Placebo recipients are treated as vaccinated for 16 weeks once trials end
29 July 2021
What was claimed
Covid-19 trial participants who received the placebo will be considered as vaccinated.
This is true, as the government has said it wants to ensure people who take part in the trials are not disadvantaged. In many cases, including the Novavax trial, participants who initially received the placebo will later be offered a vaccine. After the trial, participants have 16 weeks to get an NHS standard vaccine if they have not already received an appropriate one in their trial.
“The Novavax trial participants will have their vaccine pass in the United Kingdom. We are working with other countries to make sure that that is recognised, but as far as the UK is concerned, they will be considered fully vaccinated, whether they have had the placebo or the vaccine.”
Nadhim Zahawi 22 July 2021
In the House of Commons, vaccine minister Nadhim Zahawi was asked about the difficulties that some individuals who have taken part in the Novavax Covid-19 vaccine trials have had in being able to obtain vaccine certificates.
In response, he said that Novavax trial participants will be considered fully vaccinated whether they received the placebo or the active vaccine. This is true, but for those who’ve received the placebo, this will only be the case for the duration of the trial, and for a 16 week grace period afterwards, during which they will need to get an approved vaccine if they haven’t already.
The Novavax Covid-19 vaccine trial is a phase 3 trial of a new Covid-19 vaccine. It was led by researchers at St George's, University of London and enrolled more than 15,000 adults across the UK.
Mr Zahawi’s answer has been widelyshared on social media. Some users have suggested this means the vaccine passports areless valid, that there has been a lack oftransparency for those that received placebo, or imply that this decision is evidence that the vaccine roll out is a continuing experiment.
However, the Department for Health and Social Care (DHSC) confirmed to Full Fact that participants who receive a placebo, or a vaccine that does not become approved, will be treated as vaccinated only for the duration of the trial, and for a 16 week grace period after a trial ends. After this, they will need to obtain an approved vaccine.
Professor Paul Heath, the principal investigator behind the Novavax study, told Full Fact that all participants in the trial will have now been offered an active Covid-19 vaccine (including those who initially received placebo as part of the trial).
Some may also have asked whether they received an active vaccine or placebo (known as being ‘unblinded’), and then gone on to have an approved active vaccine, such as one from Pfizer for example.
DHSC confirmed that many vaccine trial participants will now have received an active vaccine (either due to trial design, or through unblinding). It also said that being in a Covid-19 vaccine trial should not disadvantage people, and all vaccine trial participants should be treated as fully vaccinated.
This would include for the duration of the trial, and for a 16 week grace period after it ends, if the participant received the placebo or a vaccine that does not become approved. After this they would need to obtain an approved vaccine if recommended by the doctor in charge of the trial.
The NHS is working on an update to facilitate this through the app in England, and in the meantime, vaccine trial participants across the UK will receive a letter confirming their participation in a trial and vaccine status.
In June, Deputy Chief Medical Officer Johnathan Van-Tam wrote an open letter to UK residents who have volunteered to take part in Covid-19 vaccine studies.
He said vaccine participants will not be disadvantaged, regardless of “whether you have had a vaccine that is licenced or unlicensed, whether you have had a placebo (dummy) vaccine or not, and if you are taking part in a ‘mix and match’ study”. He said that this applies to recently started, ongoing and future trials, including the Novavax trial.
Professor Van-Tam stated that trial participants will be “covered by any potential UK domestic vaccine certification from the moment you enter a trial until you leave.
“At the end, if you have had a vaccine that is not going to be licenced or a placebo (dummy), you will remain certified during a grace period to allow you to have the NHS standard vaccines if these are recommended by the doctor in charge of the trial.”
He said that this would apply domestically, and was clear that participants “should also not be disadvantaged as global travel resumes” as the DHSC “believe the added risk of allowing the relatively small number of clinical trial participants to travel (in the UK approximately 40,000 people, the vast majority of whom have been vaccinated) is strongly outweighed by the benefit of ensuring that recruitment and retention into clinical trials can continue”.