Health
What happens after the COVID vaccine is approved?
If the coronavirus vaccine is approved in the United States by the end of the year, will study participants receiving placebo be vaccinated in a hurry?
The question hasn’t received much attention General public, It’s something that worries about health professionals and pharmaceutical companies.
Today, tens of thousands of people in the United States and other countries volunteer for what is known as Phase 3. Clinical trial..
Usually half Experimental vaccine, The rest are given a placebo, but I don’t know which one was given.
The goal is to observe in the coming months how many people in each group will naturally become infected with the virus and become ill with COVID-19.
The number of vaccinated participants infected with COVID-19 Placebo Group, The US Pharmacy FDA can grant an emergency license.
However, for permanent approval, the FDA requires a longer period of study (usually 6 months).
The purpose is to confirm the safety of vaccine Certain rare side effects may not be detected during the two months currently scheduled for emergency use approval.
The problem is that, for ethical reasons, when a drug or vaccine is approved, participants who receive a placebo in a clinical trial are generally notified.
Then they can, of course, request a real vaccine or look for it on their own, but that will reduce the placebo group.
Doing so prevents a long-term comparison between the placebo group and the first vaccinated group.
Dozens of people are at even greater risk trial Not yet on a large scale: Who risks receiving a placebo if the vaccine is publicly available?
This issue was discussed by the FDA Advisory Board on Vaccines on Thursday, but no real solution was reached.
“Ethical responsibility”
Doran Fink of the FDA’s vaccine division said the study could be continued between populations for which the vaccine has not yet been approved or for which no dose is available.
But the dilemma is real for the majority.
“We are aware that there may be situations in which it may not be possible to continue placebo-controlled follow-up or initiate a placebo-controlled trial in an ongoing trial because it is no longer ethically acceptable. “I will,” Fink said Thursday.
“There is no specific treatment. At this point, I asked vaccine makers and others. Government agency Those involved in conducting these trials to think carefully about how to ensure the maintenance of clinical trials. “
Moderna (the other Pfizer), one of the two companies in the United States that wants to request an emergency license by the end of November, has sought instructions from the authorities.
“These participants are beginning to ask when they will know when to receive the research vaccine or placebo,” said Moderna’s Jacqueline Miller, who spoke at the same conference.
Pfizer and its German partner BioNTech have stated that they have an “ethical responsibility” to send a letter to the FDA and notify its members. placebo We called on groups and institutions to be open to other ways to evaluate vaccines.
For now, the FDA has only one instruction: continue testing as long as it is feasible.
© 2020 AFP
Quote: Placebo Group: What happens after the COVID vaccine is approved? (October 23, 2020) Obtained October 23, 2020 from https://medicalxpress.com/news/2020-10-placebo-group-covid-vaccine-authorized.html
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