Story at a glance
- The Associated Press reports that the FDA added new safety guidelines pharmaceutical companies must meet before their vaccine candidates will be eligible for emergency authorization.
- This is the latest chapter in a saga of tension between the White House and public health agencies.
The U.S. Food and Drug Administration (FDA) rolled out new safety standards for vaccine manufacturers developing a treatment for COVID-19.
The Associated Press reports that these guidelines were released after the White House blocked their formal release, another instance of tension between the Trump administration and public health officials.
In the documents posted on the FDA’s website, the agency said vaccine makers must monitor trial participants for at least two months to control for any safety issues or side effects caused by a vaccine candidate prior to applying for emergency use authorizations before Nov. 3.
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A senior Trump administration official told AP reporters that the White House had halted the release of the FDA plans to publish the safety guidelines due to a lack of “clinical or medical reason” for the two-month safety rule to be posted.
The FDA included the guideline in documents published ahead of an Oct. 22 meeting with its independent Vaccines and Related Biological Products Advisory Committee that specifically focuses on the development and authorization of a COVID-19 treatment.
The two-month guideline is contained within other requirements for a coronavirus vaccine that include quality control measures and clinical data that support a vaccine’s efficacy and safety.
Per FDA regulations, phase three trials for vaccines will include a focus on adverse side effects, and supporting data will include “median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile.”
Some of the outcomes to monitor include severe cases among study subjects, adverse reactions and protective immune responses to the vaccine.
For any vaccine candidate to qualify for emergency use authorization and be ready for market distribution, the FDA requires “adequate manufacturing information to ensure its quality and consistency and a determination by FDA that the vaccine’s benefits outweigh its risks based on data from at least one well-designed Phase 3 clinical trial that demonstrates the vaccine’s safety and efficacy in a clear and compelling manner,” per the briefing documents.
If the vaccine does not have follow-up data encompassing at least two months, it is not eligible for emergency use authorization approval.
An FDA spokesperson told the AP that the vaccine guidelines are still pending review, but noted that “the FDA has already communicated with individual manufacturers about its expectations.”
The timeline for a safe and effective vaccine has been hotly contested, with pharmaceutical executives and public health officials mainly saying a widespread vaccine will be ready for mass public distribution around the spring of 2021. The earliest available doses of a vaccine will be distributed among front-line workers and first responders.
Alternatively, President Trump has repeatedly stated that a vaccine could be authorized prior to Election Day in November.
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