Pfizer Volunteers Who Received Placebo May Be Offered Vaccine by March

By Dana Cruz First Posted: Jan 02, 2021 08:48 PM EST

(Photo : Spencer Platt/Getty Images) Pfizer's corporate headquarters stand in midtown Manhattan on a morning where volunteers with Doctors Without Borders dumped $17 million in fake money outside of the building to protest high vaccine prices on November 12, 2015 in New York City.

A COVID-19 vaccine could be offered to Pfizer volunteers who received a placebo during vaccine trials by March 1.

This plan by Pfizer and its partner BioNTech to offer placebo volunteers with the vaccine was put into motion months earlier than initially planned, said a report from Stat News.

Reuters said in its report that the Vaccine Transition Option will allow all Pfizer volunteers aged 16 or older to find out if they were given the placebo.

Then, these Pfizer volunteers will be given the option to receive the investigational vaccine while staying in the study, the companies said on their website from trial participants.

FDA Pushes for Placebo Participants to Remain on Group

The decision from Pfizer/BioNTech comes amid concerns between the Food and Drug Administration, the pharmaceutical company and its volunteers.

The FDA, along with its advisers, pushed hard for volunteers in placebo groups to stay in those groups in order to gather more safety and efficacy data about the vaccines.

Officials from the FDA said the "unblinding" plan from Pfizer would make it more difficult to collect data necessary for a full vaccine approval, reported New York Post.

However, Pfizer argued that they should start considering the ethical and practical reasons that came with giving their volunteers a vaccine.

"The study doctor will follow the latest guidance from the US 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 told Reuters.

The issue has grown more serious for some vaccine trial participants.

There were protests on further delays on social media and in letters to media organizations, including Stat News.

One of the volunteers, Michael Tovar, publicly campaigned for Pfizer to offer the vaccine to placebo participats faster. He also thanked the company in a tweet.

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

He said the decision to push for placebo volunteer vaccinations made the year ahead for half of Pfizer's 44,000 person trial.

Pfizer Volunteers Want Answers on Asymptomatic Infection

In a letter to researchers, participants were also asking to take additional COVID-19 tests that could help prevent asymptomatic infection.

So far, the vaccine was only proven to reduce symptomatic infection by 95%. There is currently no way to know whether people who get vaccinated can still transmit the virus to others.

When conducting clinical trials, one of the most reliable ways to find treatment is to conduct a double-blind placebo-controlled trial.

This means patients will be randomly assigned a placebo or the medication in question. Neither the participant nor the researchers would know what the patients received.

In most cases, patients who were given a placebo would be given the treatment once the study was complete.

However, the matter was questionable for the Covid vaccines as consent forms given to volunteers made no mention of when or if someone who was administered a placebo would get the two-dose vaccine.

Tags pfizer volunteers, vaccine, placebo