Brits are being urged to continue volunteering for trials to test new Covid vaccines after a Bristol research boss suggested they would be completely ruined by mass vaccination.
Professor David Wynick, who is the director of research for both of Bristol’s NHS trusts, told the board of North Bristol NHS Trust that vaccine trials that are underway or about to start would be “completely and utterly screwed” by the rollout of vaccines to protect the population against Covid-19.
But the government and the NHS are urging people to continue to take part in the vaccine trials, and the North Bristol trust has said it is confident that “ongoing studies won’t be affected”.
Professor Wynick made his comments at a meeting of the trust board on November 26, but it has taken until now for the trust to get approval from NHS England to release its response.
After updating the board on research activities at the trust, Professor Wynick said that mass vaccination would create problems for vaccine trials as it would no longer be possible or “appropriate” to have a placebo group.
Clinical trials assess the safety and effectiveness of a vaccine by giving it to one group of volunteers and comparing its effects with those of a placebo given to a “control” group of volunteers.
Professor Wynick said: “I would just leave you with a point that has literally surfaced just today, that I must admit I hadn’t really thought about, and I think it’s an interesting point for everyone to consider.
“There are a very large number of Covid vaccine trials that are ongoing or are about to start, and the downside of rolling out, at scale, the vaccines as they come along in the next two to three months is that those trials, pardon my French, are going to be completely and utterly screwed, because how do you have a control group when you don’t have those patients any more because they’re all busy being vaccinated?
“So that is something that I think we will all have to deal with, and we will need to try and find ways forwards, because clearly it’s inappropriate to have a placebo group in the face of Covid once a vaccine is available.”
Since Professor Wynick issued his warning, the UK has started rolling out the first Covid vaccine to be approved anywhere in the world – Pfizer/BioNTech’s product.
In a statement yesterday (December 10), a North Bristol NHS Trust spokesperson said: “While it’s fantastic that a number of Covid-19 vaccines are reporting success, it’s crucial we keep trialling as many different options as possible so that we are in the strongest position to beat the virus in all parts of our population.
“You can still have an approved vaccine when it is available, even if you take part in a study.
“Taking part in a trial is the best way to help effective vaccines to be identified and made available to everyone earlier and may even give you early access to a vaccine later found to be effective.
“As the first vaccines are approved and rolled out, we’re confident that ongoing studies won’t be affected, and we’ll work hand in hand with the National Institute for Health Research to overcome any challenges that the studies may face.”
The Department of Business, Energy and Industrial Strategy (BEIS), which set up the UK Government’s Vaccine Taskforce earlier this year, had a similar message.
The taskforce was set up in May to ensure the UK population has access to Covid-19 vaccines as soon as possible.
A spokesperson for the BEIS said: “Clinical trials into a number of Covid-19 vaccines continue at pace across the world and it is essential that this progress continues.
“It is important that volunteers keep taking part in the Covid-19 studies, attend their follow-up appointments and submit data on their health and Covid infections.
“No single vaccine is likely to be suitable for everyone, so we must make sure that the other studies continue to allow us to have a selection of safe and effective vaccines.”
Four vaccine trials underway in the UK
Trials underway in the UK are for vaccines being developed by Oxford/AstraZeneca, Novavax, Imperial College London, and Janssen, according to the BEIS.
Other trials include vaccines being developed by Valneva and Moderna.
As of last week, the UK had secured 357 million doses of seven different vaccines, including Pfizer/BioNTech’s approved product and vaccines still in development, should they prove effective.
GlaxoSmithKline and Sanofi announced today (December 11) they were going back to the drawing board after their first vaccine candidate proved ineffective in clinical trials.
The BEIS said data was needed about a number of vaccines and their safety and effectiveness to protect the population.
“We need volunteers to join new studies and existing studies are not yet complete, and we need the long term data to help us understand how best to use the vaccines, which are most effective and to give information on the levels of effectiveness, as well as reassurance on long term safety of them,” a spokesperson said.
More than 240 vaccines in development globally
More than 240 Covid vaccines are in development around the world, according to an article in the leading medical journal The Lancet on October 27.
Vaccine Taskforce chair Kate Bingham wrote: “The UK is at the forefront of a huge international effort to develop clinically safe and effective vaccines.
“To help to accelerate the development of successful vaccines, we launched the National Health Service Covid-19 vaccine registry and have enrolled over 295 000 volunteers, with a focus on populations who are at high risk of severe infection and mortality from Covid-19.
“We plan to accelerate recruitment in disease hotspots with mobile research teams informed by robust PCR testing.
“There will not be one successful vaccine, or one single country, that is able to supply the world.”