(Bloomberg) -- Health-care workers given a placebo in the Pfizer Inc.-BioNTech SE vaccine trial are already getting access to the newly authorized shot.
“Participants who courageously volunteered to help make a difference during this pandemic will have an option to receive the investigational vaccine while continuing to be part of the clinical trial,” Pfizer and BioNTech said on a joint website dedicated to information about the continuing studies.
Many are taking up the offer. Called “the Vaccine Transition Option,” the effort allows trial participants who got the placebo to receive the real two-dose regimen, while continuing to be monitored by investigators. But to get access, they must be eligible under the current emergency-use authorization. That means health-care workers and residents of long-term care facilities who were in the trials will be the first unblinded.
Already, some have gotten their first shot.
On Monday, John Vanchiere, the principal investigator for a trial site at Louisiana State University Health Shreveport, emailed 245 participants to let them know the trial would be slowly unblinded.
Within 24 hours, Vanchiere received 150 emails from trial participants seeking to determine if they received the vaccine. They were hungry to be included on the so-called unblinding list, he said.
Vanchiere said he immediately put out a dozen calls to participants who can now get the vaccine, and let them know which trial arm they were in. By Wednesday afternoon, seven placebo recipients got their first shot, all of them health-care workers.
“They were excited about it,” Vanchiere recalled in an interview. “One nurse said, ‘This is a great Christmas gift, I can’t wait to get this second one so I can go visit my mother.”
Pfizer spokesperson Jerica Pitts said the clinical-trial protocol was amended so that “interested and eligible participants in the placebo group would have the option to receive the vaccine at scheduled timepoints in the study.” The amendment is subject to input from regulators, Pitts said.
Previous to Holiday
Vanchiere plans to vaccinate the rest of the applicable placebo-group participants before the upcoming holiday. The trial site has 20 appointment slots available a day. Placebo-group participants who don’t yet qualify for the vaccine under the emergency clearance will likely get their first doses in April or May, Vanchiere said..
Placebo groups provide a critical point of comparison in gold-standard clinical trials, allowing researchers to study long-term side effects over time.
Over the last few months, however, U.S. regulators, drugmakers, and trial participants have engaged in an ethical debate over whether or not to provide protection to all those who joined the clinical trial. Ultimately, offering broader protection amid a nationwide surge in cases has trumped pleas to maintain the integrity of such long-term safety data.
“We don’t want people to drop out of our study,” said Vanchiere, who also serves as the chief of pediatric infectious diseases at Louisiana State University Health Shreveport. “We’d rather them stay in the trial having gotten the vaccine, so that we can continue to study them.”
Added Doses
Vanchiere said Pfizer sent the trial site added doses to inoculate its placebo participants. He’s happy he won’t need to eat into the health system’s supply to be able to offer the transition option.
That’s a win-win, he said, because amid supply constraints, clinical trials can confer protection to more people.
Following Pfizer and BioNTech’s lead, Moderna Inc. is preparing to offer its Covid-19 shot to trial participants who received a placebo in the final-stage study once the vaccine is authorized for emergency use in the U.S.
The participants will first be given the opportunity to learn whether they got the vaccine. If not, they’ll be able to request the shot, according to a letter from a study investigator to participants that was reviewed by Bloomberg.
Favorable Report
Food and Drug Administration staff released a favorable report on the Moderna shot Tuesday, saying it is 94.1% effective at preventing Covid-19 symptoms. A panel of advisers will meet later this week to vote on their recommendation, which the agency isn’t obligated to follow, but often does.
If the advisers vote to support the vaccine, it’s likely to be quickly authorized by the FDA.
The drugmaker hopes to start offering the vaccine to volunteers within one to two weeks after it gains emergency-use authorization from the FDA. Ray Jordan, a Moderna spokesman, confirmed the letter was being prepared.
Yasir Batalvi, a 24-year-old who volunteered for Moderna’s phase 3 trial, said he received the letter and is glad that Moderna is offering participants the option of taking the vaccine, if it is authorized for use.
“I don’t know if I would take the vaccine right now if I’d had a placebo,” he said in an interview. “There are front-line workers and others who are more at risk than I am. But I do think people in the study ought to get the vaccine if they want it because of the important contributions that they’ve made. We’ve all taken on a tremendous amount of risk.”
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