It has been reported that the government may use emergency powers to allow an unlicensed COVID-19 vaccine to be used in the UK.
Dr Sheuli Porkess, Director of Research, Medical and Innovation at the Association of the British Pharmaceutical Industry, said:
“Every medicine and vaccine undergoes rigorous testing to ensure it is safe and effective before it can be used. This will be no different with any vaccine that may be discovered for coronavirus.
“Any temporary authorisation given to a Covid-19 vaccine would be subject to strict conditions defined by the UK’s medicines safety regulator.
“We welcome the government consulting on plans, to ensure that the system is ready, where safety data from extensive testing overwhelmingly support the use of a vaccine.”
Prof Gino Martini, Chief Scientist at the Royal Pharmaceutical Society, said:
“Unlicensed does not mean untested and when developing medicines such as vaccines, we always make sure that the health benefits will outweigh any risks. Vaccines have played a vital role in preventing the spread of many diseases such as polio, measles and flu. These powers are needed so that the Government can act quickly to prevent another major pandemic which means rapid access to vaccines and rapid implementation of the vaccination process itself, for example using pharmacists to give them to patients.”
Prof Stephen Evans, Professor of Pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said:
“The consultation which launched on 28th August and ends today is at least partially a consequence of the vote in favour of Brexit. Assessment of the data from trials of vaccines in the EU is done by scientists from two member states and then voted on by scientists from all EU member states, co-ordinated but not controlled by the European Medicines Agency (EMA). The UK has gradually been excluded from this process and now has no say at all. Previously UK scientists were among the best in the EU and carried out many of the assessments through the MHRA (Medicines and Healthcare products Regulatory Agency). Until January 1st 2021, when we will be trying to do all the work previously shared among all the member states, vaccines continue to be licensed through the EU process.
“The proposed new legislation would have various effects, possibly the two most important features are 1) to allow UK scientists to assess all the data and offer their own advice as to whether to allow a provisional license to a vaccine applicable in the UK and 2) to ‘allow those who are registered healthcare professionals who do not normally vaccinate, and people who are not registered healthcare professionals, to safely administer a licensed or temporarily authorised COVID-19 or influenza vaccine’.
“The second part is eminently sensible and should have been planned for many months ago. If a vaccine does become available, it will require a larger proportion of the population than have ever been vaccinated in a short time period on any previous occasion. It is clear that the current system of administration would not be capable of vaccinating almost the entire population in a short time, so this could be very sensible provided the training of the new groups to carry out vaccinations is good and is perceived by the general public to be sufficient training.
“The very sad possible consequence might be a reduction in public confidence in vaccines. If it is all done properly, then no loss of confidence would be justified. The public will need to listen carefully to independent scientific opinion as a whole to be reassured that the processes, both of licensing the vaccine and of careful administration of them, are being done well.
“There is in some sense a safety net, in that the licensing process (usually extremely reliable) will not be enough; the Joint Committee on Vaccinations and Immunisations (JCVI) are a further group who decide whether a licensed vaccine is actually overall beneficial, including taking costs into account. JCVI has independent scientists and they also have an independent role in protecting public health.”
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Prof Martini – none to declare
Prof Evans: “No conflicts of interest. I am funded (one day per week) by LSHTM. They get funding from various companies, including Astra Zeneca and GSK but I am not funded by them, I have no involvement in obtaining funding from them and I am not an investigator on any grants obtained from them. I am the statistician to the ‘meta-Data Safety and Monitoring Board’ for CEPI. I am paid for my attendance at those meetings and will be paid expenses for travel if that occurs.”
Noe others received.