The U.S. Health and Human Services Department says it will require placebo testing of “all new vaccines,” raising questions about the rollout of updated COVID-19 vaccines and other vaccines.
In a statement to the Washington Post, the agency headed by Robert F. Kennedy Jr. called the new requirement “a radical departure from past practices.”
Northeastern Global News talked to Mansoor Amiji, university distinguished professor of pharmaceutical sciences, about what the shift in vaccine policy could mean for people who want to be vaccinated against the most recent variants of COVID-19 and other diseases.
Amiji also spoke about the promise of the administration’s push for a universal vaccine for influenza and COVID.
What is a placebo trial and could the new requirement slow down the rollout of new vaccines?
What the HHS is now saying is that any time a new vaccine needs to be approved, or even different versions of an existing vaccine, we need to do a placebo-controlled trial.
What that means is, we have to generate data from trials where half of the individuals receive a saline solution—the placebo—and the other half receive the actual vaccine.
The goal is to make the safest vaccines possible. They are given to healthy people, so the margin for any kind of toxicity is very, very low.
But placebo trials can last for months or years.
When you’re making modifications, such as when you are only changing the mRNA sequence in the updated COVID-19 vaccine, we don’t need to accommodate that level of study because the safety has already been established.
Annual COVID-19 shots have been treated like a booster for influenza, not like a new vaccine. Will the updated versions be treated like a new vaccine under the new requirement?
Yes, that’s the argument HHS is making.
My concern is that we will not have vaccines available for the population of the U.S. in a timely manner if we have to go back and redo these studies for products that are already approved for safety and efficacy.
So, when the fall comes and health care providers, such as pharmacists, have to dispense and administer vaccines, there will be questioning. What are we supposed to do? Are we supposed to rely on whatever is in the marketplace that is already approved but may not be as effective?
The trials are important when you are first introducing the product. But when you are modifying the product to have to go ahead and do safety and efficacy trials—which are expensive—again and again doesn’t really help us.
I think it’s going to deter a lot of companies from investing in vaccine research and development.
What happened to the anticipated April approval of the Novovax vaccine, the only non-mRNA vaccine available to protect against coronavirus? It was already approved on an emergency-use basis.
The Novovax officials submitted their documentation to the FDA, and now the FDA is saying, “We can’t approve it because of this new policy from HHS that requires you to go back and do a full-fledged clinical trial’ with a placebo comparison.”
Why are we changing the rules of the game while we’re playing the game?
The FDA commissioner said that HHS Secretary Kennedy is not anti-vaccine, that he is actually pro-safety and pro-reproducibility.
However, this policy will have a drastic effect on public health. The Novovax officials submitted their documentation to the FDA, and now the FDA is saying, “We can’t approve it because of this new policy from HHS that requires you to go back and do a full-fledged clinical trial.”
It still doesn’t help us in terms of getting the vaccine into the marketplace.
Would the requirement for placebo trials impact already existing childhood vaccines such as those for measles, mumps and rubella?
It doesn’t affect vaccines that are currently on the market.
I think a question comes in if you are coming up with a new version of an existing vaccine—how will the FDA review that? Will it require compliance with the new requirement for approval?
The HHS and the National Institutes of Health announced plans to develop a universal vaccine platform for influenza and coronavirus vaccines. How would it work and what would it do?
I personally like the idea of a universal vaccine. I think the research is driving toward that.
The idea of a universal vaccine, or what is called a gold standard vaccine, is to generate one vaccine against the flu or COVID-19 and not have to change the vaccine formula on a yearly basis to adjust for different strains.
I think universal vaccines are important, but they’ll take at least several years before they can be marketed.
For individuals, especially those in the high risk group, who want to get vaccinated for the fall, we have to rely on what’s available.
With COVID, you are still dealing with an infection that continues to be prevalent.
You cannot say that a vaccine that is modified and updated needs to go back and be evaluated in a full-fledged placebo control trial because that is a time-consuming exercise.
Will the new requirement boost or deter confidence in vaccination?
If people are concerned about the safety of a vaccine, the placebo-controlled trials and the time they will take and the data they will generate may boost their confidence.
The downside is that the product will not be available until those studies are complete. We are going to see numbers of infected individuals increase when the product is still in clinical trials.
What surprises you about the new requirement for placebo trials?
The policy does not mention that this will only be for infectious disease vaccines. Currently, there are many examples of vaccines for chronic diseases, such as cancer.
When cancer drugs are tested in trials, half the population receives the standard of care and the other half receives the other drug on top of the standard of care.
You don’t give a placebo to a cancer patient. That’s unethical.
This story is republished courtesy of Northeastern Global News news.northeastern.edu.
Citation:
US government to require placebo testing of all new vaccines: How will it affect updated COVID shots? (2025, May 2)
retrieved 2 May 2025
from https://medicalxpress.com/news/2025-05-require-placebo-vaccines-affect-covid.html
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no
part may be reproduced without the written permission. The content is provided for information purposes only.
