Pfizer Inc and its partner BioNTech are planning to give volunteers who received a placebo in its COVID-19 vaccine trial an option to receive a first dose of the vaccine by March 1, 2021, while staying within the study.
The trial’s Vaccine Transition Option allows all participants aged 16 or older the choice to discover whether they were given the placebo, “and for participants who learn they received the placebo, to have the option to receive the investigational vaccine while staying in the study,” the companies said on their website here for trial participants.
The U.S. Food and Drug Administration and a panel of its outside advisers have expressed concerns over Pfizer’s “unblinding” plan, saying it could make it harder to continue collecting data on safety and usefulness needed to win full FDA approval of the vaccine.
The companies said on the website, trial participants who received the placebo will have two doses of the investigational vaccine reserved for them within the study.
“The study doctor will follow the latest guidance from the U.S. Centers for Disease Control and Prevention and their local health authorities to offer the Vaccine Transition Option to participants in a prioritized manner,” the companies said.
While on the other hand, The World Health Organization says it has cleared the Pfizer-BioNTech coronavirus vaccine for emergency use, meaning poorer countries may soon get access to the shot already available in Europe and North America.
The Pfizer/BioNTech #COVID19 vaccine today became the first vaccine to receive WHO validation for emergency use since the outbreak began.
Equitable global access to vaccines is crucial to combat the pandemic.
👉 https://t.co/7WNcHhc3z8 pic.twitter.com/Kyjv5RNzjB
— World Health Organization (WHO) (@WHO) December 31, 2020
Every country that has a drug regulatory agency will have to issue its own approval for any COVID-19 vaccine, but countries with weak systems usually rely on WHO to vet the shots.
The global body said late Thursday that the decision to issue its first emergency use validation for a COVID-19 vaccine “opens the door for countries to expedite their own regulatory approval processes to import and administer the vaccine.”
The UN health agency said its review found the Pfizer-BioNTech vaccine, which has already received clearance in the United States, Britain, the European Union and a dozen other countries, “met the must-have criteria for safety and efficacy set out by WHO.”
The BioNTech-Pfizer vaccine has to be stored at ultra-frozen temperatures, a big hurdle for developing countries where the required freezers and reliable electricity supply may not be available.
“This requirement makes the vaccine more challenging to deploy in settings where ultra-cold chain equipment may not be available or reliably accessible,” WHO said, adding that it was “working to support countries in assessing their delivery plans and preparing for use where possible”
