go through all the regulators who will assess the suitability of it.

“Then you have to start recruiting patientsm which can take a very long time, even with cancer studies. You are talking months or years depending on the type of cancer it is, especially if it is a rare one.

“When you go through the regulators, you have to convene a safety committee, you need to call in all your patients and then you need to analyse all of the data.

"Then you need to take it to the regulators – for us it would be the MHRA – and it can sit on their desk for years.

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“The nature of science and the academic world is that you are 
generally in competition. There is a publish or die mentality. If you don’t get enough publications you can’t get money to continue your work.

"People don’t want to get gazumped so they often hide their data – not on purpose – but what they are trying to do is keep their data to themselves so they can be the first to publish and that hasn’t happened. This did not happen in the pandemic.

“I think China was the first to publish the sequencing of the genome for the virus and instead of keeping it to themselves, they released that to the world so they could take that data and that’s why we have this vaccine because we know the codes for the spike protein and it has remained stable.

“They have managed to recruit so many people into this trial so quickly and the other advantage is that coronavirus is very, very infectious so you start to see the efficacy of the vaccine very quickly

“I think people now know a bit more about clinical trials and what is involved. We have shown in record time that these clinical trials are absolutely essential.”

While pregnant women have been advised not to take the vaccine 
– because they were not included in trials  – Ms Chang believes it will be safe for the majority of people.

“Thousands of people have had this drug. If there were going to be major problems, we would have seen them by now,” she said.

“The reason pregnant women (are not advised to take it) is because they are rarely included in clinical trials.”

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“We know there are six other vaccines out there going through the process that are all pretty much targeting the same thing.

“At the moment it’s been fairly standard side-effects such as pain 
at the injecting site. There may be immunocompromised people who can’t have the vaccine but that’s fairly standard. 

She said it is possible that some of the stream-lined processes that resulted in the first vaccine being sourced relatively quickly could have implication for drug research. 

“It could but you have to have the money to do it and in the endpharmaceutical companies need to make money and they are only going to finance products that they think they can sell.”