Expert: FDA Regulatory Process for COVID-19 Vaccines, Children’s Vaccines

When Pfizer and Merck & Co. Inc. Seeking permission from the U.S. Food and Drug Administration for emergency use authorization for COVID-19 pills, an expert at Purdue University can give context on the regulatory process. He can also talk about the next steps that must be taken for the FDA to fully approve Pfizer’s vaccine for children ages 5-11.

specialize: Aaron Lottes has worked with the FDA on the approval of drug-device combination products for 13 years. Now, as an associate professor of engineering practice at Purdue’s Weldon School of Biomedical Engineering, he continues to work with FDA and industry experts to train the next generation of biomedical engineers and regulatory leaders.

In addition to the Q&A below, a video featuring Lottes comments on the FDA’s regulatory process for COVID-19 drugs and vaccines was uploaded to the AP Video Hub. All videos in the Campus Insights series are free for all AP members to download and use and can be found at or by performing a general search on Associated Press or AP Newsroom. AP members can use the video or to get a citation for a printed article.

Q: What does it mean for the FDA to allow emergency use of pills versus vaccines?

ONE: The FDA’s process for authorizing emergency drug use is actually very similar to the one that vaccines go through. When it’s available, like any other medicine, your doctor will send a prescription to the pharmacy and you’ll go get it.

Just like vaccines, there is likely to be a phased approach, where treatment could be given to more severe patients first and then extended to less severe patients. . This reflects how clinical studies are conducted and is supported by available data. Both Merck (molnupiravir) and Pfizer (Paxlovid) were initially studied in patients with COVID-19 who were at high risk of developing severe illness or being hospitalized. Newer studies are currently looking at the use of these drugs in standard-risk patients and as a prophylactic treatment to prevent the spread of COVID-19 after exposure.

Q: What are some challenges Pfizer or Merck may face when getting FDA authorization for their drug’s emergency use?

ONE: FDA will rigorously review the scientific integrity of study results to determine if available data demonstrate that known and potential benefits outweigh the risks. The number of patients with initial results from these clinical trials was lower than in vaccine studies — about 750 patients — but the results for safety and effectiveness were very high. Adverse event rates were comparable or lower in the treatment group than in the placebo group, and the risk of hospitalization or death was reduced by 50% for Merck and 89% for Pfizer. The effectiveness rate was so good that additional enrollment in the Pfizer study was stopped early to allow the study to be completed more quickly.

Moving from emergency use authorization to full approval would be a similar route to a vaccine. Authorization may be granted initially based on a small group of patients with limited follow-up, and then, once full study results are available, a request for approval may be submitted. In addition, when results are available in lower-risk patients, as well as prophylactic outcomes, indications and uses may be expanded. The FDA is working to effectively review the available information and an external advisory board meeting on the drug Merck has been scheduled for November 30.

It is also important to note that these are not entirely new drugs that have just been developed – they have been considered for antiviral use for other diseases such as SARS and MERS. But those diseases go away pretty quickly, so the impetus to develop more of these antiviral drugs also disappears and they are halted.

Q: Is there a difference in the way the FDA authorizes the emergency use of Pfizer’s vaccine for children 5-11 years of age versus the vaccine for adults and adolescents?

ONE: This is the same as the emergency use authorization process for vaccines in adults and adolescents. FDA has reviewed the available safety and efficacy data and determined that there is sufficient evidence to support authorization for emergency use. This is based on results from about 2,000 children showing that the vaccine is 90.7% effective in preventing COVID-19 and data from about 3,000 children showing no serious side effects. which is detected.

Q: What more will the FDA need from Pfizer to fully approve the vaccine for 5-11 year olds?

ONE: Approximately 4,500 children were enrolled in this study, including children under 5 years of age. Collecting initial results and long-term follow-up for all of these patients is the necessary first step toward getting closer to FDA approval. Data from post-marketing safety surveillance for adverse events, including myocarditis and pericarditis, may also help support future approval.

Contact via media: Kayla Wiles, 765-494-2432,

Source: Aaron Lottes, 765-496-6024,

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