Clinical trialists to be offered ‘top-up’ vaccine doses

Vaccine clinical trial participants are to be offered the option to get additional vaccine doses from next week, to ensure they can travel abroad to countries that currently only accept vaccination records with approved for deployment COVID-19 vaccinations.

The UK recognises those who are in COVID-19 vaccine clinical trials as fully vaccinated for the purpose of certification, both domestic and international. The majority of other countries currently do not recognise clinical trial volunteers and require visitors to have been fully vaccinated with a vaccine that has been approved for deployment by the relevant medicines regulator.

The government has therefore taken the decision that those who are in COVID-19 vaccine clinical trials who have not had a vaccine that is approved for deployment will be given the opportunity to receive two additional doses of an approved vaccine. This will allow them to have the necessary certification status to travel abroad to countries which do not currently recognise trial vaccinations.

The additional doses will initially be offered to those taking part in the Novavax trial, which includes the vast majority of those in ongoing trials for vaccines not yet approved for deployment. The offer will then be rolled out to participants in other relevant trials within the coming weeks. Novavax participants will be offered two doses of the Pfizer/BioNTech vaccine, with an eight-week interval between first and second doses.

In addition, people who have received both doses of a vaccine as part of a clinical trial will also be offered a booster jab, if eligible in line with the wider boosters advice from the Joint Committee on Vaccination and Immunisation (JCVI). This is to ensure the protection they’ve received from vaccination as part of the trial is prolonged over the winter months.

This new approach, which will apply to England, has been developed with the independent experts on the JCVI and the chief investigators for the clinical trials.

Deputy Chief Medical Officer Professor Jonathan Van-Tam said:

“COVID-19 vaccine trials have been absolutely integral to our response to the virus, and as a result we now have our renowned vaccination programme, which continues to save lives. I urge as many people as possible to continue contributing to these trials.

“The measures we have taken will allow UK COVID-19 vaccine trial participants to travel freely overseas once they have had the additional vaccinations. Those volunteers now have the flexibility to make a decision for themselves so they can, for example, visit loved ones abroad.

“We should be very clear that the results from these trials benefit the whole world, and it has to be said that if more countries around the world had reciprocated by allowing UK volunteers to enjoy fully vaccinated status for overseas travel, these measures would not have been necessary.

“As a separate issue, those in trials who are eligible for boosters should receive the booster dose in order to ensure the highest possible protection over winter.”

Principle Investigator of the Novavax clinical trial Professor Paul Heath said:

“I very much welcome this development on behalf of the more than 15,000 participants in the Novavax trial and my colleagues in the 35 UK trial sites.

“For too long the participants have been disadvantaged in terms of international travel because this vaccine is not yet approved for deployment – but trial participants now have the flexibility to receive booster doses, or additional doses for travel purposes, if they wish to.”

Published by

PIP editor

A pharmacist led training provider.

Leave a Reply

Your email address will not be published.