US Health Department mandates placebo trials for all new vaccines
What's the story
The US Department of Health and Human Services (HHS) has announced that all new vaccines will now be tested in placebo-controlled trials before being approved for public use.
Placebo testing is a method in which some people receive the vaccine and others receive an inert or 'dummy' substance before the outcomes are compared.
The policy shift—which HHS describes as "a radical departure from past practices"—is likely to have a major impact on the approval of updated COVID-19 boosters.
Impact
New policy impacts COVID-19 vaccine approvals
This new requirement could delay approval and availability of updated COVID-19 boosters by months.
The existing system allows new versions of these vaccines to be approved every year, similar to flu vaccines, and better targets circulating strains of the virus.
However, experts warn requiring placebo-controlled trials before clearing new versions would significantly slow down this process.
Concerns
Experts express concerns over new vaccine testing requirement
Dr. Paul Offit, a vaccine scientist at the Children's Hospital of Philadelphia, voiced his worries about the effects of this new mandate on the most vulnerable.
He emphasized that vaccinating every year with circulating strains leads to better antibody responses and protection from mild to moderate disease for four to six months.
This is especially important for older adults aged 75 and above.
Clarification
HHS clarifies new guidance applies to updated COVID-19 vaccines
The administration did not specify for which vaccines the testing would apply or how the change would be carried out.
But an HHS official told CNN that the new guidance applies to the updated COVID-19 vaccines too.
These are the ones developed by Pfizer and Moderna, which are "new" and need to meet much stricter scientific standards for public safety and efficacy.
Improvement
HHS aims to improve vaccine safety monitoring systems
HHS has vowed to improve existing systems of monitoring vaccine safety, which it claims fail to capture vaccine injuries.
The department said these systems have "become templates of regulatory malpractice."
In a separate report, the WSJ stated that the US is investing $500 million in a project, with the goal of making "universal" vaccines that protect against numerous viral strains simultaneously.
The project involves producing vaccinations from chemically inactivated whole viruses, similar to how flu vaccines were produced years ago.