Pfizer and BioNTech will offer their COVID-19 vaccine to trial volunteers who received a placebo as part of its ongoing phase 3 study.
The ‘Vaccine Transition Option’ will offer participants the choice to learn whether they received the investigational vaccine, recently approved in the EU as Comirnaty, or a placebo.
Following this ‘unblinding’ of the study to the volunteers, participants who had received a placebo will be offered the option to receive the vaccine while staying in the study.
Pfizer and BioNTech, who said that they had secured enough vaccine doses for placebo recipients, aim to offer the opportunity to all eligible participants within the study by 1 March 2021.
Participants can also choose to remain unblinded and continue with planned study activities.
Pfizer/BioNTech’s vaccine received its first conditional approval from the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) on 2 December 2020, and over a million people in the UK having received the vaccine so far.
Soon after the UK approval, the US Food and Drug Administration (FDA) approved the vaccine for an emergency use authorisation (EUA) just over a week later on 11 December 2020.
The FDA approval for the Pfizer/BioNTech vaccine was based on recommendations made by an advisory committee of outside experts – the Vaccines and Related Biological Products Advisory Committee (VRBPAC).
Although the experts unanimously agreed that the benefits of granting the vaccine an EUA outweighed the risks, they did have some discussions around the potential impact of ‘unblinding’ the study to participants who had received a placebo.
The FDA, as well as its expert advisers, had wanted participants to remain on the placebo for as long a duration as possible, to gain more safety and efficacy data.
Pfizer/BioNTech, which originally had been planning to offer the vaccine to placebo participants later down the line, has now accelerated its plans.
However, the companies will only offer the vaccine under the ‘Vaccine Transition Option’ to those participants who are currently eligible under the EUA. This includes healthcare workers and residents of long-term care facilities.
It is not clear when volunteers who had received a placebo, but who do not yet qualify to receive the vaccine, will be offered the jab, although Bloomberg reported that it could be as soon as April or May.
“Your continued participation in the trial will provide valuable contributions to the understanding of COVID-19 and the investigational vaccine,” the companies wrote on the Vaccine Transition Option website.
Moderna, which also has an EUA in the US, is also planning to offer its vaccine to volunteers who had received a placebo in the phase 3 study, similarly for those eligible under its own EUA.