Science vs Rules in a Pandemic

When people are dying, do you use a rules based approach to save lives or follow the science? All the science?

There is a blizzard of legislation that rightly restricts pharmaceutical companies from making exaggerated claims about their products’ performance. Consequently, they must doggedly use clinical trial data to mould their advice. Doctors, on the other hand, can look at the weight of all the scientific evidence at their disposal and make decisions in the best interest of their patients. Even if this is outside the narrow confines of the product data sheet.

The British scientists advising the Government have been looking at the whole body of evidence from many vaccines.  In addition to the recent clinical trial data, they looked at the immune system response to CoViD and other vaccines. This gives early evidence of the efficacy of CoViD vaccines even before all the trials had finished. There was also an understanding that all the CoViD vaccine trials were designed to produce a quick result as part of the race against the deaths caused by the pandemic.  These clinical trials only used a three to four week interval between first and second doses.  It is well known that many vaccines produce a better response if the second dose is delayed for longer, for three months or sometimes longer.  Had the pharmaceutical companies designed their studies this way we would still be waiting for approval, whilst the virus wreaks havoc across the world.  

This broader evaluation, and the desperate need to act quickly and save lives, enabled Britain to be the only country to disregard the clinical trials recommendations for a three-to-four week gap between doses. They follow the weight of scientific evidence and is delaying the second for up to 12 weeks.  This enables more people to be vaccinated quickly and reach as many vulnerable people as possible to cover against disease over the winter, when respiratory viruses such as ‘flu and CoViD are much more active.

This strategy has been vindicated by a new study of 12,408 people. It demonstrates that a single dose of the Oxford-Astra Zeneca vaccine is 76 per cent effective in preventing infection from 22 days after the first injection. This rises to 82.4 per cent if a second dose is given at 90 days.  More importantly, there were no deaths or even hospitalisations for all people from 22 days after receiving their first jab.

There was more good news from this study, which was done in the UK, South Africa and Brazil. It indicates that the vaccine prevents two-thirds of CoViD transmissions, meaning that vaccinated patients are much less likely to pass on the virus. This will reduce the important R number, significantly slowing the rate of transmission of the virus.  This led British authorities to start to consider easing the lockdown restriction by March.  

This study will soon be published in The Lancet, a prestigious peer reviewed scientific publication.  Professor Andrew Pollard, the chief investigator of the original Oxford Vaccine Trial and co-author of this study, said the data "supports the policy recommendation made by the joint committee on vaccination and immunisation (JCVI) for a 12-week prime-boost interval as they look for the optimal approach to rollout, and reassures us that people are protected from 22 days after a single dose of the vaccine". 

Professor Paul Hunter, from the University of East Anglia, said: “The 12-week gap between first and second dose is clearly the better strategy as more people can be protected more quickly and the ultimate protective effect is greater.” He said that although the vaccine would not prevent people passing on the virus completely “it will still go a long way to reduce the R value and transmission”.

The EU were late in ordering enough vaccines for their population by insisted on a longer, more bureaucratic negotiation process with the drug companies. On behalf of all its 27 nations they spent time trying to drive down the price and refusing to remove liability from the vaccine makers early in the vaccine development process. The longer gap between doses has also been criticised by the EU, who insist on following their rules to justify the very slow start to the European vaccination programmes and the late approval of the Oxford-Astra Zeneca vaccine.  Clement Beaune, France's Europe minister, said Britain had taken a "lot of risks" by choosing to delay the second dose. Ursula von der Leyen, the European Commission president, defended their approach and also accused British ministers of compromising safety.  She claimed Britain failed its “gigantic responsibility” to ensure the proper safety of vaccines and "the European Union should be proud of its strategy." She said, “The commission and the member states agreed not to compromise on the safety and efficacy requirements linked to the authorisation of a vaccine. Some countries started to vaccinate a little before Europe, it is true. But they resorted to emergency, 24-hour marketing authorisation procedures.” She added, “So, yes, Europe left it later, but it was the right decision." It has emerged that The European Medicines Agency was closed between 23rd December and 4th January for their annual Christmas break, further delaying approvals and slowing the vaccine roll out.  It seems the EU has working hour rules as well.

So far, the UK has completed 10 million vaccinations, 2.79 million in the last 7 days, and is protecting 15.5% of its population against serious infection. This compares to 3.2% in Germany and only 2.5% in France.

There has been some more worrying news regarding the emergence of more CoViD mutations, which may make the vaccines less effective in the future.  So far the current vaccines have proven to work against these new strains, but just in case the British Health Minister, Matt Hancock, said the Government was working closely with pharmaceutical companies to engineer modifications to their vaccines. Sir Mene Pangalos, executive vice president of biopharmaceuticals research and development at Astra Zeneca, said the firm was working on vaccines against key mutations and wanted to have them ready "as rapidly as possible. We're working very hard and we're already talking about not just the variants that we have to make in laboratories but also the clinical studies that we need to run, and we're very much aiming to try and have something ready by the autumn," he said. Pharmaceutical companies can adapt their vaccines and distribute them within months to protect against new strains. A third dose of a slightly different vaccine could be rolled out later this year.

https://ourworldindata.org/covid-vaccinations