Pfizer and BioNTech WILL offer their COVID-19 vaccine to trial participants who got the placebo by March 1 - despite FDA fears that it will cause the studies to fall apart

 Pfizer Inc and its German partner BioNTech SE plan to offer volunteers who received a placebo in their COVID-19 vaccine trial an option to receive a first dose of the jab.

The study's Vaccine Transition Option allows all participants aged 16 or older the choice to discover whether they were given the placebo or the shot.

'[F]or 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 in a statement on New Year's Eve.

Volunteers will now be able to get their first dose of the vaccine by March 1, months earlier than originally anticipated. 

Pfizer Inc and BioNTechSE will offer clinical trial participants who received a placebo an option to receive a first dose of COVID-19 jab by March 1.  Pictured: The first patient enrolled in Pfizer's COVID-19 vaccine clinical trial at the University of Maryland School of Medicine in Baltimore, receives an injection, May 4

Pfizer Inc and BioNTechSE will offer clinical trial participants who received a placebo an option to receive a first dose of COVID-19 jab by March 1.  Pictured: The first patient enrolled in Pfizer's COVID-19 vaccine clinical trial at the University of Maryland School of Medicine in Baltimore, receives an injection, May 4

The FDA was against Pfizer 'unblinding' its trial and argued that it would be harder to continue collecting data on safety and effectiveness. Pictured: Pfizer headquarters in New York City

The FDA was against Pfizer 'unblinding' its trial and argued that it would be harder to continue collecting data on safety and effectiveness. Pictured: Pfizer headquarters in New York City

The decision comes after months of debate with members of the U.S. Food and Drug Administration (FDA) and a panel of outside advisers.

Both groups expressed concerns over Pfizer's 'unblinding' plan, saying it could make it harder to continue collecting data on safety and effectiveness needed to win full FDA approval of the vaccine. 

However, participants said that they were putting their health on the line and should be able to choose whether or not they can receive the shot like members of the general public. 

Even Dr Moncef Slaoui, head of the federal government's Operation Warp Speed, said he believed volunteers should receive vaccine doses immediately.

'I think it's very important that we unblind the trial at once and offer the placebo group to receive vaccines, regardless of their risk level,' he told reporters on December 23.


'These men and women [who] volunteered have been instrumental and critical in helping us developing these vaccines and they should be rewarded for it.'

Upon the news, Michael Tovar, a volunteers who had been advocating for participants to be given vaccines, thanked the firm and CEO Albert Bourla on Twitter.  

'Thank you...for listening and for changing your study protocol to allow for speedy vaccination of your placebo arm,' he wrote.

'You have made this New Year so much brighter for the 22,000 placebo volunteers that stepped up for this vaccine.' 

According to a tweet from a Pfizer scientist, more than 2,500 volunteers who received placebos have been given their first dose of the Pfizer vaccine.


The vaccine candidate from Pfizer and BioNTech uses part of the pathogen's genetic code called messenger RNA, or mRNA, to get the body to recognize the coronavirus and attack it if a person becomes infected.

In the jab, known as BNT162b2, the mRNA encodes for all of the spike protein found on the outside of the virus that it uses to enter and infect cells.

For the trial of 44,000 participants, half were given the vaccine and the other half was group was given the placebo.

Researchers then waited until several participants become infected with the virus. If the number of people infected was significantly higher in the placebo group, then the jab was considered effective.

Clinical trial data showed that the vaccine was 95 percent effective at preventing participants from contracting COVID-19.

Trial participants who received the placebo will have two doses of the investigational vaccine reserved for them within the study, the companies said on the website.

'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.

Pfizer and BioNTech WILL offer their COVID-19 vaccine to trial participants who got the placebo by March 1 - despite FDA fears that it will cause the studies to fall apart Pfizer and BioNTech WILL offer their COVID-19 vaccine to trial participants who got the placebo by March 1 - despite FDA fears that it will cause the studies to fall apart Reviewed by CUZZ BLUE on January 05, 2021 Rating: 5

No comments:

Powered by Blogger.