Alphabet soup spells doom for additional dose of vaccine, for now

Posted at 5:55 PM, Sep 27, 2021
and last updated 2021-09-27 19:13:37-04

In August, President Joe Biden announced COVID-19 booster shots would be available for all Americans on Sept. 20.

One week later, the only FDA-approved booster shot -- PfizerNBioTech -- is only available to a certain segment of the population.

So what went wrong?

To grasp that, it would help to understand which federal health-related organizations are responsible for what.

Federal health entities in the United States are an alphabet soup of acronyms, pretty much like any other federal organization.

The Centers for Disease Control (CDC), the Food & Drug Administration (FDA) and the National Institute of Health (NIH) all are federal entities charged with public health. The NIH largely handles medical research at the federal level. The CDC detects emerging illnesses and toxins. The FDA verifies the safety of any drugs and/or vaccines developed in response to those illnesses.

All three are massive groups with many subdivisions. For example, Dr. Anthony Fauci, who has been a visible part of the COVID-19 response in the U.S., is the director of the National Institute of Allergy and Infectious Diseases -- a division of the NIH -- which conducted studies on the effectiveness of COVID-19 therapies, and of an additional dose of vaccine in multiple risk groups.

It can serve in an advisory capacity, but doesn't have the regulatory power the CDC and FDA have. And while the CDC has domain over controlling infectious disease, it has no say in the drug-approval process. It can only make recommendations.

Dr. Anthony Fauci
Director of the National Institute of Allergy and Infectious Diseases Dr. Anthony Fauci testifies before a House Committee on Energy and Commerce on the Trump administration's response to the COVID-19 pandemic on Capitol Hill in Washington on Tuesday, June 23, 2020. (Kevin Dietsch/Pool via AP)

Only the FDA can approve medicines and vaccines for legal use in the United States, such as injections against COVID-19.

That leads us to the additional/booster shot.

Biden unveiled his plan Sept. 9, in which all Americans would have the opportunity to receive a third, or additional, shot by Sept. 20. The booster shot was made available to immunocompromised patients in August. Pfizer was the only company far enough in the clinical-trial and data-submission process to reach that goal.

However, early in the day Sept. 15, it faced a setback. An FDA-assembled panel of outside experts said the clinical-trial statistics Pfizer presented did not contain enough data available for the panel to be able to make a fully informed decision. It rejected recommending the supplemental vaccine by a vote of 16-2.

Later that day, however, it softened its stance, recommending boosters be made available to people 65 years old and older.

Virus Outbreak Pfizer Vaccine Effectiveness
FILE - In this Thursday, Feb. 18, 2021 file photo, a pharmacist prepares a syringe with Pfizer’s vaccine at a COVID-19 vaccination site in New York (AP Photo/Mary Altaffer)

On Thursday, the FDA granted emergency-use authorization for a third dose to those seniors; seniors in long-term facilities; adults at high risk of severe COVID-19; and people who work in settings where they can easily contract the novel coronavirus. The CDC's Advisory Committee on Immunization Practices (ACIP) also recommended the booster that day, but not for frontline workers.

Friday, CDC Director Dr. Rochelle Walensky set aside that recommendation and aligned her organization's advice with the FDA's lead.

With the various health entities and panels in disagreement about whether healthy people need additional doses, it could be a while before they are largely available, not to mention that Moderna and Johnson & Johnson still are in the clinical data phase of the process.