The U.S. Health and Human Services Department says it will require placebo testing of “all new vaccines,” raising questions about the rollout of updated COVID-19 vaccines and other vaccines.
In a statement to the Washington Post, the agency headed by Robert F. Kennedy Jr. called the new requirement “a radical departure from past practices.”
Northeastern Global News talked to Mansoor Amiji, university distinguished professor of pharmaceutical sciences, about what the shift in vaccine policy could mean for people who want to be vaccinated against the most recent variants of COVID-19 and other diseases.
Amiji also spoke about the promise of the administration’s push for a universal vaccine for influenza and COVID.
What is a placebo trial and could the new requirement slow down the rollout of new vaccines?
What the HHS is now saying is that any time a new vaccine needs to be approved, or even different versions of an existing vaccine, we need to do a placebo-controlled trial.
What that means is, we have to generate data from trials where half of the individuals receive a saline solution—the placebo—and the other half receive the actual vaccine.
The goal is to make the safest vaccines possible. They are given to healthy people, so the margin for any kind of toxicity is very, very low.
But placebo trials can last for months or years.
When you’re making modifications, such as when you are only changing the mRNA sequence in the updated COVID-19 vaccine, we don’t need to accommodate that level of study because the safety has already been established.
Annual COVID-19 shots have been treated like a booster for influenza, not like a new vaccine. Will the updated versions be treated like a new vaccine under the new requirement?
Yes, that’s the argument HHS is making.
My concern is that we will not have vaccines available for the population of the U.S. in a timely manner if we have to go back and redo these studies for products that are already approved for safety and efficacy.
So, when the fall comes and health care providers, such as pharmacists, have to dispense and administer vaccines, there will be questioning. What are we supposed to do? Are we supposed to rely on whatever is in the marketplace that is already approved but may not be as effective?
The trials are important when you are first introducing the product. But when you are modifying the product to have to go ahead and do safety and efficacy trials—which are expensive—again and again doesn’t really help us.
I think it’s going to deter a lot of companies from investing in vaccine research and development.
What happened to the anticipated April approval of the Novovax vaccine, the only non-mRNA vaccine available to protect against coronavirus? It was already approved on an emergency-use basis.
The Novovax officials submitted their documentation to the FDA, and now the FDA is saying, “We can’t approve it because of this new policy from HHS that requires you to go back and do a full-fledged clinical trial’ with a placebo comparison.”
Why are we changing the rules of the game while we’re playing the game?
The FDA commissioner said that HHS Secretary Kennedy is not anti-vaccine, that he is actually pro-safety and pro-reproducibility.
However, this policy will have a drastic effect on public health. The Novovax officials submitted their documentation to the FDA, and now the FDA is saying, “We can’t approve it because of this new policy from HHS that requires you to go back and do a full-fledged clinical trial.”
It still doesn’t help us in terms of getting the vaccine into the marketplace.
Would the requirement for placebo trials impact already existing childhood vaccines such as those for measles, mumps and rubella?
It doesn’t affect vaccines that are currently on the market.
I think a question comes in if you are coming up with a new version of an existing vaccine—how will the FDA review that? Will it require compliance with the new requirement for approval?
The HHS and the National Institutes of Health announced plans to develop a universal vaccine platform for influenza and coronavirus vaccines. How would it work and what would it do?
I personally like the idea of a universal vaccine. I think the research is driving toward that.
The idea of a universal vaccine, or what is called a gold standard vaccine, is to generate one vaccine against the flu or COVID-19 and not have to change the vaccine formula on a yearly basis to adjust for different strains.
I think universal vaccines are important, but they’ll take at least several years before they can be marketed.
For individuals, especially those in the high risk group, who want to get vaccinated for the fall, we have to rely on what’s available.
With COVID, you are still dealing with an infection that continues to be prevalent.
You cannot say that a vaccine that is modified and updated needs to go back and be evaluated in a full-fledged placebo control trial because that is a time-consuming exercise.
Will the new requirement boost or deter confidence in vaccination?
If people are concerned about the safety of a vaccine, the placebo-controlled trials and the time they will take and the data they will generate may boost their confidence.
The downside is that the product will not be available until those studies are complete. We are going to see numbers of infected individuals increase when the product is still in clinical trials.
What surprises you about the new requirement for placebo trials?
The policy does not mention that this will only be for infectious disease vaccines. Currently, there are many examples of vaccines for chronic diseases, such as cancer.
When cancer drugs are tested in trials, half the population receives the standard of care and the other half receives the other drug on top of the standard of care.
You don’t give a placebo to a cancer patient. That’s unethical.
This story is republished courtesy of Northeastern Global News news.northeastern.edu.
Citation:
US government to require placebo testing of all new vaccines: How will it affect updated COVID shots? (2025, May 2)
retrieved 2 May 2025
from https://medicalxpress.com/news/2025-05-require-placebo-vaccines-affect-covid.html
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no
part may be reproduced without the written permission. The content is provided for information purposes only.
