No Rx Required for COVID-19 Vaccination But ACIP Calls for Better Informed Consent Process

On September 19, 2025, the Advisory Committee on Immunization Practices tied in a vote to recommend a prescription be required for a COVID-19 vaccine. Committee Chair Martin Kulldorff, PhD, broke the tie, defeating that proposal. This image was taken from the webcast of the meeting.

COVID-19 vaccines will remain available without a physician’s prescription, according to the Advisory Committee on Immunization Practices (ACIP).

However, patients need more warnings about unintended health effects caused by the shots. Doctors and the U.S. Centers for Disease Control and Prevention (CDC) also need to improve the process of developing informed consent of patients, according to ACIP.

Health and illness, the financial costs, and vaccine availability dominated staff presentations and ACIP member discussion Sept. 19, the second day of ACIP’s two-day review of inoculations for people of all ages.

A work group proposed ACIP recommend that COVID-19 shots be available by prescription only. The committee split 6-6 in their vote on that, so Chair Martin Kulldorff, PhD, split the tie with a “no” vote. “Since it’s a tie, the chair breaks it. I voted no, so the motion has failed,” he said.

Advocates for the prescription noted the seriousness of potential adverse effects from the shot — severe enough that physicians should engage patients with enough information to make an informed choice about benefits and risks. Those against it argued it would effectively limit access to shots by making it more difficult for pharmacists to administer the shots at a time when patients have a difficult time accessing doctors.

Voting favor of prescriptions were: Kirk Milhoan, MD, PhD; Robert Malone, MD, MS; Vicky Pebsworth, OP, PhD, RN; Retsef Levi, PhD; Evelyn Griffin, MD; and James V. Pagano, MD.

Voting against it were Kulldorff; Cody H. Meissner, MD; Raymond Pollak, MD, FACS, FRCS; Catherine Stein, PhD; Hillary Blackburn, PharmD, MBA; and Joseph Hibbeln, MD, ABNP, CAPT USPHS (Ret.).

The committee was unanimous in three other votes on its recommendations for COVID-19 shots. They approved:

• Vote No. 4

The pediatric and adult immunization schedules for administration of FDA-approved COVID-19 vaccines should be updated as follows:

• Adults 65 and older: Vaccination based on individual-based decision-making, also known as shared clinical decision making
• Individual 6 months to 64 years: Vaccination based on individual-based decision making — with an emphasis that the risk-benefit of vaccination is most favorable for individual who are at increased risk for severe COVID-19 disease and lowest for individuals who are not at an increased risk, according to the CDC list of COVID-19 risk factors.

While that was labeled Vote No. 4, that was the first proposal the committee actually voted on during the meeting. The prescription requirement suggestion was labeled as Vote No. 2.

• Vote No. 1

It is a sense of the committee that the CDC engages in an effort to promote more consistent and comprehensive informed consent processes, and as part of that considers adding language accessible to patients and medical providers to describe at least the six risks and uncertainties included in the work group chair presentation.

• Vote No. 3

It is the sense of the committee that in conversations with patients before COVID-19 vaccinations, authorized health care providers discuss the risks and benefits of the vaccination for the individual patient. The discussion should consider known risk factors for severe outcomes from COVID-19, such as age prior infections, immunosuppression and certain comorbidities identified by the CDC, and include a discussion of the potential benefits and risks of vaccination and related uncertainties, especially those outlined in the vaccine information statement as part of informed consent.

Key Takeaways

• COVID-19 vaccines will remain available without a prescription, as the ACIP voted against requiring prescriptions due to access concerns.
• The ACIP highlighted the need for improved informed consent processes, emphasizing patient education on vaccine risks and benefits.
• Updated immunization schedules recommend vaccination based on individual decision-making, especially for those at higher risk of severe COVID-19.
• Healthcare providers should discuss risks and benefits with patients before COVID-19 vaccination, considering individual risk factors and uncertainties.