Why it’s time to fully approve the COVID vaccines

By: Salvatore J. Giorgianni, Jr., PharmD, Sr. Science Advisor, Men’s Health Network and Jean Bonhomme, MD, MPH, Founder, National Black Men’s Health Network

Op-ed views and opinions expressed are solely those of the author.

COVID’s Delta variant is surging and so is interest in getting vaccinated among those who have not thus far. But faith in the vaccines still lags in this critical moment. Men’s Health Network and the National Black Men’s Health Network urge the FDA, and the Biden Administration, to provide current COVID-19 vaccines full regulatory approval within the next 90 days. This approval would increase Americans’ confidence that the vaccines are safe and effective, and go a long way toward stabilizing the administration’s COVID messaging.

The Emergency Use Authorization (EUA) process that was essential in getting COVID-19 vaccines out to the general public was an important first step in getting this life-saving biologic into the arms of people in the US. The EUA has served its purpose for the three currently available vaccines from Pfizer, Moderna, and Johnson & Johnson; but at this stage EUA status for these products is outdated and has outlasted its usefulness. In fact, it is now perceived as an impediment by some as it undermines faith in the vaccines.

The U.S. Food and Drug Administration (FDA) must now move on to quickly grant full approval of the Biologic License Applications (BLAs) as a fundamentally important next step in addressing vaccine hesitancy and protection of public health. After over 340 million doses of these vaccines in the U.S. and almost 3.5 billion doses worldwide, and the unprecedented level of scrutiny, there should be no doubt that these vaccines meet any reasonable standard of effectiveness and safety needed for full market approval.

There may be some technical issues related to labeling, storage and shelf-life and most certainly there are questions about the length of their ability to adequately protect from COVID-19 but these must not be allowed to impede application progress to full approval.

There are already several accepted and widely used mechanisms in the regulatory process, such as post-marketing surveillance, on-going storage studies, and label reviews that have been used to bring important products to full market approval.

Given the laudable cooperation between developers and regulators that rapidly brought these products under the infrequently used EUA process to people, it is incongruous that moving to full approval is not proceeding with the same sense of urgency and speed. The current “business-as-usual” pace which has slowed advancement for full approvals is costing more lives every day.

There are several important reasons to have these life-saving vaccines fully approved sooner rather than later. Most important of these is that full approval would remove the objection echoed by many who are hesitant to be vaccinated because they are experimental. For some this is a real lingering concern, for others it is simply a false objection, but either way it is an impediment to reaching critical levels of immunization now and should additional vaccinations be needed in the future.It will provide a layer of confidence for businesses that are considering vaccination requirements for employees and customers.

This full approval also opens the way for commercial entities to communicate about these vaccines. Current campaigns and approaches have done much good but obviously have not effectively motivated all who need to be persuaded. Harnessing the health communications skills of all stakeholders would add new and hopefully incrementally effective approaches to reach those who are still on the fence.

Scientists in the Biden Administration have every right to be concerned about the rising number of COVID-19 cases, low vaccination rates, and the very real potential for a more dangerous variant to take hold and once again devastate our country and the world.

We encourage regulators and the Biden Administration to take a close look at what is holding up full BLA approval and use appropriate approaches to address them now with the same urgency that was used in early 2020 to get these important products into the arms of people.

Dr. Salvatore J. Giorgianni

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