J&J Vaccine Decision is a (Small) Step in the Right Direction

April 23, 2021
By Naomi Lopez

A CDC advisory panel’s decision this afternoon to recommend lifting a pause on Johnson & Johnson’s COVID-19 vaccine is a welcome step in our efforts to fight rising case numbers in many parts of the country—but government overcaution and risk aversion has already hurt our nation’s dual goals of public health and economic recovery.

Last week, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) jointly announced a recommended pause in administering the Johnson & Johnson “one and done” COVID-19 vaccine due to a concern over a rare, but severe blood clot that had been reported in six patients at that time with one reported death. Today, the committee re-affirmed its recommendation for this vaccine persons age 18 years of age and older under the FDA’s Emergency Use Authorization (EUA).

Even if one agrees that the initial pause was justified to gather more information and share information with frontline workers and individuals seeking the vaccine, it’s evident that the CDC panel’s punting on making a decision on the J&J vaccine last week contributed to vaccine hesitancy among many Americans. Fortunately, when the panel met again today, it decided to reaffirm the recommendations for use of the vaccine.

This is welcome news that follows on the heels of Europe’s decision to resume the vaccine. Earlier this week, the European Medicines Agency lifted their pause on the vaccine while concluding that there is a possible link between the Johnson & Johnson vaccine and the rare but serious blood clots, and that the benefits of the vaccine are greater than the associated risks.

It’s a particularly positive development in the effort to get vaccines to some of America’s most vulnerable populations. The Johnson & Johnson vaccine is being more prevalently used for harder to reach those experiencing homelessness, homebound populations, incarcerated individuals, migrant/seasonal populations, and rural populations where the ease of logistics of this vaccine, which is a single dose and does not require ultra-cold refrigeration.

As we continue to battle COVID, healthcare workers on the front lines should have the fullest range of options and flexibility as possible to care for patients. This can and should occur, while regulators should continue to:

• share clear and concise information about the risks, especially to women age 50 and under who may be more susceptible to this rare but serious clotting issue;
• ensure clear information is shared with healthcare providers about identifying, diagnosing, and treating this rare blood clot should it arise; and
• mount a robust and continued effort to increase public awareness about both the risks and benefits of vaccination, adverse event treatment guidance, and continued surveillance and monitoring about COVID-19 vaccines.

Evaluating the safety and risks of treatments is important, but no treatment is without risk, and that there is risk involved in a treatment is not a reason for government to deny or discourage a treatment. This is especially true when, at this point in time, the benefits outweigh the risks for both public health and individual health considerations.

Healthcare providers and patients should be made aware of the risks of the vaccine, but the decision to use it need not be a top-down decision from Washington. Sharing of the known information with healthcare providers so that they, in consultation with the vaccine recipients, should guide the best course of action for their patients’ particular situations and unique sets of circumstances. While the committee’s recommendation today is not binding and is still subject to the director’s approval, today’s recommendation in an important reminder that federal bureaucrats should share information about potential and serious risks, but that they should not stand in the way of treatments that may be important to individuals and communities.

Naomi Lopez is the Director of Healthcare Policy at the Goldwater Institute.