American pharma giant Pfizer Inc and Turkish-couple owned BioNTech have planned to give volunteers who received a placebo in the coronavirus vaccine trial an option to receive a first dose of the anti-dote by March 1, 2021 - while staying within the study.
Under the trial's Vaccine Transition Option, all participants aged 16 or above have the choice to discover whether they were given the placebo and the patients, who learn they received placebo, have the option to receive the investigational vaccine while staying in the study.
On their websites, the companies have maintained that trial participants who received the placebo would have two doses of the vaccine reserved for them within the study.
“The study doctor will follow the latest guidance from the United States Centers for Disease Control and Prevention and their local health authorities to offer the Vaccine Transition Option to participants in a prioritised manner,” the companies said.
BioNTech is working flat out with partner Pfizer to boost production of their COVID-19 vaccine, its founders said, warning there would be gaps in supply until other vaccines were rolled out.
Owned by a Turkish immigrant to Germany, the startup has led the vaccine race but its shot has been slow to arrive in the European Union because of relatively late approval from the bloc’s health regulator and the small size of the order placed by Brussels.
The delays in rolling out the home-grown vaccine have caused consternation in Germany, where some regions had to halt vaccinations within days of starting an inoculation drive.
“At the moment it doesn’t look good - a hole is appearing because there’s a lack of other approved vaccines and we have to fill the gap with our own vaccine,” BioNTech CEO Ugur Sahin told news weekly Spiegel.
New highly infectious coronavirus strain
Sahin said the BioNTech/Pfizer vaccine, which uses messenger RNA to instruct the human immune system to fight the coronavirus, should be able to cope with a new, more contagious variant first detected in Britain.
“We are testing whether our vaccine can also neutralise this variant and will soon know more,” he said.
Asked about coping with a strong mutation, he said it would be possible to tweak the vaccine as required within six weeks - though such new treatments might require additional regulatory approvals.
Sahin also said BioNTech would make its vaccine, which requires storage at about minus 70 degrees Celsius (minus 94 Fahrenheit), easier to handle, adding that a next-generation vaccine could be ready by late summer.